News

When blood cancer cells break through the bone and multiply, tumor cells become dangerously diverse and the immune response in the region changes, researchers from Berlin and Heidelberg report in “Science Immunology.” The detailed insights into cancer progression could advance diagnostics and treatment.

The incurable bone marrow cancer “multiple myeloma” often develops unnoticed in the bone marrow over decades. In advanced stages, lesions form that can destroy the bone and spread to other parts of the body. An interdisciplinary team from the Berlin Institute of Health at Charité (BIH), the Max Delbrück Center, the Queen Mary University of London's Precision Healthcare University Research Institute (PHURI), the Myeloma Center at Heidelberg University Hospital (UKHD), the University of Heidelberg and the German Cancer Research Center (DKFZ), together with other national and international partners, have been investigating what happens in these lesions when myeloma cells first break through the bone. The researchers discovered that the tumor cells diversify drastically when exiting the bone marrow, which also affects the immune cells in the cancer lesions. The new findings could contribute to more precise diagnostics and therapy, they report in “Science Immunology.”

When the tumor cells leave the bone, they find themselves in a completely different environment with different environmental conditions. “We suspect that this diversity helps the cancer cells adapt to survival outside the bone, enabling them to spread to other areas of the body,” says Dr. Niels Weinhold, head of Translational Myeloma Research at the UKHD's Department of Hematology, Oncology and Rheumatology.

Using innovative single-cell and spatial omics technologies, the team also examined for the first time how the immune system reacts to this “outbreak” of cancer cells from the bone. They discovered significant changes in the type and number of immune cells in the microenvironment of the cancerous lesions. For example, certain immune cells, known as T cells, had very different receptors and surface molecules in the foci outside the bone – a possible adaptation to the newly emerged heterogeneity of the tumor cells.

Uncovering the interaction between the immune system and cancer

“There seems to be a co-evolution between tumor and immune cells, in which both sides react to changes in the other,” says Professor Simon Haas, co-corresponding author of the study. He heads a lab in the joint focus area “Single-cell approaches for personalized medicine” at the BIH, Max Delbrück Center, and Charité – Universitätsmedizin Berlin. He is also chair for single cell technologies and precision medicine at PHURI. The researchers hypothesize that this intensified interaction between the immune system and the cancer may both promote and hinder the fight against the disease. The team is currently investigating which factors contribute positively or negatively to this interaction.

For their analyses, the international team used tissue samples that originated from myeloma lesions in various parts of the body. The material was obtained either by image-guided biopsies or during operations on fracture-prone or already broken bones. “Single-cell analysis and spatial multi-omics technologies enabled us to simultaneously investigate a wide range of properties of thousands of individual cells, taking into account their exact position in the tissue,” says Dr. Llorenç Solé Boldo, one of the first authors of the study.

The results could influence the diagnosis and therapy of myeloma in the future. Currently, samples for diagnosis are usually taken from the iliac crest (part of the pelvis) of patients. However, since the study has shown that cancer and immune cells in hotspots where the cancer cells break out of bone differ significantly from those in the iliac crest, these sites may be better suited for sample collection and allow a more precise assessment of the disease and possible adjustment of therapy.

Text: UKHD

• ²²⁵Ac-satoreotide is a first-in-class Actinium-labelled somatostatin receptor 2 antagonist targeting extensive-stage Small Cell Lung Cancer or Merkel Cell Carcinoma
• Orphan Drug Designation follows outstanding preclinical data and FDA IND clearance
• Phase I/II human trials set to commence in Q1 2025 as a ‘theranostic’ targeted radionuclide treatment

Berlin, Germany, 6 February 2025 – Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ²²⁵Ac-SSO110 (satoreotide) for the treatment of patients with Small Cell Lung Cancer (SCLC).

SCLC is a deadly condition that represents a significant unmet medical need due to the limited number of treatment options available to patients with this aggressive form of cancer. Two-thirds of SCLC patients are diagnosed at an advanced stage where the disease has already spread significantly, resulting in a poor prognosis and a 5-10% overall five-year survival rate. Ariceum will commence Phase I/II human clinical development of ²²⁵Ac-satoreotide under the trial name, SANTANA-225 in Q1 2025.

Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: “Receiving ODD for ²²⁵Ac-satoreotide is a recognition of its potential as a treatment option for patients with SCLC and an important regulatory milestone for Ariceum. The FDA’s ODD will support our objective to accelerate the development of ²²⁵Ac-satoreotide through human trials to provide a potentially life-saving therapy to patients with limited alternatives.”

The FDA provides ODD to drugs and biologics that demonstrate potential for the diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 people in the U.S. The designation provides development and commercial incentives for designated compounds and medicines, including eligibility for seven years of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design, and an exemption from FDA user fees.

In October 2024, Ariceum published outstanding preclinical data demonstrating the significant potential of ²²⁵Ac-satoreotide to outperform SSTR2 targeting agonists. ²²⁵Ac-satoreotide showed a high frequency of complete durable responses and 100% survival supporting advanced clinical development in SCLC, MCC, and other aggressive cancers. ²²⁵Ac-satoreotide in combination with its companion patient selection tracer 68Ga-SSO120 is being developed as a ‘theranostic pair’ for the combined diagnosis and targeted radionuclide treatment of multiple indications expressing SSTR2, such as SCLC, MCC, and other aggressive, hard-to-treat cancers.
 

