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

This collaboration between Sanofi, RadioMedix and Orano Med focuses specifically on the late-stage project, AlphaMedix (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 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 said, “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 has recently been granted Breakthrough Therapy Designation in gastro entero pancreatic 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 1 and 2 clinical studies, which found that AlphaMedix was well tolerated and provided substantial reduction in tumor burden, with a durable response rate (ORR according to RECIST 1.1) of 62.5%. AlphaMedix is currently completing phase 2 clinical development, and the data is being discussed with the FDA for potential regulatory filing and approval.

Ebrahim S. Delpassand, Chairman and CEO, RadioMedix said, “The Breakthrough Therapy Designation of AlphaMedix is a testament of its success in validating targeted alpha therapies. We see this as a potential for the future of nuclear oncology in general, and today it is pioneering next-generation treatment for patients with neuroendocrine tumors. In our research, we have seen that significantly higher energy delivery over much shorter path lengths in the tissue of alpha emitters can overcome the limitations of currently available beta emitter radioligand therapies. We believe 212Pb is an ideal alpha emitter with highly desirable physical and supply characteristics in comparison to other alpha emitters. RadioMedix has been one of the pioneers in the field of radioligand therapy in the U.S and, through this licensing agreement with Sanofi, our goal is to bring this potentially life-saving therapy to as many patients as possible.”

Julien Dodet, President and CEO, Orano Med said, “At Orano Med, we are at the forefront of innovation in radioligand therapy and are developing a global industrial platform for the manufacture and distribution of our 212Pb-conjugated drugs. This marks a pivotal moment to expedite the development of this new therapy and in our fight against cancer. Through this agreement, we aim to lead the charge in advancing radioligand therapies with the ambition to revolutionize cancer therapeutics.”

Under the licensing agreement, Sanofi will be responsible for the global commercialization of AlphaMedix, while Orano Med will be responsible for the manufacturing of AlphaMedix through its global industrial platform currently under development. Under the terms of the agreement, RadioMedix and Orano Med will receive an upfront payment of €100 million and up to €220 million in sales milestones and be eligible for tiered royalties. This agreement is subject to standard regulatory approvals required for transactions of this nature.

Read also: CDSCO Panel Approves Sanofi's Protocol Amendment proposal for Fitusiran study