On October 27, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported that highlights from its Head and Neck Cancer Key Opinion Leader (KOL) Roundtable (Press release, PDS Biotechnology, OCT 27, 2022, View Source [SID1234622494]). The virtual event was held from 8:30 to 9:30 AM, ET on Wednesday, October 26, 2022.
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This PDS Biotech-sponsored event was organized to provide analysts, investors, and the scientific community with a comprehensive overview of the head and neck cancer treatment landscape, including current challenges and unmet medical needs, and how PDS0101, the company’s lead product candidate, might fit into the treatment paradigm. PDS0101, which combines the utility of the Versamune platform with targeted antigens in HPV-positive cancers, is currently being studied in multiple Phase 2 clinical trials, including a Phase 2 clinical trial (VERSATILE-002) investigating PDS0101 in combination with Merck’s KEYTRUDA (pembrolizumab) in patients with HPV16-positive recurrent and/or metastatic head and neck cancer.
The Head and Neck Cancer KOL Roundtable was moderated by PDS Biotech’s Chief Medical Officer, Lauren V. Wood, MD, and featured presentations from Neil D. Gross, MD, Director of Clinical Research and Head of the Oropharynx Section in the Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center; Katharine A. R. Price, MD, Co-chair, Head, and Neck Disease Group, Mayo Clinic; and Jared Weiss, MD, Section Chief, Thoracic and Head/Neck Oncology, Lineberger Comprehensive Cancer Center, UNC School of Medicine.
"We are very honored to have had the opportunity to conduct a KOL Roundtable featuring such an accomplished panel of experts in head and neck cancer research and treatment," said Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "As we advance the development of PDS0101 in multiple Phase 2 clinical trials targeting HPV-positive cancers, including recurrent and/or metastatic head and neck cancer, we are continually reminded of the need for improved treatment options for this devastating disease. On behalf of PDS Biotech, I would like to personally thank Drs. Gross, Price, and Weiss for discussing these important opportunities and where HPV-targeted immunotherapies, such as PDS0101, may help to improve the lives of head and neck cancer patients."
The webcast replay and presentation slides from PDS Biotech’s KOL Roundtable Investor Event can be accessed via the Investor Relations section of the company’s website at View Source The replay will be available for 90 days.
The following is a recap of key topics from the event:
Current Treatment of Head and Neck Cancer
Led by Dr. Neil Gross, the first presentation provided a review of the head and neck cancer environment, including a historical review of the disease, the increasing incidence of HPV-positive head and neck cancer, current treatment regimens, recurrence of disease, and physical as well as emotional treatment-related issues impacting patients and caregivers. Additionally, Dr. Gross discussed opportunities for improved interventions and strategies for de-escalating side effects inherent to current treatment approaches.
Unmet Medical Needs in Head and Neck Cancer
In the next presentation, Dr. Katharine Price discussed the challenges and opportunities facing patients with recurrent/metastatic HPV-positive head and neck cancer, including current treatment options, the potential of new immunotherapy-based treatments to improve outcomes while delaying the need for cytotoxic chemotherapy, and the need to improve quality of life for patients while on treatment.
PDS0101 for the Potential Treatment of HPV16-Positive Head and Neck Cancer
In the final KOL presentation, Dr. Jared Weiss provided a review of the ongoing Phase 2 clinical trial (VERSATILE-002) investigating PDS0101 in combination with Merck’s KEYTRUDA (pembrolizumab) in patients with HPV16-positive recurrent and/or metastatic head and neck cancer. Dr. Weiss discussed the design of the study and data observed from 17 patients, including an objective response rate of 41.5%, clinical benefit rate of 76.5%, and an overall survival rate of 87.2% at nine months. Published results indicate the overall response rate of KEYTRUDA alone as 19%, as noted in published reports. Dr. Jared Weiss also discussed the lack of differences in poor clinical outcomes for HPV-positive and negative patients with recurrent or metastatic disease.