Tuesday, October 04, 2022
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
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PDS Biotech Announces FDA Meeting Results. PDS Biotech announced the outcome of an End-of-Phase 2 meeting with the FDA to determine the clinical development pathway for PDS0101. In the meeting, data from the interim analysis of the VERSATILE-002 trial testing PDS0101 in HPV-positive head-and-neck cancer was evaluated and regulatory guidance provided. Although the trial is still ongoing, the efficacy and safety data will allow moving into a Phase 3 pivotal study ahead of schedule during 2023.
VERSATILE-002 Showed Strong Response Rates. The VERSATILE-002 Phase 2 trial was designed to test PDS0101 in HPV-positive cancer of the head and neck in combination with the checkpoint inhibitor pembrolizumab (Keytruda, from Merck). As discussed in our Research Note reviewing the data at the ASCO conference last May 31, the tumor response rate (shrinkage of 30% or more) was 41.2% (7 out of 17 patients). This compares with published data showing 19% response rate for checkpoint inhibitors alone. Progression-free survival (PFS) at nine months was 55.2% and overall survival (OS) was 87.2%.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.