According to Biospace, Seattle-based biotech firm Presage Biosciences has received FDA approval to proceed with a groundbreaking study involving the pre-GMP drug candidate PBA-0405, developed by Poland’s Pure Biologics. This marks a significant milestone, as PBA-0405 becomes the earliest-stage material to undergo evaluation in a CIVO Phase 0 clinical trial, targeting tumor cell killing with immune cells. Presage CEO Patrick Gray expresses excitement over this collaboration, emphasizing the move away from traditional preclinical models and towards more precise drug development methodologies.
Strategic Partnership Paves the Way for Innovative Clinical Trial
Presage Biosciences and Pure Biologics celebrate the FDA’s green light for testing PBA-0405 on the CIVO® platform, signaling a major advancement in drug development. The drug, engineered for ROR1-targeting, is poised to offer insights into its efficacy and impact on the tumor microenvironment, a critical step in refining oncology treatments.
Presage CEO Patrick Gray highlights the significance of evaluating pre-GMP material, showcasing the commitment to pushing boundaries and finding alternatives to traditional preclinical models. The collaboration aims to revolutionize drug development by providing a more accurate representation of drug effects within the intact tumor microenvironment.
Pure Biologics Co-Founder Dr. Filip Jelen expresses pride in the achievement, emphasizing the importance of their partnership with Presage in reaching this milestone. The teams eagerly anticipate the upcoming clinical trial, foreseeing it as a crucial step towards advancing cancer drug development.
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CIVO® Platform Revolutionizes Drug Profiling in Oncology
Presage’s Comparative In Vivo Oncology (CIVO) platform emerges as a revolutionary tool for intratumoral microdosing and comprehensive tumor profiling. With the capability to deliver multiple drugs simultaneously into trackable drug columns, CIVO enhances drug development insights by providing a detailed understanding of drug-exposed areas within the tumor microenvironment.
Presage’s dedication to translational oncology shines through as they partner with oncology-focused pharmaceutical companies, leveraging strategic alliances to unravel the complexities of drug response in the tumor microenvironment. The integration of CIVO with molecular profiling technologies further enhances the accuracy and efficiency of drug development processes.