Tuesday, May 30, 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, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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ASCO Abstracts Contain Positive Data Update. On Friday, May 26, abstracts for the Annual Meeting of the American Society of Clinical Oncology (ASCO) were released. As we expected, the data update from the Phase 2 VERSATILE-002 trial showed consistent or improved response rates, overall survival, and progression free survival, with continued safety and tolerability. We believe these data support our expectations of efficacy in the Phase 3 trial, expected to begin in late 2023.
Data Updates Confirm and Support Preliminary Findings. The abstract contains updated interim results from the Phase 2 VERSATILE-002 trial testing the combination of PDS0101 with Keytruda (an anti-PD-1 immune checkpoint inhibitor from Merck). The data presentation will include 34 patients that have reached the 12-month evaluation point, compared with the data from 17 patients evaluated after 9 months presented at ASCO 2022. These new data show strong improvements over ICI monotherapy, the current standard of care, as well as efficacy and strong duration of benefits.
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