PDS Biotechnology announces data on PDS0101 combined with chemoradiotherapy

PDS Biotechnology announced data demonstrating lead candidate PDS0101 in combination with standard-of-care chemoradiotherapy was associated with a rapid decline in human papillomavirus circulating cell-free DNA, a potential predictive biomarker of treatment response. The data from the IMMUNOCERV Phase 2 clinical trial were featured in an oral presentation by Aaron Seo, MD, PhD, of The University of Texas MD Anderson Cancer Center, at the American Society for Radiation Oncology Annual Meeting in San Diego, CA. The IMMUNOCERV Phase 2 trial is investigating PDS0101 in combination with SOC CRT in the treatment of cervical cancer patients with large tumors over 5 cm in size and/or cancer that has spread to the lymph nodes. HPV is the primary cause of cervical cancer with over 99% caused by HPV infection, and cfHPV-DNA can be detected in the blood of patients with cervical cancer. HPV type 16 is the most prominent subtype associated with cervical cancer. The study presented at ASTRO 2023 evaluated the relationship between the levels of circulating cfHPV-DNA and the extent of disease, clinical staging, and treatment response in patients with HPV-positive cervical cancer. Sixty-one patients with cervical cancer were included in the analysis either as part of a SOC treatment banking protocol or as part of the IMMUNOCERV Phase 2 clinical trial combining PDS0101 with SOC. Longitudinal plasma samples were collected from each patient at baseline, during weeks 1, 3, and 5, and at 3-4 months after CRT. In the study, HPV16 was detected in 59% of tumors and 70% of cfDNA. The median cfDNA at baseline was 28.15 copies/mL, with a range of 0 to 206,030 copies/mL. The presentation at ASTRO 2023 highlighted the following data: Earlier and greater proportion of cfDNA clearance with PDS0101 plus chemoradiation vs. SOC CRT alone. Baseline cfDNA levels correlated with the International Federation of Gynecology and Obstetrics stage and lymph node involvement; 100% of patients treated with PDS0101 had cancer that had spread to the lymph nodes