News

We are excited to invite to a further engaging panel discussion focused on the critical topic of financing models in biotechnology companies. Join us as we explore the various funding strategies that drive innovation and growth in this dynamic industry.

Diskussionsrunde beim der Talk im Cube Veranstaltungsreihe

Financing Models for Biotechs
A Panel Discussion 

• Biotech financing options
• Financing trends for biotechnology in Europe
• Essential factors to find a successful funding strategy.

With
Cornelia Jahnel, Managing General Partner, GOLDTRACK Ventures GmbH, Leipzig
Hannah-Sophie Braun, Investment Manager, Investitionsbank Berlin
Robert Schwanke, Berliner Sparkasse, FirmenCenter Gründungen, Startups und Nachfolge
Moderation: Dr. Merle Fuchs, Project Leader, Business Development, Financing, Pramomolecular GmbH, Berlin-Buch

Our esteemed panel of experts will share their insights on traditional and emerging financing options, including venture capital, public funding, and alternative investment strategies. This is an ideal opportunity to gain valuable knowledge, ask questions, and to network with industry professionals.

Whether you are a seasoned investor, a biotech entrepreneur, or simply interested in the future of biotechnology, this discussion promises to provide valuable perspectives and foster meaningful conversations. The talk will be followed by a networking event where you can socialize over snacks and drinks. Don’t miss out on this valuable event!

Further topics planned for 2025 

• International cooperation and founding programs in Life Sciences
•  Team 4.0 - Networked working in biotechnology
• Life Science Marketing: A potential way of scientist to promote their products
  CROs in diagnostics and therapeutics development
• …

About "Talk in the Cube" 
With the event series "Talk in the Cube", we bring business and science together on the Berlin-Buch campus and connect founders of start-ups or life science companies with scientists, e.g. from the Max Delbrück Center, FMP, Charité and BIH. We invite experts on business topics or trends in the life sciences and highlight aspects such as

• What innovations are there in the start-ups and who is driving them forward?
•  How does the life science business world work and where can synergies with science be created?
• How does the "networked laboratory" work and how do you live "sustainability in the laboratory"?

Target audience:
Founders & scientists from start-ups, small and medium-sized life science companies and scientific institutions. 

Costs:
Participation is free of charge. Registration is requested. 

Further information: 
Uwe Lohmeier per E-Mail: u.lohmeier@campusberlinbuch.de 

Veranstaltungsort:

BerlinBioCube (Building D95), Campus Berlin-Buch, Robert-Rössle-Straße 10, 13125 Berlin 

Quelle: Gläsernes Labor Akademie
Talk im Cube: Financing Models for Biotechs

Three researchers at Max Delbrück Center – Sofia Forslund, Friedemann Paul, and Nikolaus Rajewsky – are among the most Highly Cited Researchers in the world in 2024, making the list two years in a row. Germany ranks fourth of countries and regions, behind the U.S., mainland China and the U.K.

Sofia Forslund, Friedemann Paul and Nikolaus Rajewsky are considered among the top 1% in their fields for publishing highly influential studies that have gone on to be cited, or referenced, by many other scientists.

They are included in Clarivate’s Highly Cited Researchers 2024 list, which aims to highlight researchers who are having an outsized impact on their fields and extending the frontiers of knowledge. All three made the 2023 list as well.

Clarivate produces the list annually, based on an extensive analysis of scientific publishing data on Web of Science. Each researcher included has multiple papers ranked in the top 1% by citations for their field(s) and publication year over the past decade. Approximately one in a thousand researchers makes it onto this prestigious list.

This year, 6,636 individual researchers have been named Highly Cited Researchers. Germany ranks fourth of countries and regions with 332 highly cited researchers, behind the U.S., mainland China and the U.K.

About our researchers

Professor Sofia Forslund heads a research group at the Experimental and Clinical Research Center (ECRC), a joint institution of Charité – Universitätsmedizin Berlin and the Max Delbrück Center. The data-driven models developed by the biochemist and bioinformatician illustrate how we and our gut microbiome develop together toward health or disease.

• W3 Professorship for Sofia Forslund
• Sofia Forslund's profile

Forslund Lab

Host-microbiome factors in cardiovascular disease

Professor Friedemann Paul is Director of the ECRC. As a neuroimmunologist, he and his team focus on enhancing therapeutics and diagnostics for diseases such as Multiple Sclerosis. Additionally, they coordinate an international consortium researching inflammatory processes preceding organ malfunction or damage.

• Understanding the transition to disease
• Low levels of a simple sugar – a new biomarker for severe MS?

Paul Lab

Clinical Neuroimmunology

Professor Nikolaus Rajewsky is Director of the Berlin Institute for Medical Systems Biology at the Max Delbrück Center (MDC-BIMSB) and head of the Systems Biology of Gene Regulatory Elements lab. His lab studies how RNA regulates gene expression in health and disease, to identify diseases as early as possible, intervening before cellular dysfunctions cause harm. 

• Nikolaus Rajewsky's profile
• 3D maps of diseased tissues at subcellular precision

N. Rajewsky Lab

Systems Biology of Gene Regulatory Elements

Further information

• Highly Cited Researchers 2024 list (EN)
• Analysis (EN)

Berlin and Würzburg, Germany, October 29, 2024 – The National Cancer Institute (NCI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), two highly respected research organizations belonging to the US government's National Institutes of Health (NIH), have started a clinical trial involving 77 patients to see if Pentixapharm’s new radioactive tracer PentixaFor ([68Ga]Ga-PentixaFor) can make it easier to identify functional adrenal tumors through positron emission tomography (PET) scans.

The FDA-endorsed and US-located investigator-initiated phase II study, conducted by Dr. Liza Lindenberg and Prof. Dr. Peter Choyke (Clinical Trial number: NCT06246357) investigates the performance of PentixaFor in subtyping hormone-secreting adenomas in people suffering from primary aldosteronism (PA) or hypercortisolism (Cushing´s syndrome). The first patient was recently examined.

Primary aldosteronism is among the most common causes of secondary hypertension, a disorder affecting tens of millions of people in the United States alone. In some subtypes PA can be cured completely through a short surgical intervention, so finding a reliable tool for accurate subtyping is important and potentially beneficial to a large segment of the population. In contrast, Cushing's syndrome, also described as hypercortisolism, is a rare endocrine disorder designated as an orphan disease that is caused by chronic exposure of the body's tissues to excess levels of cortisol.

Pentixapharm itself is currently preparing a US-centric Phase III pivotal study to obtain marketing authorization for PentixaFor in PA. The work of the NCI/NIDDK will add to the global clinical evidence about the compound and make it easier to compile the necessary data.

“We are pleased that the NIH investigate the clinical value of PentixaFor at its own initiative and see this as a token of confidence in the potential of CXCR4 targeting imaging in unexplored indications expanding market opportunities for PET/CT diagnostics. In our opinion, PentixaFor has broad potential as a novel imaging modality for adrenal diseases and could be particularly helpful for individuals grappling with primary aldosteronism-induced resistant hypertension or Cushing’s disease,” stated Dr. Dirk Pleimes, Chief Medical Officer at Pentixapharm. 

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

PentixaFor (Gallium (68Ga) boclatixafortide) is an innovative PET tracer that specifically targets the chemokine-4 receptor (CXCR4), with broad applications in oncological, cardiovascular, and inflammatory diseases. Particularly in hypertension, PentixaFor has the potential to significantly improve patient management by identifying the presence of hormone-secreting adenomas through non-invasive and broadly available PET/CT imaging.

Apart from PentixaFor, the clinical pipeline also encompasses PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL). Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Recently, the EMA granted PRIME status to PentixaFor in the indication PA.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

Berlin, Germany and Sydney, Australia - 08. October 2024  - Eckert & Ziegler (ISIN DE0005659700, SDAX) and GlyTherix Ltd (GlyTherix), an Australian targeted radiotherapy company specialising in developing antibody radiopharmaceuticals for solid tumors, today announced a new global clinical supply agreement. Eckert & Ziegler will provide its GMP grade non-carrier added Lutetium-177 chloride (n.c.a. Lu-177) for use in GlyTherix's clinical trials focused on innovative treatments for aggressive and invasive cancers.

GlyTherix's radiotherapy approach combines Lu-177 with an antibody targeting Glypican-1, a protein found in aggressive cancers, to deliver localized radiation while sparing healthy tissue. Glypican-1 is an attractive tumor target that occurs in several aggressive and invasive cancers including prostate, pancreatic, bladder, lung, glioblastoma and ovarian cancer. GlyTherix plans to use 177Lu-DOTA-Miltuximab® in its planned Australian Phase Ib in early 2025, followed by US Phase II trials in 2026.

Dr. Harald Hasselmann, CEO of Eckert & Ziegler, commented, “We are happy to collaborate with GlyTherix in their mission to develop cutting-edge radiopharmaceuticals. Contributing to the success of such innovative treatments in clinical trials and beyond with our high-quality radioisotopes including Lutetium-177 is our distinct goal.”

Dr. Brad Walsh, GlyTherix Chief Executive Officer said, “We are very pleased to partner with Eckert & Ziegler to provide patients with innovative targeted radiotherapy treatments. As GlyTherix advances its clinical trials using the medical radioisotope Lu-177, it is building a global supplier network with proximity to major global markets, capable of consistently delivering high-quality radioisotopes to patients. This agreement with Eckert & Ziegler strengthens our global clinical supply network and underscores our commitment to enhancing our global radiopharmaceutical manufacturing capabilities to meet increase demand”.

About Eckert & Ziegler
Eckert & Ziegler SE, with more than 1,000 employees, is a leading specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

About GlyTherix
GlyTherix Ltd is an Australian targeted radiotherapy company specializing in developing antibody radiopharmaceuticals for solid tumours. Miltuximab® specifically targets Glypican-1, a protein found in solid tumours such as prostate, bladder, pancreatic, glioblastoma, oesophageal and ovarian cancers, and is not present in healthy tissue. The company has a strong proprietary and Intellectual Property position covering both Miltuximab® and the antigen Glypican-1. This provides robust and long-term protection for the commercialization of important new treatments to people with little hope.
GlyTherix has completed a ‘First-in-Human’ trial of 12 patients using Miltuximab® with no drug-related adverse. Miltuximab® will be used in a Phase Ib trial as an antibody theranostic. GlyTherix is interested in partnerships or collaborations with larger biotech and pharmaceutical partners.

Berlin, 2 October 2024.

Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) announces that the spin-off resolution approved at the Annual General Meeting on 26 June 2024 was entered in the commercial register of the Charlottenburg (Berlin) District Court today. With the entry in the commercial register of Eckert & Ziegler SE, the spin-off of Pentixapharm AG became legally effective. All shares in Pentixapharm AG held by Eckert & Ziegler have thus been legally transferred from Eckert & Ziegler SE to Pentixapharm Holding AG.

In compensation, the shareholders of Eckert & Ziegler SE will receive Pentixapharm Holding AG shares at a ratio of 1:1. The number of Eckert & Ziegler shares held by each Eckert & Ziegler shareholder after the close of trading today, taking into account any outstanding stock market transactions, will determine their entitlement. All Pentixapharm Holding AG shares created as part of the spin-off are expected to be admitted to the Regulated Market of the Frankfurt Stock Exchange in the Prime Standard segment on 2 October 2024.

Initial trading of the Pentixapharm Holding AG shares is scheduled for 3 October 2024. On the same day, the listing of the Eckert & Ziegler SE shares ‘ex spin-off’ is planned. The deposit-side posting of the Pentixapharm Holding shares to the securities accounts of Eckert & Ziegler shareholders is expected to take place on 7 October 2024.

