Posted by Michael Wonder on 01 Jun 2026
Nouscom receives US FDA fast track designation for NOUS-209, a novel immunotherapy for the prevention of Lynch syndrome-Associated Cancers
1 June 2026 - Nouscom today announced that the US FDA has granted fast track designation to NOUS-209 for the prevention of Lynch syndrome associated cancers in Lynch syndrome carriers with genetically confirmed mismatch repair mutations.
The designation is supported by Phase 1b/2 data in Lynch syndrome carriers, published in Nature Medicine, demonstrating NOUS-209 monotherapy was safe and induced broad, potent, functional and durable T cell responses, boosted by annual re-treatment.
