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    DRUG:

    Versamune HPV

    i
    Other names: Versamune HPV, PDS0101, Versamune-HPV, PDS 101, PDS-0101C, PDS 0101, PDS0101A, PDS0101B, Versamune® HPV
    Company:
    PDS Biotech
    Drug class:
    Immunostimulant, HPV-16 E6 protein inhibitor, HPV-16 E7 protein inhibitor
    Related drugs:
    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
    |
    Keytruda (pembrolizumab) • Versamune HPV
    2ms
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Versamune HPV
    4ms
    Testing for Safety and Immune Effects of PDS0101, an Anti-HPV Therapy, Among People Living With HIV (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Weill Medical College of Cornell University
    New P2 trial
    |
    Versamune HPV
    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
    |
    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
    |
    CD8 (cluster of differentiation 8)
    |
    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
    |
    ALK (Anaplastic lymphoma kinase)
    |
    cisplatin • Versamune HPV
    9ms
    VERSATILE-003: Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=351, Recruiting, PDS Biotechnology Corp. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Versamune HPV
    10ms
    Novel Combination Immunotherapy and Clinical Activity in Patients With HPV-Associated Cancers: A Nonrandomized Clinical Trial. (PubMed, JAMA Oncol)
    In this trial, the combination of PDS0101, PDS01ADC, and bintrafusp alfa showed an acceptable safety profile and promising antitumor activity and improved OS in patients with HPV-16-positive cancers, in both ICB-naive and ICB-resistant patients, warranting further evaluation of the combination of PDS0101 and PDS01ADC with simultaneous PD-L1/TGF-β inhibition in these populations.
    Clinical • Journal
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    bintrafusp alfa (M7824) • Versamune HPV • PDS01ADC
    11ms
    VERSATILE-003: Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=351, Not yet recruiting, PDS Biotechnology Corp.
    New P3 trial
    |
    Keytruda (pembrolizumab) • Versamune HPV
    over1year
    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, Recruiting, Mayo Clinic | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Versamune HPV
    over1year
    VERSATILE002: Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC (clinicaltrials.gov)
    P2; Trial completion date: Jul 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Versamune HPV
    almost2years
    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 | Recruiting --> Active, not recruiting | N=35 --> 22 | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    cisplatin • Versamune HPV