Sanofi, RadioMedix & Orano Med Enter Licensing Agreement Ofor Rare Cancers
Sanofi, RadioMedix & Orano Med enter licensing agreement on next-generation radioligand medicine for rare cancers
Overview
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.
About the Collaboration
- 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 tumours (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.
From Global Head of Development: SANOFI
- 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.
BTD for AlphaMedix
- AlphaMedix 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 1 and 2 clinical studies, which found that AlphaMedix was well tolerated and provided substantial reduction in tumour 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.
Words from the CEO: RadioMedix
- 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 tumours. 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 US and, through this licensing agreement with Sanofi, our goal is to bring this potentially life-saving therapy to as many patients as possible.
Words from the CEO: Orano Med
- 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.
Terms of Licensing Agreement
- 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.
Becoming Top Immunoscience Company
- In striving to become the number one immunoscience company globally, Sanofi remains committed to advancing oncology innovation.
- Through focused strategic decisions the company has reshaped and prioritized its pipeline, leveraging its expertise in immunoscience to drive progress.
- Efforts are centered on difficult-to-treat cancers such as select hematologic malignancies, and solid tumours with critical unmet needs, including multiple myeloma, acute myeloid leukaemia, certain types of lymphomas, as well as gastrointestinal and lung cancers.
About Neuroendocrine Tumours
- Neuroendocrine tumours (NETs) are a heterogeneous group of rare cancers that originate from neuroendocrine cells.
- These cancers occur mostly in the gastrointestinal tract and pancreas but can also occur in other tissues including the thymus, lung, and other uncommon sites such as ovaries, heart, and prostate.
- Most NETs strongly express somatostatin receptors.
- In the United States, around 12,000 patients annually are expected to be diagnosed with neuroendocrine tumours, with an average 5-year survival rate of 60% at a metastatic stage.
- Despite the global prevalence of NETs increasing each year, it is considered a rare cancer that is estimated to affect approximately 35/100,000 individuals worldwide.
About RadioMedix, Inc.
- RadioMedix, Inc. is a clinical-stage biotechnology company, based in Houston and Humble, Texas.
- The company is focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer.
About Orano Med
Orano Med, a subsidiary of the Orano Group, is a clinical-stage biotechnology company that develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (212Pb), an alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT).
About Sanofi
- Sanofi is an innovative global healthcare company, driven by one purpose: It chase the miracles of science to improve people’s lives.
- Its team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible.
