Orano Med Enters Next Phase of Collaboration with Roche

Paris, Dec 05 — Orano Med, a subsidiary of the Orano group specializing in nuclear medicine, announced today that its long-standing collaboration with the multinational pharmaceutical company Roche (SIX: RO, ROG; OTCQX: RHHBY) is entering the next phase. Over the past years, the companies have conducted extensive preclinical research to develop a potential novel cancer treatment approach called “two-step pretargeted radioimmunotherapy” (or PRIT). This innovative technology, which pretargets the tumor with an antibody that is subsequently able to capture chelated lead-212 (212Pb) to target tumor cells, is now ready to advance into clinical development in humans. Orano Med will be responsible for the manufacturing of 212Pb, utilizing its industrial manufacturing platform in France and the US.

Nicolas Maes, Chief Executive Officer of the Orano group, commented: “We are very pleased about the progress made in collaboration with Roche for the development of a potential new treatment approach for cancer patients. After the licensing agreement signed with Sanofi last year for our most advanced clinical program, AlphaMedix™, the achievement with this potential new drug candidate marks an important milestone that we accomplished jointly with another major player in the pharmaceutical industry. It illustrates our capacity to execute our long-term strategy, aimed at developing a solid pipeline of 212Pb-targeted alpha therapies to treat multiple oncology indications. In addition, thanks to the Orano Group’s expertise in the nuclear industry and its access to thorium-232, a scarce raw material required for producing 212Pb, Orano Med is also responsible for the entire production and distribution chain for these isotopes.”

Julien Torgue, Chief Scientific Officer of Orano Med, commented: “The application of two-step pretargeted radioimmunotherapy represents a potentially game-changing advancement in radioligand therapies and cancer treatment more broadly. Instead of delivering radiation and targeting vector together, the novel technique separates the process into two precise steps: first, allowing time for antibodies to accumulate on the tumor, and then capturing the alpha particle emitting radioactive isotope lead-212, which allows for the precise targeting of cancer cells while sparing healthy tissue. In preclinical studies, we could already demonstrate both strong efficacy and, importantly, a reduction in off-target uptake in healthy tissues. If these results translate to the clinic, this could bring us a major step closer to a more effective and for patients also safer form of radioligand therapy. We are looking forward to further continue the development of this innovative approach with Roche.”

Under the terms of the agreement, Orano Med and Roche have committed to develop this new therapeutic solution targeting a specific antigen known as carcinoembryonic (CEA), a cell surface glycoprotein overexpressed in several cancers. This antigen serves as a marker for various types of cancer, such as colorectal, pancreatic, and gastric cancers, as well as certain lung cancers. These are cancers for which the current therapeutic options are often limited or insufficient to meet patients’ needs. CEA shows restricted expression in normal tissues, making it a very suitable target for antibody-based therapies and radioimmunotherapy.

The Roche sponsored phase 1 clinical trial is expected to start in the first half of 2026, initiating the development of a broader platform dedicated to alpha radioimmunotherapies, underscoring Orano Med’s global leading position in the field of targeted alpha therapies.