PDS Biotechnology Triple Combo Therapy Shows 21 Months Of Overall Survival In HPV-Positive Cancers

  • PDS Biotechnology Corporation 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 triple combination of PDS0101 with the tumor-targeting IL-12 fusion protein M9241 and bintrafusp alfa is being studied in CPI-naïve and CPI-refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers.
  • RelatedPDS Biotech Posts 100% Clinical Response In Cervical Cancer Patients For Its Lead Program.
  • Median overall survival is 21 months in 29 checkpoint inhibitor refractory patients who received the triple combination. The reported historical median OS in patients with CPI refractory disease is 3-4 months.
  • In CPI naïve subjects, 75% remain alive at a median follow-up of 27 months. As a result, the median OS has not yet been reached. Historically median OS for similar patients with platinum-experienced CPI naïve disease is 7-11 months.
  • The objective response rate (ORR) in CPI refractory patients who received the optimal dose of the triple combination is 63% (5/8). In current approaches, ORR is reported to be less than 10%.
  • ORR in CPI naïve patients with the triple combination is 88%. In current approaches, ORR is reported to be less than 25% with FDA-approved CPIs in HPV-associated cancers.
  • Price Action: PDSB shares are up 8.564% at $10.00 on the last check Wednesday.
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