BASEL, Switzerland – Nouscom, a clinical-stage biotech company developing next-generation immunotherapies to treat cancer at all stages, from early cancer interception to late-stage metastatic disease, today 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.

Fast Track Designation is granted to investigational therapies that have the potential to address serious conditions with significant unmet medical need. It is designed to expedite development and review through more frequent, direct interactions with the FDA, and confers eligibility for Accelerated Approval, Rolling Review of a Biologics License Application (BLA), and Priority Review at BLA submission.

“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, Ph.D., 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, M.D., 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.”

About Nouscom

Nouscom is a clinical-stage biotech company pioneering next-generation neoantigen-targeted immunotherapies to treat cancer at all stages, from early cancer interception to late-stage metastatic disease. Its proprietary viral vector platform enables broad and durable immune activation by delivering optimized neoantigens that train the immune system to recognize and fight cancer. Nouscom’s lead program, NOUS-209, is an off-the-shelf immunotherapy in advanced clinical development for cancer interception in LS and the treatment of MSI mCRC. The company’s clinical stage portfolio also includes NOUS-PEV, a personalized neoantigen immunotherapy, with published data from a successfully completed Phase 1b trial¹⁰. Nouscom’s current investors include 5AM Ventures, Andera Partners, Angelini Ventures, Bpifrance, EQT Life Sciences, Indaco Venture Partners SGR, M Ventures, Panakes Partners, Revelation Partners, Versant Ventures and XGEN Ventures.

For more information on Nouscom, please visit the company’s website at www.nouscom.com or follow us on LinkedIn.