Pure Biologics' PBA-0405, a ROR1-targeting antibody, has entered a Phase 0 clinical trial, marking the first time this unique compound has been studied in humans. The trial, announced by Presage Biosciences, aims to evaluate the biological effects of PBA-0405 within the human tumor microenvironment.
PBA-0405 is engineered to induce tumor cell killing by cytotoxic immune cells. The exploratory study is designed to study the biological effects of PBA-0405 within the human tumor microenvironment.
CIVO Platform for Enhanced Drug Evaluation
The Phase 0 trial leverages Presage Biosciences' Comparative In Vivo Oncology (CIVO) platform. This platform allows for microdosing directly into a human tumor planned for surgical removal. Extensive molecular profiling technologies are then used to determine drug effectiveness in the tumor microenvironment by analyzing 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 as a Target in Oncology
ROR1 is a tumor-associated antigen expressed on many solid tumors and B cell malignancies, making it a promising target for cancer therapy.
Advantages of Phase 0 Studies with CIVO
According to Dr. Patrick Gray, Presage CEO, testing pre-GMP compounds in human tumors in situ simplifies and speeds up the drug development process. Phase 0 studies using the CIVO platform can determine tumor killing activity, synergism with approved or investigational drugs, and immuno-oncology activity.
About the CIVO Platform
The CIVO platform enables multiplexed intratumoral microdosing and the generation of detailed tumor profiling. The CIVO device can deliver up to eight different drugs or drug combinations simultaneously into trackable drug columns. Presage pairs 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.