Further information on the IPO of Pentixapharm AG can be found here: www.pentixapharm.com

About Eckert & Ziegler.
Eckert & Ziegler SE with more than 1.000 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

Interim data confirms OMT-28's strong safety profile in PMD patients, top-line data expected mid-2025

Today OMEICOS announced the completion of enrollment in its multi-center, open-label Phase 2a PMD-OPTION study of OMT-28 in Primary Mitochondrial Disease (PMD) patients suffering from myopathy and cardiomyopathy. Top-line data are expected to become available by mid- 2025.

“Initial data analysis confirms the strong safety profile and very good tolerability of OMT-28 in the target population. Furthermore, the clinical data obtained so far looks promising for relevant endpoints, which bodes well for our goal to provide a much-needed new treatment option for patients underserved by current therapies” said Robert Fischer.

The primary endpoints of the PMD-OPTION study are safety and tolerability of OMT-28 and the response rate of patients showing a reduction of Growth differentiation factor 15 (GDF-15) levels by at least 20% compared to baseline. GDF-15, which is produced in response to mitochondrial stress, inflammation or hypoxia, is emerging as a strong risk predictor in many diseases including cardiometabolic and PMD. The study also evaluates a range of secondary and exploratory endpoints to determine the effect of OMT-28 on relevant clinical symptoms, standard functional parameters of physical strength, heart function, quality of life, and key metabolic biomarkers.

PMD patients suffer from debilitating and life-threatening health consequences, such as severely limited physical stamina and disease-related changes in the heart and skeletal muscles, as well as associated neurological disorders. OMEICOS’ therapeutic strategy with OMT-28 could translate into improved cell metabolism and mitochondrial function, which in turn would bring significant quality of life benefits to PMD patients and their families. The PMD-OPTION study has enrolled a total of 28 PMD patients and features a 12-week untreated run-in phase, capturing the patients’ natural history and baseline parameters. Subsequently, all patients receive a 24 mg once-daily dose of OMT-28 for a treatment period of up to 24 weeks.

About OMT-28

OMT-28 is a first-in-class small molecule that has demonstrated cell protective, anti-inflammatory and anti-atherosclerotic properties. OMEICOS has generated comprehensive preclinical and clinical datasets demonstrating the compounds strong safety profile and tolerability as well as its therapeutic potential in cardiovascular diseases targeting inflammation in atherosclerosis and cardiomyopathy, as well as other age-related diseases including AMD. In the active PMD-OTION Phase 2 clinical study, OMEICOS is evaluating OMT-28 in Primary Mitochondrial Disease patients.

About OMEICOS

OMEICOS Therapeutics has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat mitochondrial dysfunction, inflammatory, cardiovascular and other diseases. Epoxyeicosanoids activate cell type-specific endogenous pathways that promote organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. For more, please visit: www.omeicos.com

Joint press release by Heinrich Heine University Düsseldorf and Max Delbrück Center

Researchers in Berlin and Düsseldorf have implicated a new gene in the progression of Huntington’s disease in a brain organoid model. The gene may contribute to brain abnormalities much earlier than previously thought. The study was published in “Nature Communications.”

For the first time, researchers have implicated the gene CHCHD2 in Huntington’s Disease (HD) – an incurable genetic neurodegenerative disorder – and identified the gene as a potentially new therapeutic target. In a brain organoid model of the disease, the researchers found that mutations in the Huntington gene HTT also affect CHCHD2, which is involved in maintaining the normal function of mitochondria. The study was published in “Nature Communications.”

Six different labs at the Max Delbrück Center participated in the study, led by Dr. Jakob Metzger of the “Quantitative Stem Cell Biology” lab at the and the “Stem Cell Metabolism” lab of Professor Alessandro Prigione at Heinrich Heine University Düsseldorf (HHU). Each lab contributed their unique expertise on Huntington’s disease, brain organoids, stem cell research and genome editing. “We were surprised to find that Huntington’s disease can impair early brain development through defects associated with mitochondrial dysfunction,” says Dr. Pawel Lisowski, co-lead author in the Metzger lab at the Max Delbrück Center.

Moreover, “the organoid model suggests that HTT mutations damage brain development even before clinical symptoms appear, highlighting the importance of detecting the late-onset neurodegenerative disease early,” Selene Lickfett, co-lead author and a doctoral student in the Faculty of Mathematics and Natural Science in the lab of Prigione at HHU adds.

The unusual repetition of three letters

An organoid is a three-dimensional, organ-like structure that researchers grow in a laboratory from stem cells. Depending on the disease and research question, organoids can be grown from different types of tissue. Only a few millimeters in size, they serve as a model for how different cell types interact. No other bench-top model provides such a detailed look at the function of cells in the human body

Huntington’s disease is caused when the nucleotides Cytosine, Adenine and Guanine are repeated an excessive number of times in the in the Huntington gene HTT. People with 35 or less repeats are generally not at risk of developing the disease, while carrying 36 or more repeats has been associated with disease. The greater the number of repeats, the earlier the disease symptoms are likely to appear, explains Metzger, a senior author of the study. The mutations cause nerve cells in the brain to progressively die. Those affected, steadily lose muscle control and develop psychiatric symptoms such as impulsiveness, delusions and hallucinations. Huntington’s disease affects approximately five to 10 in every 100,000 people worldwide. Existing therapies only treat the symptoms of the disease, they don’t slow its progression or cure it.

The challenge of HTT gene editing

To study how mutations in the HTT gene affect early brain development, Lisowski, first used variants of the Cas9 gene editing technology and manipulation of DNA repair pathways to modify healthy induced pluripotent stem cells such that they carry a large number of CAG repeats. This was technically challenging because gene editing tools are not efficient in gene regions that contain sequence repeats, such as the CAG repeats in HTT, says Lisowski.

The genetically modified stem cells were then grown into brain organoids – three-dimensional structures that resemble early-stage human brains. When the researchers analyzed gene expression profiles of the organoids at different stages of development, they noticed that the CHCHD2 gene was consistently under expressed, which reduced metabolism of neuronal cells. CHCHD2 is involved in ensuring the health of mitochondria – the energy producing structures in cells. CHCHD2 has been implicated in Parkinson’s disease, but never before in Huntington’s.

They also found that when they restored the function of the CHCHD2 gene, they could reverse the effect on neuronal cells. “That was surprising,” says Selene Lickfett. “It suggests in principle that this gene could be a target for future therapies.”

Moreover, defects in neural progenitor cells and brain organoids occurred before potentially toxic aggregates of mutated Huntingtin protein had developed, adds Metzger, indicating that disease pathology in the brain may begin long before it is clinically evident.

“The prevalent view is that the disease progresses as a degeneration of mature neurons,” says Prigione. “But if changes in the brain already develop early in life, then therapeutic strategies may have to focus on much earlier time-points.”

Wide reaching implications

“Our genome editing strategies, in particular the removal of the CAG repeat region in the Huntington gene, showed great promise in reversing some of observed developmental defects. This suggests a potential gene therapy approach,” says Prigione. Another potential approach could be therapies to increase CHCHD2 gene expression, he adds.

The findings may also have broader applications for other neurodegenerative diseases, Prigione adds. “Early treatments that reverse the mitochondrial phenotypes shown here could be a promising avenue for counteracting age-related diseases like Huntington’s disease.”

Text: Gunjan Sinha

Further information

Metzger Lab

Quantitative Stem Cell Biology

N. Rajewsky Lab

Systems Biology of Gene Regulatory Elements

 E. Wanker Lab

Proteomics and Molecular Mechanisms of Neurodegenerative Diseases

Kühn Lab

Genome Engineering & Disease Models

 Organoids

Agnieszka Rybak-Wolf

Pluripotent Stem Cells

Sebastian Diecke

Prof. Alessandro Prigione Lab

Literature

Pawel Lisowski, Selene Lickfett, Agnieszka Rybak-Wolf, et al. (2024): “Mutant Huntingtin impairs neurodevelopment in human brain organoids through CHCHD2-mediated neurometabolic failure,” Nature Communications. DOI: 10.1038/s41467-024-51216-w

Photo: Healthy organoids (left) show an organized neurogenic zone (shown in yellow) and neural progenitor cells (shown in red/pink). Huntington’s Disease organoids (right) exhibit almost no neural progenitors (red) and also show defects in cellular polarity (yellow). These defects have been described in the literature in human fetuses with Huntington’s disease. (Photo Credit: Selene Lickefett, Heinrich-Heine-Universität Düsseldorf, Werner Dykstra, Max Delbrück Center)

In the presence of the Saxon State Ministers Martin Dulig and Thomas Schmidt as well as the Mayor of Dresden Dirk Hilbert, the medical technology company Eckert & Ziegler today inaugurated its new 1,700 square meter facilities in Dresden with around 200 guests. The Dresden-Rossendorf site produces and delivers high-tech systems for the production of radiopharmaceuticals worldwide and provides services for the handling and disposal of radioactive products in cancer medicine. Eckert & Ziegler is investing up to € 50 million in the expansion of the production site. The new buildings that have now been completed are the basis for the company's further expansion and create the foundation for employement of up to 100 additional highly qualified staff in plant engineering and radiopharmacy in Saxony.

Dr. Gunnar Mann, member of the Group Executive Committee of Eckert & Ziegler SE: "The expansion of our production capacities is the answer to the rapidly growing demand for nuclear medicine compounds for cancer diagnostics and therapy. We currently have around 100 employees at our Rossendorf site, and we want to be able to double this number."

Martin Dulig, Minister of State for Economic Affairs, Labor and Transport of the Free State of Saxony: "The new building is proof of the growing success of Eckert & Ziegler in the region, but also of the fertile conditions that this location offers. The company is now making a further contribution to ensuring that we in Saxony, especially in our state capital and in Radeberg - together with the scientific institutions and the nuclear medicine companies active here and their well over 1,000 employees - are a leading radiopharmaceutical center in Europe!"

Thomas Schmidt, Minister of State for Regional Development of the Free State of Saxony: "Dresden-Rossendorf is becoming a Silicon Valley of radiopharmacy. With the neighboring "Helmholtz-Zentrum", a large number of available specialists, a growing number of companies and an ideal infrastructure for further investments, Saxony has a rapidly developing, highly innovative technology cluster in this field."

Dirk Hilbert, Lord Mayor of the City of Dresden: "Our strategy is the right one. We are investing EUR 6.8 million in the expansion of the Dresden-Rossendorf commercial area in order to make such establishments possible. We are happy that an internationally leading company such as Eckert & Ziegler has chosen Dresden as the location for their expansion. In addition to the semiconductor industry, we are thus setting a further focus on cutting-edge medical and nuclear research.

About Eckert & Ziegler
With over 1,000 employees, Eckert & Ziegler SE is one of the leading providers of isotope technology components for nuclear medicine and radiotherapy. At its locations worldwide, the company offers services and products in the field of radiopharmacy, from early development to commercialization. The Eckert & Ziegler shares (ISIN DE0005659700) are listed on the TecDAX index of Deutsche Börse.
Contributing to saving lives.

Isotope Technologies Dresden GmbH (ITD), a wholly owned subsidiary of Eckert & Ziegler SE based in Dresden, specializes in plant engineering for handling radioactive materials and offers tailor-made hot cell solutions to international customers in the healthcare sector, industry and research and development facilities.

Gamma-Service Recycling GmbH (GSR), a wholly owned subsidiary of Eckert & Ziegler SE based in Leipzig, specializes in handling and transporting radioactive materials in Germany and abroad.

A team led by Charité – Universitätsmedizin Berlin, German Rheumatology Research Center and the Max Delbrück Center have defined key cells behind severe kidney damage in lupus. The research, published in “Nature,” can inform future antibody therapies.

A Berlin-led research team has uncovered critical regulators of severe kidney damage in patients with lupus, an autoimmune disorder affecting an estimated five million people worldwide, most of which are young women. A small, specialized population of immune cells – called innate lymphoid cells (ILCs) – trigger an avalanche of effects that cause harmful kidney inflammation, also known as lupus nephritis.

