PDS Biotechnology (PDSB) – Midyear Review: Has PDS Turned The Corner?


Tuesday, July 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.

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

Amended Phase 3 Clinical Trial Will Test Two Drugs. During 2Q24, the design of the Phase 3 trial testing Versamune HPV with Keytruda added a second treatment arm to test Versamune, PDS01ADC, and Keytruda against the active control arm of Keytruda alone. We believe this new trial design answers several questions that have caused PDSB to stagnate over the past year. A meeting with the FDA to ensure alignment on the trial design is expected during July 2024.

Thoughtful Consideration Has Led To Improved Trial Design. There are several points from the Phase 2 trial data that lead us to believe that adding the third arm to Phase 3 study improves its design. We believe the Triple-combination could have more rapid enrollment, produce data for product approvals, and support extensive use as a first-line therapy.


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