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PDS 0101

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Drug Profile

PDS 0101

Alternative Names: PDS 101; PDS-0101; PDS-0101C; PDS0101A; PDS0101B; Versamune-HPV; Versamune®-HPV16

Latest Information Update: 11 Jun 2025

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At a glance

  • Originator PDS Biotechnology Corporation
  • Developer Merck & Co; National Cancer Institute (USA); PDS Biotechnology Corporation
  • Class Antineoplastics; Cancer vaccines; Immunotherapies; Papillomavirus vaccines; Peptide vaccines
  • Mechanism of Action CD4-positive T-lymphocyte stimulants; CD8 positive T lymphocyte stimulants; Immunostimulants; Interferon gamma stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Squamous cell cancer
  • Phase II Anal cancer; Anal intraepithelial neoplasia; Cancer; Cervical cancer; Cervical intraepithelial neoplasia; Head and neck cancer; Oropharyngeal cancer; Penile cancer; Rectal cancer; Vulvovaginal cancer

Most Recent Events

  • 02 Jun 2025 Updated efficacy and adverse events data from phase II VERSATILE-002 trial in Squamous cell cancer released by PDS Biotechnology Corporation
  • 22 May 2025 Efficacy data from a phase II trial in Squamous cell cancer released by PDS Biotech
  • 28 Mar 2025 No recent reports of development identified for clinical-Phase-Unknown development in Oropharyngeal-cancer(Combination therapy, Neoadjuvant therapy) in USA (SC, Injection)

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