Sanofi, RadioMedix and Orano Med have entered into an exclusive licensing agreement worth €320m to develop a next-generation radioligand therapy for rare cancers.
The deal centres around AlphaMedix, a targeted alpha therapy currently being evaluated in adult patients with unresectable or metastatic, progressive somatostatin-receptor expressing neuroendocrine tumours (NETs).
Sanofi will be responsible for the global commercialisation of the candidate, while Orano Med will handle the manufacturing. In exchange, RadioMedix and Orano Med will receive an upfront payment of €100m and will be eligible for up to €220m in sales milestones, as well as tiered royalties.
Approximately 12,000 people are diagnosed with NETs, a group of rare cancers that originate from neuroendocrine cells, in the US every year. They usually occur in the gastrointestinal tract and pancreas, but can also occur in other tissues, including the thymus and lung.
AlphaMedix is specifically designed to target the somatostatin receptor, which is overexpressed in most NETs.
The candidate has already been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) for gastroenteropancreatic NETs in patients who are naïve to peptide-receptor radionuclide therapy.
The regulator’s decision was supported by results from early- and mid-stage clinical studies, which showed that AlphaMedix was well tolerated and provided substantial reduction in tumour burden, with a durable response rate of 62.5%.
The therapy is currently completing phase 2 clinical development and the data is being discussed with the FDA for potential regulatory filing and approval.
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.”
The deal comes just over two months after Sanofi entered into a $700m strategic collaboration with Belharra Therapeutics to advance the discovery of small molecule therapeutics for immunological diseases.
The company also recently announced an artificial intelligence collaboration with Formation Bio and OpenAI aimed at accelerating drug development, and signed a licensing agreement worth over $1.2bn to co-commercialise Novavax’s COVID-19 vaccine and develop combination vaccines for COVID-19 and influenza.
