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    DRUG CLASS:

    hTERT inhibitor

    Related drugs:
    15d
    INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) (clinicaltrials.gov)
    P1/2, N=52, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    temozolomide • Libtayo (cemiplimab-rwlc) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
    5ms
    When UV1 cancer vaccine meets immune checkpoint blockade: Positive immune response but negative clinical outcome. (PubMed, Med)
    present findings from the phase 2 FOCUS trial evaluating UV1 vaccine combined with pembrolizumab in PD-L1-positive recurrent/metastatic head and neck squamous cell carcinoma. While UV1 elicited human telomerase reverse transcriptase-specific T cell responses in 86% of patients, clinical outcomes showed no improvement over pembrolizumab monotherapy.1 This discordance between immune activation and therapeutic efficacy underscores the necessity for further disease understanding and vaccine design in the future.
    Clinical data • Journal • Checkpoint inhibition
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    PD-L1 (Programmed death ligand 1) • TERT (Telomerase Reverse Transcriptase)
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    PD-L1 expression
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    Keytruda (pembrolizumab) • UV1
    5ms
    INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma (clinicaltrials.gov)
    P1/2, N=35, Completed, Inovio Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> May 2025 | Trial primary completion date: Dec 2025 --> May 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Tecentriq (atezolizumab) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
    7ms
    INO 5401 Vaccination in BRCA1/2 Mutation Carriers (clinicaltrials.gov)
    P1, N=44, Active, not recruiting, University of Pennsylvania | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    INO-5401 • rocakinogene sifuplasmid (INO-9012)
    8ms
    UV1 vaccination in pembrolizumab-treated patients with recurrent or metastatic head and neck cancer: A randomized multicenter phase 2 trial. (PubMed, Med)
    The addition of UV1 to pembrolizumab was safe but did not show an efficacy signal in this study population.
    P2 data • Journal
    |
    PD-L1 (Programmed death ligand 1) • TERT (Telomerase Reverse Transcriptase)
    |
    Keytruda (pembrolizumab) • UV1
    11ms
    DOVACC: Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer (clinicaltrials.gov)
    P2, N=184, Recruiting, Nordic Society of Gynaecological Oncology - Clinical Trials Unit | Trial completion date: Dec 2026 --> Dec 2030 | Trial primary completion date: Dec 2024 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Myriad myChoice® CDx
    |
    Lynparza (olaparib) • Imfinzi (durvalumab) • UV1
    12ms
    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.
    Review • Journal
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    TERT (Telomerase Reverse Transcriptase)
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    UCPVax • UV1 • Vx-001
    12ms
    Serum cytokines as a biomarker for immune checkpoint inhibitor toxicity in patients with pleural mesothelioma. (PubMed, Front Immunol)
    Patients with pleural mesothelioma treated with nivolumab and ipilimumab with or without UV1 vaccine in the NIPU study were included. Elevated levels of certain cytokines, both before and after onset of treatment, correlate with specific irAEs in PM patients receiving ICIs. These cytokines may be used as biomarkers to predict and detect irAES.
    Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    TNFA (Tumor Necrosis Factor-Alpha) • IL2RA (Interleukin 2 receptor, alpha) • CCL4 (Chemokine (C-C motif) ligand 4) • CCL11 (C-C Motif Chemokine Ligand 11) • IL4 (Interleukin 4) • IL16 (Interleukin 16)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • UV1
    12ms
    A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer. (clinicaltrials.gov)
    P1/2, N=18, Completed, Ultimovacs ASA | Active, not recruiting --> Completed
    Trial completion
    |
    Leukine (sargramostim) • UV1
    12ms
    A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (clinicaltrials.gov)
    P1/2, N=22, Completed, Ultimovacs ASA | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    Leukine (sargramostim) • UV1
    12ms
    Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma (clinicaltrials.gov)
    P1/2, N=12, Completed, Ultimovacs ASA | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    Yervoy (ipilimumab) • Leukine (sargramostim) • UV1
    1year
    INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) (clinicaltrials.gov)
    P1/2, N=52, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    temozolomide • Libtayo (cemiplimab-rwlc) • INO-5401 • rocakinogene sifuplasmid (INO-9012)