PRINCETON, N.J., May 03, 2024 -- PDS Biotechnology Corporation (Nasdaq: PDSB), a late-stage immunotherapy company, announced further details regarding its virtual Key Opinion Leader (KOL) event scheduled for Wednesday, May 8, 2024, at 1:30 PM ET. This webinar will highlight updated positive data from the VERSATILE-002 Phase 2 clinical trial, address the current unmet need in HPV-positive head and neck cancer, and outline the next steps for PDS Biotech's upcoming triple combination trial involving Versamune® HPV and PDS01ADC (IL-12 fused antibody drug conjugate).
The event will feature presentations from prominent figures in the medical field. Dr. Jared Weiss, Section Chief of Thoracic and Head/Neck Oncology and a Professor of Medicine at the University of North Carolina, will discuss the updated results from the VERSATILE-002 clinical trial. Dr. Robert Haddad, Professor of Medicine at Harvard Medical School and the Dana-Farber Cancer Institute, will shed light on the unmet needs in HPV-positive head and neck squamous cell cancer (HNSCC). The session will be moderated by Dr. Kirk Shepard, PDS Biotech's Chief Medical Officer, who will also present the upcoming steps on the clinical path toward registration for the Versamune® HPV and PDS01ADC based triple combination.
The VERSATILE-002 trial (NCT04260126) is evaluating the efficacy of Versamune® HPV in combination with the immune checkpoint inhibitor KEYTRUDA® (pembrolizumab) in patients suffering from unresectable, recurrent, or metastatic HPV16-positive HNSCC. After the formal presentations, a live Q&A session will be conducted.
Dr. Jared Weiss's extensive background includes an undergraduate degree from Brown University and an M.D. from Yale University. He completed his residency at Harvard's Beth Israel Deaconess Medical Center and his fellowship at the Hospital of the University of Pennsylvania. Currently, he holds a tenured professorship at the University of North Carolina's Lineberger Comprehensive Cancer Center, where he serves as section chief of thoracic and head/neck oncology. Dr. Weiss has contributed significantly to the development of various approved cancer treatment agents, including pembrolizumab and durvalumab. His clinical practice focuses on lung and head/neck cancers, and his research interests lie in personalized and adaptive immunotherapy for cancer, with a particular focus on small-cell lung cancer and NUT carcinoma.
Dr. Robert Haddad, a Professor of Medicine at Harvard Medical School and the Division Chief at the Dana-Farber Cancer Institute's Head and Neck Oncology Program, has a robust medical education background from Saint Joseph University and completed his residency at St. Luke’s Roosevelt Hospital Center. His fellowship was at the Greenbaum Cancer Center, University of Maryland. Dr. Haddad's research focuses on advanced treatment methodologies for head and neck cancer, including induction chemotherapy and novel immunotherapeutic agents. He has been pivotal in advancing phase II and III trials, contributing to new therapies for head and neck cancer patients. Additionally, Dr. Haddad is involved in teaching and lecturing extensively on the subject and has authored over 200 publications related to head and neck cancer.
PDS Biotechnology is dedicated to revolutionizing the way the immune system targets and eradicates cancers and developing infectious disease vaccines. The company plans to commence a pivotal clinical trial in 2024 to advance its lead program targeting advanced head and neck squamous cell cancers (HNSCC). PDS Biotech's primary program combines the IL-12 fused antibody drug conjugate PDS01ADC with the T-cell activator Versamune® HPV and a standard immune checkpoint inhibitor. Preliminary data suggests significant tumor shrinkage and positive survival outcomes, indicating favorable tolerability and potential broad utility across various tumor types and standard treatment regimens.
PDS Biotech's innovative "inside-outside" mechanism has demonstrated the ability to disrupt a tumor’s defenses while generating potent, targeted killer T-cells. With encouraging data from over 350 patients, the company's platforms show promise for extensive applicability. Additionally, PDS Biotech's Infectimune® based vaccines have shown the potential to induce robust, durable antibody and T-cell responses in pre-clinical studies, suggesting long-term efficacy in a range of infectious diseases.
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