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    DRUG:

    UCPVax

    i
    Other names: UCPVax, hTERT-derived peptide vaccine, Human telomerase reverse transcriptase peptide-based vaccine, UCP2-UCP4 vaccine, IVI-1001
    Company:
    Invectys
    Drug class:
    Immunostimulant
    Related drugs:
    7ms
    UCPVAX-GLIO: A PHASE II TRIAL EVALUATING THE IMMUNOGENICITY AND EFFICACY OF AN ANTI-TELOMERASE VACCINE IN PATIENTS WITH NEWLY DIAGNOSED GBM (EANO 2023)
    One month after completion of radiation/ temozolomide (TMZ), patients started UCPvax vaccinations on days 1, 8, 15, 29, 36 and 43, then every two months until tumor progression. In this population of unmethylated MGMT GBM patients, UCPVax is highly immunogenic and provides an interesting OS rate. These data strongly support the completion of the second ongoing cohort, assessing UCPvax in combination with TMZ for GBM patients with methylated MGMT promoter status.
    Clinical • P2 data • IO biomarker
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule)
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    IDH1 mutation
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    temozolomide • UCPVax
    9ms
    Evaluation of the interest to combine a CD4 Th1-inducer cancer vaccine derived from telomerase and atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma: a randomized non-comparative phase II study (TERTIO - PRODIGE 82). (PubMed, BMC Cancer)
    Combining anti-PD-1/PD-L1 therapy with an anti-telomerase vaccine gains serious consideration in HCC, in order to extend the clinical efficacy of anti-PD-1/PD-L1. Indeed, anti-cancer vaccines can induce tumor-specific T cell expansion and activation and therefore restore the cancer-immunity cycle in patients lacking pre-existing anti-tumor responses. Thus, there is a strong rational to combine immune checkpoint blockade therapy and anticancer vaccine (UCPVax) in order to activate antitumor T cell immunity and bypass the immunosuppression in the tumor microenvironment in HCC. This pivotal proof of concept study will evaluate the efficacy and safety of the combination of a CD4 Th1-inducer cancer vaccine derived from telomerase (UCPVax) and atezolizumab plus bevacizumab in unresectable HCC, as well as confirming their synergic mechanism, and settling the basis for a new combination for future clinical trials.
    P2 data • Journal
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    TERT (Telomerase Reverse Transcriptase) • CD4 (CD4 Molecule)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • UCPVax
    9ms
    UCPVax-Glio: Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma (clinicaltrials.gov)
    P2, N=56, Active, not recruiting, Centre Hospitalier Universitaire de Besancon | Recruiting --> Active, not recruiting | Trial completion date: May 2023 --> Dec 2024 | Trial primary completion date: Nov 2022 --> Dec 2023
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    IFNG (Interferon, gamma)
    |
    temozolomide • UCPVax
    11ms
    Combination of UCPVax Vaccine and Atezolizumab for the Treatment of Human Papillomavirus Positive Cancers (VolATIL) (clinicaltrials.gov)
    P2, N=47, Active, not recruiting, Centre Hospitalier Universitaire de Besancon | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Tecentriq (atezolizumab) • UCPVax
    over1year
    UCPVax: Universal Cancer Peptide-based Vaccination in Metastatic NSCLC (clinicaltrials.gov)
    P1/2, N=54, Active, not recruiting, Centre Hospitalier Universitaire de Besancon | Trial primary completion date: May 2022 --> Aug 2022
    Trial primary completion date • Metastases
    |
    IFNG (Interferon, gamma)
    |
    UCPVax
    over1year
    Safety, Immunogenicity, and 1-Year Efficacy of Universal Cancer Peptide-Based Vaccine in Patients With Refractory Advanced Non-Small-Cell Lung Cancer: A Phase Ib/Phase IIa De-Escalation Study. (PubMed, J Clin Oncol)
    UCPVax was highly immunogenic and safe and provide interesting 1-year OS rate in heavily pretreated advanced NSCLC.
    P2a data • Journal
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    CD4 (CD4 Molecule)
    |
    UCPVax
    over1year
    A Phase II Study Evaluating the Interest to Combine UCPVax, a Telomerase CD4 T1-Inducer Cancer Vaccine, and Atezolizumab for the Treatment of HPV Positive Cancers: VolATIL Study. (PubMed, Front Oncol)
    This pivotal proof of concept study will evaluate the efficacy and safety of the combination of a telomerase-based T1 inducing vaccine (UCPVax) and an anti-PD-L1 (atezolizumab) immunotherapy in HPV cancers, as well as confirming their synergic mechanism, and settling the basis for a new combination for future clinical trials. https://www.clinicaltrials.gov/, identifier NCT03946358.
    P2 data • Journal
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    Tecentriq (atezolizumab) • UCPVax
    almost2years
    UCPVax-Glio: Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma (clinicaltrials.gov)
    P2, N=56, Recruiting, Centre Hospitalier Universitaire de Besancon | Active, not recruiting --> Recruiting | Phase classification: P1/2 --> P2 | N=28 --> 56 | Trial primary completion date: Dec 2021 --> Nov 2022
    Enrollment open • Phase classification • Enrollment change • Trial primary completion date
    |
    IFNG (Interferon, gamma)
    |
    temozolomide • UCPVax
    almost2years
    UCPVax: Universal Cancer Peptide-based Vaccination in Metastatic NSCLC (clinicaltrials.gov)
    P1/2, N=54, Active, not recruiting, Centre Hospitalier Universitaire de Besancon | Recruiting --> Active, not recruiting | Trial completion date: Jun 2022 --> Dec 2023 | Trial primary completion date: Sep 2021 --> May 2022
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    IFNG (Interferon, gamma)
    |
    UCPVax
    over2years
    UCPVax-Glio: Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma (clinicaltrials.gov)
    P1/2, N=28, Active, not recruiting, Centre Hospitalier Universitaire de Besancon | Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2021 --> Dec 2021
    Enrollment closed • Trial primary completion date
    |
    IFNG (Interferon, gamma)
    |
    temozolomide • UCPVax
    over2years
    UCPVax: Universal Cancer Peptide-based Vaccination in Metastatic NSCLC (clinicaltrials.gov)
    P1/2, N=54, Recruiting, Centre Hospitalier Universitaire de Besancon | Trial completion date: Oct 2021 --> Jun 2022 | Trial primary completion date: Jan 2021 --> Sep 2021
    Trial completion date • Trial primary completion date
    |
    IFNG (Interferon, gamma)
    |
    UCPVax
    4years
    UCPVax-Glio: Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma (clinicaltrials.gov)
    P1/2, N=28, Recruiting, Centre Hospitalier Universitaire de Besancon
    New P1/2 trial
    |
    IFNG (Interferon, gamma)
    |
    temozolomide • UCPVax