Sanofi inks radioligand therapy licensing deal for rare cancers

Sanofi has entered into an exclusive licensing agreement with RadioMedix and Orano Med to further develop the radioligand therapy, AlphaMedix, aimed at treating rare cancers. AlphaMedix, also known as 212Pb-DOTAMTATE, is a late-stage therapeutic project designed for adults suffering from unresectable or metastatic, progressive somatostatin-receptor expressing neuroendocrine tumors. This therapy is a form of targeted alpha therapy (TAT) that incorporates a somatostatin receptor-targeting peptide complex radiolabeled with the isotope lead-212 (212Pb), which generates alpha particles in vivo.

RadioMedix, a US-based biotechnology firm, focuses on developing radiopharmaceuticals for positron emission topography imaging and TAT, which are crucial for addressing unmet medical needs in cancer treatment. Orano Med, a French company, specializes in lead-212 radioligand therapies targeting cancer, making it an ideal collaborator in this venture.

The United States Food and Drug Administration (FDA) had previously granted breakthrough therapy designation to AlphaMedix for treating gastroenteropancreatic neuroendocrine tumors. This designation followed promising results from Phase I and II clinical trials that indicated the therapy's tolerability and substantial tumor burden reduction, achieving a durable response rate of 62.5%. Currently, AlphaMedix is in the final stage of Phase II clinical development.

Sanofi will spearhead the global commercialization of AlphaMedix once it secures the necessary approvals. Meanwhile, Orano Med will oversee the manufacturing process through its expanding global industrial platform. Financially, Sanofi has agreed to provide an upfront payment of €100 million to RadioMedix and Orano Med, with the potential for up to €220 million in additional sales-based milestones, along with royalty payments.

Dr. Dietmar Berger, Sanofi's global head of development and chief medical officer, expressed enthusiasm for the partnership, stating: "We are excited to develop a leading-edge project in the rapidly evolving field of radioligand therapies in rare cancers. Early results for 212Pb have demonstrated its differentiated biophysical and clinical profile, reinforcing its potential to be a transformative radioligand therapeutic for patients across multiple difficult-to-treat rare cancers. This agreement underscores our efforts to explore innovative collaborations that leverage novel technologies to address the needs of people living with cancer."

This collaboration represents a significant step in the ongoing efforts to develop advanced treatments for challenging cancer types. By combining Sanofi's expertise in drug commercialization with RadioMedix and Orano Med's specialized knowledge in radiopharmaceuticals and radioligand therapies, the partnership aims to bring a potentially transformative treatment to patients with rare, hard-to-treat cancers.