Wednesday, October 12, 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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Survival Data Extended To 16 Months. PDS Biotech announced an interim data update from its Phase 2 clinical trial testing PDS0101 in combination with two immunotherapy drugs (bintrafusp alfa, a bifunctional checkpoint inhibitor and IL-12, an immunocytokine). This trial is being conducted at the National Cancer Institute and is known as the “NCI trial” or the “Triple-Therapy” trial.
Trial Design. The study enrolled patients with HPV-positive tumors of multiple tissues who had failed prior therapy. Patients were stratified into two arms, separating those that had not received checkpoint inhibitor (CPI naive) therapy from those that had progressed after receiving CPI therapy (CPI refractory). Patients received a combination of PDS0101 with M9241, a tumor-targeting IL-12, and bintrafusp alfa, a bifunctional checkpoint inhibitor. Following the interim data announcement at the ASCO Meeting in May 2022, PDS announced that it would move forward to pivotal trials in CPI refractory patients.
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.