About Ariceum Therapeutics
Ariceum Therapeutics is a private, clinical stage radiopharmaceutical company focused on the diagnosis and precision treatment of certain neuroendocrine and other aggressive, hard-to-treat cancers. The name Ariceum is an anagram of ‘Marie Curie’ whose discovery of radium and polonium have been huge contributions to finding treatments for cancer.

Ariceum’s lead targeted systemic radiopharmaceutical candidate, SSO110 (“satoreotide”) labelled with Lutetium-177 (¹⁷⁷Lu) and Actinium-255 (²²⁵Ac) is an antagonist of the somatostatin type 2 (SSTR2) receptor which is overexpressed in aggressive neuroendocrine tumours (NETs) such as small cell lung cancer (SCLC) or Merkel Cell Carcinoma (MCC), all of which have limited treatment options and poor prognosis. Satoreotide is being developed as a ‘theranostic pair’ for the combined diagnosis and targeted radionuclide treatment of these tumours. Ariceum is also developing a radiolabelled PARP-inhibitor (ATT001), currently in Phase 1 clinical development under the trial name CITADEL-123. ATT001 was part of the acquisition of Theragnostics Ltd which was closed in June 2023.

Ariceum Therapeutics, launched in 2021, acquired all rights to satoreotide from Ipsen, which has remained a shareholder of the Company. Ariceum is headquartered in Berlin, with operations in Germany, Switzerland, Australia, the United Kingdom, and the United States.

Ariceum is led by a highly experienced management team and supported by specialist investors including EQT Life Sciences (formerly LSP), HealthCap, Pureos Bioventures, Andera Partners, and Earlybird Venture Capital. For further information, please visit www.ariceum-therapeutics.com.

The Max Delbrück Center congratulates Professor Heike Graßmann, who has served as Administrative Director of the research center since 2018, on her appointment as State Secretary for Science, Culture, and Tourism in Saxony. Graßmann will assume her new role in Dresden on February 1, 2025.

Today, Saxony's Minister-President Michael Kretschmer (CDU) announced the appointment of Professor Heike Graßmann, previously the Administrative Director of the Max Delbrück Center for Molecular Medicine in the Helmholtz Association in Berlin, as the new State Secretary in the Ministry of Science, Culture, and Tourism. In her new role, Graßmann will work closely with State Minister Sebastian Gemkow.

“The scientific landscape in Saxony is outstanding. Our researchers and the diverse institutions in Saxony have an excellent international reputation. I am very much looking forward to helping shape science policy and further developing Saxony as a hub of excellence. I am eager to bring my extensive experience to this new role,” said Graßmann.

“I warmly congratulate my colleague Heike Graßmann and wish her every success in her new position. Heike is an excellent manager and a highly respected expert in the German scientific landscape,” said Professor Maike Sander, Scientific Director of the Max Delbrück Center. “I deeply appreciate her outstanding contributions to the Max Delbrück Center and our excellent collaboration. As Administrative Director, she has positioned our research center’s administration to meet future challenges effectively. Her efforts to advance digitalization, strengthen cooperation between science and administration, foster community spirit, and enhance diversity have left a lasting impact. She also played a pivotal role in strengthening the Max Delbrück Center’s network in Berlin.”

About Heike Graßmann

Born in Thuringia, Graßmann (53) is an accomplished science manager with an impressive career. Since October 2018, she has served as Administrative Director of the Max Delbrück Center, overseeing areas such as finance, human resources, legal affairs, and infrastructure. She has also driven initiatives in internationalization, digitalization of administration, and diversity and cultural topics.

Before joining the Max Delbrück Center, Graßmann, who holds a PhD in business administration, served as Administrative Managing Director of the Helmholtz Centre for Environmental Research (UFZ) in Leipzig for many years. Since 2022, she has been a member of the University Council at Leipzig University and holds an honorary professorship at the State Academy for Studies in Leipzig, part of the University of Cooperative Education Saxony.

Graßmann has long been committed to talent management, gender equality, and diversity at the Max Delbrück Center and beyond. She mentors young women in various programs and served as treasurer for BR50, the Berlin Association of Non-University Research Institutes, where she helped establish a network for administrative leaders in Berlin. She currently chairs the organizing committee for the Long Night of Sciences in Berlin.

Graßmann studied business administration at Martin Luther University Halle-Wittenberg, where she also worked as a research associate. Before joining the UFZ, she served as personal assistant to the Executive Board at the Helmholtz Centre for Environmental Research and the Chancellor at Leipzig University. From 2012 to 2018, she led the finance department at the UFZ before becoming its Administrative Managing Director.

Source: Press Release Max Delbrück Center
Heike Graßmann new State Secretary in Saxony

Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) today signed a licence agreement with Qi Kang Medical, Ltd (QKM), a joint venture between Eckert & Ziegler and the Chinese company DC Pharma, for the cyclotron technology used by Eckert & Ziegler to manufacture Ac-225. The contract guarantees Eckert & Ziegler a one-time payment of EUR 10 million and additional royalties on Ac-225 sales.

For Eckert & Ziegler the licence and collaboration agreement is an important step towards establishing the company as a major supplier of Ac-225 for the radiopharmaceutical industry. Eckert & Ziegler is already supplying Ac-225 and will be able to provide the market with significantly increased quantities of Ac-225 in GMP quality from 2025.

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.

