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DRUG CLASS:

HPV-16 E6 protein inhibitor

1m
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
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Keytruda (pembrolizumab) • Versamune HPV
2ms
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
2ms
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
3ms
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)
3ms
H-200-001: A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers (clinicaltrials.gov)
P1/2, N=198, Completed, Hookipa Biotech GmbH | Active, not recruiting --> Completed | Trial completion date: Jun 2026 --> Jan 2025 | Trial primary completion date: Jun 2025 --> Jan 2025
Trial completion • Trial completion date • Trial primary completion date
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Keytruda (pembrolizumab) • eseba-vec (HB-200) • HB-201
4ms
New P2 trial
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Versamune HPV
4ms
New trial
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HPV-T
5ms
VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions (clinicaltrials.gov)
P2, N=35, Completed, AIDS Malignancy Consortium | Active, not recruiting --> Completed | Trial completion date: Jun 2026 --> Jun 2025 | Trial primary completion date: Jun 2025 --> Dec 2024
Trial completion • Trial completion date • Trial primary completion date
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CD4 (CD4 Molecule)
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bizalimogene ralaplasmid (VGX-3100)
5ms
Reduction of NFX1-123 and HPV 16 E6 and E7 Decreased Telomerase and CENP-F in Cervical Cancer Cell Lines. (PubMed, Cancers (Basel))
These findings highlight the shared role that NFX1-123 has with HPV 16 oncogenes in driving and maintaining RNA, cell cycle, and carcinogenesis pathways, and specifically regulating hTERT, telomerase, and CENP-F.
Preclinical • Journal
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TERT (Telomerase Reverse Transcriptase)
6ms
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=24, Active, not recruiting, Mayo Clinic | Recruiting --> Active, not recruiting | Trial completion date: Jul 2025 --> Oct 2026 | Trial primary completion date: Jul 2025 --> Oct 2026
Enrollment closed • Trial completion date • Trial primary completion date
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Keytruda (pembrolizumab) • Versamune HPV
7ms
Combination of HDAC inhibition and cytokine enhances therapeutic HPV vaccine therapy. (PubMed, J Immunother Cancer)
Together, these findings provide a rationale for the combination of HPV vaccine, NHS-IL12, and Entinostat in the clinical setting for patients with HPV16-associated malignancies.
Journal • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8)
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Jingzhuda (entinostat) • Versamune HPV • PDS01ADC
7ms
A Vaccine (PDS0101) and Chemoradiation for the Treatment of Stage IB3-IVA Cervical Cancer, the IMMUNOCERV Trial (clinicaltrials.gov)
P2, N=22, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Mar 2025 --> Mar 2027 | Trial primary completion date: Mar 2025 --> Mar 2027
Trial completion date • Trial primary completion date
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ALK (Anaplastic lymphoma kinase)
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cisplatin • Versamune HPV