PentixaPharm GmbH

BERLIN and WURZBURG, Germany I November 21, 2024 I Pentixapharm Holding AG, a biopharmaceutical company developing innovative first-in-class radiopharmaceuticals, today announced that the first patient has been treated in a Phase I/II clinical trial evaluating the safety and efficacy of Lu177-PentixaTher, a novel radiopharmaceutical therapy, in adults for relapsed/refractory CXCR4 positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The trial, funded by the French Ministry of Health and led by a renowned investigator team from the University Hospital in Nantes, represents a significant step toward expanding targeted radiotherapy options for hematologic malignancies. The investor-initiated study, named PENTILULA (ClinicalTrials.gov ID: NCT06356922) is a multicenter, open-label trial in which up to 21 patients with relapsed/refractory AML or ALL will be enrolled over a period of 24 months, with a total study duration of 36 months. The primary objective is to determine the maximal tolerated dose (MTD) of Lu177-PentixaTher, and to examine key efficacy parameters such as overall response rate (ORR) and complete remission (CR) after infusion of the novel radiotherapeutic agent. Following a peer-reviewed publication in January 2023 in the prestigious Journal of Nuclear Medicine highlighting promising clinical results in the treatment of patients suffering from T-cell lymphoma, further evidence continues to be built up about the potential of Pentixapharm’s lead candidate, PentixaTher, for the treatment of haemato-oncological diseases. The study is significant for Pentixapharm insofar as the incidence of ALL and AML, and hence the medical need, is much higher than that for T-Cell lymphoma. The PENTILULA trial is the first trial that combines PentixaTher with Lutetium-177, a radioisotope widely and successfully used for the treatment of castration resistant prostate cancer or neuroendocrine tumors. Acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) are aggressive and life-threatening blood cancers that affect thousands of people worldwide each year. AML is the most common type of acute leukemia in adults, with an incidence of approximately 20,000 new cases per year and low five-year survival rate of 31.9% in the United States [1]. ALL is the most common type of cancer in children, with a high incidence in adults as well. Current treatment options often involve intensive chemotherapy and stem cell transplantation, which can have severe side effects. Effective radiotherapies in other indications are currently reimbursed with more than 100,000 USD per patient. “Although treatments for acute leukemia have advanced, many patients continue to have limited options and face poor outcomes. We believe PentixaTher holds significant potential to address these unmet needs, offering a valuable radiopharmaceutical theranostic approach tailored to the individual patients with hematologic malignancies,” explains Dr. Dirk Pleimes, Group CEO and CMO at Pentixapharm. “We are delighted that leading experts such as Professor Françoise Kraeber-Bodéré of the Nuclear Medicine Department and Professor Patrice Chevallier of the Hematology Department in Nantes have decided to initiate this study to evaluate this novel radiotherapeutic treatment option. We are committed to providing our full support, leveraging our therapeutic knowledge with PentixaTher and facilitating access to the compound to drive this important research forward.” Professor Françoise Kraeber-Bodéré is the Head of the department of Nuclear Medicine at the University Hospital in Nantes, France, and an expert of the Oncology committee of the French Society of Nuclear Medicine (SFMN) as well as of the Oncology and Therapy committee of the European Association of Nuclear Medicine. She is on the scientific board of the French Lymphoma research group LYSA and expert for PET imaging in lymphoma and myeloma. Professor Patrice Chevallier is a specialist in Hematology and member of the executive committee and scientific council of HéMA, an umbrella organization for hemato-oncological research in Western France. 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. Its Pipeline includes PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68 based companion diagnostic for blood cancers and cardiovascular diseases. PentixaTher is an innovative radiotherapeutic that specifically targets the chemokine-4 receptor (CXCR4). Background material about its potential for the treatment of haematooncological diseases can be found at: About Nantes University Hospital Nantes University Hospital (CHU de Nantes) is one of France’s leading healthcare institutions, recognized for its excellence in various medical specialties including cardiology, transplants, oncology, and neuroscience. The hospital is also a key player in medical research and innovation, conducting thousands of clinical trials and contributing to significant advancements in healthcare. [1] https://seer.cancer.gov/statfacts/html/amyl.html SOURCE: Pentixapharm

