Sanofi has entered into an exclusive licensing agreement with RadioMedix, Inc., a U.S.-based biotechnology company developing radiopharmaceuticals for PET imaging and targeted alpha therapy (TAT), and Orano Med, a French subsidiary of the Orano Group focused on lead-212 (212Pb) radioligand therapies (RLTs). This collaboration aims to develop new treatments for rare cancers, specifically targeting unmet medical needs.
The partnership centers around AlphaMedix™ (212Pb-DOTAMTATE), a late-stage radioligand therapy currently under evaluation for treating adult patients with unresectable or metastatic, progressive somatostatin-receptor-expressing neuroendocrine tumors (NETs). AlphaMedix™ utilizes a somatostatin receptor-targeting peptide radiolabeled with lead-212 (212Pb), an in vivo alpha particle generator.
Dietmar Berger, Sanofi’s Chief Medical Officer and Global Head of Development, expressed excitement about the project, highlighting the promise of 212Pb in treating rare cancers. “Early results for 212Pb have shown a differentiated biophysical and clinical profile, positioning it as a potential transformative treatment for multiple hard-to-treat rare cancers,” Berger said. The agreement aligns with Sanofi’s efforts to foster innovative collaborations and leverage novel technologies in oncology.
AlphaMedix™ recently received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in patients new to peptide-receptor radionuclide therapy. The designation was granted based on promising phase 1 and 2 clinical trial results, showing substantial tumor reduction and a durable response rate of 62.5%. With phase 2 development nearing completion, discussions with the FDA are ongoing regarding potential regulatory approval.
RadioMedix’s Chairman and CEO, Ebrahim S. Delpassand, emphasized the importance of this milestone in validating targeted alpha therapies. He noted that 212Pb’s ability to deliver significantly higher energy over shorter tissue path lengths addresses limitations seen in beta emitter radioligand therapies. Delpassand highlighted RadioMedix’s role as a pioneer in radioligand therapy and its commitment to expanding access to this life-saving treatment through the partnership with Sanofi.
Julien Dodet, President and CEO of Orano Med, described the agreement as a critical step in accelerating the development and distribution of 212Pb-based drugs. Orano Med is developing a global industrial platform for manufacturing these therapies and aims to revolutionize cancer treatment through radioligand therapies.
Under the terms of the licensing agreement, Sanofi will handle global commercialization of AlphaMedix™, while Orano Med will manage manufacturing. RadioMedix and Orano Med will receive an upfront payment of €100 million, with potential sales milestones of up to €220 million, and will be eligible for tiered royalties. The agreement is subject to regulatory approvals.
Sanofi’s commitment to advancing oncology innovation aligns with its goal of becoming a global leader in immunoscience. By reshaping its pipeline and focusing on difficult-to-treat cancers such as multiple myeloma, acute myeloid leukemia, and select solid tumors, the company continues to drive progress in oncology research.
