Nouscom to Current Closing Outcomes from Profitable Part Ib/II Trial of NOUS-209 in Individuals Residing with Lynch Syndrome, Demonstrating Highly effective Potential to Intercept Most cancers in its Earliest Levels of Improvement

• Lynch Syndrome (LS) is a standard hereditary situation that considerably will increase the chance of creating most cancers, particularly colorectal and endometrial cancers
• NOUS-209 is an off-the-shelf immunotherapy designed to harness the ability of the immune system to acknowledge and get rid of most cancers earlier than tumors develop
• Full security and immunogenicity outcomes from a Part Ib/II examine of NOUS-209 in LS to be offered in an oral presentation at AACR 2025
• Following constructive conferences with FDA, NOUS-209 scientific information assist development to a doubtlessly registration-enabling scientific examine for most cancers interception in LS

BASEL, Switzerland, March 25, 2025 – Nouscom, a clinical-stage biotech firm creating next-generation neoantigen-targeted off-the-shelf and personalised most cancers immunotherapies, as we speak introduced it is going to give an oral presentation of the entire security and immunogenicity outcomes from a Part Ib/II examine evaluating NOUS-209 in people with Lynch Syndrome (LS) on the American Academy of Most cancers Analysis (AACR) Annual Assembly being held in Chicago, IL, USA on April 25-30, 2025.

Summary Highlights:

• The Part Ib/II trial enrolled 45 LS carriers, assessing the security and immunogenicity of NOUS-209 as a most cancers interception technique.
• NOUS-209 was protected and properly tolerated, with no treatment-related critical opposed occasions reported.
• Immunogenicity evaluation confirmed neoantigen-specific T cell responses in 100% of evaluable contributors (N=37).
• NOUS-209 induced strong, polyfunctional and sturdy CD8 and CD4 T cell responses towards a number of frameshift peptide (FSP) neoantigens.
• Knowledge assist the additional scientific improvement of NOUS-209 monotherapy, highlighting its potential to effectively stimulate the immune system to intercept most cancers in LS carriers.

Oral Presentation Particulars:

• Title: Nous-209 Off-the-Shelf Neoantigen Immunotherapy induces strong neoantigen T cell response with the potential to intercept most cancers in Lynch Syndrome carriers
• Session: Sizzling Subjects in Most cancers Prevention
• Date & Time: April 29, 2025, at 2:30-4:30pm CDT

LS is a standard inherited situation attributable to DNA restore gene mutations. It impacts roughly 1 in 300 individuals, resulting in a considerably elevated lifetime most cancers danger of as much as 80%. Whereas present LS illness administration depends on frequent screenings or preventive surgical procedure, most cancers interception with NOUS-209 goals to coach the immune system to acknowledge and get rid of precancerous and cancerous cells earlier than they absolutely develop, develop and unfold.

NOUS-209 is an off-the-shelf immunotherapy designed to focus on tumors with particular genetic deficiencies often called mismatch restore deficiency (dMMR) and/or microsatellite instability (MSI). These tumors produce distinctive markers, FSPs, which function tumor-specific neoantigens. As a result of FSPs are completely present in tumors, they’re readily recognizable by the immune system and subsequently are ultimate targets for immunotherapy. NOUS-209 encodes 209 distinctive FSP neoantigens shared throughout a number of MSI tumor varieties, enabling its potential to deal with a broad vary of MSI-associated cancers.

Following constructive Kind B and C conferences with the US Meals and Drug Administration (FDA), Nouscom has a transparent path ahead for the development of NOUS-209 to a doubtlessly registration-enabling Part 2/3 scientific examine for most cancers interception in individuals dwelling with LS.