Source: Press Release Eckert & Ziegler
Eckert & Ziegler Signs Licence Agreement for Actinium-225 with Chinese Joint Venture

Berlin, Germany, 14 January 2025 – Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announced that the US Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to commence a Phase I/II clinical trial (‘SANTANA-225’) of its proprietary radiolabelled peptide, ²²⁵Ac-SSO110, in patients with small cell lung cancer (SCLC) or Merkel Cell Carcinoma (MCC).

The SANTANA-225 trial is a global, open-label Phase I/II study, that will assess the safety, tolerability, preliminary efficacy and recommended Phase II dose of ²²⁵Ac-SSO110 in patients with extensive-stage SCLC or MCC who are on first-line maintenance therapy with checkpoint inhibitors. Ariceum is working with its partners and clinical sites in the US and other countries to commence recruitment of patients in Q1 2025.

Germo Gericke, Chief Medical Officer at Ariceum Therapeutics, said: “This is an important milestone, not only for Ariceum but for the whole field of targeted radionuclide cancer treatments. ²²⁵Ac-SSO110 is the first somatostatin receptor 2 (SSTR2) antagonist labelled with Actinium-225 to undergo human trials, providing the optimum combination of a long half-life α particle emitter with a long tumour retention tracer. Based on encouraging clinical data with ¹⁷⁷Lu-SSO110 and very promising pre-clinical data of ²²⁵Ac-SSO110, we are very optimistic about the potential for patients with difficult to treat cancers.”

²²⁵Ac-SSO110 is being developed together with its companion patient selection tracer ⁶⁸Ga-SSO120 as a ‘theranostic pair’ targeted radionuclide treatment of multiple indications expressing SSTR2, such as SCLC, MCC, and other aggressive cancers. Ariceum has recently expanded its global supply agreements for the medical radionuclides Actinium-225 (²²⁵Ac) and Lutetium-177 (¹⁷⁷Lu), which will be used to radiolabel SSO110.

-Ends-

About Ariceum Therapeutics
Ariceum Therapeutics is a private, clinical stage radiopharmaceutical company focused on the diagnosis and precision treatment of certain neuroendocrine and other aggressive, hard-to-treat cancers. The name Ariceum is an anagram of ‘Marie Curie’ whose discovery of radium and polonium have been huge contributions to finding treatments for cancer.

Ariceum’s lead targeted systemic radiopharmaceutical candidate, SSO110 (“satoreotide”) labelled with Lutetium-177 (¹⁷⁷Lu) and Actinium-255 (²⁵⁵Ac) is an antagonist of the somatostatin type 2 (SSTR2) receptor which is overexpressed in aggressive neuroendocrine tumours (NETs) such as small cell lung cancer (SCLC) or Merkel Cell Carcinoma (MCC), all of which have limited treatment options and poor prognosis. Satoreotide is being developed as a ‘theranostic pair’ for the combined diagnosis and targeted radionuclide treatment of these tumours. Ariceum is also developing a radiolabelled PARP-inhibitor (ATT001), currently in Phase 1 clinical development under the trial name CITADEL-123. ATT001 was part of the acquisition of Theragnostics Ltd which was closed in June 2023.

Ariceum Therapeutics, launched in 2021, acquired all rights to satoreotide from Ipsen, which has remained a shareholder of the Company. Ariceum is headquartered in Berlin, with operations in Germany, Switzerland, Australia, the United Kingdom, and the United States.

Ariceum is led by a highly experienced management team and supported by specialist investors including EQT Life Sciences (formerly LSP), HealthCap, Pureos Bioventures, Andera Partners, and Earlybird Venture Capital. For further information, please visit www.ariceum-therapeutics.com.

Eckert & Ziegler (ISIN DE0005659700, SDAX) and GlyTherix Ltd (GlyTherix), an Australian targeted radiotherapy company specialising in developing antibody radiopharmaceuticals for solid tumors, today announced the expansion of their existing Lutetium-177 based collaboration with a global supply agreement for Actinium-225 (Ac-225). Eckert & Ziegler will provide high-quality Ac-225 to support GlyTherix’s clinical research and development activities on innovative alpha radiotherapeutics.

In December 2024 Eckert & Ziegler announced the start of their Ac-225 production as part of the collaboration with the Nuclear Physics Institute of the Czech Academy of Sciences (ÚJF). The establishment of Ac-225 manufacturing in GMP quality is ongoing and expected to be finalized in the first half of 2025, enabling new possibilities for pharmaceutical companies developing alpha-emitting drugs.

GlyTherix's radiotherapy approach combines a radionuclide 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. GlyTherix has commenced its Ac-225-based research and development activities at the Australian ARC Research Hub for Advanced Manufacture of Targeted Radiopharmaceuticals (AMTAR) at the University of Queensland.

“We are happy to extend our collaboration with GlyTherix to fully support the planned development activities also for Actinium-225-based radiopharmaceuticals,” said Dr. Harald Hasselmann, CEO of Eckert & Ziegler. ”Increasing the availability of Ac-225 is our key objective as it will accelerate both progress in clinical research and commercial applications, which will ultimately result in the improved access to cancer therapies for patients globally.”

Dr. Brad Walsh, GlyTherix Chief Executive Officer commented, “We are pleased to be able to rely on Eckert & Ziegler also for the supply of Actinium-225. Alongside with Lutetium-177, Actinium-225 will become an important part of our clinical program later this year. It is therefore vital securing a reliable network for global supply of the alpha emitter to consistently support our upcoming trials.”

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 events. 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.

