Why PDS Biotech Shares Are Jumping Today

  • PDS Biotechnology Corporation PDSB announced interim data from the VERSATILE-002 Phase 2 trial of PDS0101 in combination with Merck & Co Inc's MRK Keytruda (pembrolizumab), in patients with unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer.
  • The estimated 12-month overall survival rate was 87.1%. Published results are 36-50%, with approved Immune Checkpoint Inhibitors (ICI) used alone.
  • Median progression-free survival was 10.4 months. Published results are a median PFS of 2-3 months for approved ICIs when used as monotherapy in patients with similar PD-L1 levels.
  • Related: PDS Biotech, Merck Germany Enter Licensing Pact For Investigational Cancer Treatment.
  • A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34).
  • The confirmed and unconfirmed objective response rate was 41.2% (14/34 patients), identical to the preliminary response rate data PDS Biotech reported at ASCO 2022 (7/17 patients). 
  • These responses have been confirmed in nine of the 34 patients (26.5%), including one complete response.
  • 15/34 patients (44.1%) had stable disease.
  • 9/34 patients (26.5%) had progressive disease.
  • "The interim data showed an estimated 12-month survival rate of 87% and a progression-free survival of 10.4 months, which is very encouraging given the poor prognosis these patients face," stated Lauren V. Wood, M.D., PDS Biotech's Chief Medical Officer and a co-author of the study. 
  • The company said that PDS0101, in combination with Keytruda, was associated with 8% of patients experiencing a Grade 3 treatment-related adverse event without more serious Grade 4 or 5 events. 
  • Price Action: PDSB shares are up 26.96% at $8.53 during the premarket session on the last check Friday.
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