The research, published this week in “Nature,” upends conventional wisdom that autoantibodies – proteins produced by immune cells that mistakenly attack healthy tissues – are primarily responsible for lupus nephritis.

“While autoantibodies are required for tissue damage, they are by themselves not sufficient. Our work reveals that ILCs are required to amplify the organ damage,” says Dr. Masatoshi Kanda, a senior paper author who was a Humboldt Fellow at Max Delbrück Center and is now at the Department of Rheumatology and Clinical Immunology, Sapporo Medical University in Japan.

Lupus, or systemic lupus erythematosus, is most often diagnosed between the ages of 15 and 45. Symptoms can range from mild to severe. But what causes kidney damage in some patients – some to the point of requiring dialysis – has been unclear.

“The role of ILCs in lupus or lupus nephritis was entirely unknown,” says Professor Antigoni Triantafyllopoulou, a senior paper author at the German Rheumatology Research Center (DRFZ), an institute of the Leibniz Association, and at the Department of Rheumatology and Clinical Immunology at Charité – Universitätsmedizin Berlin. “We have now identified most of the circuit controlled by ILCs by looking at the whole kidney at single-cell resolution.”

Unusual immune cells

ILCs are a small group of immune cells that – unlike most other immune cells that circulate throughout the body – live in a specific tissue or organ.

“They are in the tissue all the time, from the time of embryonic development, which makes them very different from other immune cells,” says Professor Andreas Diefenbach, a senior paper author and director of the Institute of Microbiology, Infectious Diseases and Immunology at Charité – Universitätsmedizin Berlin.

Diefenbach’s lab was among those that discovered ILCs in the mid-2000s. Most of his research is focused on ILCs in the gut and how they modify tissue function. In this study, Triantafyllopoulou and Kanda teamed up with his group and Dr. Mir-Farzin Mashreghi at the DRFZ to find out whether ILCs were present in the kidney and what role they might play in lupus nephritis.

The whole single-cell picture

To unravel this mystery, the team turned to single-cell RNA sequencing, which identifies genes that are active, or “switched on,” in individual cells and helps researchers understand the cell’s identity and function.

Kanda, a rheumatologist who was studying bioinformatics in Professor Norbert Hübner’s lab at the Max Delbrück Center at the time, developed a specialized protocol for single-cell RNA sequencing of mouse and human kidneys. “Masatoshi’s protocol was very good at pulling out and preserving multiple types of kidney cells, which gave us a much more complete overview of how lupus affects the whole kidney,” explains Triantafyllopoulou. The team sequenced nearly 100,000 individual kidney and immune cells of various types and functions.

The key receptor

Through experiments in mice, the team learned that a subgroup of ILCs with a receptor called NKp46 must be present and activated to cause lupus nephritis. When NKp46 is activated, this subgroup of cells ramped up production of a protein called GM-CSF, which stimulates invading macrophages to multiply. Macrophages are large immune cells that gobble up dying cells and microbes. In the kidney, a flood of incoming macrophages caused severe tissue damage and buildup of scar tissue, called fibrosis.

“These ILCs are really amplifiers in this system,” Diefenbach says. “They are small in population, but they seem to fertilize the whole process.”

When the team blocked NKp46 with antibodies or the receptor was genetically removed, kidney tissue damage was minimal. They also blocked GM-CSF with similar anti-inflammatory effects.

“Critically, autoantibody levels did not change when NKp46 was inhibited, but kidney tissue damage was reduced, which shows autoantibodies are not directly responsible for kidney inflammation,” Triantafyllopoulou explains.

The team also compared the results to sequencing data from tissue taken from human patients with lupus and found ILCs present, though more work is required to fully understand how to target ILCs in human kidneys. Nevertheless, the insights gained through these detailed studies point to new antibody therapies for patients with severe forms of lupus. The hope is to prevent the need for kidney dialysis in these patients.

Text: Laura Petersen

Source: Joint press release by Charité – Universitätsmedizin Berlin, Max Delbrück Center and the German Rheumatology Research Center
Surprising mechanism of lupus kidney damage identified

Eckert & Ziegler and Telix Pharmaceuticals Limited (Telix) today announced the signing of a significant multi-year agreement under which Eckert & Ziegler will serve as the European contract manufacturing organization (CMO) for Telix's ProstACT GLOBAL Phase III study. The contract covers the supply of the entire European patient base from the state-of-the-art facility in Berlin. In addition, Eckert & Ziegler will also be a provider of the crucial starting material in the form of their high-purity, non-carrier added GMP-grade Lutetium-177 (Lu-177).

Telix's ProstACT GLOBAL study is investigating the benefits and risks of Lutetium (Lu 177) rosopatamab tetraxetan, a radio-labeled antibody drug conjugate (rADC), in adult males with prostate-specific membrane antigen (PSMA) positive prostate cancer in combination with standard of care.

"We are happy to further expand our long-standing and successful collaboration with Telix," said Dr. Harald Hasselmann, CEO of Eckert & Ziegler SE. "This contract underlines not only the importance of our leading-edge facility in Berlin, but also our role as an integral service provider in the continuously growing radiopharmaceutical market."

Darren Patti, Group Chief Operating Officer of Telix, added: "The decision to work with Eckert & Ziegler is based on their outstanding expertise and the quality of their facilities. We are convinced that this continued strategic partnership will contribute significantly to the success of our ProstACT GLOBAL study."

The collaboration marks an important step in both companies' ongoing efforts to advance innovative solutions in the field of radiopharmaceuticals. Eckert & Ziegler operates several CMO sites worldwide and offers a range of other services along the entire value chain.

Source: Press Release Eckert & Ziegler
Eckert & Ziegler becomes European contract manufacturer for Telix's innovative Phase III ProstACT GLOBAL study

Eckert & Ziegler Radiopharma GmbH (Eckert & Ziegler) has received approval from the European Commission (EC) for its Ge-68/Ga-68 radionuclide generator GalliaPharm®. The generator was first launched in 2014 and is today approved in 17 European countries and many other key international markets. With the EC approval, an additional 14 countries in the European Economic Area (EEA) will gain access to GalliaPharm®, once national approval procedures have been completed. Consequently, it will soon be the first generator for the production of Gallium-68 commercially available in the entire EEA.

"Over the past decade, diagnostics with gallium-68-based drugs have experienced a huge growth, which we were able to actively influence with our GalliaPharm^®," explained Dr. Harald Hasselmann, CEO of Eckert & Ziegler SE. "We are happy that our continued efforts to shape the landscape of nuclear medicine in Europe and around the world, are improving patient access and driving innovation forward."

Radionuclide generators offer a cost-effective alternative for the radiolabeling of biomolecules, which can be used in positron emission tomography (PET) or other applications. To date, radiolabeled products have mainly been a cancer diagnostic tool, with Gallium-68-based PET diagnostics being used primarily for tumors of the prostate or neuroendocrine system.

For other diseases, radioisotopes such as fluorine-18 are mostly used to radiolabel biomolecules. This requires millions to be invested in cyclotrons. The Ge-68/Ga-68 generator, on the other hand, has a compact size and can be purchased much more affordably. This reduces costs in nuclear medicine clinics and practices and increases flexibility.

About Eckert & Ziegler
Eckert & Ziegler SE, with more than 1,000 employees, is a leading specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
 

Source: Press Release Eckert & Ziegler
Eckert & Ziegler extends GalliaPharm® availability to the entire European Economic Area

The Max Delbrück Center, Berlin, celebrates its new, innovative research building with a “topping-out ceremony.” The Imaging Innovation Center, designed by the architectural firm heinlewischer, will host researchers specializing in imaging and analysis alongside data experts under one roof starting in 2026.

A state-of-the-art facility for leading researchers in imaging and AI is almost complete: After nearly a year and a half of construction, the architects, builders and scientists is celebrating the new Imaging Innovation Center (IIC) of the Max Delbrück Center for Molecular Medicine in the Helmholtz Association with a “topping out ceremony” on July 11, 2024, on the Campus Buch in Berlin. In the new building, research teams and technology experts from the Max Delbrück Center, including the platforms for Advanced Light Microscopy and Electron Microscopy, as well as new working groups, will cooperate closely to develop imaging technologies starting in 2026. The new IIC will integrate imaging with data analyses and include AI-supported methods. Physicists, biophysicists, life scientists, and bioinformaticians will work closely together. Additionally, companies will have the opportunity to test and make available the latest developments in a "Demonstrator Space for Microscopy."

Imaging as a driving force in biomedicine

"Imaging techniques significantly advance biomedical research and have led to revolutionary discoveries. Any innovation in microscopy that allows us to observe biological phenomena between molecules in cells, organs, and the organism with higher temporal and spatial resolution can dramatically change our understanding of diseases," said Professor Holger Gerhardt, Deputy Scientific Director of the Max Delbrück Center, at the topping-out ceremony. He further added: "Investing in the use and development of imaging techniques and image data analysis in our new IIC is an important strategic positioning. It is essential to fulfill our mission: Discovery for Tomorrow's Medicine."

Heike Graßmann, Administrative Director of the Max Delbrück Center, expressed gratitude to the federal and state governments as well as all the companies and craftsmen involved in the construction: "If you want to enable world-leading research in Berlin in the coming decades, you have to invest wisely today. Thanks to the strategically forward-looking decision by the federal and state governments, we are able to invest nearly 32 million euros in the construction of this new life sciences research building on our campus. I am particularly pleased that we have managed to advance the construction so significantly in just one and a half years by working together diligently."

Highly sensitive microscopy on almost 3000 square meters

The three-and-a-half-story building with a total usable area of 2.675 square meters was planned by the architects at heinlewischer, which has already realized several buildings on the campus. The construction costs of the publically funded building, originally to be named Optical Imaging Center, amount to €31,873 million. The building is located directly next to the Isolde-Diedrich House for Cryo-Electron Microscopy and integrates ideally into the ensemble of research buildings on the campus. Like the Cryo-EM, the IIC rests on a massive base plate that compensates for shifts in the building’s structure. This low-vibration construction, ensures that the highly sensitive light and electron microscopes are not affected by any movement. A highly precise air conditioning system will ensure stable temperature and constant humidity in the laboratories. The building will be built to the highest energy conservation standards, i.e., prepared for the transition to future energy sources and is equipped with photovoltaics and geothermal collectors; it is expected to receive the silver certificate of the sustainable building rating system BNB.

The architect Dr. Alexander Gyalokay from heinlewischer said: "It is always a challenge to meet the specific requirements of science on the one hand and the demands for flexibility and cost-effectiveness on the other. Optical imaging requires vibration-resistant buildings with temperature-stable rooms, which we will construct here in a rare concentration. We are proud to be involved in such a project."

Further Information

• Architekturbüro heinlewischer
• Imaging at the Max Delbrück Center
• Campus Buch

A new NMR spectrometer has been in operation at the Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP) since the end of May. What makes it special is that it is based on a new type of ceramic high-temperature superconductor. Peter Schmieder, head of the NMR technology platform at the FMP, explains the technology behind it and the capabilities of the new device.

The first NMR spectrometer was to be installed in the basement, says Peter Schmieder. However, magnets of this magnitude have a very strong magnetic field, and it would have been impractical to clear the ground floor to prevent anyone from working in the field's vicinity. "So, we constructed a separate building for the spectrometer. Later, other devices found a place there, and soon a second building was added," reports the head of the NMR technology platform.

Now, there is no more space in the second building either, and a third one had to be built for the new NMR spectrometer. The device is the eleventh of its kind since researchers at the FMP began conducting studies using nuclear magnetic resonance (NMR) spectroscopy in 1995. Peter Schmieder has been involved from the beginning. He has supervised the construction of each of the devices, all of which are still in operation.

