Nouscom to Present Final Results from Successful Phase Ib/II Trial of NOUS-209 in People Living with Lynch Syndrome, Demonstrating Powerful Potential to Intercept Cancer in its Earliest Stages of Development

• Lynch Syndrome (LS) is a common hereditary condition that significantly increases the risk of developing cancer, especially colorectal and endometrial cancers
• NOUS-209 is an off-the-shelf immunotherapy designed to harness the power of the immune system to recognize and eliminate cancer before tumors develop
• Full safety and immunogenicity results from a Phase Ib/II study of NOUS-209 in LS to be presented in an oral presentation at AACR 2025
• Following positive meetings with FDA, NOUS-209 clinical data support advancement to a potentially registration-enabling clinical study for cancer interception in LS

/EIN News/ -- BASEL, Switzerland, March 25, 2025 - Nouscom, a clinical-stage biotech company developing next-generation neoantigen-targeted off-the-shelf and personalized cancer immunotherapies, today announced it will give an oral presentation of the complete safety and immunogenicity results from a Phase Ib/II study evaluating NOUS-209 in individuals with Lynch Syndrome (LS) at the American Academy of Cancer Research (AACR) Annual Meeting being held in Chicago, IL, USA on April 25-30, 2025.

Abstract Highlights:

• The Phase Ib/II trial enrolled 45 LS carriers, assessing the safety and immunogenicity of NOUS-209 as a cancer interception strategy.
• NOUS-209 was safe and well tolerated, with no treatment-related serious adverse events reported.
• Immunogenicity analysis showed neoantigen-specific T cell responses in 100% of evaluable participants (N=37).
• NOUS-209 induced robust, polyfunctional and durable CD8 and CD4 T cell responses against multiple frameshift peptide (FSP) neoantigens.
• Data support the further clinical development of NOUS-209 monotherapy, highlighting its potential to efficiently stimulate the immune system to intercept cancer in LS carriers.
  
  

Oral Presentation Details:

• Title: Nous-209 Off-the-Shelf Neoantigen Immunotherapy induces robust neoantigen T cell response with the potential to intercept cancer in Lynch Syndrome carriers
• Session: Hot Topics in Cancer Prevention
• Date & Time: April 29, 2025, at 2:30-4:30pm CDT
  
  

LS is a common inherited condition caused by DNA repair gene mutations. It affects approximately 1 in 300 people, leading to a significantly increased lifetime cancer risk of up to 80%. While current LS disease management relies on frequent screenings or preventive surgery, cancer interception with NOUS-209 aims to train the immune system to recognize and eliminate precancerous and cancerous cells before they fully develop, grow and spread.

NOUS-209 is an off-the-shelf immunotherapy designed to target tumors with specific genetic deficiencies known as mismatch repair deficiency (dMMR) and/or microsatellite instability (MSI). These tumors produce unique markers, FSPs, which serve as tumor-specific neoantigens. Because FSPs are exclusively found in tumors, they are readily recognizable by the immune system and therefore are ideal targets for immunotherapy. NOUS-209 encodes 209 unique FSP neoantigens shared across multiple MSI tumor types, enabling its potential to treat a broad range of MSI-associated cancers.

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 people living with LS.

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) 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 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 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 MSI-associated cancers.

About NOUS-209
NOUS-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 peptides (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 1b trial were published in Science Translational Medicine⁶.

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 trial.⁷
Nouscom exclusively out-licensed VAC-85135, an off-the-shelf immunotherapy developed under a multi-project agreement, which is currently under evaluation in a Phase 1 trial for the treatment of Myeloproliferative Neoplasms sponsored by Janssen Research & Development and Bristol Myers Squibb.

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

References

1. Dominguez-Valentin et al., Genetics in Medicine, 2020.
2. Dominguez-Valentin et al., The Lancet, 2023.
3. Strafford, Reviews in Obstetrics & Gynecology, 2012.
4. Ahadova et al., International Journal of Cancer 2020.
5. 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).
6. D’Alise et al., Science Translational Medicine, 2022.
7. D’Alise et al., Clin Cancer Res, 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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