UCPVax / Invectys - LARVOL DELTA

A phase II study of an anti-telomerase CD4+ T-helper vaccine (UCPVax) with or without temozolomide in newly diagnosed glioblastoma. (ASCO 2025) - P2 | "UCPVax demonstrated robust immunogenicity, even when co-administered with TMZ, and was associated with improved overall survival (OS) in GBM patients who developed an epitope spreading response. These findings support further clinical investigation of TERT-derived CD4+ helper vaccine in GBM patients."

P2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD4 • IDH1

Optim-UCPVax: Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Centre Hospitalier Universitaire de Besancon | Active, not recruiting ➔ Completed | N=111 ➔ 60 | Trial completion date: Sep 2025 ➔ Nov 2024

Enrollment change • Trial completion • Trial completion date • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TERTIO: Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived from Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=105 | Recruiting | Sponsor: Centre Hospitalier Universitaire de Besancon | Trial completion date: Sep 2027 ➔ Sep 2029

Trial completion date • Hepatocellular Cancer • Oncology • Solid Tumor

UCPVax-Glio: Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma (clinicaltrials.gov) - P2 | N=67 | Completed | Sponsor: Centre Hospitalier Universitaire de Besancon | Active, not recruiting ➔ Completed

Trial completion • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IFNG

UCPVax: Universal Cancer Peptide-based Vaccination in Metastatic NSCLC (clinicaltrials.gov) - P1/2 | N=82 | Completed | Sponsor: Centre Hospitalier Universitaire de Besancon | Active, not recruiting ➔ Completed | N=54 ➔ 82

Enrollment change • Trial completion • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IFNG

UCPVax: Universal Cancer Peptide-based Vaccination in Metastatic NSCLC (clinicaltrials.gov) - P1/2 | N=54 | Active, not recruiting | Sponsor: Centre Hospitalier Universitaire de Besancon | Trial completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IFNG

Telomerase-based vaccines: a promising frontier in cancer immunotherapy. (PubMed, Cancer Cell Int) - "While DNA vaccines demonstrate promising immunogenicity, peptide vaccines, such as UV1, UCPVax, and Vx-001, have shown clinical efficacy in certain cancer types. Accordingly, we discuss the mechanisms of action, preclinical and clinical data, and the potential of these vaccines to elicit robust and durable anti-tumor immune responses. This review highlights the potential of telomerase-based vaccines as a promising strategy for cancer treatment and identifies areas for future research."

Journal • Review • Gene Therapies • Oncology • TERT

Combination of UCPVax Vaccine and Atezolizumab for the Treatment of Human Papillomavirus Positive Cancers (VolATIL) (clinicaltrials.gov) - P2 | N=47 | Completed | Sponsor: Centre Hospitalier Universitaire de Besancon | Active, not recruiting ➔ Completed | Trial completion date: Oct 2025 ➔ Nov 2024 | Trial primary completion date: Sep 2024 ➔ Mar 2024

Trial completion • Trial completion date • Trial primary completion date • Anal Carcinoma • Cervical Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Atezolizumab plus UCPvax telomerase CD4 TH1-inducer cancer vaccine for the treatment of chemorefractory HPV+ cancers: Safety and efficacy results of the VolATIL phase II study (ESMO 2024) - P2 | "Atezolizumab and hTert-derived CD4 TH1 inducing vaccine induced durable clinical responses in advanced HPV+ squamous cell carcinoma and deserves further investigations."

Clinical • P2 data • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Vulvar Cancer • CD4

UCPVAX-GLIO: A PHASE II TRIAL EVALUATING THE IMMUNOGENICITY AND EFFICACY OF AN ANTI-TELOMERASE VACCINE IN PATIENTS WITH NEWLY DIAGNOSED GBM (EANO 2023) - P2 | "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 • IO biomarker • P2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD4 • IDH1 • IFNG

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) - P2 | "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."