BERLIN and WURZBURG, Germany, Nov. 21, 2024 (GLOBE NEWSWIRE) -- Pentixapharm Holding AG, a biopharmaceutical company developing innovative first-in-class radiopharmaceuticals, today announced that the first patient has been treated in a Phase I/II clinical trial evaluating the safety and efficacy of Lu177-PentixaTher, a novel radiopharmaceutical therapy, in adults for relapsed/refractory CXCR4 positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The trial, funded by the French Ministry of Health and led by a renowned investigator team from the University Hospital in Nantes, represents a significant step toward expanding targeted radiotherapy options for hematologic malignancies. The investor-initiated study, named PENTILULA (ClinicalTrials.gov ID: NCT06356922) is a multicenter, open-label trial in which up to 21 patients with relapsed/refractory AML or ALL will be enrolled over a period of 24 months, with a total study duration of 36 months. The primary objective is to determine the maximal tolerated dose (MTD) of Lu177-PentixaTher, and to examine key efficacy parameters such as overall response rate (ORR) and complete remission (CR) after infusion of the novel radiotherapeutic agent. Following a peer-reviewed publication in January 2023 in the prestigious Journal of Nuclear Medicine highlighting promising clinical results in the treatment of patients suffering from T-cell lymphoma, further evidence continues to be built up about the potential of Pentixapharm’s lead candidate, PentixaTher, for the treatment of haemato-oncological diseases. The study is significant for Pentixapharm insofar as the incidence of ALL and AML, and hence the medical need, is much higher than that for T-Cell lymphoma. The PENTILULA trial is the first trial that combines PentixaTher with Lutetium-177, a radioisotope widely and successfully used for the treatment of castration resistant prostate cancer or neuroendocrine tumors. Acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) are aggressive and life-threatening blood cancers that affect thousands of people worldwide each year. AML is the most common type of acute leukemia in adults, with an incidence of approximately 20,000 new cases per year and low five-year survival rate of 31.9% in the United States [1]. ALL is the most common type of cancer in children, with a high incidence in adults as well. Current treatment options often involve intensive chemotherapy and stem cell transplantation, which can have severe side effects. Effective radiotherapies in other indications are currently reimbursed with more than 100,000 USD per patient. “Although treatments for acute leukemia have advanced, many patients continue to have limited options and face poor outcomes. We believe PentixaTher holds significant potential to address these unmet needs, offering a valuable radiopharmaceutical theranostic approach tailored to the individual patients with hematologic malignancies,” explains Dr. Dirk Pleimes, Group CEO and CMO at Pentixapharm. “We are delighted that leading experts such as Professor Françoise Kraeber-Bodéré of the Nuclear Medicine Department and Professor Patrice Chevallier of the Hematology Department in Nantes have decided to initiate this study to evaluate this novel radiotherapeutic treatment option. We are committed to providing our full support, leveraging our therapeutic knowledge with PentixaTher and facilitating access to the compound to drive this important research forward.” Professor Françoise Kraeber-Bodéré is the Head of the department of Nuclear Medicine at the University Hospital in Nantes, France, and an expert of the Oncology committee of the French Society of Nuclear Medicine (SFMN) as well as of the Oncology and Therapy committee of the European Association of Nuclear Medicine. She is on the scientific board of the French Lymphoma research group LYSA and expert for PET imaging in lymphoma and myeloma. Professor Patrice Chevallier is a specialist in Hematology and member of the executive committee and scientific council of HéMA, an umbrella organization for hemato-oncological research in Western France. 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. Its Pipeline includes PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68 based companion diagnostic for blood cancers and cardiovascular diseases. PentixaTher is an innovative radiotherapeutic that specifically targets the chemokine-4 receptor (CXCR4). Background material about its potential for the treatment of haematooncological diseases can be found at: https://edoc.mdc-berlin.de/id/eprint/24012/1/24012oa.pdf About Nantes University Hospital Nantes University Hospital (CHU de Nantes) is one of France's leading healthcare institutions, recognized for its excellence in various medical specialties including cardiology, transplants, oncology, and neuroscience. The hospital is also a key player in medical research and innovation, conducting thousands of clinical trials and contributing to significant advancements in healthcare. For more information, please contact: Pentixapharm Holding AGPhillip Eckert, Investor Relationsir@pentixapharm.comTel. +49 30 94893232www.pentixapharm.com [1] https://seer.cancer.gov/statfacts/html/amyl.html

Glycotope’s target discovery unit acquisition will double Pentixapharm’s development pipeline, according to the company’s CEO. Image Credit: Vitalii Vodolazskyi / Shutterstock. German radiopharmaceutical biotech Pentixapharm has acquired Germany-based Glycotope’s target discovery unit for an undisclosed sum to expand its oncology pipeline. Pentixapharm plans to turn the preclinical antibodies against multiple cancer targets into radiopharmaceuticals. In addition to the preclinical assets, the company added Glycotope’s laboratories, cell banks, tumour target database, and equipment to its portfolio. “The acquisition will broaden Pentixapharm’s Intellectual Property portfolio beyond the one built around the CXCR4 receptor. This will immediately double the development pipeline and significantly expand the associated business and clinical development opportunities,” explained Pentixapharm CEO Hakim Bouterfa. “Glycotope’s pipeline comprises several candidates that can be used immediately for proof-of-concept studies as next-generation radiopharmaceuticals. We look forward to maximising the synergy of Pentixapharm’s know-how and Glycotope’s target discovery for the benefit of patients in both diagnostics and therapeutic applications.” Pentatixapharm’s clinical pipeline consists of PentixaTher, a Yttrium-90-based treatment for central nervous system lymphoma. The radiotherapy is being evaluated in an open-label Phase I/II dose-finding trial (NCT06132737). The company is also developing a companion diagnostic for PentixaTher, called PentixaFor. The diagnostic is being trialled in a Phase III trial (NCT06125028) for staging of marginal zone lymphoma, a subtype of non-Hodgkin B-cell lymphoma. See Also: Roche gains FDA approval for Vabysmo prefilled syringe Aflibercept biosimilar by Lupin for Wet (Neovascular / Exudative) Macular Degeneration: Likelihood of Approval The acquisition will also see around 40 of Glycotope’s staff, including executives, R&D specialists, and administrators, added to Pentixapharm’s employment. While Pentixapharm is currently owned by Eckert & Ziegler (EZAG), a company specialising in providing isotope-related components for medical, scientific and industrial use, it plans to detach from EZAG and list on the Frankfurt Stock Exchange. Radiopharmaceuticals have been an area of interest in the past few years, attracting significant investment and acquisitions. Eli Lilly has signed two high-profile deals for radiopharmaceuticals; a $140m partnership with Radionetics Oncology and a discovery collaboration agreement with Aktis Oncology potentially worth over $1.7bn. Bristol Myers Squibb also jumped on the radiopharmaceuticals trend and paid $4.2bn to acquire RayzeBio . Novartis also shelled out $1.75bn and purchased US-based Mariana Oncology. AstraZeneca also started its radiopharmaceutical pipeline with a $2.4bn acquisition of Fusion Pharmaceuticals in March this year.