On July 25, 2024 Presage Biosciences, a biotechnology company that directly measures activity of oncology drugs within human tumors, reported the Phase 0 dosing of the first cancer patient with Pure Biologics’ PBA-0405, an antibody that targets ROR1 (Press release, Presage Biosciences, JUL 25, 2024, View Source [SID1234645092]). PBA-0405 has been engineered to induce tumor cell killing by cytotoxic immune cells. This exploratory study is designed to study the biological effects of PBA-0405 within the human tumor microenvironment.
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In January, Presage and Pure Biologics announced the U.S. Food and Drug Administration issued a Study May Proceed notification for Phase 0 testing of a pre-GMP first-in-human drug candidate with Presage’s Comparative In Vivo Oncology (CIVO) platform. CIVO enables microdosing directly in a human tumor that is planned for surgical removal. Extensive molecular profiling technologies determine drug effectiveness in the tumor microenvironment by analysis of the expression of thousands of genes.
"With the dosing of the first patient in our exploratory Phase 0 study, PBA-0405 is the first ROR1-targeting compound with a unique mode of action to enter studies in patients. We’re encouraged by the preclinical data we’ve seen so far and are eager to evaluate its pharmacodynamic activity in human studies", said Dr. John Weinberg, Chief Medical Officer of Pure Biologics. ROR1 is a tumor-associated antigen expressed on many solid tumors and B cell malignancies.
"We are very excited to partner with Pure Biologics to evaluate their pre-GMP oncology drug in a first-in-human Phase 0 CIVO study" said Dr. Patrick Gray, Presage CEO. "Testing of pre-GMP compounds in human tumors in situ simplifies and speeds up the drug development process. Our Phase 0 studies can determine tumor killing activity, synergism with approved or investigational drugs, and immuno-oncology activity."
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 immunohistochemistry, in situ hybridization, and molecular profiling technologies in both preclinical and Phase 0 trials to inform and de-risk oncology drug development.