Sanofi, RadioMedix, and Orano Med Announce Licensing Deal for Next-Gen Radioligand Cancer Medicine

Sanofi has entered into an exclusive licensing agreement with RadioMedix, Inc., a US-based biotechnology company, and Orano Med, a French clinical-stage biotechnology company. This partnership aims to advance treatments for rare cancers through innovative radiopharmaceuticals. Specifically, the collaboration will focus on AlphaMedixTM (212Pb-DOTAMTATE), a targeted alpha therapy (TAT) currently in late-stage development for treating adult patients with unresectable or metastatic, progressive somatostatin-receptor expressing neuroendocrine tumors (NETs).

AlphaMedixTM utilizes a somatostatin receptor-targeting peptide complex radiolabeled with lead-212 (212Pb) to generate alpha particles in vivo, providing a novel approach to cancer treatment. The biophysical and clinical characteristics of 212Pb have shown promising results, positioning AlphaMedixTM as a potential breakthrough in radioligand therapies for hard-to-treat rare cancers.

Dietmar Berger, Sanofi’s Chief Medical Officer and Global Head of Development, expressed enthusiasm for the project, highlighting that the early results for 212Pb show its potential as a transformative therapeutic for multiple difficult-to-treat rare cancers. This agreement reflects Sanofi's commitment to exploring innovative collaborations to meet the needs of cancer patients.

AlphaMedix has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in patients who have not undergone peptide-receptor radionuclide therapy. This designation was supported by phase 1 and 2 clinical studies, which demonstrated that AlphaMedixTM was well tolerated and significantly reduced tumor burden, achieving a durable response rate of 62.5%. The therapy is currently nearing the completion of phase 2 clinical development, with discussions ongoing with the FDA for potential regulatory approval.

Ebrahim S. Delpassand, Chairman and CEO of RadioMedix, underscored the importance of the Breakthrough Therapy Designation, seeing it as a validation of targeted alpha therapies. He noted that 212Pb offers higher energy delivery over shorter path lengths in tissue, potentially overcoming limitations of existing beta emitter radioligand therapies. RadioMedix aims to leverage this licensing agreement with Sanofi to make this life-saving therapy accessible to more patients.

Julien Dodet, President and CEO of Orano Med, emphasized the significance of this agreement in propelling the development of 212Pb-conjugated drugs. Orano Med is dedicated to leading advancements in radioligand therapies, with the ambition to revolutionize cancer treatment. The company is expanding its global industrial platform to manufacture and distribute these novel therapies.

Under the licensing agreement, Sanofi will handle the global commercialization of AlphaMedix. Orano Med will manage the manufacturing through its developing global industrial platform. RadioMedix and Orano Med will receive an upfront payment of €100 million, up to €220 million in sales milestones, and will be eligible for tiered royalties. The agreement is subject to standard regulatory approvals.

Sanofi continues to prioritize oncology innovation, focusing on difficult-to-treat cancers such as multiple myeloma, acute myeloid leukemia, certain lymphomas, and specific gastrointestinal and lung cancers. The company aims to leverage its expertise in immunoscience to drive progress in these areas.

Neuroendocrine tumors (NETs) are rare cancers originating from neuroendocrine cells, primarily affecting the gastrointestinal tract and pancreas but can also occur in other tissues like the thymus, lung, ovaries, heart, and prostate. Approximately 12,000 patients in the US are diagnosed with NETs annually, with a 5-year survival rate of 60% at the metastatic stage. Despite increasing global prevalence, NETs remain a rare cancer, affecting about 35 per 100,000 individuals worldwide.

RadioMedix, based in Houston, Texas, specializes in developing radiopharmaceuticals for PET imaging and targeted therapies. Orano Med, a subsidiary of the Orano Group, focuses on developing targeted therapies using lead-212 (212Pb), an alpha-emitting radioisotope. The company operates manufacturing facilities and R&D centers in France and the US, aiming to expand its capacities further.

Sanofi is a global healthcare company dedicated to transforming medicine and improving lives, focusing on developing treatments and vaccines while emphasizing sustainability and social responsibility.

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