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PDS Biotech Announces Release of Interim Data for PDS0101 in NCI-Led Phase 2 Clinical Study in Oral Presentation at ASCO 2021 Annual Meeting
Tumor reduction was observed in 83% (5 of 6) of HPV16-positive relapsed or refractory checkpoint inhibitor naïve advanced cancer patients and 58% (7 of 12) of
About this update from Pds Biotechnology Corporation
[{"type":"text","content":"Tumor reduction was observed in 83% (5 of 6) of HPV16-positive relapsed or refractory checkpoint inhibitor naïve advanced cancer patients and 58% (7 of 12) of HPV16-positive relapsed or refractory advanced cancer patients who have also failed checkpoint inhibitor therapy\nFLORHAM PARK, N.J., June 08, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune® T-cell activating technology, today announced the presentation of interim data from the Phase 2 trial led by the National Cancer Institute (NCI), of the National Institutes of Health (NIH), at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting. The Phase 2 trial (NCT04287868) studies PDS0101 (Versamune®-HPV16) in combination with two investigational immune-modulating agents: bintrafusp alfa (M7824), a bifunctional “trap” fusion protein targeting TGF-β and PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine. PDS0101 is an immunotherapy candidate designed to treat cancers caused by infection with HPV16 (HPV16-positive cancers) by activating the immune system to produce in vivo CD8+ (killer) T-cells to target and kill tumors that are HPV16-positive. Analyses of immune responses and other immune correlates are ongoing. Highlights from the presentation include the following: Data from a total of 25 patients with data available as of the time of presentation submission: Update on the data previously reported for the original fourteen (14) HPV16-positive patients who were in the subject of the abstract published on May 19th.An additional seven (7) HPV16-negative patients (patients whose cancer was NOT caused by HPV16 infection) who were not discussed in the abstract.An additional four (4) HPV16-positive patients who are checkpoint inhibitor refractory whose data became available after the abstract submission. 100% (25/25) of patients enrolled had failed chemotherapy treatment.96% (24/25) of patients enrolled had failed both chemotherapy and radiation treatment.56% (14/25) of patients enrolled had failed checkpoint inhibitor therapy (checkpoint inhibitor refractory).Most types of HPV-related cancers (anal, cervical, head and neck, vaginal and vulvar cancers) were represented among the study subjects. The following update was p...