Source: Press Release Eckert & Ziegler
Eckert & Ziegler and GlyTherix Extend Collaboration With Actinium-225 Supply Agreement

Researchers at the Experimental and Clinical Research Center in Berlin are developing a targeted treatment for muscular dystrophy with the help of gene-editing. Preclinical research led by the Spuler Lab published in “Nature Communications” now paves the way for first-in-human clinical trials.

Researchers at the Experimental and Clinical Research Center (ECRC), a joint institution of the Max Delbrück Center and Charité – Universitätsmedizin Berlin, have developed a promising gene-editing approach intended to restore the function of a protein that is essential to repair and regrow muscle in patients with muscular dystrophy diseases.

The dysferlin protein is primarily responsible for repairing cell membranes. People with certain mutations in the gene coding for dysferlin develop muscular dystrophy – a group of muscle wasting diseases that affect thousands around the world.

Professor Simone Spuler and her team led by Dr. Helena Escobar in the Myology Lab at ECRC have successfully removed muscle stem cells from two patients with limb-girdle muscular dystrophy, corrected the genetic error and restored functioning dysferlin proteins in cell culture. In new mouse models of the disease, they used the same process to collect cells, edit them and transplant the corrected cells back into mice, where protein function was restored and muscles began to regrow.

The preclinical findings, reported in “Nature Communications,” give the team confidence to move forward to human clinical trials. This would involve taking muscle cells from patients, editing them in the lab and transplanting the patient’s own cells back into targeted muscles. The researchers note this therapy is not a complete cure – it would be limited to one or two muscles.

“We have over 600 muscles in our body and it is not easy to target all of them,” says Spuler. “We are starting very humble with targeting one or two muscles. But if this therapy works, it will heal the muscle.”

Body of work

For nearly 20 years, Spuler and her collaborators have been working to understand dysferlin, its role in muscular dystrophy and ways to cure these rare but devastating inherited diseases. In the case of limb-girdle muscular dystrophy, muscle deterioration is progressive and young adults lose the ability to walk and normal use of their arms and hands.

“You go from being a good athlete in your teens to being in a wheelchair by 40,” says Spuler, who sees this first-hand with her patients at an outpatient clinic at ECRC.

Escobar, first paper author and molecular biologist in Spuler’s Lab, has been working on methods to collect muscle stem cells from patients and use gene-editing tools to fix mutations.

“We started with a more common mutation so that we can help as many patients as possible,” Escobar says.

Classical CRIPSR

To fix the dysferlin mutation, Escobar uses CRISPR-Cas9, which is often described as “gene-editing scissors” and for which a Nobel Prize was awarded in 2020. The molecular scissors are guided to a precise location along a DNA molecule and then cut it, forcing the cell to repair the DNA. The aim is for the mutation to be corrected during the repair process, resulting in a properly functioning gene. The researchers tested their editing system in several cellular models all with very similar results: It worked with a high success rate and minimal unintended consequences.

Notably, the editing did not result in an exact match to the desired genetic sequence and there were four changes in the generated dysferlin protein. The team conducted a thorough analysis of the changes in collaboration with Professor Oliver Daumke, who heads the Structural Biology of Membrane-Associated Processes Lab at Max Delbrück Center.

“Even with these four changes, the generated protein is very similar in function to the wild type, which is the version we see in healthy individuals. It localized along damaged cell membranes and muscle was regenerated,” Escobar says.

Crucial model and clinical trial

As part of this project, the researchers developed a new mouse model in collaboration with Dr. Ralf Kühn, who leads the Genome Engineering & Disease Models Lab at Max Delbrück Center. The mouse model closely mimics the specific dysferlin mutation and resulting disease, and enabled the researchers to evaluate how the complete therapy works – taking muscle stem cells, correcting them and transplanting the cells back. They especially wanted to learn if the immune system would reject the cells or attack the generated dysferlin proteins.

“We didn’t see an immune response against the transplanted cells or generated proteins, which is promising for taking this into a clinical trial,” Spuler says.

The team is now seeking funds to launch the first human clinical trial. If the trial is successful, it would still be many years before it is broadly accessible.

Simone Spuler and Helena Escobar are co-inventors on a pending patent application on gene editing of human muscle stem cells. Spuler is co-founder of MyoPax GmbH and MyoPax Denmark ApS. The study was funded by the Gisela Krebs foundation.

Left: Muscle fibers expressing dysferlin (purple) made from gene-edited muscle stem cells transplanted into a mouse that lacks dysferlin. Right: Muscle fibers from the recipient mouse that are diseased and lack dysferlin.© Andreas Marg, AG Spuler, ECRC

Source: Press Release Eckert & Ziegler
Developing a CRISPR therapy for muscular dystrophy

The German Research Foundation (DFG) has announced that biochemist Ana Pombo from the Max Delbrück Center is among this year’s winners of the Gottfried Wilhelm Leibniz Prize. With a grant of €2.5 million, the Leibniz Prize is one of the highest endowed research prizes in Germany.

Cells neatly fold two meters of their DNA into a nucleus only ten micrometers in diameter. Professor Ana Pombo is exploring this genome contortion mechanism to better understand how environmental exposures and experiences affect the spatial interaction between genes and their “on” and “off” switches.  In 2017, her research group at the Berlin Institute for Medical Systems Biology of the Max Delbrück Center (MDC-BIMSB) published a method in the journal “Nature” that can map the 3D architecture of entire genomes. By understanding how conformational changes in DNA affect how genes are regulated, researchers can develop ways to intervene.

