PBA-0111 received "Study may proceed" letter from FDA

Pure Biologics took another significant step forward by receiving a "study may proceed" letter from the US Food and Drug Administration (FDA) to test PBA-0111 in a Phase 0 clinical study in solid tumor cancer patients. This approval marks Pure Biologics' second FDA approval shortly after the approval of PBA-0405 for the Phase 0 clinical trials.

The Phase 0 study will be a multicenter, open-label study conducted in the United States in up to 9 patients with head and neck carcinoma or soft tissue sarcoma. The Phase 0 study will focus on detection of early signs of pharmacodynamic activity of PBA-0111 in forms of biomarkers, after a single-dose injection intratumorally. Pure Biologics has partnered with Presage Biosciences, Inc. (Seattle, USA) to execute the studies. The Phase 0 study is expected to be completed in the end of 2024.

Zermatt consulting is proud to be part of the second eIND application by Pure Biologics in a short period of time.