OBI Pharma Partner, Biosion, Announces FDA Approval of IND Application for Phase 1/2 Trial of OBI-992 (TROP2 ADC)

Biosion Inc.'s partner, OBI Pharma (4174.TWO), has received clearance from the U.S. Food and Drug Administration (FDA) for an investigational new drug (IND) application related to OBI-992, a novel antibody drug conjugate (ADC) cancer therapy targeting TROP2. The FDA approval allows OBI Pharma to conduct a Phase 1/2 study of OBI-992, which utilizes a targeting antibody discovered through Biosion's SynTracer® High Throughput Endocytosis Platform. The licensing agreement for this antibody was established in December 2021, with OBI Pharma holding ex-China commercial rights and Biosion retaining rights within China.

Expressing satisfaction with the FDA clearance, Hugh M. Davis, Ph.D., Chief Business & Development Officer and President of Biosion USA, Inc., highlighted OBI-992's superiority in pre-clinical studies over other TROP2 ADCs. He emphasized the validation of Biosion's SynTracer® platform in identifying antibodies suitable for novel ADC therapies.

OBI Pharma's plan involves enrolling patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and gastric cancer (GC), among others. The Phase 1/2 clinical study, set to begin in early 2024, aims to assess OBI-992's safety, pharmacokinetics, and preliminary efficacy.

Wayne Saville, M.D., Chief Medical Officer at OBI Pharma, highlighted OBI-992's potential as a novel anti-TROP2 ADC with best-in-class attributes. The clinical trial will explore its safety, pharmacokinetics, and efficacy in treating various cancers.

Heidi Wang, Ph.D., CEO of OBI Pharma, underlined OBI-992 as a product of their design and engineering, demonstrating exceptional preclinical efficacy, safety, and stability in in-vivo studies compared to other TROP2 ADCs. The company is eager to commence the first-in-human clinical trial, emphasizing their commitment to advancing promising therapeutics for cancer patients.

OBI-992 (BSI-992) specifically targets TROP2, a protein highly expressed in solid tumors like lung, breast, ovarian, and gastric cancers. The ADC carries a potent topoisomerase I inhibitor payload designed to effectively combat solid tumors. With a hydrophilic, enzyme-cleavable linker ensuring stability in circulation and controlled release within tumor cells, OBI-992 (BSI-992) has demonstrated notable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety profile in preclinical animal models. OBI Pharma holds ex-China commercial rights for OBI-992 (BSI-992), while Biosion retains rights within China.

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