For her groundbreaking work, the primary committee of the German Research Foundation (DFG) has honored Ana Pombo and nine other scientists with Germany’s most significant research award. She will receive the Gottfried Wilhelm Leibniz Prize at a ceremonial event on March 19, 2025. The prize comes with a grant of €2.5 million.

“We seek to reverse disease-causing cellular changes at the earliest possible stage. Achieving this requires a deep understanding of the mechanisms that govern genome function,” says Professor Maike Sander, Scientific Director of the Max Delbrück Center. “Ana Pombo's groundbreaking work is making a fundamental contribution to this goal. As a true pioneer in the field, we extend our warmest congratulations to her.” 

About Ana Pombo

Ana Pombo was born in 1969 in Portugal and studied biochemistry at the University of Lisbon. After completing her doctorate at the University of Oxford, she initially worked as a group leader at the MRC London Institute of Medical Sciences at Imperial College London, U.K. In 2013, she joined the Max Delbrück Center and simultaneously took on a professorship in Transcriptional Regulation and Genome Architecture at Humboldt University in Berlin. She is the Deputy Director of MDC-BIMSB and Deputy Program Spokesperson for the Max Delbrück Center. In 2007, she received the Robert Feulgen Prize and is a member of the European Molecular Biology Organization (EMBO) and the European Academy of Sciences.

Ana Pombo joins two previous winners at the Max Delbrück Center: Professor Nikolaus Rajewsky and Professor Carmen Birchmeier. Since 1985, the DFG has been honoring outstanding top researchers with the Leibniz Prize. The award provides recipients with opportunities to expand their research and hire highly qualified early-career scientists. The 2025 Leibniz Prizes will be presented in a ceremony on March 19, 2025, in Berlin. The award ceremony will be preceded by an event celebrating the 40th anniversary of the program, where all previous prize recipients will be able to connect and network.

Source: Press Release Max Delbrück Center
Leibniz Prize awarded to Ana Pombo

Eckert & Ziegler Radiopharma GmbH (Eckert & Ziegler), a leading provider of isotope technology for nuclear medicine and radiopharmaceutical applications, announces the submission of its GalliaPharm® 68Ge/68Ga Radionuclide Generator for approval in Japan. This will pave the way for broader access to cutting-edge diagnostic tools including 68Ga-PSMA-11 in Japan. For GalliaPharm®, Novartis Pharma K.K., will manage safety information and distribution of the product in Japan.

GalliaPharm® is widely used as a high-quality GMP grade generator for Gallium-68, supporting the production of radiopharmaceuticals for positron emission tomography (PET) imaging, particularly in oncology including the diagnosis of prostate cancer through PSMA imaging. An approval in Japan will provide the local healthcare community with an accessible and reliable tool to label Gallium-68 radiopharmaceuticals, offering new precision in diagnostic imaging that may improve early disease detection and patient outcomes.

“This step with the MHLW for us is a critical one,” stated Dr. Deljana Werner, Head of QA and Regulatory Affairs for the Medical Division of Eckert & Ziegler SE. “As a company committed to advancing nuclear medicine globally, we see GalliaPharm®’s entry into the Japanese market as a pivotal opportunity to support medical professionals in enhancing patient care through precise and innovative imaging solutions.”

By seeking approval in Japan, Eckert & Ziegler reinforces its commitment to meeting the specific needs of diverse healthcare markets, tailoring its innovations to support local advancements in nuclear medicine. This step not only underscores the company’s dedication to providing advanced radioisotopes for medical applications worldwide, but also strengthens its position as a trusted partner in the evolving landscape of radiopharmaceuticals.

About Eckert & Ziegler SE
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 SE shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse

Source: Press Release Eckert & Ziegler
Eckert & Ziegler Submits GalliaPharm® for Approval by Japan’s Health Authority MHLW

For almost a year, “Talk im Cube” has been bringing science and business together on the Campus Berlin-Buch

Since last February “Talk im Cube” regularly invites to exciting panel discussions followed by networking. The compact format is aimed at the campus community, scientists, start-ups and investors in Life Science. The Talks 2024 highlighted topics such as Female start-ups in the life sciences”, exit strategies, bridging preclinical to clinical or cancer drug development from a treating oncologist’s perspective.

An inspiring “Talk in the Cube” on financing models for start-ups took place on 28^th November.

Merle Fuchs, CEO and cofounder PRAMOMOLECULAR GmbH, Berlin-Buch discussed with Cornelia Jahnel, GOLDTRACK Ventures GmbH, Leipzig, Hannah-Sophie Braun, Investitionsbank Berlin and Robert Schwanke, Berliner Sparkasse the challenging fields of Biotech financing options, financing trends for biotechnology in Europe and ways for Biotech Start-Ups to find successful funding strategies.

What do VC investors expect from start-up teams?

Putting together a team for a successful spin-off is a learning process for scientists who want to found a company. Cornelia Jahnel and Hannah-Sophie Braun agreed that science and business must be mapped: Either someone has the market knowledge or is willing to acquire it or is willing to bring someone into the team who has these skills. Furthermore, someone on the team should keep an eye on the milestones and the final business goal.

How do you successfully get in touch with VC investors?

