While it’s put more emphasis on becoming an “immunology powerhouse” in recent quarters, Sanofi still shows signs of interest in oncology.
On Thursday it announced licensing deals with the radiopharma companies RadioMedix and Orano Med worth a total of €100 million (about $110 million) in upfront payments. The two companies are working together on AlphaMedix, a breakthrough therapy-designated medicine in Phase 2 testing.
Sanofi plans to take the companies’ experimental radioligand — which is being developed for gastroenteropancreatic neuroendocrine tumors, or GEP-NETs — and move quickly to regulators and onto the market. That would put it in competition with Novartis, which sells the radiopharmaceutical Lutathera, approved by the FDA in early 2018.
The companies said they are wrapping up the Phase 2, and data are “being discussed with the FDA for potential regulatory filing and approval.” The targeted alpha therapy contains a somatostatin receptor-targeting peptide that is radiolabeled with lead-212, or 212Pb.
The radiopharmaceutical field is new for Sanofi, and the company had pulled back in other areas of oncology with the offloading of T cell engagers to Vir Biotechnology and the shuttering of a natural killer cell therapy biotech amid a “full pipeline reprioritization project.”
Houman AshrafianOn Sanofi’s second-quarter earnings call this summer, R&D head Houman Ashrafian said the company didn’t currently have any radiopharmaceutical projects in its portfolio. “We remain watchful in this space and are thoughtful about making moves into truly differentiated therapies,” he said on the July 25 call.
A Sanofi spokesperson confirmed to Endpoints News that AlphaMedix is the first radioligand therapy in Sanofi’s pipeline.
Radiopharmaceuticals have run into supply chain and manufacturing issues, making it a tough field to enter. But the space has seen a burst of activity in interest in recent years with multiple large pharmaceutical companies lining up deals, including Bristol Myers Squibb, AstraZeneca, Novartis and Eli Lilly. Bayer also has work in the field, and its radioisotope supplier PanTera announced a $103 million financing on Wednesday.
In addition to the €100 million upfront, RadioMedix and Orano Med could bag up to approximately €220 million ($242 million) in aggregate sales milestones, the companies said. They could also receive tiered royalties. Sanofi will lead commercialization and Orano Med will run manufacturing, the companies said.
Ebrahim Delpassand“We believe 212Pb is an ideal alpha emitter with highly desirable physical and supply characteristics in comparison to other alpha emitters,” RadioMedix CEO and chair Ebrahim Delpassand said in a press release. Delpassand has a long history in the field and was listed as a trial investigator in a publication on Lutathera.
In June, Orano Med unveiled its alpha therapy production site near Indianapolis. It also started construction last year on a facility in France for the European market, and it has a research unit in Plano, TX. In total, Orano Med said it expects to make 10,000 doses a year as of 2025 and 100,000 or more by the end of the decade.