The new device is special because it employs a technology recognized with the Nobel Prize in Physics in 1987: the high-temperature superconductor. "High-temperature means the material develops superconducting properties at a temperature above minus 200 degrees Celsius," explains Peter Schmieder. In this state, the inside of the magnet is free from electrical resistance and provides a stable field after charging without further power supply for many years (persistent magnet). The oldest magnet at the FMP, still with conventional superconductors, has maintained its field for a quarter of a century. This allows for highly precise analyses of increasingly complex biological systems, such as protein structures. "The quality of the measurement, meaning its sensitivity and the resolution in the spectra, depends on the field strength of the magnet – the stronger, the better," says Peter Schmieder.

The magnet in the new device achieves the currently highest possible stable magnetic field of 28 Tesla, which corresponds to a resonance frequency of 1.2 gigahertz (GHz), a 20 percent higher resonance frequency than what could be achieved with conventional superconductors. This is due to the material used: the innermost part of the coil was made with ceramic superconductors, a tricky task because the material is more brittle than metal. The manufacturer worked on this development for over a decade. However, the operating temperature of the new superconductors remains at -271 °C to ensure the material can support the strong magnetic field. The new NMR device on the Buch campus is one of only ten that have been put into operation worldwide so far.

The 28-Tesla field is a million times stronger than Earth's magnetic field. Since the magnets in the NMR devices are shielded and the generated magnetic fields are static and not fluctuating, they pose no problems for healthy people without pacemakers. However, Peter Schmieder and his team leave mobile phones and watches at the door before entering one of the rooms with the NMR spectrometers.

The setup of the new NMR device is now complete. The 8-ton magnet was moved into the building on an air cushion and then positioned vertically. After the setup was completed, it had to be cooled down. "That alone took three weeks. You do it very slowly to avoid mechanical stresses in the coil," reports Peter Schmieder. When the coil reaches a temperature of two Kelvin (-271.15 degrees Celsius or two degrees Celsius above absolute zero), the magnet is charged. This is the tricky part: if something goes wrong, the coil loses its superconductivity, the cooling medium helium warms up and evaporates into the atmosphere, and the entire – expensive and lengthy – process has to be restarted. "But everything went according to plan, the magnet is on field, meaning it has reached its field of 28 Tesla," Peter Schmieder is pleased to report. Afterwards, the hardware was tested to check if the device's specifications regarding electronics and measuring equipment were met.

Since the end of May, the test operation with the first scientific measurements has been running.
"The primary challenge in protein NMR spectroscopy lies in the numerous signals that exhibit only minor differences from one another. This is why achieving high resolution is crucial," says Peter Schmieder. Additionally, this technology is particularly suitable for determining the mobility of proteins. The experimental setup for measurements in solutions or in solids is different, which is why the old NMR devices at the FMP are used for one measurement type each – currently five for solid-state measurements and five for solution measurements. However, the new device is designed to be used for both measurement types. This allows for a wide variety of investigations to be carried out with the new state-of-the-art magnet. The main users of the new device will be the NMR groups working at the FMP. Adam Lange's group uses solid-state NMR to investigate the structure and dynamics of pharmacologically relevant membrane proteins, while in Sigrid Milles' group solution NMR is used to characterize intrinsically disordered proteins (IDPs). Han Sun's group utilizes anisotropic NMR to determine the structure and stereochemistry of small molecules and peptides, while Hartmut Oschkinat's group characterizes biofilm proteins using solution and solid-state NMR.

Source: Press Release LEIBNIZ-FORSCHUNGSINSTITUT FÜR MOLEKULARE PHARMAKOLOGIE (FMP)
Giant with a Ceramic Heart

Professor Holger Gerhardt from the DZHK partner site Berlin was newly elected to the Board of Directors by the General Assembly: He will take office on 1 July 2024.

Holger Gerhardt succeeds Thomas Sommer and represents the Max Delbrück Center for Molecular Medicine in the Helmholtz Association (Max Delbrück Center) on the DZHK Board of Directors. Together with Stefanie Dimmeler (Wolfgang Goethe University Frankfurt), chairwoman, and Steffen Massberg (Klinikum der Universität München) as member of the board, Holger Gerhardt will remain on the three-member board until the end of 2026. The statutes of the Deutschen Zentrum für Herz-Kreislauf-Forschung (DZHK) stipulate that the Max Delbrück Center and a university or university hospital must be represented on the board. The Max Delbrück Centre is a founding member of the DZHK.

Holger Gerhardt has held a DZHK professorship for Experimental Cardiovascular Research at the Charité in Berlin since 2014 and heads the "Integrative Vascular Biology" working group at the Max Delbrück Centre in Berlin-Buch. He is also Vice-Chairman of the Max Delbrück Center. At the DZHK, the 55-year-old was most recently the spokesperson for the Berlin partner site.

"The DZHK is a globally unique interdisciplinary research network with the task of jointly tackling the growing challenges in the diagnosis, treatment and prevention of cardiovascular diseases. In addition to my research, it is a great pleasure to support the strategic development of the DZHK as a member of the Executive Board.

The biologist investigates how blood vessels form during the development of organisms and looks for ways to stop pathological vessel growth. The aim of his research is to gain a better understanding of blood vessel formation and its dysfunction in diseases, particularly cardiovascular diseases and tumours.

The DZHK board is looking forward to working with Holger Gerhardt and would like to thank Thomas Sommer for his excellent and longstanding cooperation. Sommer, an expert in cellular biochemistry, served as Acting Scientific Director of the Max Delbrück Center from 2014 to 2022, with a three-year break.

Further information

• Profile of Holger Gerhardt: When new blood vessels sprout
• Holger Gerhardt's lab at the Max Delbrück Center
• Holger Gerhardt at the DZHK

On July 8, the Max Delbrück Center and Bruker will kick off a strategic partnership to build a first-of-its-kind innovation hub for systems medicine. The new center will focus on the development and application of mass spectrometry based single-cell and multi-omics technologies.

The Max Delbrück Center and Bruker have launched a strategic collaboration that aims to capitalize on the expertise of both partners to accelerate innovations in systems medicine. The partnership will allow Max Delbrück Center scientists and Bruker to work side-by-side on co-creating tools and solutions for precision medicine.

The new “MDC-Bruker Center of Excellence for Single Cell Omics” will be located at the Berlin Institute for Medical Systems Biology of the Max Delbrück Center (MDC-BIMSB) in Berlin-Mitte. The “industry-on-campus” approach will provide scientists at the Max Delbrück Center easy access to the latest mass spectrometry technologies, as well as Bruker’s expertise in single-cell and spatial proteomics. At the same time, Bruker will gain valuable opportunities for clinical applications based on close collaborations with the Max Delbrück Center and its research partners, such as the Charité – Universitätsmedizin Berlin, including within the Einstein Center for Early Disease Interception.

The opening event on July 8 will include a symposium featuring two world-renowned keynote speakers: Professor Matthias Mann, Director of the Max Planck Institute of Biochemistry and a pioneer in mass spectrometry-based proteomics, and Professor Amos Tanay from the Weizmann Institute of Science, who is trailblazing the combination of single-cell work and analysis of massive electronic health records.

Complementary technologies

The Max Delbrück Center has developed innovative single-cell sequencing and spatial technologies that enable scientists to map cells within tissues in 2D and 3D. Additionally, it has established single-cell and spatial proteomics platforms broadly applicable to patient archival samples in various disease contexts. However, understanding health and disease requires the ability to analyze biological information at the genomic, transcriptomic, proteomic and metabolomic level. But so far, most existing methods focus on a single modality.

The proteomic technologies were developed based on Bruker’s timsTOF Ultra system – a highly sensitive mass spectrometer capable of profiling proteins from single cells from cell culture and archived tissue. While this technology provides unprecedented insight into cell-to-cell proteome heterogeneity, it doesn’t provide transcriptomic or metabolomic information, nor does it reveal the dynamics of cellular processes.

Scientific and economic connectivity

Now, the Max Delbrück Center and Bruker plan to expand their cooperation. Their first joint R&D project will create a broadly applicable platform to simultaneously profile proteins and metabolites, as well as lipids to understand disease processes at the level of single or a few cells. Ultimately, the aim is to develop a multi-omics workflow that could be applied in diverse clinical settings. The co-creation project totaling €1.2 million is supported by the Helmholtz Association in the framework of its Transfer campaign. Bruker is co-financing 20 %.

Collaboration between the two partners could lead to a long-term partnership and new joint R&D projects that include external partners to explore new applications of the co-developed single-cell multi-omics platform.

“Projects like this one – and the Center of Excellence as a whole – align perfectly with our strategic goal to adapt emerging technologies for medical innovation,” says Professor Maike Sander, Scientific Director of the Max Delbrück Center. “Our ‘industry-on-campus’ model with Bruker aims to sustainably develop an innovation ecosystem that attracts international talent. Academic and industry partners are already interested in collaborating.”

Dr. Severin Fischer, State Secretary in the Berlin Senate Department for Economics, Energy and Public Enterprises, says: “When science and industry work together, the whole of Berlin wins. We specifically support this and want to develop our city into the number one innovation location in Europe. The pioneering cooperation between the Max Delbrück Center and Bruker is a further step in this direction and shows how we can leverage our great potential for medical progress and economic strength.”

A vibrant environment for biomedical research

“We are very excited to be working with the world-class researchers in proteomics, metabolomics as well as genomics and transcriptomics at the Max Delbrück Center to realize our joint vision of using a multi-omics approach to understanding biology and disease at the single-cell level,” says Dr. Rohan Thakur, President of the Life Science Mass Spectrometry business at Bruker Switzerland AG. “We are also pleased to be making this investment to increase our presence in Berlin, where initiatives supported by the Berlin Senate like the Einstein Center for Early Disease Interception are creating a vibrant and collaborative environment for biomedical research.”

“This unique partnership with Bruker allows us to jointly develop solutions for cell-based interceptive medicine,“ says Professor Nikolaus Rajewsky, Scientific Director of the MDC-BIMSB and co-spokesperson of the Einstein Center. “Our society is aging and chronic and severe diseases such as cancer, neurodegeneration and cardio-vascular diseases are on the rise. To tackle these grand medical challenges, strong interdisciplinary teams of scientists from academia and industry are essential.”

“Through innovations in ultrasensitive mass spectrometry, the proteomics research field has made a significant leap forward in recent years to measure single-cell proteomes at unprecedented biological resolution,” says Dr. Fabian Coscia, head of the Spatial Proteomics Group at the Max Delbrück Center and member of the MDC-Bruker core team. “This is an excellent foundation for our planned activities to further develop this technology for multi-omics approaches and to gain deeper insights into health and disease states.”

Further information

• Opening event
• Profile on Fabian Coscia
• Spatial Proteomics Lab
• Stefan Kempa, head of Proteomics & Metabolomics technology platform
• 3D maps of diseased tissues at subcellular precision
• Profile on Nikolaus Rajewsky
• Systems Biology of Gene Regulatory Elements Lab
• Profile on Matthias Selbach
• Proteome Dynamics Lab
• Einstein Center for Early Disease Interception
• Bruker

https://www.mdc-berlin.de/news/press/new-center-excellence-single-cell-omics

Through various initiatives, the Max Delbrück Center contributes to an objective debate on animal testing. For the second time, the “Understanding Animal Research” initiative has awarded the center the seal of approval for exemplary communication in experimental animal research.

New immunotherapies against cancer, experiments that can pave the way for new pain medications, hearts that do not scar after a heart attack but renew muscle cells – it would be easy to skip a crucial aspect of scientific successes: animal research. The Max Delbrück Center consciously takes a different path. It communicates openly and transparently when new knowledge is based on experiments involving animals, explaining why these experiments are necessary, what the 3R principles (Replace, Reduce, Refine) entail, and what limitations current alternative methods have.

