Sanofi’s $110 million bet on a radioligand seems to be paying off after the neuroendocrine tumor treatment hit the key endpoints of a phase 2 study.
The asset in question, dubbed AlphaMedix, is a targeted alpha therapy designed to deliver a payload to cells that express somatostatin, a receptor found in most neuroendocrine tumors. Sanofi secured the candidate after handing over 100 million euros (what was at the time $110 million) upfront in a deal with RadioMedix and Orano Med a year ago.
Now, Sanofi has a fresh readout that validates that nine-figure fee. In a study of 61 patients with unresectable or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who were roughly split between those who had previously received Novartis’ beta particle emitter Lutathera and those who had not, AlphaMedix was shown to hit the primary endpoints of overall response rate and safety.
When it came to the study’s secondary endpoints of progression-free survival and overall survival, Sanofi only said “benefits were observed” across both cohorts.
Sanofi is holding back any data for the European Society for Medical Oncology Congress in Germany later in the month but said the findings will “form the basis of discussions with health authorities.”
“The promising AlphaMedix-02 results represent a significant step forward, reinforcing the potential of targeted alpha therapy to deliver precise treatment for GEP-NETs,” Christopher Corsico, M.D., global head of development at Sanofi, said in an Oct. 8 release.
“These data, demonstrating clinically meaningful activity and a manageable safety profile, underscore our unrelenting commitment to developing innovative therapies for patients with difficult-to-treat cancers,” Corsico added. “We look forward to advancing AlphaMedix and working with Orano Med and regulators to bring this important treatment to the GEP-NET community as soon as possible.”
“The positive results from the AlphaMedix-02 study represent a pivotal movement for the Orano Med 212Pb-based platform and underscore the profound potential of lead-212-based radiopharmaceuticals in addressing critical unmet needs for patients with GEPNETs,” Orano Med’s chief medical officer Volker Wagner, M.D., Ph.D., said in a statement.
“These data reinforce our belief that delivering highly potent alpha-emitters directly to cancer cells could potentially offer a meaningful new treatment option for people living with GEP-NETs,” Wagner added.
After staying on the sidelines of the radioligand race, the acquisition of AlphaMedix in September 2024 marked Sanofi’s entry into the space. That deal also saw Sanofi commit up to 220 million euros in sales milestone payments, with Orano Med handling manufacturing of the therapy and Sanofi to oversee global commercialization.
Sanofi was presumably happy with the deal, as weeks later the French pharma returned to Orano Med with 300 million euros to set up a more permanent radioligand project.