- New data from the Phase 1b/2 trial of NOUS-209 in Lynch Syndrome (LS) carriers have been accepted for an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026
- NOUS-209 is an off-the-shelf cancer immunotherapy designed to induce T cells against neoantigens present in tumors and precancer lesions of LS carriers
- The presentation will report the safety and immunogenicity of NOUS-209 re-treatment, together with clinical follow-up extending beyond one year
- Follows the recent U.S. FDA Fast Track Designation (FTD) for NOUS-209 and reinforces Nouscom’s momentum toward initiation of a registration-enabling trial
BASEL, Switzerland – July 20, 2026 – 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 new data from its Phase 1b/2 trial of NOUS-209 in Lynch Syndrome (LS) carriers have been accepted for an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23–27 in Madrid, Spain.
The oral presentation, titled “Safety and Immunogenicity of Re-vaccination with Nous-209: a neoantigen vaccine for cancer interception in Lynch syndrome carriers,” will be given by Eduardo Vilar-Sanchez, M.D., Ph.D., chair ad interim of Clinical Cancer Prevention at The University of Texas MD Anderson Cancer Center. It will report the safety and immunogenicity of NOUS-209 re-treatment alongside clinical follow-up extending beyond one year, further reinforcing the strength and durability of the data supporting NOUS-209 as a potential cancer interception immunotherapy for LS carriers.
“This is yet another recognition of the outstanding data we have generated for NOUS-209 in Lynch Syndrome – the fourth oral presentation of data from this trial, following AACR 2025 and SITC 2023 and 2025,” said Marina Udier, Ph.D., Chief Executive Officer of Nouscom. “Together with our recent FDA Fast Track Designation, it strengthens our conviction and momentum as we advance NOUS-209 into a registration-enabling trial to deliver the first cancer interception immunotherapy for Lynch Syndrome carriers who face up to 80% lifetime risk of developing cancer.”
The NOUS-209 cancer interception program is supported by Phase 1b/2 data in LS carriers published in Nature Medicine (D’Alise et al., 2026), demonstrating that NOUS-209 was safe and induced broad, potent, functional and durable T cell responses, boosted by annual re-treatment, with no new advanced adenomas detected one year post-treatment – providing the first clinical evidence of cancer interception in LS carriers.
The clinical trial NCT05078866 was a collaborative effort between the National Cancer Institute’s Cancer Prevention Clinical Trials Network (CP-CTNet) and the iCAN-PREVENT consortium at MD Anderson. The NCI, part of the National Institutes of Health, provided primary funding through Award Number UG1-CA-242609, with additional support from the Data Management, Auditing, and Coordination Center (grant U24CA242637).
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About NOUS-209
NOUS-209 is an investigational off-the-shelf cancer immunotherapy that targets tumors with mismatch repair deficiency (dMMR) and microsatellite instability (MSI). These tumors are characterized by unique markers known as frameshift peptide (FSP) neoantigens, which are unique to cancerous cells and absent in healthy cells. NOUS-209 comprises two proprietary viral vectors able to deliver 209 shared FSP neoantigens and train the immune system to recognize and attack cancerous and precancerous cells before tumors can develop.
Phase 1b/2 data demonstrated the safety of NOUS-209 and its ability to stimulate potent immune responses in LS carriers1,2, supporting its advancement into a registration-enabling Phase 2/3 trial in cancer interception. NOUS-209 is also being studied in Phase 2 studies in combination with pembrolizumab in a difficult-to-treat patient population of advanced dMMR and/or MSI-H metastatic CRC (mCRC) patients refractory to anti-PD-1 therapy3 and in first-line treatment of advanced dMMR and/or MSI-H mCRC. Data from the successfully completed Phase 1b trial were published in Science Translational Medicine4.
About Lynch Syndrome
Lynch Syndrome (LS) is a common inherited condition that significantly increases a person’s risk of developing cancer over their lifetime, especially colorectal cancer (CRC) (up to 50% risk, compared to 2% for general population), endometrial cancer (up to 50% risk, compared to 1-2% for general population) and urothelial cancer (up to 25% risk, compared to 1-2% for general population)5,6,7,8. LS also elevates the risk of developing other cancers including gastric, ovarian, prostate and pancreatic. LS is caused by inherited mutations in specific genes responsible for repairing DNA, leading to the buildup of harmful genetic errors that can accumulate, triggering development of tumors. Currently, managing LS is limited to frequent screenings such as colonoscopy to catch cancer early, but is not shown to reduce cancer incidence9, and elective surgery, which is invasive, expensive, and negatively impacts quality of life. As a pioneering approach to cancer interception, Nouscom’s investigational immunotherapy, NOUS-209, is designed to train the immune system to recognize and stop cancer before it develops.
About Cancer Interception
Cancer interception is an innovative approach that aims to stop cancer in its earliest stages before tumors fully develop and spread. Unlike traditional therapies that target established cancers, interception strategies harness advancements in immuno-oncology that can train the immune system to recognize and eliminate precancerous and cancerous cells. This approach is particularly relevant for those with high-risk genetic conditions such as LS who have high predisposition to developing MSI-associated cancers.
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.
References
- D’Alise, AM. et al. Nous-209 neoantigen vaccine for cancer prevention in Lynch Syndrome carriers: a phase 1b/2 trial. Nature Medicine (2026); DOI: 10.1038/s41591-025-04182-9.
- Willis et al, Cancer Res (2025) 85 (8_Supplement_1): 6427.
- Abstract is available on the ESMO website, here.
- D’Alise et al., Science Translational Medicine, 2022.
- Dominguez-Valentin et al., Genetics in Medicine, 2020.
- Dominguez-Valentin et al., The Lancet, 2023.
- Strafford, Reviews in Obstetrics & Gynecology, 2012.
- Richters et al., World Journal of Urology, 2020.
- Ahadova et al., International Journal of Cancer 2020.
- D’Alise et al., Clin Cancer Research, 2024.
Contacts
Nouscom
Rick Davis, COO
info@nouscom.com
+41 61 201 1835
MEDiSTRAVA
Sylvie Berrebi, Sandi Greenwood, Mark Swallow
nouscom@medistrava.com
+44 (0)203 928 6900
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