For this proactive approach, the German initiative “Understanding Animal Research” has awarded the Max Delbrück Center the quality seal of “Quality approval for exemplary communication of experimental animal research” for the second time. For more than ten years, “the center has consistently set standards in educating about animal research, with a clear focus on active dialogue with the public,” the judges stated.

Facilitating direct exchange

In addition to the comprehensive information available on the website, the initiative praises the Max Delbrück Center's events that facilitate direct exchange and encourage scientists to speak openly about animal research: “By actively interacting with the public and supporting educational events, the center contributes to building a productive dialogue on animal research.”

The seal was awarded to five institutions nationwide during the initiative's anniversary event on July 1, 2024. “Understanding Animal Research” was founded by the Alliance of Science Organizations and the German Research Foundation (DFG). The Max Delbrück Center is one of the 53 initial signatories of the Transparency Agreement Initiative, launched in 2021.

Further Information

• Information on the quality seal on the website of "Understanding Animal Experiments" (only in German)
• Animal research and ethics – information provided by the Max Delbrück Center
• Lab animal report, 2023

Würzburg and Berlin, Germany, 3 July 2024 – Pentixapharm AG, a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals against a range of malignancies, has announced the execution of an agreement, effective July 1^st, to acquire the target discovery business of Berlin-based Glycotope GmbH.

The deal encompasses a portfolio of preclinical antibodies against multiple oncology targets that can be developed into radiopharmaceuticals. It also includes Glycotope’s laboratories, cell banks, tumor target data base, and the equipment needed to exploit the discovery platform, along with a range of patents, licenses, and other tangible assets. In total, Pentixapharm will be able to add an integrated team of 40 seasoned executives, R&D specialists, and administrators to its staff.

“The acquisition will broaden Pentixapharm’s Intellectual Property portfolio beyond the one built around the CXCR4 receptor. This will immediately double the development pipeline and significantly expand the associated business and clinical development opportunities,” explained Hakim Bouterfa, CEO of Pentixapharm AG. “Glycotope’s pipeline comprises several candidates that can be used immediately for proof-of-concept studies as next generation radiopharmaceuticals. We look forward to maximizing the synergy of Pentixapharm’s know-how and Glycotope’s target discovery for the benefit of patients in both diagnostics and therapeutic applications.”

“The transaction provides Pentixapharm not just with a chance to build a clinical pipeline beyond the company’s current CXCR4-ligand based programs, but also substantially strengthens its administrative and managerial capacities,” noted Andreas Eckert, Chairman of the Supervisory Board of both Pentixapharm and mother company Eckert & Ziegler SE (EZAG). “It adds a critical number of talents to the planned secession of Pentixapharm to Frankfurt Stock Exchange, thereby facilitating a seamless separation from EZAG. The offices and laboratories included in the deal are large enough to allow a consolidation of all Berlin-based activities into one loaction."

The transaction will also affect the composition of the Pentixapharm Management Board once the company becomes listed on the Frankfurt Stock Exchange. Hakim Bouterfa, current CEO of Pentixapharm, is designated to move to the Company’s Supervisory Board. He will be succeeded by Dirk Pleimes, currently Pentixapharm’s Chief Medical Officer. Patrik Kehler, former Chief Scientific Officer (CSO) of Glycotope, will assume the CSO position at Pentixapharm, while Glycotope’s former CEO, Henner Kollenberg, will take over the responsibility for administrative and business development issues as Chief Business Officer.

Patrik Kehler, newly appointed Chief Scientific Officer of Pentixapharm, explained: “The target discovery unit’s development activities focus on tumor-associated carbohydrate structures, so-called GlycoTargets. Their major advantage ist the reduced normal tissue binding compared to conventional antibodies. Based on their superior tumor-specificity, they are suitable for development in an array of different modes of action. In the radiopharmaceuticals field, they have the potential to close the treatment gap that exists for the majority of solid tumors.”

About the Glycotope Target Discovery Unit

The target discovery unit utilizes a proprietary technology platform to develop uniquely tumor-specific monoclonal antibodies or fragments thereof. They target specific tumor-associated carbohydrate structures or protein/carbohydrate combined glycoepitopes (GlycoTargets). The unit has to date discovered in excess of 200 GlycoTargets (www.glycotope.com). Many of these have been outlicensed to major pharmaceutical companies around the world, where they are currently in pre-clinical and clinical development.

About Pentixapharm AG

Pentixapharm is a radiopharmaceutical development company founded in 2019 with its headquarters in Würzburg, Germany. It is currently wholly owned by the Eckert & Ziegler Group but bound to be spun-off to the Frankfort Stock Exchange soon. Pentixapharm is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline encompasses PENTIXATHER, am Yttrium-90 based therapeutic against CNS lymphoma, and PENTIXAFOR, a Gallium-68 based companion diagnostic. Clinical studies for both compounds have already commenced in Europe, with a dose-finding study for PENTIXATHER and a Phase III registration study for PENTIXAFOR. Additionally, PENTIXAFOR is being developed as a diagnostic tool for primary aldosteronism (PA), a significant cause of hypertension. Pentixapharm is currently preparing a US centric Phase III registration study in PA that will start in 2025.

Pentixapharm AG, a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals against a broad range of malignancies, announced today that the General Shareholder Meeting of Pentixapharm resolved the appointment of the distinguished endocrinologist Prof. Dr. med. Marcus Quinkler to the Company's Supervisory Board. The assignment will become effective with the registration of the split-off of Pentixapharm AG from Eckert & Ziegler SE in the commercial register.

“We welcome Marcus Quinkler as a valuable addition to our Board. He is a recognized expert among others in primary aldosteronism, the focus area of our Phase III lead program PENTIXAFOR (PTF-302). He will also help Pentixapharm to advance its ongoing clinical assessments of the Company’s novel, CXCR4-based radiopharmaceutical therapeutic and diagnostic programs.” explained Dr. Hakim Bouterfa, Founder and Chief Executive Officer of the Pentixapharm Holding AG.

Marcus Quinkler is a specialist of internal medicine and endocrinology, diabetology and andrology. Formerly at the endocrinology department at the Charité-Universitätsmedizin, Campus Mitte, Berlin, currently leading a specialized endocrine practice in Berlin, Dr. Quinkler has significantly contributed to the field, serving as an adjunct professor at Charité.

His academic training includes a medical degree and doctorate from the Free University of Berlin, a research fellowship at the University of Birmingham, U.K., funded by the DFG, and a postdoctoral thesis at the Charité to qualify as a professor. Dr. Quinkler has led significant clinical guideline developments and held editorial roles in prominent journals. His accolades include the Schoeller-Junkmann Prize and the Arthur-Jores Honorary Prize from the German Society for Endocrinology (DGE). From 1996 to 2024, Dr. Quinkler has authored over 270 peer-reviewed publications.

Dr. Marcus Quinkler added: “Pentixapharm’s CXCR4-ligand technologies are being evaluated not only in hematological indications but also for a range of other applications beyond cancer. Notably, their advanced diagnostic program in Primary Aldosteronism holds significant promise as a meaningful alternative to the current gold standard, potentially improving patient outcomes and enhancing cardiovascular health. I am pleased to join the Board at this pivotal moment and support the Company in their future growth.”
Dr. Quinkler will strengthen the Supervisory Board of Pentixapharm AG next to Chairman Dr. Andreas Eckert, Jens Giltsch and Dr. Harald Hasselmann, who also serves as CEO of Eckert & Ziegler SE.

About Pentixapharm AG

Pentixapharm is a radiopharmaceutical development company founded in 2019 with its headquarters in Würzburg, Germany. It is currently wholly owned by the Eckert & Ziegler Group but bound to be spun-off to the Frankfort Stock Exchange soon. Pentixapharm is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular and endocrine diseases.

Pentixapharm’s clinical program encompasses PENTIXATHER, am Yttrium-90 based therapeutic against CNS lymphoma, and PENTIXAFOR, a Gallium-68 based companion diagnostic. Clinical studies for both compounds have already commenced in Europe, with a dose-finding study for PENTIXATHER and a Phase III registration study for PENTIXAFOR.  Additionally, PENTIXAFOR is being developed as a diagnostic tool for primary aldosteronism, a significant cause of hypertension. Pentixapharm aims to initiate an advanced clinical trial in the United States in 2025.

Berlin researchers and their partners describe how aggressive variants of multiple myeloma can be detected early. Their comprehensive study in “Nature Cancer” shows how changes in genetic material affect the protein profile of the tumor cells, and thus the mechanisms involved in the disease.

Multiple myeloma is one of the most common forms of cancer of the immune cells in the bone marrow. Despite advances in treatment and the introduction of new cellular immunotherapies, there is no cure at present. Even when patients respond to treatment at first, the cancer comes back. To be able to intervene faster and on a more targeted basis, a researchers led by Professor Jan Krönke from the Department of Hematology, Oncology and Cancer Immunology at Charité – Universitätsmedizin Berlin, and Dr. Philipp Mertins, head of the Proteomics technology platform of the Max Delbrück Center and the Berlin Institute of Health at Charité (BIH), teamed up with other partners for a comprehensive study of this disease at the molecular level. They now describe how highly aggressive types of tumors can be detected early on in an article published in the journal “Nature Cancer.” They show how changes in genetic material affect the protein profile of the tumor cells, and thus the mechanisms involved in the disease.

In multiple myeloma, the immune cells in the bone marrow, known as plasma cells, mutate and become cancerous. Plasma cells are responsible for producing antibodies. All humans have many different kinds of plasma cells that form large numbers of different antibodies. This allows the body to recognize and fight various pathogens. In multiple myeloma, a single plasma cell mutates into a tumor cell. That cell reproduces unchecked, forming a monoclonal cell population. This means many cells are formed, all of them exactly the same and genetically identical at first. The mutated cells often also produce large volumes of antibodies or fragments of them – but they do not function properly. Over the course of the disease, most patients develop tumors at various locations in the bone marrow, hence the “multiple” in the disease’s name. Immunodeficiency, kidney failure, bone loss, and bone fractures are just some of the consequences of this uncontrolled cell growth.

What path does the tumor take?

No two cases of cancer are alike, and multiple myeloma is no exception. Tumors develop differently in different individuals, including at different rates. This makes it more difficult to predict how the disease will progress and choose the optimum treatment. While the mutated plasma cells do not spread much in some cases, in others they are extremely aggressive, leading to a poor prognosis.

But what causes so much divergence in the course of multiple myeloma? In cooperation with protein analysis experts from the Max Delbrück Center and BIH, the researchers conducted a detailed study of genetic and molecular changes occurring in the tumor cells in a group of more than one hundred patients. The study included data from patients in the German Multiple Myeloma Study Group (DSMM), which is coordinated by the University Hospital of Würzburg. This allowed the researchers to include clinical data on patients who had received standardized treatment over a period of eight years or more following initial diagnosis.

Systems medicine and big data

While changes in the genome and their effects on the proteome are already well described for other types of cancer, this is the first detailed proteo-genomic study of multiple myeloma. “Genetic data alone is insufficient to explain the mechanisms involved in this disease,” Mertins says. “We wanted to know the consequences of genetic changes at the protein level and compare this molecular biology data against the actual course of the disease in patients.” The team was supported in collecting and analyzing the large volumes of data by experts at Charité, BIH, and the German Cancer Consortium (DKTK).

Cutting-edge mass spectrometry methods made it possible to map the protein profile of mutated plasma cells and compare it against that of healthy plasma cells in people without the disease. The researchers found that both genetic changes and changes in signaling pathways lead to uncontrolled activation of cancer cells. Regulatory processes at the protein level had the stronger influence. The researchers identified a protein constellation that suggests the disease will take a particularly aggressive course, regardless of other known risk factors.