This question is essential for founders in the life sciences and the panelists made the following recommendations:

Small investment conferences and pitches help to get feedback such as: Am I still too early? Contact via LinkedIn and presentations at international conferences are a good option – for example biotech conferences in Riyadh, London or in Saxony, such as the Finance Days in Leipzig. Thinking internationally is important for start-ups, even though conferences are very expensive for them, while VC investors don't have to pay for them. To be able to assess which conferences are important, one should see which ones your competitors are attending.

If Start-ups are looking for contact with VC investors, they could be supported by Business angels who have excellent contacts and are highly professional.

Further important advices:

• Pitch whenever you can to enlarge your network.
• Whenever you can, ask for introductions or referrals from third parties when contacting  investors and try to avoid “cold inquiries”.
• It is essential to learn Story Telling and to condense information you want to provide. Keep in mind: Most of the VC investors are not experts in your field – therefore starting  to explain how to cure a patient with your invention instead of starting to delve into the depths of the technology.

Female founders

Women in C-level positions and as founders are currently rare are rare but the times are changing. There are more and more female managers at biotech funds and VCs are trying to support women for start-ups and leading positions. Role models need to be established and well-balanced, diverse management teams, i.e. with women / men in different age groups are key for being successful.

What is the best way to start?

Robert Schwanke and Merle Fuchs are convinced that both the Business Plan Competition and the Science for Life Competition are very good starting points for receiving early feedback and entering the ecosystem.

Hannah-Sophie Braun recommended mentoring programs such as the Creativ Destruction Lab (CDL) to get support with fundraising.

Merle Fuchs emphasized the need to go abroad as a high-tech start-up and recommended, for example, the Boston Incubator, which was very helpful for her company's development.

The tendency for programs such as Biolabs from the USA to come increasingly to Europe, was also discussed.

How can the German and European market become more attractive for VC?

Cornelia Jahnel is convinced that funds are needed as role models and that this will change the market: “That's why we are setting up a fund. It can't all be about state funding (EXIS, EXIST 1, EXIST 2...). Instead of grant thinking: Big Thinking! We go out to attract VCs from the US and Scandinavia. We in Germany tend to be risk averse, but there is a shift.”

Hanna-Sophie Braun confirmed this: “Large parts of the companies are moving to the USA, including some of the teams, and we need to be active here.”

Networking and feedback

Hanna-Sophia Braun finally remarked: “Networking is important, but choose the right funds and get feedback as often as possible from people who are more experienced than you.”

Cornelia Jahnel added: “Regardless whether you are fundraising or whether you plan to start a business: Mingle in different groups to share your ideas, to share how it went, to share what was good and what didn't work for you.”

Talk in the Cube - Outlook for 2025

The next Talk in the Cube is scheduled for 20 February 2025 on the topic “Intellectual Property Strategies in Life Sciences” – with the European Patent Attorneys Dr. Sun Jin Lee (Maiwald GmbH) and Dr. Oliver Ladendorf  (Kraus & Lederer PartGmbB). More information and registration shortly here: https://lnkd.in/dF9sfq6a

Other topics planned for 2025:

• International cooperation and funding programs in Life Sciences
• Life Science Marketing: ways to promote your products
• CROs in diagnostics and therapeutics development

Eckert & Ziegler, one of the world’s largest providers of isotopes for medical, scientific and industrial use, and Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announced the signing of a global supply agreement for the medical radionuclides Actinium-225 (Ac-225) and Lutetium-177 (Lu-177).

Following limited global availability, alongside increasing demand for Ac-225, which comes with intricate manufacturing complexities, this collaboration is a significant step forward in accelerating Ariceum’s novel targeted radiopharmaceutical pipeline programs.

Under the terms of the agreement, Eckert & Ziegler will supply Ariceum with the required quantities of non-carrier-added (n.c.a.) Ac-225 and Lu-177. Both radionuclides will be used to radiolabel Ariceum’s proprietary lead radiopharmaceutical drug (SS0110) satoreotide targeting hard-to-treat cancers in clinical studies and subsequent commercial phases. The agreement also includes options for expansion to other drugs as well as the use of additional radionuclides in preparation for future commercialization activities.

Dr. Harald Hasselmann, Chief Executive Officer of Eckert & Ziegler, commented: “In collaborating with Ariceum, we support their mission to develop innovative radiopharmaceuticals for the benefit of patients. Both the production start for Ac-225, announced earlier this week, and the successful European approval of Theralugand^®, show that our goal is to sustainably reduce the shortage of high-quality radioisotopes. We aim to foster the progress of novel treatments in clinical trials and beyond, and thus contribute to saving lives.”

Manfred Rüdiger, Chief Executive Officer of Ariceum Therapeutics, said: “This important global supply agreement with Eckert & Ziegler for n.c.a. Ac-225 and Lu-177 will ensure an adequate supply of radionuclide isotopes to conduct our clinical trials. We are looking forward to working with the Eckert & Ziegler team to build a robust supply chain and to reliably deliver targeted theranostic treatments for patients with hard-to-treat cancers. Our lead radiopharmaceutical drug, satoreotide is a first-in-class, antagonist of the somatostatin receptor 2 (SSTR2) labelled with Ac-225 to enter clinical development in small cell lung cancer and in Merkel Cell Carcinoma very soon.”

About Eckert & Ziegler SE
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 SE shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.

