PDS Biotechnology Corporation Announces Opening of Phase 2 Clinical Trial for Head and Neck Cancer Treatment

Strategic Insights -

PDS Biotechnology Corporation has announced the opening of its VERSATILE-002 Phase 2 clinical trial for the treatment of head and neck cancer that has returned or spread. In collaboration with Merck, the trial will evaluate the efficacy and safety of combining PDS0101, a Versamune-based immunotherapy targeting human papillomavirus (HPV)-associated cancers, with KEYTRUDA (pembrolizumab), a checkpoint inhibitor. The trial will enroll approximately 100 patients across 25 sites in the U.S. and will be led by Principal Investigator Dr. Timothy Panella at the University of Tennessee Medical Center.

Key Takeaways:

  • PDS Biotechnology Corporation has announced the opening of its VERSATILE-002 Phase 2 clinical trial for the treatment of head and neck cancer that has returned or spread.
  • The trial will evaluate the efficacy and safety of combining PDS0101, a Versamune-based immunotherapy, with KEYTRUDA (pembrolizumab), a checkpoint inhibitor.
  • The trial will enroll approximately 100 patients across 25 sites in the U.S. and be led by Principal Investigator Dr. Timothy Panella at the University of Tennessee Medical Center.
  • The main efficacy endpoint in this study is the objective response rate (ORR) at nine months following the initiation of treatment with the combination.
  • PDS Biotech is collaborating with Merck on the trial and has partnered with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center on separate Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer, respectively.
  • The trial's opening demonstrates the company's commitment to developing a safe and effective treatment option for patients with this aggressive cancer and strengthens its collaboration with Merck.
  • The University of Tennessee Medical Center is the first site to open, and Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002.
  • Patients interested in enrolling in this clinical study should email info@pdsbiotech.com or visit the website at http://pdsbiotech.com/VERSATILE-002 to learn more.
  • PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the company's proprietary Versamune T-cell activating technology platform.
  • The Versamune technology effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in the production of potent disease-specific killer T-cells and neutralizing antibodies.

Statistics:

  • The trial will enroll approximately 100 patients across 25 sites in the U.S.
  • The main efficacy endpoint in this study is the objective response rate (ORR) at nine months following the initiation of treatment with the combination.
  • KEYTRUDA was approved by the FDA in June 2019 as a first-line treatment for recurrent or metastatic head and neck cancer.
  • The trial's opening demonstrates the company's commitment to developing a safe and effective treatment option for patients with this aggressive cancer.

Sources:

  • GlobeNewswire - "PDS Biotechnology Corporation (PDSB) Announces Opening of Phase 2 Clinical Trial for Head and Neck Cancer Treatment"; available at
  • (quote) "PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the company's proprietary Versamune T-cell activating technology platform."
  • PDS Biotech's website (www.pdsbiotech.com)