PDS Biotech Pauses Recruitment In PDS0101 Combo Cancer Trial

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  • PDS Biotechnology Corporation PDSB has temporarily suspended recruitment in the National Cancer Institute (NCI)-led Phase 2 trial of PDS0101 combo trial in advanced HPV cancers
  • The issue is not specific to the PDS0101 trial and is unrelated to the triple combination's safety or efficacy concerns. 
  • The NCI anticipates that the issue should be resolved timely.
  • The trial is evaluating the novel combination in both checkpoint inhibitor naïve and refractory patients with advanced HPV-associated cancers that have progressed or returned after treatment. 
  • PDS Biotech's lead candidate, PDS0101, combines the Versamune platform with targeted antigens in HPV-expressing cancers. 
  • In partnership with Merck & Co Inc MRK, PDS Biotech is evaluating PDS0101 combined with Keytruda in a Phase 2 study in head and neck cancer. 
  • PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.
  • Price Action: PDSB shares are down 4.07% at $11.56 during the premarket session on the last check Thursday.
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