Shares of PDS Biotechnology Corp (NASDAQ: PDSB) jumped in morning trading on Monday as the clinical-stage immunotherapy company announced preliminary efficacy and safety data for Phase 2 clinical studies of PDS0101. PDS0101 is the company’s immunotherapy candidate for cervical cancer.
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Dr. Frank Bedu-Addo, President and CEO of PDS Biotech commented, “We’ve remained focused on progressing our four Phase 2 clinical programs, most recently, announcing data from our IMMUNOCERV trial in locally, advanced cervical cancer.”
Immunocerv is PDS’s standard-of-care chemoradiotherapy (CRT) that indicated that “100% (9/9) of patients had a clinical response with tumor shrinkage of over 60% at the midpoint evaluation, and 89% (8/9) of patients had a complete response with no evidence of disease at day 170, when treated with a combination of PDS0101 and chemotherapy. “
Moreover, PDS’s PDS0101-based triple combination trial indicated “66% (19/29) survival at median follow up of 16 months in checkpoint inhibitor refractory HPV-positive cancer patients that appears to show signs of clinical efficacy, durability, and safety, consistent with the data presented at the American Society for Clinical Oncology 2022.”
PDS Biotech also announced its fiscal Q3 results and reported a loss of $0.26 per share versus a loss of $0.24 in the same period last year. At the end of Q3, PDS’s cash balance stood at $71.6 million.
