First targeted alpha therapy receives breakthrough designation

Peptide

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to AlphaMedix (212Pb-DOTAMTATE) for the treatment of adult patients with unresectable or metastatic, progressive somatostatin receptor expressing gastroenteropancreatic neuroendocrine tumours (GEP-NETs) who are naïve to peptide receptor radionuclide therapy (PRRT).

AlphaMedix is a targeted alpha therapy currently in Phase II clinical development, which consists of an SSTR-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles.

Due to their high energy and short path length, alpha emitters enable specific targeting and killing of individual cancer cells, while minimising toxicity to surrounding healthy tissue.

AlphaMedix, developed by radiopharmaceutical companies RadioMedix and Orano Med, is the first targeted alpha therapy to receive Breakthrough Therapy Designation.

“We believe that AlphaMedix has potential to demonstrate substantial benefit over currently FDA approved PRRT with beta-particle emitters for patients with metastatic or inoperable SSTR-expressing GEP-NETs,” said Ebrahim Delpassand, Chairman and Chief Executive Officer of RadioMedix.

The Breakthrough Therapy Designation is based on the results from Phase I and the ongoing Phase II clinical trials that assessed the safety and efficacy of AlphaMedix. In the Phase I study, treatment was well-tolerated, with a response rate of 62.5% for the GEP-NET patients who had never received PRRT with Lutathera, which is based on the beta-particle emitter Lutetium-177. In the Phase II trial, the target response rate has already been achieved ahead of top-line data, expected in mid-2024.

“Based on positive results from our clinical studies to date, we are convinced that Targeted Alpha Therapies, such as AlphaMedix, will lead the next generation of radioligand therapies, providing increased cytotoxicity against cancer cells but limited toxicity to adjacent healthy cells,” said Julien Dodet, President and Chief Executive Officer of Orano Med.

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