About Ariceum Therapeutics, GmbH
Ariceum Therapeutics (Ariceum) is a private, clinical stage radiopharmaceutical company focused on the diagnosis and precision treatment of certain neuroendocrine and other aggressive, hard-to-treat cancers. The name Ariceum is an anagram of ‘Marie Curie’ whose discovery of radium and polonium have been huge contributions to finding treatments for cancer.
Ariceum’s lead targeted systemic radiopharmaceutical product, 177Lu-satoreotide tetraxetan (“satoreotide”), is an antagonist of the somatostatin type 2 (SSTR2) receptor which is overexpressed in neuroendocrine tumours (NETs) and some aggressive cancers such as small cell lung cancer (SCLC), or Merkel Cell Carcinoma (MCC), all of which have few treatment options and poor prognosis. Satoreotide is being developed as a ‘theranostic pair’ for the combined diagnosis and targeted radionuclide treatment of these tumours. Ariceum is also developing a radiolabelled PARP-inhibitor (ATT001), currently in Phase 1 clinical development under the trial name CITADEL-123. ATT001 was part of the acquisition of Theragnostics Ltd which was closed in June 2023.
Ariceum Therapeutics, launched in 2021, acquired all rights to Satoreotide from Ipsen. Ipsen remains a shareholder in the Company. Ariceum is headquartered in Berlin, with operations in Germany, Switzerland, Australia, United Kingdom and United States of America and with activities currently across the globe.
Ariceum is led by a highly experienced management team and supported by specialist investors including EQT Life Sciences (formerly LSP), HealthCap, Pureos Bioventures, Andera Partners and Earlybird Venture Capital. For further information, please visit  www.ariceum-therapeutics.com.

Source: Press Release Eckert & Ziegler
Eckert & Ziegler and Ariceum Therapeutics Sign Global Supply Agreement for the Development of Next-Generation Radiotherapeutics for Precision Cancer Treatments

For three decades, Thomas Sommer conducted research at the Max Delbrück Center and shaped its development: as a scientist, ombudsman, committee representative, and interim board member. On December 6, the center will honor him with a symposium on his favorite topic — the cell's recycling system.

On December 6, 2024, the Max Delbrück Center will bid farewell to a long-time friend who has significantly influenced the institution: Professor Thomas Sommer. He joined the center as a junior group leader in the early 1990s — and remained for 30 years. He served as an ombudsman for PhD candidates multiple times and twice took on the role of interim head of the Max Delbrück Center, most recently from 2019 to 2022. As a manager and networker, he represented the center in various committees. Now, he is starting a new chapter in his career. Sommer has become the managing director of the Institute for Biomedical Translation (IBT) Lower Saxony in Hanover, which supports biomedical startups in the region.

Basic research and application are inseparable, Sommer says, as all therapies originate from basic research. He promoted this philosophy in his roles at the Max Delbrück Center, helping to create the structures that allow researchers to both understand the fundamentals of life and develop new therapeutic approaches.

A symposium on the cell’s recycling system

His research career has been dedicated to studying the ubiquitin-proteasome system, also known as the cell's recycling system. Ubiquitin acts as a tag, marking proteins that have accumulated defects for various reasons, which render them nonfunctional or even harmful, and prepares them for disposal. The cell breaks down the marked proteins and reuses their components to create new ones.

The recycling system is the focus of the symposium titled "Targeted proteolysis: From basic discovery to clinical application," featuring keynote lectures by Nobel Prize-winning chemist Professor Aaron Ciechanover from the Israel Institute of Technology in Haifa and Professor Fleur M. Ferguson from the University of California, San Diego. A festive farewell party will follow at 4:00 PM.

Source: Press Release Max Delbrück Center
The Max Delbrück Center bids farewell to Thomas Sommer

The Supervisory Board of Eckert & Ziegler SE has appointed Dr. Gunnar Mann (57) as a new member of the Executive Board, effective 1 January 2025. He will assume operational responsibility for the Medical segment.

Dr. Mann who holds a doctorate in physics, joined Eckert & Ziegler in 1998 and initially started as head of development. He then served as managing director of various subsidiaries of Eckert & Ziegler SE and was appointed to the Group Executive Committee in 2011. Dr. Mann has proven expertise in the areas of radiation physics, process management and implementation of investment projects.

Jutta Ludwig, whose contract as a member of the Executive Board expires as planned on December 31, 2024 will join the Supervisory Board as a delegated member on January 1, 2025. Frank Perschmann will leave the Supervisory Board of Eckert & Ziegler SE at the end of the year.

“Dr. Mann knows Eckert & Ziegler like only few others and brings exactly the experience and expertise needed to expand production capacity in the growing medical segment and to set up facilities for new products,” explains Dr. Andreas Eckert, Chairman of the Supervisory Board of Eckert & Ziegler SE. “On behalf of the Supervisory Board, I would like to thank Mrs. Ludwig for her contribution in strengthening our position in China and I am pleased that her expertise will remain with the company. I would also like to express my thanks to Mr. Perschmann for his many years of work on the Supervisory Board and for his valuable input in the strategic development of the Group.”

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
Eckert & Ziegler: Changes in the Executive Board and Supervisory Board

Eckert & Ziegler Radiopharma GmbH (Eckert & Ziegler) today celebrates the successful start of Actinium-225 (Ac-225) production, addressing the global shortage of this critical radionuclide. This milestone marks a major success of the common project with the Nuclear Physics Institute of the Czech Academy of Sciences (ÚJF). The test production demonstrated that the choice of technology was appropriate to achieve the expected parameters of the product.

