FDA Approves OBI-992 TROP2 ADC for Phase 1/2 Trial

OBI Pharma, a clinical-stage oncology firm based in Taiwan, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2 clinical trial for OBI-992, an innovative antibody-drug conjugate (ADC) that targets TROP2, a protein frequently found in various solid tumors. The antibody component of OBI-992 was identified using Biosion's SynTracer® High Throughput Endocytosis Platform and licensed to OBI Pharma in December 2021. OBI Pharma holds the commercial rights for OBI-992 outside China, while Biosion retains the rights within China.

Biosion's Chief Business & Development Officer and President of Biosion USA, Hugh M. Davis, expressed enthusiasm about the FDA clearance, highlighting the superiority of OBI-992 over other TROP2 ADCs in pre-clinical studies. He emphasized the capabilities of Biosion's SynTracer® platform in identifying antibodies for novel ADC therapies and the potential impact of this treatment on global patients.

The clinical trial aims to assess the safety, pharmacokinetics, and preliminary efficacy of OBI-992. It is expected to involve patients with advanced solid tumors, such as non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and gastric cancer (GC), with the potential to include other cancer types. OBI Pharma's Chief Medical Officer, Wayne Saville, M.D., anticipates the first patient dosing to occur in early 2024.

Heidi Wang, Ph.D., CEO of OBI Pharma, stated that OBI-992 is a novel anti-TROP2 ADC that has shown exceptional preclinical efficacy, safety, and stability. She is eager to start the first-in-human clinical trial, demonstrating OBI Pharma's dedication to bringing promising therapeutics to cancer patients.

OBI-992 is designed to deliver a potent topoisomerase I inhibitor payload to solid tumors. TROP2, the target of OBI-992, is prevalent in many solid tumors, making it a suitable target for cancer therapy. The ADC utilizes a hydrophilic, enzyme-cleavable linker that remains stable in the bloodstream until it reaches tumor cells, where it releases its cytotoxic payload. OBI-992 has shown significant antitumor efficacy and favorable safety in animal models.

OBI Pharma, established in 2002, is focused on developing innovative cancer therapeutics for patients with significant unmet needs. The company's portfolio includes immuno-oncology vaccines targeting Globo H, as well as ADC pipelines targeting TROP2, Nectin-4, and HER2. OBI Pharma also has a small-molecule prodrug in its pipeline that releases a potent DNA-alkylating agent in the presence of the AKR1C3 enzyme.

Biosion, founded in 2017, is a global clinical-stage biotechnology company that develops breakthrough antibody-based therapies for immune and oncologic diseases. The company has a pipeline of innovative biologics developed through its proprietary technologies, including the H³ antibody discovery platform and the Flexibody® bispecific platform. Biosion's lead asset, Bosakitug, is in phase II for severe asthma and atopic dermatitis, with additional partnered assets in various stages of development.