Presage Biosciences, a biotechnology company whose mission is to enable precision drug response evaluation in the human tumor microenvironment (TME), announced 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.
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| [16-January-2024] |
| SEATTLE, Jan. 16, 2024 /PRNewswire/ -- Presage Biosciences, a biotechnology company whose mission is to enable precision drug response evaluation in the human tumor microenvironment (TME), announced 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. 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.
“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 About Presage
SOURCE Presage Biosciences Inc |
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