Twist Bioscience Reports Clinical Advancement of Pure Biologics' Antibody Found Through Its Libraries

Twist Bioscience Corporation, listed on NASDAQ under the ticker TWST, has announced a significant milestone in its collaboration with Pure Biologics. The first patient has been dosed in an exploratory Phase 0 clinical trial of PBA-0405, a fully human IgG1 antibody developed using Twist Biopharma Solutions' synthetic antibody phage display libraries. This development marks a critical step in the application of Twist's innovative synthetic antibody libraries towards discovering new drug candidates for challenging cancer indications.

Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience, emphasized the importance of this milestone. She noted that solid tumors have traditionally posed significant challenges for drug developers. The initiation of this trial validates the potential of Twist’s synthetic antibody libraries in identifying novel treatments for difficult-to-treat cancers.

PBA-0405 targets ROR1, a tumor-associated antigen found in many solid tumors and B cell malignancies. The antibody is engineered to make tumors detectable to the immune system and to trigger an immune response by recruiting and activating cytotoxic immune cells. This approach aims to enhance the body's natural ability to fight cancer.

The Phase 0 trial, conducted by Pure Biologics, is a multi-center, single-arm, open-label study designed to investigate the biological effects of PBA-0405 within the tumor microenvironment. The study administers the antibody intratumorally in microdose quantities using the CIVO device. It will assess the pharmacodynamic activity of PBA-0405 in various solid tumors, including head and neck squamous cell carcinoma, specific subtypes of soft-tissue sarcomas, and triple-negative breast cancer.

Pieter Spee, Ph.D., Chief Scientific Officer at Pure Biologics, expressed optimism about the trial. He highlighted that PBA-0405 is the first ROR1-targeting compound of its kind to enter patient studies. The preclinical data has been promising, and there is eagerness to evaluate its pharmacodynamic activity in human trials.

The collaboration between Twist Bioscience and Pure Biologics, initiated in 2021, involves Twist Biopharma Solutions providing access to select synthetic antibody phage display libraries. These libraries are derived from human sequences and optimized using advanced techniques, including artificial intelligence and big data analytics. The goal is to discover, validate, and optimize new antibody candidates for immuno-oncology applications. Pure Biologics is responsible for the clinical development and potential regulatory submission of PBA-0405.

Twist Biopharma Solutions, a division of Twist Bioscience, offers an integrated suite of in vitro, in vivo, and in silico tools for antibody discovery research. The division combines high-throughput DNA synthesis technology with expertise in antibody engineering to provide comprehensive antibody discovery solutions. This includes constructing proprietary antibody libraries and employing sophisticated bioinformatics to expedite the discovery process.

Twist Bioscience Corporation itself is a leading company in synthetic biology and genomics. It has developed a disruptive DNA synthesis platform that allows for the industrial-scale manufacturing of synthetic DNA. Twist's technology is used to produce a wide range of synthetic DNA-based products, including genes, tools for next-generation sequencing (NGS) preparation, and antibody libraries for drug discovery and development. The company is also exploring future applications in digital data storage using DNA and biologics drug discovery.

In summary, the dosing of the first patient in the Phase 0 trial of PBA-0405 represents a significant advancement in the collaboration between Twist Bioscience and Pure Biologics. This trial will provide valuable insights into the potential of PBA-0405 as a novel treatment for challenging solid tumors and contribute to the ongoing efforts to develop innovative cancer therapies.