PDS Biotechnology Moves Forward With Full Enrollment In PDS0101 Trial In HPV-Associated Cancers, Shares Retreat

PDS Biotechnology Corporation (NASDAQ: PDSB) said it had achieved interim efficacy goal in Phase 2 trial evaluating the Company's PDS0101 to treat advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment.
The trial, led by the National Cancer Institute (NCI), is evaluating PDS0101 in combination with two investigational immune-modulating agents, bintrafusp alfa (M7824), a TGF-β trap/ anti-PD-L1 bifunctional fusion protein, and NHS-IL12 (M9241), a DNA-targeted immunocytokine. The study will now progress to full enrollment of approximately 20 in this group of checkpoint inhibitor naïve patients.
Full enrollment is triggered by objective responses measured by radiographic tumor responses among at least three of the first eight patients.
Also, preliminary efficacy assessment of the triple combination in an added group of approximately 20 patients who have failed prior therapy with checkpoint inhibitors is ongoing.
Price Action: PDSB shares are trading lower by 13.1% at $3.37 on the last check Wednesday after trading higher in the pre-market session.