DA Breakthrough Designation for AlphaMedix in Neuroendocrine Tumors

RadioMedix, Inc., a Houston-based clinical technology company and sponsor of the AlphaMedix clinical trial, and Orano Med, a clinical biotechnology company developing next-generation cancer therapies, are two radiopharmaceutical companies that have announced clinical trials. The FDA granted Breakthrough Therapy Designation (BTD) to Alphamedics (212Pb-DOTAMTATE) for the treatment of adult patients with unresectable, metastatic somatostatin receptor-expressing gastroenteropancreatic neuroendocrine tumor (GEP-NET), also previously administered with a radionuclide receptor peptide. Reveal PRRT).

AlphaMedix is ​​a targeted alpha drug currently in phase 2 clinical development, containing a lead-212 (212Pb)-labeled SSTR-targeting peptide complex, which acts as an alpha particle generator in vivo. Because of their high potency and short length, alpha receptors can target and kill individual cancer cells while minimizing toxicity to surrounding healthy tissue. AlphaMedix is ​​the first targeted alpha drug to receive clinical certification.

“The US FDA clinical decision and number 039 demonstrates the potential of AlphaMedix as a breakthrough drug that can redefine the treatment of patients with neuroendocrine tumors. AlphaMedix may demonstrate a significant benefit over the currently FDA-approved PRRT that includes a beta-particle inhibitor for patients with SSTR-expressing or metastatic GEP-NETs. The FDA's decision is good news for patients with this disease and is an important sign that the development of this new treatment will be accelerated," said Ebrahim Delpassand, MD, president and CEO of RadioMedix.

Breakthrough Therapy Signature is based on the results from a Phase 1 clinical trial evaluating the safety and efficacy of AlphaMedix and an ongoing Phase 2 clinical trial. In the Phase 1 study, positive treatment with a response rate (ORR according to RECIST 1.1) of 62.5% in patients with GEP-NET who did not receive PRRT with the lutetium-based beta particle emitter Lutathera -177 Phase 2 clinical trial has already reached its response rate ahead of the main data expected by mid-2024 and confirmed the great need in the medical community of an alpha drug prescribed with lead-212.

Based on the positive results of clinical studies, we are confident that targeted alpha therapies such as AlphaMedix will lead the next generation of radioligand therapies that increase cytotoxicity to cancer cells but reduce toxicity to nearby healthy cells. This FDA recognition confirms Orano Med's commitment to making 212 new treatments available to the medical community and patients worldwide," said Julien Dodet, President and CEO of Orano Med.