On January 16, 2024 Presage Biosciences, a biotechnology company whose mission is to enable precision drug response evaluation in the human tumor microenvironment (TME), reported that the U.S. Food and Drug Administration (FDA) has issued a Study May Proceed notification for testing a pre-GMP drug candidate with the CIVO platform (Press release, Presage Biosciences, JAN 16, 2024, View Source [SID1234639277]). The drug candidate, PBA-0405, is owned by Poland-based biopharmaceutical company, Pure Biologics, and represents the earliest stage material to date that will be evaluated in patients in a CIVO Phase 0 clinical trial. PBA-0405 is a ROR1-targeting compound that has been engineered to induce tumor cell killing by cytotoxic immune cells.

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"We are very excited by this first opportunity to evaluate pre-GMP material in partnership with Pure Biologics," said Patrick Gray, PhD, Presage CEO. "This is a tremendous step forward for both Presage and overall drug development. We continue to push the bounds on finding alternatives to using preclinical models that fail to capture the effects of novel agents in the intact TME."

"The Pure Biologics team is incredibly proud of this momentous achievement," said Dr. Filip Jelen, Pure Biologics Co-Founder and President of the Management Board." "Our partnership with Presage was key in achieving this milestone and we eagerly await the first insights into drug efficacy and impact on the tumor microenvironment."

About CIVO
Comparative In Vivo Oncology (CIVO) is Presage’s patented platform that enables multiplexed intratumoral microdosing and generation of detailed tumor profiling. The CIVO device can deliver up to eight different drugs or drug combinations simultaneously into trackable drug columns. Presage’s CIVO technology and analysis capabilities are unparalleled at providing insight into drug-exposed areas of the intact tumor microenvironment. Presage is pairing the use of CIVO with molecular profiling technologies in both preclinical and Phase 0 trials in order to inform and de-risk oncology drug development.