PDS Biotech Posts 100% Clinical Response In Cervical Cancer Patients For Its Lead Program

  • PDS Biotechnology Corporation PDSB announced updated clinical data from the ongoing IMMUNOCERV Phase 2 clinical trial.
  • The study is investigating PDS0101 in combination with standard-of-care chemoradiotherapy (CRT) for the potential treatment of cervical cancer in patients with large tumors over 5 cm in size and/or cancer that has spread to the lymph nodes (lymph node metastasis).
  • 100% (9/9) of patients treated with the combination of PDS0101 and CRT had a clinical response with tumor shrinkage >60% at mid-point evaluation by MRI.
  • Related: PDS Biotech Highlights Expanded Data From PDS0101 Triple Combination Trial In HPV-Positive Cancers.
  • 89% (8/9) of patients treated with PDS0101 and CRT demonstrated a complete response (CR) on day 170. One patient who received 3 of the five scheduled doses of PDS0101 showed signs of residual disease. 
  • One patient with a CR died from an event unrelated to their underlying disease or treatment.
  • 1-year disease-free survival and 1-year overall survival of 89% (8/9) in patients treated with the combination of PDS0101 and CRT.
  • The toxicity of PDS0101 remains limited to low-grade local injection site reactions.
  • PDS Biotech's cash balance as of September 30, 2022, was approximately $71.6 million.
  • Price Action: PDSB shares are up 27.40% at $7.13 on the last check Monday.
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