Pharma Focus Asia

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

Tuesday, January 09, 2024

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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