Nouscom to Present Updated Positive Data on NOUS-209’s Potential to ‘Intercept’ Cancer in Lynch Syndrome Carriers at SITC 2024

BASEL, Switzerland – 4^th October 2024 - Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vector-based cancer vaccines targeting neoantigens, announces that updated safety data, as well as compelling immunogenicity and durability of T cell response from its Phase 1b/2 study evaluating NOUS-209 in Lynch Syndrome carriers will be presented at the 39^th Society for Immunotherapy of Cancer (SITC) 2024 annual meeting (6^th - 10^th November 2024, Houston, TX, USA).

NOUS-209 is an innovative and unique off-the-shelf vaccine encoding 209 neoantigens that are shared across sporadic and hereditary Microsatellite Instable (MSI) tumors. Lynch Syndrome (LS) is one of the most prevalent hereditary cancer syndromes affecting approximately one in 300 people. LS carriers have a high-risk predisposition to developing MSI tumors with an up to 80% lifetime risk of developing colorectal cancer (CRC). Currently, there are no treatment options for LS carriers, other than active surveillance and / or prophylactic surgery. NOUS-209 monotherapy has the potential to ‘intercept’ cancer before it occurs in these individuals.

Interim results in the first ten LS participants from a Phase 1b/2 study (NCT05078866) were reported in a late-breaking abstract and presented at the SITC 2023 demonstrating good safety and robust and broad CD4 and CD8 T cell immunity of NOUS-209 monotherapy (D’Alise et al.¹).

Abstract details are as follows:

• Abstract Title: Nous-209 vaccine induces shared neoantigen immunogenicity for cancer interception in healthy Lynch Syndrome carriers: results from Phase Ib/II trial
• Abstract Number: 638
• Presenter: Dr Eduardo Vilar

NOUS-209 is also being evaluated in a randomized, global multicenter Phase 2 trial for the treatment of deficient mismatch repair (dMMR)/MSI-High tumor patients with unresectable or metastatic CRC in combination with pembrolizumab (NCT04041310).

Reference

1. D’Alise M, Willis J, Leoni G, et al. 1526 Nous-209 genetic vaccine encoding shared cancer neoantigens is safe and elicits robust immune response in healthy Lynch syndrome carriers: interim results from Phase 1 cancer interception trial. Journal for ImmunoTherapy of Cancer 2023;11: doi: 10.1136/jitc-2023-SITC2023.1526

About Lynch Syndrome

Lynch Syndrome (LS) is a common hereditary condition associated with an increased predisposition to develop colorectal cancer (CRC) and other type of cancers, including endometrial, gastric and ovarian cancers. LS carriers have about 50% to 80% lifetime risk of CRC, a 40% to 60% risk of endometrial cancer, and an elevated risk of developing several other tumor types (Bonadona et al. JAMA 2011).

LS is caused by mutations in one of the four DNA mismatch repair (MMR) genes, leading to tumors that accumulate a large number of neoantigens. In the general population, approximately 1 in 300 individuals have LS. In the US, it’s estimated that nearly one million individuals are affected by LS. Despite this, LS remains vastly underdiagnosed and current intervention options are limited to surveillance and/ or prophylactic surgery.

Vaccine-based strategies to target neoantigens, such as NOUS-209, are being explored for their potential to stimulate the immune system to recognize and intercept tumors before they occur or in their early stages.

About Nouscom

Nouscom is a clinical-stage immuno-oncology company developing next-generation, off-the-shelf and personalized cancer immunotherapies. Nouscom’s proprietary viral vector platform has the capacity to encode for large payloads of neoantigens or other immunomodulators and clinically demonstrated to safely and potently harness the power of the immune system.

Nouscom is currently advancing the clinical development of its wholly owned programs:

• NOUS-209, an off-the-shelf cancer immunotherapy for the treatment of MSI solid tumors in combination with pembrolizumab in randomized Phase 2 trials. 

• NOUS-209, an off-the-shelf monotherapy in Lynch Syndrome carriers with the potential to ‘intercept cancer’ before it occurs. A Phase 1b/2 is being conducted under a clinical trial collaboration and supply agreement with the National Cancer Institute (NCI).

• NOUS-PEV, a personalized cancer immunotherapy, is expected to enter randomized Phase 2 trials in indications with high unmet medical need in 2025.

Nouscom has also 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.