Unlocking new therapies

“Our findings will help subcategorize patients more effectively going forward, personalizing their treatment,” Krönke concludes. “We’ve identified key proteins and signaling pathways that can serve as the basis for even more effective, better tolerated treatments for multiple myeloma, for example for immune therapies such as CAR T-cell therapy.” In further steps, the researchers plan to study which of the target structures they have identified are in fact good candidates for new therapeutic approaches.

The study is a crucial resource for research and applied development, says Dr. Evelyn Ramberger, first author of the study: “To make the complex data set manageable, we programmed an interactive, freely available online tool.” This has given cancer researchers easy access to the results, so they can use the information to develop new therapies and tests to help guide treatment. For example, it may be possible to treat patients with an especially aggressive form of multiple myeloma with more intensive therapies right at the outset.

Text: Charité

Source: Joint press release of Charité, BIH at Charité, and the Max Delbrück Center
Multiple myeloma: Early detection of aggressive tumors

The Annual General Meeting of Eckert & Ziegler SE (ISIN DE0005659700) today resolved to split-off Pentixapharm AG from Eckert & Ziegler SE and to distribute a dividend of EUR 0.05 per share for the 2023 financial year.

As in the previous year, the Annual General Meeting was held as an in-person event at Eckert & Ziegler SE's headquarters in Berlin. A total of 57.6% of the company's share capital was represented.

The detailed voting results of the Annual General Meeting and the presentation by the Chairman of the Executive Board are published on the Eckert & Ziegler SE website:

About Eckert & Ziegler
Eckert & Ziegler SE with more than 1.000 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
 

Source: Press Release Eckert & Ziegler
Annual General Meeting of Eckert & Ziegler SE Approves Split-Off of Pentixapharm AG

An open-source platform developed by researchers in Nikolaus Rajewsky’s lab at the Max Delbrück Center creates molecular maps from patient tissue samples with subcellular precision, enabling detailed study and potentially enhancing routine clinical pathology. The study was published in “Cell.”

Researchers in the Systems Biology Lab of Professor Nikolaus Rajewsky have developed a spatial transcriptomics platform, called Open-ST, that enables scientists to reconstruct gene expression in cells within a tissue in three dimensions. The platform produces these maps with such high resolution, that researchers are able to see molecular and (sub)cellular structures that are often lost in traditional 2D representations. The paper was published in the journal “Cell.” 

In tissues from the brains of mice, Open-ST was able to reconstruct cell types at subcellular resolution. In tumor tissue and a healthy and metastatic lymph node from a patient with head and neck cancer, the platform captured the diversity of immune, stromal, and tumor cell populations. It also showed that these cell populations were organized around communication hotspots within the primary tumor, but this organization was disrupted in the metastasis.

Such insights can help researchers understand how cancer cells interact with their surroundings and, potentially begin exploring how they evade the immune system. Data can also be used to predict potential drug targets for individual patients. The platform is not restricted to cancer and can be used to study any type of tissue and organism.

“We think these types of technologies will help researchers discover drug targets and new therapies,” says Dr. Nikos Karaiskos, a senior scientist in the Rajewsky lab at the Berlin Institute for Medical Systems Biology of the Max Delbrück Center (MDC-BIMSB) and a corresponding author on the paper.

Unveiling the spatial complexity of tissues

Transcriptomics is the study of gene expression in a cell or a population of cells, but it usually does not include spatial information. Spatial transcriptomics, however, measures RNA expression in space, within a given tissue sample. Open-ST offers a cost-effective, high-resolution, easy-to-use method that captures both tissue morphology and spatial transcriptomics of a tissue section. Serial 2D maps can be aligned, reconstructing the tissue as 3D “virtual tissue blocks.”

“Understanding the spatial relationships among cells in diseased tissues is crucial for deciphering the complex interactions that drive disease progression,” says Rajewsky, who is also Director of MDC-BIMSB. “Open-ST data allow to systematically screen cell-cell interactions to discover mechanisms of health and disease and potential ways to reprogram tissues.”

Open-ST images from cancer tissues also highlighted potential biomarkers at the 3D tumor/lymph node boundary that might serve as new drug targets. “These structures were not visible in 2D analyses and could only be seen in such an unbiased reconstruction of the tissue in 3D,” says Daniel León-Periñán, co-first author on the paper.

“We have achieved a completely different level of precision,” adds Rajewsky. “One can virtually navigate to any location in the 3D reconstruction to identify molecular mechanisms in individual cells, or the boundary between healthy and cancerous cells, for example, which is crucial for understanding how to target disease.”

Cost-effective and accessible technology

One significant advantage of Open-ST is cost. Commercially available spatial transcriptomics tools can be prohibitively expensive. Open-ST, however, uses only standard lab equipment and captures RNA efficiently, reducing costs significantly. Lower costs also mean that researchers can scale up their studies to include large sample sizes, to study patient cohorts, for example.

The researchers have made the entire experimental and computational workflow freely available to enable widespread use. Importantly, the platform is modular, says León-Periñán, so Open-ST can be adapted to suit specific needs. “All the tools are flexible enough that anything can be tweaked or changed.”

“A key goal was to create a method that is not only powerful but also accessible,” says Marie Schott, a technician in the Rajewsky lab and co-first author on the paper. “By reducing the cost and complexity, we hope to democratize the technology and accelerate discovery.”

Text: Gunjan Sinha

Source: Press Release Max Delbrück Center
3D maps of diseased tissues at subcellular precision

Pentixapharm AG, a radiopharmaceutical development company wholly owned by Eckert & Ziegler SE, today announced that it has received encouraging feedback from the U.S. Food and Drug Administration (FDA) following a recent Type C meeting with the Agency to directly proceed into a pivotal phase III registration study with its radiopharmaceutical diagnostic Ga68-PentixaFor in Primary Aldosteronism (PA). PA is an adrenal gland disorder also known as Conn’s syndrome and the most frequent cause of secondary hypertension (high blood pressure).

While the FDA minutes from the Type C meeting do not constitute a formal approval of a particular development plan, they indicate that the clinical data compiled by various academic groups independently from Pentixapharm might serve as confirmatory evidence, relieving the Company of the requirement to conduct a second well-controlled clinical investigation. The minutes also confirm that Ga68-PentixaFor addresses an unmet medical need for a serious condition and therefore meets two essential criteria for fast track and breakthrough designation, which Pentixapharm can request with its Investigational New Drug (IND) submission to initiate the phase III trial.

Ga68-PentixaFor is a novel tracer used in the positron emission tomography (PET) imaging of aldosterone-hypersecreting adenomas in patients diagnosed with PA. The estimated prevalence of this disease has increased considerably over the years, exceeding 20% in some populations of resistant hypertension¹. The disorder is characterized by either a unilateral aldosterone-producing adenoma (APA) or bilateral adrenal hyperplasia (BAH). The current gold standard for differentiating these conditions is adrenal venous sampling (AVS), a complex and invasive procedure. The vast majority of patients with unilateral PA who undergo adrenalectomy after successful AVS experience complete biochemical normalization². However, there is a risk of misdiagnosing a bilateral case, in which a patient would not benefit from the removal of the gland.

Dr. Dirk Pleimes, Chief Scientific & Medical Officer at Pentixapharm AG, commented: “The FDA feedback represents a major milestone for our Company in the development of our lead diagnostic. We aim to evaluate Ga68-PentixaFor as a first-in-class, non-invasive and accurate alternative to adrenal venous sampling, offering the potential to transform diagnostic subtyping in Primary Aldosteronism and improve patient outcomes. This discussion with US regulatory authorities provided important feedback, enabling us to proceed to a US-centric registrational Phase III trial to support global authorization applications.”

About Pentixapharm AG

Pentixapharm is a radiopharmaceutical development company founded in 2019, with its headquarters in Würzburg, Germany. It is wholly owned by the Eckert & Ziegler Group, one of the world's largest providers of isotope technology for medical, scientific and industrial use.  Pentixapharm is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular and endocrine diseases.

[1] Yozamp N, Vaidya A. The Prevalence of Primary Aldosteronism and Evolving Approaches for Treatment. Curr Opin Endocr Metab Res. 2019 Oct;8:30-39. doi: 10.1016/j.coemr.2019.07.001. Epub 2019 Jul 9. PMID: 32832727; PMCID: PMC7442120.

[2] Zhou, Y., Zhang, M., Ke, S., & Liu, L. (2017). Hypertension outcomes of adrenalectomy in patients with primary aldosteronism: a systematic review and meta-analysis. BMC endocrine disorders, 17(1), 1-9.

Source: Press Release Eckert & Ziegler
Eckert & Ziegler Subsidiary Pentixapharm Receives Encouraging FDA Feedback to Initiate Phase III Trial with PentixaFor as Radiopharmaceutical Diagnostic in Primary Aldosteronism

Eckert & Ziegler Radiopharma GmbH (Eckert & Ziegler), in collaboration with the Nuclear Physics Institute of the Czech Academy of Sciences (Ústav jaderné fyziky, “UJF”), announces the grand opening of a pioneering Actinium-225 (Ac-225) production facility. This milestone, celebrated yesterday with an official ceremony featuring Czech Prime Minister Petr Fiala, marks the culmination of a longstanding partnership between Eckert & Ziegler and UJF. The facility is now close to operational readiness, and after additional testing, commercial production is slated to commence at the beginning of Q3/2024.

Currently, Ac-225-based radiopharmaceuticals are under clinical investigation for various cancers, including prostate tumors, colorectal cancer, and leukemia. A substantial increase in the demand for Ac-225 is projected over the next decade, driven by its expanding clinical applications and the promising results seen in ongoing trials. Despite its therapeutic promise, sufficient quantities of Ac-225 remain scarce.

"Eckert & Ziegler, in conjunction with UJF, has explored one of the most promising cyclotron-based production pathways for Ac-225," said Dr. Lutz Helmke, Managing Director of Eckert & Ziegler Radiopharma GmbH. "Our collaboration signifies a major leap forward in isotope production, addressing the critical shortage of this isotope poised to revolutionize modern oncology."

The newly inaugurated laboratory will leverage cutting-edge technologies, including a customized production line provided by Isotope Technologies Dresden GmbH, which represents the Plant Engineering business of Eckert & Ziegler. Radium-226, necessary for irradiation processes, will also be supplied by Eckert & Ziegler.

"Today's opening marks a significant achievement in our collaboration with Eckert & Ziegler," commented Prof. Ondřej Lebeda, Head of Department of Radiopharmaceuticals at UJF. "This new facility is a testament to our joint dedication to innovation in the therapeutic landscape for many cancer patients."

Actinium-225 has emerged as a highly promising agent in the targeted therapy of small tumors and metastases. Its high-energy cascade of alpha particles with short penetration depths allows for precise targeting of tumor cells, including difficult-to-reach micro metastases, while minimizing impact on surrounding healthy tissue.

About Eckert & Ziegler
Eckert & Ziegler SE, with more than 1,000 employees, is a leading specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

About UJF
The Nuclear Physics Institute of the Czech Academy of Sciences is a public research institution that conducts research in a broad field of nuclear physics, both experimental and theoretical. Its Department of radiopharmaceuticals focuses on the investigation and production of novel medical radionuclides as well as radionuclides important for physical research.
 

Source: Press Release Eckert & Ziegler
Eckert & Ziegler and UJF Open State-of-the-Art Actinium-225 Production Facility

Eckert & Ziegler SE (ISIN DE0005659700) was honored with the “Best Managed Companies Award” at an award ceremony in Frankfurt am Main on May 23, 2024. With this award, Deloitte Private, UBS, Frankfurter Allgemeine Zeitung and the Federation of German Industries (Bundesverband der Deutschen Industrie e.V.) recognize outstandingly managed medium-sized companies.

