PDS Biotechnology Corp. (PDSB) – Triple Therapy Registration Trial Requirements Announced

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Tuesday, February 28, 2023

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.

Refer to the full report for the price target, fundamental analysis, and rating.

Triple Therapy Advances.  PDS Biotech announced that the FDA has agreed to requirements for a registration trial using PDS0101 “Triple Combination” therapy in head and neck cancer. The study will test the combination of PDS0101, PDS0301, and a commercially available checkpoint inhibitor. We believe the changes from the previous trial should make regulatory approval faster, with additional tumor types added after market entry.

New Combination Eliminates An Unapproved Checkpoint Inhibitor. The new Triple Combination uses PDS010 to stimulate an immune response against the HPV antigen, PDS0301 to stimulate a robust immune response, and a checkpoint inhibitor to allow the immune system to recognize the tumor cells. The previous trial included bintrafusp alfa, an experimental checkpoint inhibitor. We believe the change to an approved checkpoint inhibitor simplifies the regulatory path.

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