Presage Biosciences, a US-based biotechnology company that directly measures activity of oncology drugs within human tumours, announced on Thursday that it has commenced Phase 0 dosing of the first cancer patient with Poland-based Pure Biologics' PBA-0405, an antibody that targets ROR1.

PBA-0405 has been engineered to induce tumour cell killing by cytotoxic immune cells. This exploratory study is designed to study the biological effects of PBA-0405 within the human tumour microenvironment.

In January, Presage and Pure Biologics announced that 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 tumour that is planned for surgical removal. Extensive molecular profiling technologies determine drug effectiveness in the tumour microenvironment by analysis of the expression of thousands of genes.

Dr John Weinberg, Pure Biologics chief medical officer, said, '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.'