Business
PDS Biotechnology Expands CRADA with the National Cancer Institute to Include Second Versamune®-Based Anti-Cancer Product
NCI to study PDS0103, in addition to planned Phase 2 clinical evaluation of PDS0101 in combination with other therapeutic agents PRINCETON, N.J., April 29,
About this update from Pds Biotechnology Corporation
[{"type":"text","content":"NCI to study PDS0103, in addition to planned Phase 2 clinical evaluation of PDS0101 in combination with other therapeutic agents\nPRINCETON, N.J., April 29, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, today announced an expansion of its previously announced Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to include studies of PDS0103, a Versamune®-based product incorporating novel mucin-1 (MUC1) epitopes developed by the NCI. This expansion adds to the NCI’s ongoing evaluation of PDS0101 in combination with two separate immune-modulating agents, NHS-IL12 and M7824, which will be evaluated in a phase 2 clinical trial in advanced HPV-associated cancers (NCT04287868).\n Under the expanded CRADA, PDS Biotech will collaborate with the NCI Center for Cancer Research’s Genitourinary Malignancies Branch (GMB) and the Laboratory of Tumor Immunology and Biology (LTIB) to conduct preclinical studies of PDS0103, and potentially human clinical studies in combination with other therapeutic agents. PDS0103 combines Versamune® with novel highly immunogenic agonist epitopes of the mucin-1 (MUC1) oncogenic C-terminal region, designed and developed by the LTIB. PDS0103 is targeting ovarian, breast, colorectal and lung cancers where over-expression of MUC1 is associated with a high degree of unmet need. “We are excited to further our collaboration with Dr. Schlom, Dr. Gulley, and their teams at the NCI to progress the development of PDS0103 and expand the CRADA beyond the previously announced collaboration involving PDS0101. PDS0103 monotherapy has demonstrated encouraging results in ongoing preclinical studies,” commented Dr. Bedu-Addo, Chief Executive Officer of PDS Biotechnology. “Based on the strong T-cell activation potential of the Versamune®-based products, we believe that PDS0101 and PDS0103 present an opportunity to improve immunotherapeutic treatment outcomes across multiple cancer indications. We look forward to working with the NCI as we jointly advance the development of PDS0101 and PDS0103.” Dr. Jeffrey Schlom, Chief, LTIB, and Dr. James Gulley, Chief, GMB, at NCI will serve as princ...