Journal • P2 data • CNS Disorders • Gastrointestinal Cancer • Hepatocellular Cancer • Immune Modulation • Oncology • Psychiatry • Solid Tumor • CD4 • TERT

UCPVax-Glio: Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma (clinicaltrials.gov) - P2 | N=56 | Active, not recruiting | Sponsor: 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 • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IFNG

Optim-UCPVax: Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=111 | Active, not recruiting | Sponsor: Centre Hospitalier Universitaire de Besancon | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2025 ➔ Sep 2023

Enrollment closed • Metastases • Trial primary completion date • Immune Modulation • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Universal Cancer Vaccine derived engineered TCR: Genetic engineering and functional analysis of novel hTERT-specific HLA Class II-restricted TCR for Adoptive Cell Therapy (EACR 2023) - "Oncol., 2023) recently published the safety, immunogenicity, and efficacy of a novel cancer vaccine (UCPVax) through a phase Ib/phase IIa de-escalation study...Most interestingly, when co-cultured with peptide-loaded HLA-matched cancer cells, we obtained in-vitro antigen-specific activation for both CD4+ as well as CD8+ T-cells, suggesting co-receptor independent TCR downstream signaling.ConclusionWe now aim to investigate the in-vivo efficacy and safety of the transgenic TCR, alongside their T-cell polarization, differentiation profile, and cytotoxic capacity. At last, we will employ non-viral genome editing to broaden hTERT-specific T-cell therapy for cancer treatment."

Oncology • CD4 • CD8 • IFNG • IL2

Anti-telomerase vaccine in patients with newly diagnosed, unmethylated MGMT glioblastoma: A phase II study. (ASCO 2023) - P2 | " Key inclusion criteria were: histologically confirmed, non-mutated IDH1 glioblastoma, unmethylated MGMT promoter status, previous treatment with concomitant radiotherapy and temozolomide (TMZ), Karnofsky Performance status (KPS) ≥ 70%, steroids < 10mg/ day equivalent prednisone, and lymphocytes count ≥ 0.8 x 109/L. UCPVax is highly immunogenic and provides an interesting OS rate in this population of poor prognosis, unmethylated MGMT GBM patients. These data support further clinical studies of UCPvax in GBM patients. Clinical trial information: NCT04280848."

Clinical • P2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Pain • Solid Tumor • CD4 • IDH1 • IFNG

Combination of UCPVax Vaccine and Atezolizumab for the Treatment of Human Papillomavirus Positive Cancers (VolATIL) (clinicaltrials.gov) - P2 | N=47 | Active, not recruiting | Sponsor: Centre Hospitalier Universitaire de Besancon | Recruiting ➔ Active, not recruiting

Enrollment closed • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Immune Modulation • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

UCPVax therapeutic vaccination promotes cytotoxic and Th1 polarized antitumor CD4 T cells and epitope spreading in patients with advanced non-small cell lung cancer (ESMO-IO 2022) - P1/2, P2 | "Finally, patients displayed polyfunctional anti-UCP CD4 response and epitope spreading had a better survival. Conclusions UCPVax vaccination promotes highly functional and long-lasting tumor specific CD4 T cell responses associated with the improvement of patients' survival."

Clinical • Late-breaking abstract • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • IFNG • IL2 • TNFA

Combination of UCPVax Vaccine and Atezolizumab for the Treatment of Human Papillomavirus Positive Cancers (VolATIL) (clinicaltrials.gov) - P2 | N=47 | Recruiting | Sponsor: Centre Hospitalier Universitaire de Besancon | Trial completion date: Feb 2023 ➔ Oct 2025 | Trial primary completion date: Sep 2022 ➔ Sep 2024

Trial completion date • Trial primary completion date • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Immune Modulation • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

TERTIO: Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=105 | Recruiting | Sponsor: Centre Hospitalier Universitaire de Besancon | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

UCPVax: Universal Cancer Peptide-based Vaccination in Metastatic NSCLC (clinicaltrials.gov) - P1/2 | N=54 | Active, not recruiting | Sponsor: Centre Hospitalier Universitaire de Besancon | Trial primary completion date: May 2022 ➔ Aug 2022

Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IFNG

TERTIO: Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=105 | Not yet recruiting | Sponsor: Centre Hospitalier Universitaire de Besancon

New P2 trial • Breast Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

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."

Journal • P2a data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4

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) - P2 | "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."

Journal • P2 data • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8

UCPVax-Glio: Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma (clinicaltrials.gov) - P2 | N=56 | Recruiting | Sponsor: 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 change • Enrollment open • Phase classification • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • IFNG

UCPVax: Universal Cancer Peptide-based Vaccination in Metastatic NSCLC (clinicaltrials.gov) - P1/2 | N=54 | Active, not recruiting | Sponsor: 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 • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IFNG