Following a multi-level application process, the participating companies were assessed for their excellence in the following core areas: strategy, productivity and innovation, culture and commitment as well as finance and governance. High performance in all four areas is a prerequisite for the award. The award winners were then selected by a jury consisting of renowned representatives from business, science and the media.

“We are delighted to receive the Best Managed Companies award and consider this to be confirmation of our long-term corporate strategy. The award is also an acknowledgement of our employees, who contribute significantly to the success of our company every day with great dedication,” says Dr. Harald Hasselmann, CEO of Eckert & Ziegler SE. “This is a fantastic team achievement, which we are very excited about.”

“Eckert & Ziegler is an outstanding example of a Best Managed Company that impresses with its powerful mix of vision, productivity, innovative spirit and strong, value-oriented leadership. In addition, the company has the remarkable ability to harmonize attractive work and economic growth. It is an example of how companies can make a big difference in their region,” emphasizes Dr. Christine Wolter, Partner and Lead of Deloitte Private.

About Eckert & Ziegler
Eckert & Ziegler SE with more than 1.000 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

About Best Managed Companies Program
The Best Managed Companies Program is a competition and seal of quality for successful medium-sized companies. It was launched by Deloitte in Canada in the 1990s and has since been successfully introduced in more than 45 countries. Companies with an annual turnover of at least 150 million € and headquarters in Germany can apply. In addition, the companies must be medium-sized or family-owned and show successful economic development in recent years.

Press Release:
Eckert & Ziegler receives “Best Managed Companies Award”

Captain T Cell, a spin-off from the Max Delbrück Center, raised €8.5 million in startup funding. The startup focuses on developing T cells to target solid tumors. The funds are intended to move a new generation of T cell therapies towards the clinic.

Captain T Cell GmbH announced the successful closing of a seed financing round totaling €8.5 million. The company announced this on May 22, 2024. A syndicate of experienced life science investors including i&i Biotech Fund I SCSp, Brandenburg Kapital GmbH, and HIL-INVENT Ges.m.b.H participated in the round. In addition, the German Federal Ministry of Education and Research (BMBF), is supporting the Company, which is based in Berlin-Schoenefeld, as part of its GO-Bio program. Biotech expert Jörn Aldag has been appointed as the Chairman of the Board of Directors.

Captain T Cell is a spin-off from the Max Delbrück Center for Molecular Medicine in the Helmholtz Association. The startup builds on years of research and innovations conducted in the labs on Campus Buch and utilizes technologies developed there. Furthermore, the Max Delbrück Center provided significant financial and infrastructural support throughout the pre-seed phase and remains a close partner of the company, along with technology transfer consultancy Ascenion. Ascenion had supported the Captain T Cell team for several years before its foundation and negotiated the license agreement with Captain T Cell for the Max Delbrück Center.

The funds will be used to accelerate a new generation of T cell therapies against solid tumors towards the clinic. Captain T Cell develops first-in-class efficacy-enhanced TCR-T cells for solid tumors that are not addressed by existing therapies. In preclinical in vivo models, the Company has been able to completely eradicate aggressive tumors using these efficacy-enhanced T cells. A key technology established by the Captain T Cell team is its proprietary TCR-ALLO platform for off-the-shelf treatment of solid tumors. The tool can be expanded to a variety of cancer indications.

Dr. Felix Lorenz, CEO of Captain T Cell, said: “This successful financing round allows us to accelerate our high-potential therapies and brings us closer to providing life-saving options for patients underserved by current treatments. We are steadfast in our mission to progress our lead candidate towards the clinic and to establish our TCR-ALLO platform as a leader in off-the-shelf solid tumor therapeutics.”

Further information

• New funding for Captain T Cell
• Therapeutics Development

The BIO International Convention attracts 15,000+ biotechnology and pharma leaders for one week of intensive networking to discover new opportunities and promising partnerships. Campus Berlin-Buch GmbH is attending this year's event, June 3-6, in San Diego.

Meet our Managing Director, Dr. Christina Quensel, at the German Pavilion at BIO 2024 and learn more about Berlin-Buch – the location of future innovation. Excellent biomedical research and one of the largest biotech parks in Germany define the Science and Technology Campus Berlin-Buch. It offers start-ups and companies in the fields of biotech and medtech state-of-the-art laboratory and office space on a gross floor area (GFA) of around 45,000 m². Recently, 14,000 m² GFA of our newly opened start-up center for biotech and medtech start-ups, the BerlinBioCube, was added to this. The inspiring life science community on-site facilitates direct exchange and joint projects.

We look forward to presenting our life science ecosystem and its opportunities to shape the future of medicine in Berlin. You can find us at booth 4217, see you there!

#BIO2024

Photo: Peter Himsel / Campus Berlin-Buch GmbH

The Life Science Learning Lab at the Berlin-Buch research campus offers both school students and teachers the opportunity to immerse themselves in science. This year, the facility celebrates its 25th anniversary

A white coat is more than just a protective garment. It is a symbol. Claudia Jacob, who heads the Life Science Learning Lab at the Berlin-Buch research campus, has often observed this phenomenon. Each year, some 14,000 school students and teachers visit the learning laboratory in the green setting in the north of Berlin. “They take on a different role when they put on their lab coats,” remarked Claudia Jacob. “Their curiosity seems to be awakened in an instant.” In the late 1990s, the founding director of the Max Delbrück Center, Professor Detlev Ganten, had the idea of establishing an information center to keep citizens abreast of developments in genetic engineering and biotechnology. The aim was for visitors to be able to look over the shoulders of scientists working in the lab. But Dr. Ulrich Scheller, then head of the public relations team at Campus Berlin-Buch GmbH (CBB) and now one of its managing directors, knew that just watching was not enough. The biochemist is convinced that “if you want to get people excited about research, you have to give them a chance to work with pipettes and test tubes.” And so the concept was revised.

In April 1999, after three years of renovation, the Life Science Learning Lab opened its doors as a student lab in the listed carriage house on the research campus.

More than 20 different courses

It all began with four molecular genetics experiments. Today, 25 years later, there are six laboratories in all, making it one of the largest facilities of its kind in Germany. The CBB runs the Life Science Learning Lab together with the Max Delbrück Center and the Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP); they are supported by numerous sponsors and partners, including the campus-based company Eckert & Ziegler, a provider of isotope technology for medical, scientific and industrial use. Together, they offer more than 20 experimental courses covering topics such as molecular biology, cell biology, neurobiology, chemistry, radioactivity and ecology. “We are one of the few student labs in Germany where young people can even conduct experiments with CRISPR-Cas9 gene scissors,” remarked Ulrike Mittmann, scientific leader of the Molecular Biology Laboratory. Since molecular biology involves working with cells and pathogens or genetically modifying organisms, strict safety regulations apply. Schools, unlike the Life Science Learning Lab, cannot adhere to such strict regulations. As a result, the facility is a vehicle for exposing young people to current research topics.

Something for everyone

The Forschergarten at the Life Science Learning Lab also caters to young children of elementary school and kindergarten age. Moreover, there are working groups for school students, vacation courses, lectures and laboratory courses to prepare students for college. Teachers attend professional development sessions to learn about newly designed courses in the Life Science Learning Lab. In the “Lab meets Teacher” format, the Max Delbrück Center also offers teachers insights into current research topics and methods, such as single-cell analysis and Artificial Intelligence in biomedicine. Together with the Max Delbrück Center, the FMP and the Experimental and Clinical Research Center, the Life Science Learning Lab organizes the regional competition “Jugend forscht” Berlin-Brandenburg – most recently in February of this year. A total of 95 school students presented their projects at the Max Delbrück Communications Center and were given an insight into the research facilities and the Student Lab on the campus during the supporting program. “Fostering young talent is the primary goal of the Life Science Learning Lab,” commented Ulrich Scheller. “In addition to providing basic knowledge for all, we also support high-achieving school students to prepare them for a career in science or the life sciences sector.” After all, young talent is in short supply everywhere, including research labs. That is why it is important to encourage young people to train or study in this field, said Scheller. His co-managing director Dr. Christina Quensel added: “We want to show young people that researchers do not focus on abstract issues that no one else understands, but that their work affects society as a whole.” That is why ethical issues are on the agenda alongside the school curriculum. For example, why are animal experiments necessary, why should we be particularly cautious about stem cell therapies, and what does a genetic fingerprint reveal about a person? Both researchers and students benefit from this face-to-face interaction. “It is important that scientists occasionally come down from the ivory tower of basic research and explain their work in a way that is easy to understand,” stated Christina Quensel. “Many a scientist has chosen to change careers to teaching after such an experience.”

Parallels to soccer

To develop the course content, the Life Science Learning Lab team works closely with teachers from four partner schools in Berlin. They help the lab staff prepare cutting-edge research topics to fit the framework curriculum. “It takes a lot of effort for teachers to come to us with a class,” Ulrich Scheller explained. “They have to inform the parents, collect money and take the suburban train to Berlin-Buch. That means we have to give them something they can use for their classes.”

Anyone who has seen Claudia Jacob welcoming new students to her neurobiology class has no doubt that she manages to do just that. She has the youngsters put on special glasses and lets them play with various balls in the foyer of the Max Delbrück Communications Center. Ripples of laughter fill the room. The glasses change the angle of vision, making throwing and catching virtually impossible – this is what it feels like when our brains and nervous systems are misled. “Starting the class in this way sparks curiosity in the subject,” stated Claudia Jacob. It is much easier to understand when you experience firsthand what is about to be tested in various experiments. Biology is then no longer just a school subject, but the science that teaches us how an organism works. “It’s like soccer”, said Ulrike Mittmann, putting it in a nutshell. “Even if you can recite all the rules and know in theory that the ball has to go into the net, that doesn’t make you a world champion. The only way to become a world champion is to actually sprint across the field.”

For this reason, hands-on experience is a top priority in the Life Science Learning Lab. How much caffeine is in cola, how scented oils are extracted from plants, how long it takes for a nerve impulse to travel from the brain to the big toe – these are just some of the things students learn under the guidance of Claudia Jacob and her colleagues. At the end, they present their results to the class. The content of the course is not set in stone, and new things are being added all the time. Dr. Bärbel Görhardt, scientific leader of the Chemistry Laboratory, is currently designing two new courses: one on dyes in algae and how they can be extracted, and another on enzymes, which act as catalysts to initiate or accelerate various chemical reactions in the body.

Digitization in the laboratory

“In the future, we would like to link the activities of the Life Science Learning Lab more closely to current research on campus,” said Professor Maike Sander, Scientific Director and Chair of the Board of the Max Delbrück Center. One of the goals is to introduce students to innovative technologies such as single-cell sequencing and new imaging techniques. In addition, budding researchers are always guaranteed a place in the courses – perhaps not always in person, but in the form of short videos. In these videos, students explain their own experiments, which are not so dissimilar to those in the Life Science Learning Lab. “This allows the young people to see that their experiments are close to real research,” remarked Maike Sander. New media is also being used more extensively: for example, students can wear virtual reality goggles to see inside a human heart. “When they see a misfolded protein with their own eyes and observe the chain reaction that occurs, they can better understand how this affects the function of the heart,” explained Sander. As part of its graduate program, the Max Delbrück Center has launched a communications course in which doctoral students produce explainer videos and animations for the Life Science Learning Lab. In addition, the Max Delbrück Center plans to provide digital workbooks and teaching materials for schools. The FMP is also keen to focus more on current scientific and technological developments. “One exciting area is Artificial Intelligence, where we want to develop projects that allow students to understand the basics of AI and where we see areas of application in our research areas,” explained Professor Dorothea Fiedler, Director of the FMP. And the lab leaders of the Life Science Learning Lab would like to see more digitization of their work: for example, students could receive work instructions on tablets and store and share their results in the cloud. New media also offer great opportunities for microscopy, commented Ulrike Mittmann: “Looking at your own blood cells not just through an eyepiece, but on a large screen – and then taking the image home as a screensaver on your smartphone – that would be awesome!”