About Lynch Syndrome
Lynch Syndrome (LS) is a standard inherited situation that considerably will increase an individual’s danger of creating most cancers over their lifetime, particularly colorectal most cancers (CRC) (as much as 50% danger, in comparison with 2% for common inhabitants) and endometrial most cancers (as much as 50% danger, in comparison with 1-2% for common inhabitants)^1,2,3. LS additionally elevates the chance of creating different cancers together with gastric, ovarian, prostate and pancreatic. LS is attributable to inherited mutations in particular genes answerable for repairing DNA, resulting in the buildup of dangerous genetic errors that may accumulate, triggering improvement of tumors. At present, managing LS is proscribed to frequent screenings – comparable to colonoscopy to attempt to catch most cancers early, however which is not going to forestall most cancers incidence⁴ – or elective surgical procedure, which is invasive, costly and negatively impacts high quality of life. As a pioneering strategy to most cancers interception, Nouscom’s investigational immunotherapy, NOUS-209, is designed to coach the immune system to acknowledge and cease most cancers earlier than it develops.

About Most cancers Interception
Most cancers interception is an modern strategy that goals to cease most cancers in its earliest phases, earlier than tumors absolutely develop and unfold. Not like conventional therapies that concentrate on established cancers, interception methods harness developments in immuno-oncology which can be in a position to prepare the immune system to acknowledge and get rid of precancerous and cancerous cells. This strategy is especially essential for these with high-risk genetic situations comparable to LS who’re predisposed to creating MSI-associated cancers.

About NOUS-209
NOUS-209 is an investigational off-the-shelf most cancers immunotherapy that targets tumors with mismatch restore deficiency (dMMR). These tumors produce distinctive markers often called frameshift peptides (FSPs), that are distinctive to the most cancers and absent in wholesome cells. NOUS-209 is comprised of two proprietary viral vectors in a position to ship 209 shared FSP neoantigens and prepare the immune system to acknowledge and assault cancerous and pre-cancerous cells earlier than tumors can develop.

Part Ib/II information (NCT05078866⁵) demonstrated the security of NOUS-209 and its means to stimulate potent immune responses in LS carriers, supporting its development right into a doubtlessly registration-enabling Part 2/3 trial in most cancers interception. It is usually being studied in a randomized Part 2 examine together with pembrolizumab for the therapy of superior dMMR and/or microsatellite instability (MSI) metastatic colorectal cancers (mCRC). Knowledge revealed from the efficiently accomplished Part 1b trial have been revealed in Science Translational Drugs⁶.

About Nouscom
Nouscom is a clinical-stage biotech firm pioneering next-generation neoantigen-targeted immunotherapies to deal with most cancers in any respect phases, from early most cancers interception to late stage metastatic illness. Its proprietary viral vector platform permits broad and sturdy immune activation by delivering optimized neoantigens that prepare the immune system to acknowledge and battle most cancers. Nouscom’s lead program, NOUS-209, is an off-the-shelf immunotherapy in superior scientific improvement for most cancers interception in LS and the therapy of MSI-mCRC. The corporate’s scientific stage portfolio additionally contains NOUS-PEV, a personalised neoantigen immunotherapy, with revealed information from a efficiently accomplished Part 1b trial.⁷
Nouscom completely out-licensed VAC-85135, an off-the-shelf immunotherapy developed beneath a multi-project settlement, which is at the moment beneath analysis in a Part 1 trial for the therapy of Myeloproliferative Neoplasms sponsored by Janssen Analysis & Improvement and Bristol Myers Squibb.

For extra info on Nouscom, please go to the corporate’s web site at www.nouscom.com or comply with us on LinkedIn.

References

1. Dominguez-Valentin et al., Genetics in Drugs, 2020.
2. Dominguez-Valentin et al., The Lancet, 2023.
3. Strafford, Critiques in Obstetrics & Gynecology, 2012.
4. Ahadova et al., Worldwide Journal of Most cancers 2020.
5. The scientific trial NCT05078866 was led by researchers at The College of Texas MD Anderson Most cancers Middle, in collaboration with the Most cancers Prevention Scientific Trials Community and sponsored by the Nationwide Most cancers Institute (grant # UG1CA242609).
6. D’Alise et al., Science Translational Drugs, 2022.
7. D’Alise et al., Clin Most cancers Res, 2024.

Contacts
Nouscom
Rick Davis, COO
[email protected]
+41 61 201 1835

MEDiSTRAVA
Sylvie Berrebi, Sandi Greenwood, Mark Swallow
[email protected]
+44 (0)203 928 6900

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