Twist Bioscience Corporation, a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, announced that the first patient has been dosed in Pure Biologics’ exploratory Phase 0 clinical study of PBA-0405. PBA-0405 is a fully human IgG1 antibody that was discovered using Twist Biopharma Solutions’ synthetic antibody phage display libraries. Twist Biopharma Solutions, a division of Twist Bioscience, provides an integrated offering of in vitro, in vivo, and in silico tools for antibody discovery research. This exploratory study is designed to provide early insights into the biological effects of PBA-0405 within the tumor environment.
“Solid tumors are historically difficult for drug developers to target and treat. This is the first antibody identified using our Twist Biopharma Solutions Library of Libraries to be tested in patients and it validates the potential of our synthetic antibody libraries to be used to discover novel drug candidates for hard-to-treat cancer indications,” said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. “This is one of two of Pure’s candidates discovered using our synthetic antibody libraries and we look forward to seeing their progression.”
PBA-0405 targets ROR1, a tumor-associated antigen expressed on many solid tumors and B cell malignancies. PBA-0405 is designed to make tumors visible to the immune system, and to induce an immune response by recruiting and activating tumor-killing cytotoxic immune cells.
Pure Biologics’ multi-center, single arm, open-label pharmacodynamic biomarker Phase 0 trial is designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device. The study will evaluate the pharmacodynamic activity of PBA-0405 in solid tumors including head and neck squamous cell carcinoma, certain subtypes of soft-tissue sarcomas and triple-negative breast cancer. Pure Biologics is conducting the clinical study and holds full responsibility for the development and potential regulatory submission of PBA-0405. ClinicalTrials.gov ID NCT06273852
“With the dosing of the first patient in our exploratory Phase 0 study, PBA-0405 is the first ROR1-targeting compound of its mode of action to enter into 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 Pieter Spee, PhD, Chief Scientific Officer at Pure Biologics. “By working with Twist Bioscience to leverage their synthetic antibody libraries for early-stage discovery, we were able to move quickly to the development stage. We look forward to continuing to advance our pipeline of immuno-oncology antibody candidates and drive toward our goal of delivering first-in-class therapies to patients.”
SOURCE: Businesswire