On November 5, 2024 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized neoantigen cancer immunotherapies, reported further promising data from the fully enrolled Phase 1b/2 study evaluating NOUS-209 for its potential to ‘intercept’ cancer in Lynch Syndrome (LS) carriers (Press release, NousCom, NOV 5, 2024, View Source;utm_medium=rss&utm_campaign=nouscoms-off-the-shelf-neoantigen-immunotherapy-nous-209-continues-to-elicit-potent-and-durable-immune-responses-in-lynch-syndrome-carriers-highlighting-its-potential-to-intercept [SID1234647734]).
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These updated data demonstrate that NOUS-209 monotherapy induces potent, broad and durable immune responses in all LS carriers evaluated and continues to be well-tolerated with no treatment-related serious adverse events reported. The new data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Houston, TX, USA on Saturday 9th November 2024.
NOUS-209 is an off-the-shelf immunotherapy encoding 209 neoantigens that are shared across both sporadic and hereditary deficient Mismatch Repair (dMMR) / Microsatellite Instable (MSI) tumors. LS carriers have a high-risk, genetic predisposition to developing MSI tumors such as colorectal cancer (CRC) and other types of life-threatening cancers, including endometrial, gastric and ovarian. Once diagnosed, people with LS undergo intensive and invasive surveillance programs that may include pre-emptive surgery but otherwise have no approved treatment options available.
In the ongoing Phase 1b/2 trial evaluating NOUS-209 as a monotherapy (NCT05078866), immune responses were evaluated in 23 LS carriers. NOUS-209 monotherapy continued to be safe, well tolerated and to generate potent immunogenic CD4 and CD8 T cell responses in all 23 participants. T cell responses were shown to be potent, broad and durable against multiple neoantigens encoded within NOUS-209. These data continue to support future clinical development of NOUS-209 as a valuable intervention for intercepting cancer in LS carriers.
Final data from the Phase 1b/2 study are expected to be available in mid-2025 and discussions with regulators regarding the future clinical development of NOUS-209 in LS carriers are underway.
The study is 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).
"Lynch Syndrome affects about one in 300 people, making it one of the most common hereditary cancer syndromes. Vaccine development is a significant step forward for the LS community, which currently relies on routine screening tools for cancer prevention", said the study’s principal investigator, Eduardo Vilar-Sanchez, M.D., Ph.D., Professor of Clinical Cancer Prevention at MD Anderson. "The updated data further suggest that cancer interception may be possible and that NOUS-209 has the potential to become an important intervention for people with LS, who face an elevated risk of developing life-threatening cancers, such as colorectal, gastric, and endometrial."
Dr. Elisa Scarselli, Chief Scientific Officer of Nouscom, added: "These exciting data substantially reinforce those first presented in a late-breaking oral abstract presentation at SITC (Free SITC Whitepaper) last year1, and further highlight the ability of NOUS-209 monotherapy to safely and effectively induce long-lasting immune responses in Lynch Syndrome carriers. This strengthens our belief that the immune system can be primed to intercept pre-malignant lesions and prevent the development of MSI tumors. We greatly appreciate the contribution and dedication of our collaborators at the US National Cancer Institute, clinical investigators and LS carriers who participated in this trial, all of whom share our commitment to intercept cancer."
Dr. Marina Udier, Chief Executive Officer of Nouscom, commented: "The data we are seeing from the Phase 1b/2 trial with NOUS-209 as a monotherapy in Lynch Syndrome carriers are extremely encouraging. Together with the previously published positive Phase 1 data of NOUS-209 in combination with pembrolizumab in dMMR/MSI cancers, and our ongoing randomized Phase 2 trial of NOUS-209, also in combination with pembrolizumab in dMMR/MSI metastatic CRC, NOUS-209 has demonstrated induction of powerful neoantigen-specific immune responses. These responses could lead to clinical benefits and highlight the transformative potential of NOUS-209, from cancer interception to treatment of metastatic disease2,3.
"Primary data read-outs from both the randomized Phase 2 trial in MSI mCRC and the Phase 1b/2 trial in LS are expected by mid-2025. We are excited to plan the future clinical development for NOUS-209 including a path towards registration."
Details of the poster presented at SITC (Free SITC Whitepaper) 2024 are as follows:
Title: Nous-209 vaccine induces shared neoantigen immunogenicity for cancer interception in healthy Lynch Syndrome carriers: results from Phase Ib/II trial
Number: 638
Date: Saturday, 9th November 2024
Session: Clinical Trials in Progress
Presenter: Dr. Eduardo Vilar-Sanchez, M.D., Ph.D., Professor of Clinical Cancer Prevention at MD Anderson
The abstract can be viewed on SITC (Free SITC Whitepaper)’s website.