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    DRUG:

    NOUS-209

    i
    Other names: GAd20-209-FSP, NOUS-209, MVA-209-FSP
    Associations

    News

    Trials
    Company:
    Nouscom
    Drug class:
    Immunostimulant
    Related drugs:
    Associations

    News

    Trials
    25d
    Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients (clinicaltrials.gov)
    P1/2, N=60, Recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2025 --> Jul 2025 | Trial primary completion date: Mar 2025 --> Jul 2025
    Trial completion date • Trial primary completion date
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    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    BRAF mutation • MSH2 mutation • MLH1 mutation • PMS2 mutation
    |
    NOUS-209
    2ms
    Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients (clinicaltrials.gov)
    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
    Enrollment change • Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
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    BRAF mutation • MSH2 mutation • MLH1 mutation • PMS2 mutation
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    NOUS-209
    11ms
    Neoantigen Based Therapeutic Cancer Vaccines: Rationale, Practice and Perspectives in Endometrial Cancer (EACR 2023)
    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.
    MSi-H Biomarker • IO biomarker
    |
    TP53 (Tumor protein P53) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • PMS2 (PMS1 protein homolog 2)
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    MSI-H/dMMR • TP53 wild-type • MSH6 expression
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    NOUS-209
    1year
    Results of phase I-II bridging study for Nous-209, a neoantigen cancer immunotherapy, in combination with pembrolizumab as first line treatment in patients with advanced dMMR/MSI-h colorectal cancer. (ASCO 2023)
    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.
    Clinical • P1/2 data • Combination therapy • Metastases
    |
    MSI (Microsatellite instability)
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    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • NOUS-209
    over1year
    Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients (clinicaltrials.gov)
    P1/2, N=45, Recruiting, National Cancer Institute (NCI) | Phase classification: P2 --> P1/2
    Phase classification • IO biomarker
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    BRAF mutation • MSH2 mutation • MLH1 mutation • PMS2 mutation
    |
    NOUS-209
    over1year
    Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors (clinicaltrials.gov)
    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
    Enrollment change • Trial completion date • Trial primary completion date
    |
    MSI (Microsatellite instability) • IFNG (Interferon, gamma)
    |
    MSI-H/dMMR
    |
    NOUS-209
    over1year
    Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients (clinicaltrials.gov)
    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
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • IO biomarker
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    BRAF mutation • MSH2 mutation • MLH1 mutation • PMS2 mutation
    |
    NOUS-209
    over1year
    Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients (clinicaltrials.gov)
    P2, N=45, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Sep 2022 --> Feb 2023
    Trial initiation date • IO biomarker
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    BRAF mutation • MSH2 mutation • MLH1 mutation • PMS2 mutation
    |
    NOUS-209
    2years
    First clinical and immunogenicity results including all subjects enrolled in a phase I study of Nous-209, an off-the-shelf immunotherapy, with pembrolizumab, for the treatment of tumors with a deficiency in mismatch repair/microsatellite instability (dMMR/MSI). (ASCO 2022)
    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.
    Clinical • P1 data • Mismatch repair • Microsatellite instability
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    MSI (Microsatellite instability) • IFNG (Interferon, gamma)
    |
    MSI-H/dMMR
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    Keytruda (pembrolizumab) • NOUS-209
    2years
    Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients (clinicaltrials.gov)
    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
    Phase classification • Trial completion date • Trial initiation date • Trial primary completion date • IO biomarker
    |
    BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    BRAF mutation • MSH2 mutation • MLH1 mutation • PMS2 mutation
    |
    NOUS-209
    over2years
    Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors (clinicaltrials.gov)
    P1/2, N=84, Recruiting, Nouscom SRL | Active, not recruiting --> Recruiting
    Enrollment open
    |
    MSI (Microsatellite instability) • IFNG (Interferon, gamma)
    |
    MSI-H/dMMR
    |
    NOUS-209
    over2years
    Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors (clinicaltrials.gov)
    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
    Clinical • Enrollment closed • Trial completion date • Trial primary completion date
    |
    MSI (Microsatellite instability) • IFNG (Interferon, gamma)
    |
    MSI-H/dMMR
    |
    NOUS-209
    over2years
    Phase I Interim Study Results of Nous-209, an Off-the-Shelf Immunotherapy, with Pembrolizumab, for the Treatment of Tumors with a Deficiency in Mismatch Repair/ Microsatellite Instability (dMMR/MSI) (SITC 2021)
    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 data • Mismatch repair • Microsatellite instability
    |
    MSI (Microsatellite instability) • IFNG (Interferon, gamma)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • NOUS-209
    over2years
    Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors (clinicaltrials.gov)
    P1/2, N=84, Recruiting, Nouscom SRL | Active, not recruiting --> Recruiting | Phase classification: P1 --> P1/2 | N=34 --> 84
    Clinical • Enrollment open • Phase classification • Enrollment change
    |
    MSI (Microsatellite instability) • IFNG (Interferon, gamma)
    |
    MSI-H/dMMR
    |
    NOUS-209
    almost3years
    [VIRTUAL] Initial results from a phase I study of Nous-209, an off-the-shelf viral vectored immunotherapy encoding 209 shared frame shift peptide neoantigens, with pembrolizumab, for the treatment of tumors with a deficiency in mismatch repair/microsatellite instability (ESMO 2021)
    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 data • Mismatch repair • Microsatellite instability
    |
    MSI (Microsatellite instability) • IFNG (Interferon, gamma)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • NOUS-209
    almost3years
    Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors (clinicaltrials.gov)
    P1, N=34, Active, not recruiting, Nouscom SRL | Recruiting --> Active, not recruiting | Trial primary completion date: May 2023 --> May 2022
    Clinical • Enrollment closed • Trial primary completion date
    |
    MSI (Microsatellite instability) • IFNG (Interferon, gamma)
    |
    MSI-H/dMMR
    |
    NOUS-209
    over3years
    A genetic vaccine encoding shared cancer neoantigens to treat tumors with Microsatellite Instability. (PubMed, Cancer Res)
    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.
    Journal • Microsatellite instability
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    MSI (Microsatellite instability) • CD8 (cluster of differentiation 8)
    |
    NOUS-209
    over3years
    Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors (clinicaltrials.gov)
    P1, N=34, Recruiting, Nouscom SRL | Trial primary completion date: Dec 2021 --> May 2023
    Clinical • Trial primary completion date
    |
    MSI (Microsatellite instability) • IFNG (Interferon, gamma)
    |
    MSI-H/dMMR
    |
    NOUS-209
    over3years
    Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors (clinicaltrials.gov)
    P1, N=34, Recruiting, Nouscom SRL | Trial completion date: Jan 2023 --> Apr 2023 | Trial primary completion date: Jul 2021 --> Dec 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    MSI (Microsatellite instability) • IFNG (Interferon, gamma)
    |
    MSI-H/dMMR
    |
    NOUS-209