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    DRUG CLASS:

    HPV-16 E6 protein inhibitor

    Related drugs:
    19d
    Hypoxia, metastatic origin and HPV16 E6/E7 expression differentially shape the radiation response in head and neck squamous cell carcinoma cell lines. (PubMed, Sci Rep)
    Our findings demonstrate that oxygen tension and biological factors-including metastatic origin and E6/E7 expression-modulate radiation response in HNSCC cell lines. These results highlight the need for biomarker-driven strategies that consider both hypoxic tumor microenvironment and key biological factors such as metastatic origin and HPV‑related E6/E7 oncogene expression.
    Preclinical • Journal
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    CXCL8 (Chemokine (C-X-C motif) ligand 8) • CASP3 (Caspase 3)
    1m
    A novel mRNA-based therapeutic vaccine elicits robust anti-tumor immunity against HPV-associated malignancies. (PubMed, Front Immunol)
    In this study, we developed TriStim-E6/E7, a novel HPV mRNA vaccine that combines E6/E7 antigens with three T cell co-stimulatory molecules (CD80, 4-1BBL, and CD70)...Additionally, a "cytokine release storm" experiment using PBMC-reconstituted mice confirmed a favorable safety profile of TriStim-E6/E7 mRNA. These findings collectively demonstrate the promising therapeutic potential of TriStim-E6/E7 mRNA for clinical translation against HPV-associated malignancies.
    Journal
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    CD8 (cluster of differentiation 8) • CD70 (CD70 Molecule) • CD4 (CD4 Molecule) • CD27 (CD27 Molecule) • CD80 (CD80 Molecule)
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    BNT113
    2ms
    A Randomized, Double-Blind, Placebo-Controlled Phase III Study in China to Evaluate the Efficacy and Safety of VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation with CELLECTRA™ 5PSP for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix (ChiCTR2300071848)
    P3, N=198, Completed, Chinese Academy of Medical Sciences Cancer Hospital; Beijing Apollo Saturn Biomedicine Technology Co. LTD | Recruiting --> Completed | N=84 --> 198
    Trial completion • Enrollment change
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    bizalimogene ralaplasmid (VGX-3100)
    2ms
    A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer (clinicaltrials.gov)
    P1/2, N=20, Active, not recruiting, Mayo Clinic | Completed --> Active, not recruiting | Trial completion date: Apr 2025 --> Sep 2026
    Enrollment closed • Trial completion date
    |
    Keytruda (pembrolizumab) • Versamune HPV
    4ms
    A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer (clinicaltrials.gov)
    P1/2, N=20, Completed, Mayo Clinic | Active, not recruiting --> Completed | Trial completion date: Oct 2026 --> Apr 2025 | Trial primary completion date: Oct 2026 --> Apr 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Versamune HPV
    4ms
    TG4001.12: Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers (clinicaltrials.gov)
    P1/2, N=143, Active, not recruiting, Transgene | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    Bavencio (avelumab) • tipapkinogene sovacivec (TG4001)
    5ms
    HPV16 E6 TCR T Cells for Cervical Carcinoma (clinicaltrials.gov)
    P1/2, N=5, Terminated, TCRCure Biopharma Ltd. | N=18 --> 5 | Trial completion date: Aug 2025 --> Jan 2026 | Recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Jan 2026; Study terminated due to strategic portfolio decision to reallocate resources to higher-priority programs
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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    HLA-A*02 positive
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    cyclophosphamide • fludarabine IV
    5ms
    A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC) (clinicaltrials.gov)
    P1, N=7, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=10 --> 7
    Enrollment closed • Enrollment change
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    NavDx®
    |
    eseba-vec (HB-200) • HB-201
    7ms
    VERSATILE-003: Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=351, Active, not recruiting, PDS Biotechnology Corp. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Keytruda (pembrolizumab) • Versamune HPV
    8ms
    QUILT-3.100: IBRX-042 In Participants With HPV-Associated Tumors (clinicaltrials.gov)
    P1, N=12, Active, not recruiting, ImmunityBio, Inc. | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2025 --> Sep 2027
    Enrollment closed • Trial primary completion date
    8ms
    VERSATILE-002: Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC (clinicaltrials.gov)
    P2, N=95, Completed, PDS Biotechnology Corp. | Active, not recruiting --> Completed
    Trial completion
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression
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    PD-L1 IHC 22C3 pharmDx
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    Keytruda (pembrolizumab) • Versamune HPV
    9ms
    Anisomelic acid promotes proteasomal degradation of HPV16 E6 via E3 ligase recruitment: A mass spectrometry-based interactome study. (PubMed, J Proteomics)
    To our knowledge, this represents the first comprehensive proteomics framework of the HPV16 E6 interactome under small-molecule treatment conditions. These findings support a model in which AA facilitates proteasome-mediated elimination of E6, and the dataset itself provides a timely and valuable resource for HPV biology and therapeutic development.
    Journal
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    TP53 (Tumor protein P53) • CDC20 (Cell Division Cycle 20) • TRIP12 (Thyroid Hormone Receptor Interactor 12)