Nouscom Presents Positive Final Results from Completed Phase Ib/II Study of Neoantigen Immunotherapy NOUS-209 at AACR 2025, Demonstrating a Highly Potent and Durable Immune Response in Lynch Syndrome Carriers
Lynch Syndrome (LS) is a common hereditary condition that significantly increases the lifetime risk of cancer, especially colorectal and endometrial, to as high as 80%
NOUS-209 is an off-the-shelf immunotherapy designed to harness the power of the immune system to recognize and eliminate cancer cells before tumors develop
Final results from a Phase Ib/II study of NOUS-209 monotherapy in LS carriers confirm its safety and immunogenicity, supporting advancement to a potentially registration-enabling study for cancer interception
T cells induced by NOUS-209 were shown to directly kill tumor cells ex vivo, confirming functional anti-cancer activity
Nouscom, a clinical-stage biotech company developing next-generation neoantigen-targeted off-the-shelf and personalized cancer immunotherapies, today announced complete safety and immunogenicity results from a Phase Ib/II study evaluating NOUS-209 in individuals with Lynch Syndrome (LS) at the American Association for Cancer Research (AACR) Annual Meeting 2025. The study found that NOUS-209 monotherapy was safe, well-tolerated and induced potent, broad and durable immune responses in all LS carriers evaluated.
LS is a common inherited condition that significantly increases a person's risk of developing microsatellite instability (MSI)-associated cancers over their lifetime. Managing LS is limited to frequent screenings or elective organ removal surgery. NOUS-209 is an investigational off-the-shelf cancer immunotherapy that targets tumors with mismatch repair deficiency (dMMR) and/or MSI. These tumors produce markers known as frameshift peptide neoantigens (FSPs). NOUS-209 is a pioneering approach to cancer interception comprising two proprietary viral vectors that deliver 209 shared FSP neoantigens and train the immune system to recognize and attack cancerous and pre-cancerous cells before tumors can fully develop.
The completed Phase Ib/II trial evaluated safety and immunogenicity in 45 LS carriers demonstrated;
Favorable Safety Profile: NOUS-209 was well tolerated, with no serious treatment-related adverse events across the entire study population.
Potent and Durable Immunogenicity Profile: Neoantigen-specific T cell responses were reported in 100% of evaluable participants (n=37). Responses were robust, reaching a mean of ~1100 interferon-gamma (IFN-γ) spot forming cells (SFC) per million of Peripheral Blood Mononuclear Cells (PBMCs). Immune responses were durable, with tumor-specific T cells detected after 1 year in >85% of participants (n=33).
Broad, Polyspecific T Cell Response: Immune responses were confirmed against 115 different FSP neoantigens to date, validating the ability of NOUS-209 to elicit broad polyspecific immune responses.
Desired T Cell Phenotype: NOUS-209 induced neoantigen-specific CD8 and CD4 T cells, exhibiting an effector memory phenotype associated with long-lived immunity critical for sustained surveillance and ability to eliminate emerging tumor cells.
Demonstration of Tumor Cell Killing: T cells induced by NOUS-209 were shown to directly kill tumor cells ex vivo, confirming functional anti-cancer activity.
Target Validation in LS-Associated Premalignant and Cancer Lesions: The vast majority of the immunogenic FSP neoantigens were shown to be present in both pre-cancerous as well as cancer lesions from independent cohorts of LS carriers.
These data support the further clinical development of NOUS-209 as a monotherapy in LS carriers. Following positive Type B and C meetings with the US Food and Drug Administration (FDA), Nouscom has a clear path forward for the advancement of NOUS-209 to a potentially registration-enabling Phase 2/3 clinical study for cancer interception in those living with LS.
