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PDS Biotech Announces Initiation of Phase 2 Trial of PDS0101 Led by the National Cancer Institute
FLORHAM PARK, N.J., June 15, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel
About this update from Pds Biotechnology Corporation
[{"type":"text","content":"FLORHAM PARK, N.J., June 15, 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 that the first patient has been dosed in the National Cancer Institute’s (NCI) Phase 2 clinical study of PDS0101 in the treatment of advanced human papillomavirus (HPV) associated cancers. This clinical trial involves a combination of PDS0101 with two clinical development-stage immune-modulating agents, Bintrafusp alfa (M7824) and NHS-IL12.\n The NCI Center for Cancer Research’s Genitourinary Malignancies Branch (GMB) and Laboratory of Tumor Immunology and Biology (LTIB) are jointly leading this Phase 2 trial evaluating PDS0101, which combines the Versamune® platform with targeted antigens in HPV-expressing cancers, in combination with Bintrafusp alfa (M7824) and NHS-IL12. The trial will evaluate the objective response rate of this novel triple combination in approximately 35 patients with advanced HPV-associated cancers. The first eight patients will be evaluated for safety and objective response before the trial progresses to full enrollment. “We are excited to have the first patient dosed in this NCI-led Phase 2 clinical trial, which is an important next step in further demonstrating the power of our novel Versamune® platform to induce high levels of tumor-specific CD8 killer T-cells,” commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. “We believe that PDS0101’s demonstrated preclinical efficacy when combined with these two immune-modulating agents, has the potential to significantly improve clinical outcomes for patients with advanced HPV-associated cancers.” Dr. Jeffrey Schlom, Chief, LTIB, and Dr. James Gulley, Chief, GMB, at NCI are serving as principal investigators for the NCI, while Dr. Frank Bedu-Addo and Dr. Lauren Wood, PDS Biotech’s Chief Executive Officer and Chief Medical Officer respectively, will serve as PDS Biotech’s investigators. The studies are being performed as part of a Cooperative Research and Development Agreement (CRADA) between PDS Biotech and the NCI. Dr. Julius Strauss, Staff Clinician, LTIB, is serving as the principal investigator of this phase 2 clinical trial of PDS0101 in advanced HPV-as...