PDS Biotechnology (NASDAQ:PDSB) announced the publication of interim Stage 1, Phase 2 clinical data for its lead antibody-drug conjugate (ADC) candidate, PDS01ADC, in JCO Oncology Advances on April 15, 2026.
The results, derived from the first stage of the ongoing study (N=9), suggest a potent therapeutic signal in patients with difficult-to-treat advanced cancers, specifically those that have progressed despite standard therapies.
The data for Stage 1 reported a remarkable 77.8% objective response rate (ORR), with approximately 85% of patients achieving 24-month survival.
Furthermore, the median extrahepatic progression-free survival (PFS) was not reached, with a minimum follow-up period of 13.1 months.
While the company noted that no head-to-head randomized comparison was performed in this specific study, the results significantly outpaced historical comparators from a parallel trial conducted without PDS01ADC, which showed a 35% ORR, approximately 40% two-year survival, and a median PFS of only 8.1 months.
PDS01ADC is a tumor-targeting IL-12 fused to an antibody that specifically targets DNA released by dying cancer cells in the tumor microenvironment.
By delivering IL-12 directly to the tumor, the therapy aims to stimulate a localized immune response while minimizing systemic toxicity.