PDS Biotech Highlights Expanded Data From PDS0101 Triple Combination Trial In HPV-Positive Cancers

  • PDS Biotechnology Corp PDSB announced expanded interim data in the Phase 2 trial investigating the PDS0101-based triple combination therapy in advanced human papillomavirus (HPV)-positive cancers.
  • The trial investigates PDS0101 in combination with two investigational immune-modulating agents – M9241 and bintrafusp alfa.
  • The triple combination is being studied in CPI-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers. 
  • M9241 and bintrafusp alfa are owned by Merck KGaA MKKGY, Darmstadt, Germany.
  • Survival data: 66% (19/29) of HPV 16-positive CPI refractory patients in the cohort were alive at a median follow-up of 16 months. Historically, this group has a median overall survival of only 3-4 months.
  • Safety profile: 48% (24/50) of patients experienced Grade 3 treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 AEs. There were no grade 5 treatment-related AEs.
  • About 75% (6/8) of CPI naïve patients were alive at a median of 25 months of follow-up. 38% (3/8) of responders had a complete response. 
  • In June, the FDA granted Fast Track Designation to PDS Biotechnology's PDS0101 plus Merck & Co Inc MRK Keytruda (pembrolizumab) for recurrent or metastatic HPV16-positive head and neck cancer.
  • Price Action: PDSB shares are up 12.36% at $3.76 on the last check Tuesday.
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