Sanofi will advance the development of AlphaMedix along with RadioMedix and Orano Med. Credit: ArDanMe/Shutterstock.

Sanofi has signed an exclusive licensing agreement with RadioMedix and Orano Med to advance the radioligand therapy AlphaMedix for rare cancers.

US-based biotechnology company RadioMedix develops radiopharmaceuticals for positron emission topography imaging and targeted alpha therapy (TAT), targeting unmet medical needs in the cancer field.

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French company Orano Med specialises in lead-212 (212Pb) radioligand therapies (RLTs) targeting cancer.

The partnership is centred on AlphaMedix (212Pb-DOTAMTATE), a late-stage project currently under evaluation for treating adult patients with unresectable or metastatic, progressive somatostatin-receptor expressing neuroendocrine tumours.

AlphaMedix is a TAT comprising a somatostatin receptor-targeting peptide complex radiolabeled with 212Pb which acts as an in vivo generator of alpha particles.

The US Food and Drug Administration previously awarded breakthrough therapy designation for the asset to treat gastroenteropancreatic neuroendocrine tumours.

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This designation follows Phase I and II trials that demonstrated the therapy’s tolerability and significant tumour burden reduction, achieving a 62.5% durable response rate.

AlphaMedix is in the final stage of Phase II clinical development.

Sanofi will lead the worldwide commercialisation of the asset contingent on the receipt of approval.

Orano Med will manage AlphaMedix’s manufacturing through its developing global industrial platform.

RadioMedix and Orano Med will receive €100m upfront payment from Sanofi.

Sanofi will pay up to a further €220m based on sales-based milestones apart from royalty payments.

Sanofi development global head and chief medical officer Dietmar Berger stated: “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.”

The recent development comes after Sanofi announced the inauguration of its new modular vaccine and biomedicine production unit, Modulus, in Neuville-sur-Saône, France.