Sanofi, RadioMedix, and Orano Med have announced an exclusive licensing agreement to develop a next-generation radioligand therapy, AlphaMedix, for rare cancers. The collaboration aims to address unmet needs in treating unresectable or metastatic, progressive somatostatin-receptor expressing neuroendocrine tumors (NETs).
AlphaMedix, a targeted alpha therapy (TAT) that consists of a somatostatin receptor-targeting peptide complex radiolabeled with lead-212 (212Pb), is currently completing phase 2 clinical development and has already been granted Breakthrough Therapy Designation by the FDA for gastroenteropancreatic NETs in patients who are naïve to peptide-receptor radionuclide therapy.
Clinical Efficacy and Regulatory Status
The FDA's decision was supported by early- and mid-stage clinical studies, which demonstrated that AlphaMedix was well-tolerated and provided a substantial reduction in tumor burden. The studies reported a durable response rate of 62.5%, according to RECIST 1.1 criteria. These data are currently being discussed with the FDA for potential regulatory filing and approval.
Ebrahim S. Delpassand, chairman and CEO of RadioMedix, stated, "The Breakthrough Therapy Designation of AlphaMedix is a testament of its success in validating targeted alpha therapies...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."
Commercial and Manufacturing Agreement
Under the licensing agreement, Sanofi will be responsible for the global commercialization of AlphaMedix, while Orano Med will handle the manufacturing through its global industrial platform. RadioMedix and Orano Med will receive an upfront payment of €100 million and are eligible for up to €220 million in sales milestones, along with tiered royalties.
Dietmar Berger, chief medical officer, global head of development at 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 [AlphaMedix] 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."
Neuroendocrine Tumors (NETs)
NETs are a group of rare cancers originating from neuroendocrine cells, commonly found in the gastrointestinal tract and pancreas. In the United States, approximately 12,000 people are diagnosed with NETs annually. Most NETs strongly express somatostatin receptors, making them a suitable target for therapies like AlphaMedix.
Julien Dodet, president and CEO of Orano Med, added, "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."
