Pure Biologics today announced the successful completion of its Phase 0 clinical study for the novel cancer therapy, PBA-0405. Conducted by Presage Biosciences (Seattle, USA), the multi-center study demonstrated PBA-0405’s potential to activate tumor-infiltrating immune cells and induce cancer cell killing in real cancer patient settings.
The open-label study enrolled six patients with head and neck carcinoma and soft tissue sarcoma, administering intra-tumoral microdoses of PBA-0405, dosed in up to six different sites in the tumor, prior to scheduled surgery. Biomarkers indicating drug activity were analyzed in 84 different tumor sites from five evaluable patients, with four patients showing clear signs of immune-cell activation and cancer cell killing. No significant safety concerns were observed. These results underscore the therapeutic promise of PBA-0405.
Pieter Spee, Chief Scientific Officer of Pure Biologics, commented:
The high failure rate of drug candidates in clinical development often stems from inadequate efficacy and safety profiles. By demonstrating PBA-0405’s intended therapeutic mode of action in actual cancer patients early in development, we have significantly de-risked this program, which can now move forward into further clinical development. We are thrilled by these results and eager to move forward with our oncology pipeline.
Jason Frazier, VP of Technology at Presage Biosciences, said:
The success of the PBA-0405 phase 0 CIVO study is highly encouraging and follows on previous successful studies conducted with other leading oncology companies. We are excited to collaborate further on Pure Biologics’ next phase 0 study for PBA-0111, set to begin patient enrolment next month.
The next step for Pure Biologics involves launching a phase 0 study for PBA-0111, which has received FDA approval and is poised to commence shortly. These developments reinforce Pure Biologics’ strategic focus on advancing breakthrough therapies that address unmet medical needs in oncology.