Presage Biosciences Begins Dosing First Patient with Pure Biologics' ROR1 Antibody for Cancer Treatment

SEATTLE, July 25, 2024 – Presage Biosciences, a biotech firm specializing in the direct measurement of oncology drug activities within human tumors, has initiated Phase 0 dosing of the first cancer patient with PBA-0405, an antibody developed by Pure Biologics that targets ROR1. PBA-0405 is designed to trigger tumor cell destruction through cytotoxic immune cells. This exploratory trial aims to observe the biological effects of PBA-0405 within the human tumor microenvironment.

Earlier this year, Presage and Pure Biologics announced that the U.S. Food and Drug Administration had given the green light for Phase 0 testing of this pre-GMP first-in-human drug candidate using Presage's Comparative In Vivo Oncology (CIVO®) platform. The CIVO platform allows microdosing directly into a human tumor slated for surgical excision. This enables extensive molecular profiling to assess drug efficacy within the tumor microenvironment by examining the expression of thousands of genes.

Dr. John Weinberg, Chief Medical Officer of Pure Biologics, commented, "With the initiation of our exploratory Phase 0 study, PBA-0405 becomes the first ROR1-targeting compound with a unique action mechanism to be tested in patients. We are encouraged by the promising preclinical data and are eager to assess its pharmacodynamic activity in human trials." ROR1 is known to be a tumor-associated antigen found in numerous solid tumors and B cell malignancies.

Dr. Patrick Gray, Presage CEO, expressed enthusiasm about the partnership with Pure Biologics to test their pre-GMP oncology drug in a first-in-human Phase 0 CIVO study. He emphasized that testing pre-GMP compounds in situ within human tumors simplifies and accelerates the drug development process. Phase 0 studies can identify tumor-killing activity, potential synergism with approved or investigational drugs, and immuno-oncology activity.

The CIVO platform, a patented technology by Presage, is designed for multiplexed intratumoral microdosing and detailed tumor profiling. The CIVO device can administer up to eight distinct drugs or drug combinations simultaneously into identifiable drug columns. This technology provides unmatched insights into drug-exposed regions of the intact tumor microenvironment. Presage is integrating the CIVO platform with immunohistochemistry, in situ hybridization, and molecular profiling technologies in both preclinical and Phase 0 trials to inform and reduce risks in oncology drug development.

Presage Biosciences is a translational oncology company committed to deciphering the complexities of drug response within the tumor microenvironment. By forming strategic alliances with oncology-focused pharmaceutical partners and other innovators in spatial biology and oncology drug development, Presage aims to advance the understanding and effectiveness of cancer treatments. The company is privately held and headquartered in Seattle.