PDS Biotechnology announces interim data in a Phase 2 trial of PDS0101

PDS Biotechnology announced expanded interim data in a Phase 2 clinical trial investigating the PDS0101-based triple combination therapy in advanced human papillomavirus, or HPV, -positive cancers. The triple combination of PDS0101 with the tumor-targeting IL-12 fusion protein M9241, and bintrafusp alfa, a bifunctional fusion protein targeting two independent immunosuppressive pathways, is being studied in CPI-naive and CPI-refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers. The triple combination Phase 2 trial is being conducted at the Center for Cancer Research, or CCR, at the National Cancer Institute, or NCI, one of the Institutes of the National Institutes of Health. All patients in the study had failed prior treatment with chemotherapy and 90% had failed radiation treatment. The interim efficacy data involves 37 HPV16-positive evaluable patients, including 29 patients who have, in addition, failed treatment with CPIs. Highlights of the expanded interim data are as follows and are consistent with the results presented at American Society of Clinical Oncology, or ASCO, Annual Meeting 2022 and prior interim data announced in October: Both M9241 and bintrafusp alfa are owned by Merck KGaA, Darmstadt, Germany, and its affiliates.