'Currently, individuals with Lynch Syndrome rely on frequent screenings, such as colonoscopies, to manage their markedly increased risk of developing cancer. These latest data are a step toward a completely new approach – leveraging the immune system for cancer interception,' said the study's principal investigator, Eduardo Vilar-Sanchez, M.D., Ph.D., Professor of Clinical Cancer Prevention at The University of Texas MD Anderson Cancer Center. 'NOUS-209 has shown clear evidence that the T cells it activates can persist over time, effectively target and kill tumor cells and develop into memory cells that support long-term immune protection. These findings support NOUS-209's potential as a cancer interception strategy.'
'Nouscom's proprietary viral vector platform is uniquely positioned to deliver rapid, potent and broad immune activation against a large number of shared neoantigens, with minimal reactogenicity and durable immune responses,' said Dr. Elisa Scarselli, Chief Scientific Officer of Nouscom. 'These compelling Phase Ib/II data further reinforce our confidence in NOUS-209 monotherapy to safely and effectively prime the immune system to recognize and intercept pre-malignant and cancer lesions before they progress into tumors in LS carriers.'
Dr. Marina Udier, Chief Executive Officer of Nouscom, added: 'We are enormously pleased with these robust Phase Ib/II data and look to progress toward a potentially registration-enabling Phase 2/3 clinical study for cancer interception in LS. We remain deeply committed to advancing NOUS-209 and bring better solutions for people living with LS who urgently need and deserve a better way to manage their cancer risk.'
The study was led by researchers at MD Anderson, in collaboration with the Cancer Prevention Clinical Trials Network and sponsored by the National Cancer Institute (grant # UG1CA242609) of the National Institutes of Health. These data were presented during the Hot Topics in Cancer Prevention session, and the abstract is available on the AACR website here.
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About Lynch SyndromeLynch 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) and endometrial cancer (up to 50% risk, compared to 1-2% for general population)1,2,3. 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 try to catch cancer early, but which will not prevent cancer incidence4 - or 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 InterceptionCancer 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 are able to train the immune system to recognize and eliminate precancerous and cancerous cells. This approach is particularly crucial for those with high-risk genetic conditions such as LS who are predisposed to developing microsatellite instability (MSI) -associated cancers.
About NOUS-209NOUS-209 is an investigational off-the-shelf cancer immunotherapy that targets tumors with mismatch repair deficiency (dMMR). These tumors produce unique markers known as frameshift peptide neoantigen (FSPs), which are unique to the cancer and absent in healthy cells. NOUS-209 is comprised of two proprietary viral vectors able to deliver 209 shared FSP neoantigens and train the immune system to recognize and attack cancerous and pre-cancerous cells before tumors can develop.
Phase Ib/II data (NCT050788665) demonstrated the safety of NOUS-209 and its ability to stimulate potent immune responses in LS carriers, supporting its advancement into a potentially registration-enabling Phase 2/3 trial in cancer interception. It is also being studied in a randomized Phase 2 study in combination with pembrolizumab for the treatment of advanced dMMR and/or microsatellite instability (MSI) metastatic colorectal cancers (mCRC). Data published from the successfully completed Phase Ib trial were published in Science Translational Medicine6.
About NouscomNouscom 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 Ib trial.7
For more information on Nouscom, please visit the company's website at www.nouscom.com or follow us on LinkedIn.
References
Dominguez-Valentin et al., Genetics in Medicine, 2020.
Dominguez-Valentin et al., The Lancet, 2023.
Strafford, Reviews in Obstetrics & Gynecology, 2012.
Ahadova et al., International Journal of Cancer 2020.
The clinical trial NCT05078866 was led by researchers at The University of Texas MD Anderson Cancer Center, in collaboration with the Cancer Prevention Clinical Trials Network and sponsored by the National Cancer Institute (grant # UG1CA242609) of the National Institutes of Health.
D'Alise et al., Science Translational Medicine, 2022.
D'Alise et al., Clin Cancer Res, 2024.
ContactsNouscomRick Davis, COOinfo@nouscom.com+41 61 201 1835
MEDiSTRAVASylvie Berrebi, Sandi Greenwood, Mark Swallownouscom@medistrava.com+44 (0)203 928 6900
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