NOUS-209

P1/2, N=60, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting

P1/2, N=60, Recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2025 --> Jul 2025 | Trial primary completion date: Mar 2025 --> Jul 2025

P1/2, N=60, Recruiting, National Cancer Institute (NCI) | N=45 --> 60 | Trial completion date: Jul 2025 --> Mar 2025 | Trial primary completion date: Jul 2025 --> Mar 2025

FSPs were compared to the the previously validated pool of nAgs included in the Nous-209 vaccine at present under evaluation in metastatic MSI solid tumours by Nouscom® (NCT04041310).Results and DiscussionsOf the 35 patients with dMMR, 4 showed an absence of protein expression for hMLH1, 20 for hMLH1/PMS2, 1 for hMSH2/hMSH6, 2 for hMSH6, 7 for PMS2, and 1 for hMSH2 alone...Moreover, samples of our series that showed loss of expression of hMLH1 or hMLH1/PMS2 showed a higher number of FSPs (21 FSPs). Several potential indels leading to FSPs have been reported as well as the identification of a molecular-defect-based behaviour in nAgs enrichment and demonstration of the feasibility of the proteogenomic approach in nAgs prediction and targeting for immunotherapy.ConclusionnAgs have a special value combined as biomarker-driven therapy to novel drug combinations resulting in a novel therapeutic approach that could remodel the management of malignant gynecological cancers.

The combination of Nous-209 and pembrolizumab is safe, well tolerated and shows encouraging clinical efficacy in patients with treatment-naive dMMR/MSI-H mCRC eligible for anti-PD-1 therapy. The study is ongoing and expanding to Phase II randomization with a new accelerated Nous-209 vaccination schedule. Clinical trial information: NCT04041310.

P1/2, N=45, Recruiting, National Cancer Institute (NCI) | Phase classification: P2 --> P1/2

P1/2, N=115, Recruiting, Nouscom SRL | N=84 --> 115 | Trial completion date: Jul 2024 --> Jul 2026 | Trial primary completion date: Jul 2023 --> Mar 2025

P2, N=45, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Trial completion date: Dec 2024 --> Jul 2025 | Initiation date: Feb 2023 --> Sep 2022 | Trial primary completion date: Dec 2024 --> Jul 2025

P2, N=45, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Sep 2022 --> Feb 2023

The combination of the Nous-209 and pembrolizumab is safe and well tolerated, and shows signs of clinical efficacy. Nous-209 elicits a neoantigen-specific T cell response expanding within the tumor, possibly contributing to the clinical outcome.

P2, N=45, Not yet recruiting, National Cancer Institute (NCI) | Phase classification: P1/2 --> P2 | Trial completion date: Dec 2025 --> Dec 2024 | Initiation date: Jun 2022 --> Sep 2022 | Trial primary completion date: Dec 2025 --> Dec 2024

P1/2, N=84, Recruiting, Nouscom SRL | Active, not recruiting --> Recruiting

P1/2, N=84, Active, not recruiting, Nouscom SRL | Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: May 2022 --> Jul 2023

No dose limiting toxicities (DLTs) were observed, and the treatment combination was determined to be safe and tolerable. Vaccine immunogenicity was demonstrated by ex-vivo interferon-gamma ELISpot assay in 67% of subjects in dose level 1, and 100% of patients with evaluable samples in dose level 2 Conclusions The combination of the Nous-209 genetic polyvalent cancer vaccine and pembrolizumab has been demonstrated to be safe, immunogenic, and continues to show early signs of clinical efficacy, which may be attributed to the vaccine contribution

P1/2, N=84, Recruiting, Nouscom SRL | Active, not recruiting --> Recruiting | Phase classification: P1 --> P1/2 | N=34 --> 84

Combination of the Nous-209 genetic polyvalent cancer vaccine and pembrolizumab has been demonstrated to be safe, immunogenic, and has early signs of clinical efficacy, which may be attributed to the relative vaccine contribution.

P1, N=34, Active, not recruiting, Nouscom SRL | Recruiting --> Active, not recruiting | Trial primary completion date: May 2023 --> May 2022

Nous-209 is an "off-the-shelf" cancer vaccine encoding many neoantigens shared across sporadic and hereditary MSI tumors. These results indicate that Nous-209 can induce the optimal breadth of immune responses that might achieve clinical benefit to treat and prevent MSI tumors.

P1, N=34, Recruiting, Nouscom SRL | Trial primary completion date: Dec 2021 --> May 2023

P1, N=34, Recruiting, Nouscom SRL | Trial completion date: Jan 2023 --> Apr 2023 | Trial primary completion date: Jul 2021 --> Dec 2021