Sanofi, RadioMedix, Orano Med agree on next-gen radioligand for rare cancers

Sanofi has taken a significant step forward in developing treatments for rare cancers by entering an exclusive licensing agreement with RadioMedix, Inc. and Orano Med. RadioMedix, a U.S.-based clinical-stage biotechnology company, specializes in radiopharmaceuticals for PET imaging and targeted alpha therapy (TAT) for cancer. Orano Med, a subsidiary of the Orano Group from France, focuses on lead-212 (212Pb) radioligand therapies (RLTs) for cancer treatment.

The collaboration between these companies centers around AlphaMedixTM (212Pb-DOTAMTATE), a late-stage project aimed at treating adult patients with unresectable or metastatic, progressive somatostatin-receptor expressing neuroendocrine tumors (NETs). AlphaMedixTM is a targeted alpha therapy (TAT) using a somatostatin receptor-targeting peptide complex radiolabeled with lead-212, which acts as an in vivo generator of alpha particles.

Dietmar Berger, Chief Medical Officer and Global Head of Development at Sanofi, expressed enthusiasm about this venture. He emphasized the project's potential to be a transformative treatment for various rare cancers due to its differentiated biophysical and clinical profile. Berger highlighted that this collaboration aligns with Sanofi's commitment to leveraging novel technologies to address the needs of cancer patients.

AlphaMedixTM has recently received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in patients who have not undergone peptide-receptor radionuclide therapy. This designation was based on phase 1 and 2 clinical studies, which demonstrated that AlphaMedixTM was well tolerated and significantly reduced tumor burden, with an objective response rate (ORR) of 62.5%. The therapy is now in the final stages of phase 2 clinical development, and Sanofi is in discussions with the FDA for potential regulatory approval.

Ebrahim S. Delpassand, Chairman and CEO of RadioMedix, highlighted the importance of the Breakthrough Therapy Designation. He noted that AlphaMedixTM's success validates the potential of targeted alpha therapies in the field of nuclear oncology. Delpassand believes that the higher energy delivery and shorter path lengths of alpha emitters can address the limitations of current beta emitter radioligand therapies. RadioMedix aims to bring this promising therapy to as many patients as possible through its partnership with Sanofi.

Julien Dodet, President and CEO of Orano Med, emphasized that this agreement marks a pivotal moment in advancing radioligand therapies. Orano Med is committed to innovation in this field and is developing a global industrial platform for manufacturing and distributing 212Pb-conjugated drugs. Dodet expressed confidence that this collaboration would expedite the development of new cancer therapies and revolutionize cancer treatment.

Under the terms of the agreement, Sanofi will handle the global commercialization of AlphaMedixTM, while Orano Med will manage its manufacturing through a global industrial platform currently under development. RadioMedix and Orano Med will receive an upfront payment of €100 million and up to €220 million in sales milestones, along with tiered royalties. The agreement is subject to standard regulatory approvals.

Sanofi aims to become the leading immunoscience company globally by advancing oncology innovations and prioritizing its pipeline. The company focuses on difficult-to-treat cancers such as multiple myeloma, acute myeloid leukemia, certain types of lymphomas, gastrointestinal cancers, and lung cancers.

Neuroendocrine tumors (NETs) are a rare and heterogeneous group of cancers that originate from neuroendocrine cells, primarily occurring in the gastrointestinal tract and pancreas but also in other tissues like the thymus, lung, ovaries, heart, and prostate. In the U.S., approximately 12,000 patients are diagnosed with NETs annually, with a 5-year survival rate of 60% at the metastatic stage. Despite its rarity, NETs are becoming more prevalent globally, affecting around 35 out of every 100,000 individuals.

RadioMedix, based in Houston and Humble, Texas, focuses on developing targeted radiopharmaceuticals for cancer diagnosis, monitoring, and therapy. Orano Med, a subsidiary of the Orano Group, specializes in lead-212 (212Pb) based targeted therapies. Both companies are dedicated to advancing cancer treatment through innovative approaches.

Sanofi, a global healthcare company, is committed to transforming medicine by pursuing scientific breakthroughs to improve lives. The company provides life-changing treatments and vaccines to millions of people worldwide, prioritizing sustainability and social responsibility.

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