French pharmaceutical and healthcare company Sanofi has teamed up with RadioMedix and Orano Med, for the late-stage development of AlphaMedix (212Pb-DOTAMTATE).
RadioMedix is a US clinical-stage biotechnology company developing radiopharmaceuticals for PET imaging and targeted alpha therapy (TAT) against unmet medical needs in cancer.
Orano Med is a French clinical-stage biotechnology company developing lead-212 (212Pb) radioligand therapies (RLTs) against cancer.
AlphaMedix is a late-stage project currently being evaluated for the treatment of adult patients with a rare cancer type, somatostatin-receptor-expressing neuroendocrine tumours (NETs).
Under the exclusive licencing agreement, Orano Med will be responsible for the manufacturing of AlphaMedix through its global industrial platform currently under development.
Sanofi will be responsible for the global commercialisation of AlphaMedix.
RadioMedix and Orano Med will receive an upfront payment of €100m and up to €220m in sales milestones and be eligible for tiered royalties.
Sanofi development global head, chief medical officer Dietmar Berger 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 is a TAT that contains a somatostatin receptor-targeting peptide complex radio-labelled with lead-212 (212Pb) and serves as an in-vivo generator of alpha particles.
The drug has recently received the US Food and Drug Administration (FDA) Breakthrough Therapy Designation (BTD) in gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
The FDA BTD was granted based on results from Phase 1 and 2 clinical studies.
In the study, AlphaMedix was well tolerated and provided a substantial reduction in tumour burden, with a durable response rate (ORR) of 62.5%.
AlphaMedix is currently at the end of Phase 2 clinical development, and the data is being discussed with the FDA for potential regulatory filing and approval.
RadioMedix chairman and CEO Ebrahim Delpassand said: “The Breakthrough Therapy Designation of AlphaMedix is a testament to 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 tumours.
Orano Med president and CEO Julien Dodet said: “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.”
