Nouscom, a clinical-stage biotech company developing next-generation immunotherapies to treat cancer at all stages, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to NOUS-209 for the prevention of Lynch syndrome (LS)-associated cancers in LS carriers with genetically confirmed mismatch repair (MMR) mutations.
“Lynch syndrome carriers face up to 80% lifetime risk of developing cancer. Yet their only options today are intensive surveillance or prophylactic organ removal surgery,” said Marina Udier, chief executive officer of Nouscom.
“Fast Track Designation from the FDA validates the urgency of the need and the strength of our NOUS-209 program. Building on promising phase 1b/2 results published in Nature Medicine, we are now advancing NOUS-209 into a registration-enabling trial — with the goal of delivering the first cancer interception immunotherapy for Lynch syndrome carriers.”
The designation is supported by phase 1b/2 data in LS carriers, published in Nature Medicine (D’Alise et al., 2026), demonstrating NOUS-209 monotherapy was safe and induced broad, potent, functional and durable T cell responses, boosted by annual retreatment. No new advanced adenomas were detected one-year post-treatment, providing first clinical evidence of cancer interception in LS carriers.
“Fast Track Designation will accelerate our dialogue with the FDA as we prepare for our registration-enabling study,” said Sven Gogov, chief medical officer of Nouscom.
“Together with our prior FDA and EMA alignment on the registrational path, FTD provides both speed and regulatory clarity as we work to bring this transformative immunotherapy to Lynch Syndrome carriers.”
NOUS-209 is an investigational off-the-shelf cancer immunotherapy that targets tumours with mismatch repair deficiency (dMMR) and microsatellite instability (MSI). These tumours produce unique markers known as frameshift peptide (FSP) neoantigens, which are unique to cancerous cells and absent in healthy cells. NOUS-209 is comprised of two viral vectors able to deliver 209 shared FSP neoantigens and train the immune system to recognise and attack cancerous and precancerous cells before tumours can develop.