Thursday, May 09, 2024
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, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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New Trial Design Will Test Two Drugs Against Standard Of Care. PDS Biotech held a KOL event featuring two prominent oncologists to discuss head and neck cancer and its clinical program data. The presentations included a review of current treatments and its two Phase 2 studies. The new Phase 3 study design was announced, now planned with three arms to test Versamune HPV with Keytruda, Versamune HPV and PDS01ADC with Keytruda, and Keytruda alone.
Phase 2 Trials Greatly Improved Patient Outcomes. The Phase 2 VERSATILE-002 trial testing Versamune HPV with Keytruda had strong improvements over current treatments in several clinical endpoints. During 2023, PDS discussed the path to approval for Versamune with the FDA. This led to design of the Phase 3 VERSATILE-003 trial testing the two-drug combination, similar to VERSATILE-002.
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