A truly worthwhile contribution

Inspiring a passion for research is important to everyone involved, including Paola Eckert-Palvarini, member of the Supervisory Board of Eckert & Ziegler SE. She initiated not only the Forschergarten, but also the Radioactivity Laboratory. “Radioactivity has a bad reputation in Germany,” remarked the radiation physicist, “out of ignorance.” She wants to put an end to that. In addition to experiments, she also passes on practical knowledge. Natural radiation is everywhere: “There is cosmic radiation from space, radioactive elements and rocks in the ground emit radiation, as do certain foods and even we humans.” This natural background radiation is not a health hazard. It is a different matter for radiation generated and used in industry and medicine, such as measuring the thickness of paper or treating cancer. But there is no reason to be afraid, the scientist explained: “Because we can measure radioactivity, we can use it wisely and protect ourselves from it.” Eckert-Palvarini also wants to explain how research works and what it takes to keep research results from disappearing into a drawer. The scientist is also an entrepreneur. “Research is not just about standing in a lab and chasing your own dream,” she stated. “It is also about putting discoveries and inventions to work for people.” That includes patents and licenses, as well as starting up companies. The students sometimes ask her lots of questions about these issues. “Of all the things I do, the student courses are the most rewarding,” remarked Eckert-Palvarini. “Afterwards, I go home feeling like I’ve really done something worthwhile.”

Future euphoria at Berlin-Buch

After 25 years in existence, the Life Science Learning Lab is now poised to grow beyond the boundaries of the research campus. In the new Education and Integration Center, to be built on the open space at Groscurthstraße 21-33 in the center of Berlin-Buch, it will operate three laboratories – “not quite as technically sophisticated as the laboratories on campus, but more suitable for families, where children can be introduced to scientific topics in a playful way,” explained Ulrich Scheller. This development places the Life Science Learning Lab in the heart of Berlin-Buch – the location of future innovation, where it will take on another task for society as a whole: Teaching people of all ages how science works. This includes showing them that it is part of normal scientific discourse for researchers to hold different views. “In research, many different paths lead to the goal,” noted Christina Quensel. “And it can happen that new knowledge turns everything we thought we knew upside down. We want to share this future euphoria with the public.” Dorothea Fiedler is of the same opinion: “We do not just want to communicate knowledge, but also to stimulate curiosity and foster the ability to apply and question scientific methods.” Claudia Jacob also considers this important – “especially in this day and age when so many skeptics of science are coming on the scene and spreading their alternative truths.” Putting on a lab coat and assuming the role of researcher can help us all to form an informed opinion.

Text: Jana Ehrhardt-Joswig / Campus Berlin-Buch GmbH

Neuroscientists Gary Lewin and James Poulet at the Max Delbrück Center for Molecular Medicine have won highly coveted and competitive ERC Advanced Grants to study pain and the neural mechanisms that underlie temperature perception.

The European Research Council (ERC) has awarded Max Delbrück Center neuroscientist Professor Gary Lewin his third prestigious Advanced Grant of €2.5 million over five years to study how nerves in the skin become overly sensitive to mechanical stimuli and cause chronic pain. “The research could lead to new pain medicines, which are sorely needed,” says Lewin.

The ERC has also awarded Max Delbrück Center neuroscientist Professor James Poulet a €2.5 million Advanced Grant to study the relationship between core body temperature in mammals and their perceptions of external temperature. Poulet’s research is basic in nature and focuses on understanding how the healthy brain functions.

Perception of mechanical pain

Gary Lewin, Group Leader of the Molecular Physiology of Somatic Sensation lab, has been researching the perception of touch and pain for over 25 years. He is a pioneer in the study of the molecular mechanisms responsible for sensing mechanical pressure on the skin – a stroke or pinch for example – in mammals.

Earlier this year, Lewin and his team reported discovering a new ion channel – pores in cellular membranes through which charged biomolecules pass through to generate the electrical activity of cells. The ion channel, called Elkin1, is present in sensory endings in the skin. It plays an essential role in transmitting the sense of touch via nerve fibers to the brain. The study was published last month in the journal “Science.”

With his new Advanced Grant, Lewin now aims to use proteomic techniques that quantify all proteins in single cells to identify ion channels in skin involved in transmitting the sense of pain. “One of the approaches we want to take is to compare the proteomes of cells that transduce these persistent mechanical stimuli to cells that don't,” Lewin explains.

Hypersensitive nerves cause many types of chronic pain syndromes, says Lewin. For example, pressure sensitive nerve fibers may become hypersensitive to mechanical stimuli causing painful sensations to the slightest touch. “We want to find the distinctive molecules that are exclusively involved in the transduction of persistent mechanical painful stimuli,” he adds.

The research could lead to new types of pain treatments. It has been decades since a new pain medication has been introduced to the market, says Lewin, who developed an antibody-based pain treatment 28 years ago. The antibody was never marketed for use in humans but is now the basis of a medication given to dogs and cats suffering from chronic arthritis pain. Moreover, many existing pain medications do not provide sufficient relief for people suffering from chronic pain, he adds.

Lewin is thrilled to be among the selected awardees: “I’m very happy. It's so gratifying that the ERC felt that our project was both interesting and new, to fund me for a third time.”

Maintaining a healthy body temperature

How the brain perceives different types of sensory stimuli is a fundamental, but unsolved, problem in neuroscience. It has long been thought that the brain regulates internal body temperature and senses external temperatures via separate networks of neuronal cells, explains James Poulet, Group Leader of the Neural Circuits and Behavior lab. But Poulet’s research suggests this view is too simplistic.

In a research paper published in the journal “Nature” last year, Poulet and his colleagues identified the primary cortical representation of temperature, a “thermal cortex,” in a posterior region of the insular cortex. This region not only responds to external temperature, but may also compare core temperature with skin temperature to create a signal by which the brain perceives the difference between the two.

“Rather than being completely separate systems, we think that brain networks that control our core physiology and those that sense the environment communicate closely with each other,” Poulet says.

With his Advanced Grant, Poulet and his colleagues will compare human and mouse, which are warm-blooded, to naked mole-rats, which are cold-blooded, to identify the cellular networks that integrate sensory and core body-state information. The researchers plan to use a combination of techniques that include neural recordings and anatomical tracing, which identifies connections between brain areas.

Poulet’s lab also plans to study individual differences in core body temperature and how they contribute to differences in perception of external temperature – a phenomenon that may explain why one person might feel the need to wear a jacket when the outside temperature is 15 degrees Celsius, while another is comfortable in a T-shirt.

Although the research will have implications for diseases that involve disrupted physiology, Poulet is more focused on studying how the brain works. “Understanding the healthy brain is how we're going to solve brain diseases in the long term,” he says.

Poulet is “happily surprised and excited,” at having won an Advanced Grant. “It's a real honor.”

Prof. Dr. Fan Liu from the Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP) has recently received several awards for her contributions to the field of cross-linking mass spectrometry. The scientist is dedicated to better understanding the interactions between proteins at the cellular level. Additionally, she is developing methods and standards to refine this complex and indispensable technology for many research questions, making it more broadly applicable.

A lot is already known about the processes in human cells, but this knowledge is insufficient to understand, for example, how neurodegenerative diseases originate and can be cured. "To counteract diseases, we first need to know exactly how the cell functions in its normal state," says FMP researcher Prof. Dr. Fan Liu.

The biologist specializes in analyzing the interactions of proteins in cells. Such protein-protein interactions (PPI) underlie nearly all cellular processes. Deciphering them is crucial to understand the regulatory mechanisms of the cell under physiological and pathological conditions. Fan Liu and other researchers worldwide use cross-linking mass spectrometry (XL-MS) for this purpose. It is the only technology currently available that can both reveal the identities of interacting proteins and localize their binding interfaces. Additionally, XL-MS provides information about the three-dimensional structures of proteins.

Since 2017, Fan Liu has been the head of the "Structural Interactomics" research group and the Mass Spectrometry technology platform at FMP, and she also holds a professorship for Structural Interactomics at the Charité. She is working on developing new XL-MS methods and applying them to highly complex biological samples. Her goal is to gain more comprehensive insights into the naturally occurring three-dimensional structures and interactions of proteins in a cell, to better understand its general biological state and the cellular processes that are currently active.

Until a few years ago, XL-MS experiments were limited to simple mixtures of purified proteins, but they can now provide deep insights into the cellular proteome and interactome – the totality of proteins and PPI within a cell. Fan Liu has made significant contributions to this dramatic improvement: "I have developed several key methods for proteome-wide XL-MS studies and new applications that enable unprecedented insights into various complex biological systems," she says. This includes a workflow that significantly accelerates the identification of thousands of cross-links in intact human cells, with a much larger number of proven PPIs. Fan Liu and her team have also developed approaches for standardization and quality assurance in XL-MS, as well as software solutions for automatic analysis and visualization of XL-MS data.

For these diverse achievements, Fan Liu received together with Dr. Jonas Warneke from the University of Leipzig the Mattauch-Herzog Sponsorship Award in March 2024, presented by the German Society for Mass Spectrometry (DGMS) and endowed with 12,500 euros. "I am very pleased that my work in the field of XL-MS has been recognized. My goal is to provide better access to cellular data across numerous biological fields and to translate this information into useful applications," says Fan Liu about the award.

Back in January, the FMP researcher had already been named one of the "2024 Rising Stars in Proteomics and Metabolomics" by the Journal of Proteome Research (JPR) of the American Chemical Society. A few weeks later, she and Patrik Verstreken from the Leuven Brain Institute received a Collaborative Pairs Pilot Project Award from the Neurodegeneration Challenge Network (NDCN) of the Chan Zuckerberg Initiative. The researchers aim to study the interactions between synaptic proteins of hibernating animals to better understand how hibernators counteract the permanent loss of synapses. Through this, Fan Liu and Patrik Verstreken hope to gain insights into how synapse loss in human neurodegenerative diseases can be mitigated.

Source: Press Release at the website of the Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP): The Protein Expert

Eckert & Ziegler BEBIG GmbH, subsidiary of Eckert & Ziegler SE with focus on brachytherapy solutions for the treatment of prostate cancer as well as eye and brain tumors, obtained the MDR certificate for its proprietary prostate seeds from DEKRA Certification B.V. as one of the first companies in its market. This important milestone guarantees a high level of patient safety and the long-term availability of the seeds within the EU.

The Medical Device Regulation (MDR) is a European Union directive (EU 2017/745) with the aim of improving the quality of medical devices and increasing patient safety. Prostate seeds have been manufactured and internationally marketed by Eckert & Ziegler since 1999 and contribute several million euros in annual sales to the Eckert & Ziegler Group's earnings.

"We are very pleased about the first successful MDR certification. It confirms that our quality management system and the prostate seeds comply with the stringent requirements and that we can continue to provide them to our users as a safe medical device. This is not only a significant achievement for the distribution of our brachytherapy products, but for the entire Eckert & Ziegler Group," explained Katrin Antonenko, Managing Director of Eckert & Ziegler BEBIG GmbH. "We are already working intensively on the certification of our other medical products in order to ensure patient care for further applications in the long term. We will benefit from the experience gained from the successful approval process."

In prostate seed brachytherapy, pinhead-sized implants are inserted directly in the prostate. Due to the proximity of the radiation source to the tumor, the surrounding healthy tissue is spared as much as possible in this minimally invasive radiation procedure.

About Eckert & Ziegler.
Eckert & Ziegler SE with more than 1.000 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse

Source: Press Release
Eckert & Ziegler Receives MDR Certification for Prostate Seeds, Paving the Way for Long-term Supply