Business
PDS Biotech Provides Business Update and Reports Fourth-Quarter and Full-Year 2022 Financial Results
Successful meeting with FDA to discuss registrational pathway for triple combination of PDS0101, PDS0301, and a commercial immune checkpoint inhibitor100%
About this update from Pds Biotechnology Corporation
[{"type":"text","content":"Successful meeting with FDA to discuss registrational pathway for triple combination of PDS0101, PDS0301, and a commercial immune checkpoint inhibitor100% (9/9) clinical response (>60% tumor shrinkage at mid-point evaluation) in IMMUNOCERV trial for high-risk cervical cancer patients with tumors >5 cm in PDS0101 + CRT based on preliminary dataCompany to host conference call and webcast today, March 28, 2023, at 8:00 AM ET FLORHAM PARK, N.J., March 28, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today provided a business update and announced its financial results for the year ended December 31, 2022. Fourth Quarter 2022 and Recent Business Highlights: PDS0101 Lead Drug Candidate VERSATILE-002 Phase 2 combination trial with Merck & Co. Inc.’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer. Completed first stage of enrollment in checkpoint inhibitor refractory armPresented initial data on methods for investigating efficacy of PDS0101 in combination with KEYTRUDA® (pembrolizumab) with respect to T cell activation and functionality at the ESMO Targeted Anticancer Therapies Congress 2023 National Cancer Institute (NCI)-led Phase 2 triple combination trial in patients with advanced HPV-positive cancers. Successful meeting with U.S. Food and Drug Administration (FDA) to discuss regulatory pathway for triple combination of PDS0101, PDS0301, and an approved immune checkpoint inhibitor (ICI)Reported median overall survival (OS) of 21 months in advanced, ICI refractory cancer HPV-positive patients (N=29) having few remaining treatment options IMMUNOCERV Phase 2 clinical trial of PDS0101 with chemoradiotherapy (CRT) in patients with locally advanced cervical cancer. 100% (9/9) clinical response (>60% tumor shrinkage at mid-point evaluation), and 89% (8/9) complete response based on preliminary dataStudy demonstrated strong infiltration of T cells into the tumors, elimination of circulating tumor DNA PDS0301 Antibody-Conjugated Interleukin 12 (IL-12) Signed exclusive global license agreement for PDS0301, a novel, investigational, proprietary investigational tumor targeting, antibody-co...