In parallel with production, Eckert & Ziegler has commenced the validation process to produce GMP-grade Ac-225, crucial for clinical and commercial use. It is expected to become available in the first half of 2025, unlocking new opportunities for pharmaceutical companies developing alpha-emitting radiopharmaceuticals.

The production facility employs innovative cyclotron-based methods to generate Ac-225 from Radium-226, marking a pivotal advancement in isotope production. "This milestone underscores our commitment to advancing cancer treatment through the reliable supply of radioisotopes," said Dr. Lutz Helmke, Managing Director of Eckert & Ziegler Radiopharma GmbH. "The commencement of Ac-225 production not only addresses the current shortage but also fortifies Eckert & Ziegler’s position as a key player in the future of radioligand therapy."

The successful start of Ac-225 production is a direct result of the close collaboration between Eckert & Ziegler and the ÚJF. Drawing on decades of expertise in nuclear research and radiopharmaceutical development, ÚJF has played a crucial role in designing and optimizing this production pathway for Ac-225. Incorporating custom-engineered solutions by Isotope Technologies Dresden GmbH, Eckert & Ziegler’s hot cell division, the production process is designed to be efficient and sustainable.

The start of production positions Eckert & Ziegler at the forefront of the radiopharmaceutical industry's transformation, offering a reliable and scalable source of Ac-225 for clinical development and commercial manufacturing.

About Eckert & Ziegler SE
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 SE shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
 

Source: Press Release Eckert & Ziegler
Eckert & Ziegler Begins Production of Actinium-225, Paving the Way for GMP-Grade Supply

Eckert & Ziegler Radiopharma GmbH (Eckert & Ziegler) today received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand®, by the European Commission (EC). This enables the use of the radiopharmaceutical medicinal product Theralugand® in routine clinical applications throughout the European Economic Area (EEA).

Theralugand® provides high-purity Lutetium-177 produced in compliance with GMP standards with specifications designed for the labelling of therapeutic radiopharmaceuticals. The approval unlocks its potential to support innovative cancer therapies such as those targeting neuroendocrine tumors and metastatic prostate cancer. The previous, GMP-certified Lutetium-177 was limited to investigational use in clinical studies.

Eckert & Ziegler collaborates with pharmaceutical companies worldwide to develop and manufacture Lutetium-177-based radiopharmaceuticals, furthering the reach of targeted radiotherapies for the global market. Through these partnerships, Eckert & Ziegler plays a vital role in providing innovative cancer treatments.

“We are excited to achieve the EC approval for Theralugand®, a critical step in making innovative treatment options widely available for clinical applications across Europe,” said Dr. Harald Hasselmann, CEO of Eckert & Ziegler SE. “This accomplishment reflects our dedication to the production and distribution of reliable therapeutic radiopharmaceuticals.”

Eckert & Ziegler is gearing up to meet the rising global demand for Lutetium-177 by actively expanding production capacities, ensuring a stable supply of this critical therapeutic radioisotope.

About Eckert & Ziegler SE
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 SE shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

Strengthening transatlantic economic relations: Berlin delegation trip to the USA - with a focus on life science and health

What an intensive, rewarding week in the USA. Our Managing Director, Dr. Christina Quensel, was part of the “Berlin goes USA” business delegation from Berlin Partner for Business and Technology, the Berlin Chamber of Industry and Commerce and the Berlin Senate Chancellery.

 “With this large delegation trip, Berlin has shown a strong commitment to our business location and the healthcare industry in the capital region,” says Dr. Quensel. “The tour was perfectly prepared with a tight schedule. It was a great opportunity for networking and learning from the local life science hubs. A big thank you from us to the organizers and hosts!

The delegation trip was also a great opportunity for the many start-ups that were there - including MyoPax and Captain T Cell with their pioneering therapeutic approaches developed on the Berlin-Buch campus.

It was exciting to see, for example, how strong the life science ecosystem in New York has become in a very short time and what interesting programs New York State offers for international exchange in the life science scene.

There were also interesting new insights at the Life Science Hub Boston, a regular venue for the BIO International Convention.

The Bayer Co.Lab in Boston Cambridge is part of the international Bayer Co.Lab network with the aim of accelerating innovation. The Co.Lab in Berlin will reopen next week and also offers young life science companies the uncomplicated opportunity to move from one location to another and thus also be on site in Boston and take advantage of its dynamic ecosystem.

The CIC (Cambridge Innovation Center) directly opposite impresses with its active networking and lively exchange between various pharmaceutical companies, venture capitalists and start-ups. As a place for networking, the CIC is so interesting that large pharmaceutical companies are setting up shop there. Start-ups, in turn, can rent workstations there at affordable prices so that they can immerse themselves in the ecosystem.

Cambridge, with Harvard University and MIT, shows the effect of the spatial concentration of life science companies: within a 5-mile radius, there is an enormous density of people who all work in the same field and meet daily in the cafés of Kendall Square: Pharma, venture capitalists, founders and researchers.

By comparison, our life science ecosystem in the Berlin-Brandenburg capital region is growing and offers very good conditions. Lighthouse projects such as “Unite” can provide and bundle additional resources and opportunities in tech transfer. Above all, there is potential in better integration of the hubs: from the Charité and Bayer in Berlin-Mitte, the FU in Dahlem, the science and biotech campus in Berlin-Buch to the Potsdam Science Park. A higher density increases the attraction for pharmaceutical companies and venture capitalists - Boston is a prime example of this.”

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