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PDS Biotechnology Reports Clinical Data for Its Novel Immunotherapy PDS0101 in Follow up to Phase 1 Human Trial
60% of evaluable patients demonstrated a clinical response Clinical activity observed at all dose levels Data support previously reported in-vivo induction of
About this update from Pds Biotechnology Corporation
[{"type":"text","content":"60% of evaluable patients demonstrated a clinical response\n Clinical activity observed at all dose levels Data support previously reported in-vivo induction of active HPV-specific (granzyme B-inducing) CD8+ (killer) T-Cells in patients Plan to initiate three Phase 2 studies for PDS0101 starting in 1Q 2020 BERKELEY HEIGHTS, N.J., Sept. 19, 2019 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immuno-oncology company pioneering the development of novel immunotherapies, today announced that it has reviewed limited available patient clinical outcome data from its previously reported Phase 1 study. In the study, 60% of evaluable patients had a clinical response (as defined below). The primary focus of the study was safety and evaluation of immune biomarkers resulting from administration of Versamune®-based PDS0101 in patients with cervical intraepithelial neoplasia (CIN) infected with multiple high-risk, cancer-causing types of human papillomavirus (HPV). These newly-available clinical data are the result of a post-hoc follow up which was not part of the protocol design. The novel Versamune® mechanisms of action and the resulting unique regression of advanced preclinical tumors were recently published (Journal of Immunology, Vol. 202, Issue 1215 June 2019). The Phase 1 clinical trial was an open-label, dose-escalating study that included 12 patients; 3 receiving a 1mg dose, 3 receiving a 3 mg dose, and 6 receiving a 10mg dose. All 12 patients completed three doses of PDS0101. As previously reported, no dose-limiting toxicities or long-term safety concerns were observed. PDS0101 was immunologically active at all three doses and resulted in a strong increase (5 to 73-fold) in circulating HPV disease-attacking T-cells in 10/12 subjects, quantified by either INF-γ or granzyme-b ELISPOT studies of blood drawn approximately 14 days after subcutaneous injection. The potentially unique ability of PDS0101 to safely generate high levels of circulating, granzyme-b inducing (cytolytically active) CD8+ (killer) T-cells prompted a retrospective evaluation of clinical outcomes. PDS received limited follow-up clinical data from eleven out of the twelve patients and was able to review the source data reported for all but two of these patients (both in the 10mg dose group and whose data were reported by correspondenc...