On July 18, 2024 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported that the first patient has been dosed in Pure Biologics’ exploratory Phase 0 clinical study of PBA-0405 (Press release, Twist Bioscience, JUL 18, 2024, View Source [SID1234644963]). 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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."
About the Collaboration
PBA-0405 was discovered as part of an ongoing collaboration between Twist Bioscience and Pure Biologics. Under the terms of the agreement announced in 2021, Twist Biopharma Solutions, a division of Twist Bioscience, grants Pure Biologics access to select synthetic antibody phage display libraries derived only from sequences that exist in the human body and further optimized by leveraging state-of-the-art approaches, including artificial intelligence and big data analytics. Certain libraries among the portfolio are deliberately tailored to match chosen classes of biological targets as well as to enhance bispecific antibody forming capabilities. Together, the companies work to discover, validate and optimize new antibody candidates against targets useful for immuno-oncology applications. Pure Biologics will pay Twist annual maintenance fees in addition to future payments for clinical and commercial achievement for any antibodies resulting from the collaboration. The Phase 0 study does not trigger a milestone payment for Twist.