Sanofi, RadioMedix, and Orano Med announce licensing agreement on next-generation radioligand medicine for rare cancers

Sanofi, RadioMedix, and Orano Med announce licensing agreement on next-generation radioligand medicine for rare cancers

Paris, France, and Houston, Texas, September 12, 2024. As part of its effort to develop innovative treatments for people living with rare cancers, Sanofi has entered into an exclusive licensing agreement with RadioMedix, Inc., a US clinical-stage biotechnology company developing radiopharmaceuticals for PET imaging and targeted alpha therapy (TAT) against unmet medical needs in cancer, and Orano Med, a French clinical-stage biotechnology company, subsidiary of the Orano Group, developing lead-212 (²¹²Pb) radioligand therapies (RLTs) against cancer.

This collaboration between Sanofi, RadioMedix and Orano Med focuses specifically on the late-stage project, AlphaMedix^TM (²¹²Pb-DOTAMTATE), which currently is being evaluated for the treatment of adult patients with unresectable or metastatic, progressive somatostatin-receptor expressing neuroendocrine tumors (NETs), a rare cancer. AlphaMedix^TM is a TAT which consists of a somatostatin receptor-targeting peptide complex radiolabeled with lead-212 (²¹²Pb) that serves as an in vivo generator of alpha particles.

Dietmar Berger
Chief Medical Officer, Global Head of Development, Sanofi
“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.”

AlphaMedix^TM has recently been granted Breakthrough Therapy Designation in gastroenteropancreatic neuroendocrine tumors (GEP-NETs) from the US Food and Drug Administration (FDA) for patients who are naïve to peptide-receptor radionuclide therapy. The FDA’s decision was based on findings from phase 1ⁱ and 2 clinical studies, which found that AlphaMedix^TM was well tolerated and provided substantial reduction in tumor burden, with a durable response rate (ORR according to RECIST 1.1) of 62.5%.ⁱ AlphaMedix^TM is currently completing phase 2 clinical development, and the data is being discussed with the FDA for potential regulatory filing and approval.