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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.

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