OBI Pharma's partner Biosion announces FDA clearance for the Phase 1/2 study of OBI-992 (TROP2 ADC)

09 January 2024 | Tuesday | News

The Partner of Biosion Inc. (Biosion) , OBI Pharma (4174.TWO), announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for OBI-992, to conduct a Phase 1/2 study of its novel antibody drug conjugate (ADC) cancer therapy targeting TROP2. The targeting antibody was discovered through Biosion's SynTracer® High Throughput Endocytosis Platform and was licensed to OBI Pharma in Dec 2021. OBI Pharma owns ex-China commercial rights for OBI-992 (BSI-992), and Biosion owns China rights.
Image Source : Public Domain

Image Source : Public Domain

  • First clinical trial to evaluate the safety and efficacy of OBI-992 (a.k.a BSI-992), a novel antibody drug conjugate (ADC) targeting TROP2
  • - Dosing of first patient in the Phase 1/2 clinical trial expected in early 2024


"We are very pleased to see OBI Pharma receive FDA clearance for OBI-992 (BSI-992)," said Hugh M. Davis, Ph.D., Chief Business & Development Officer, and President of Biosion USA, Inc. "OBI-992 demonstrated superiority over other TROP2 ADCs in pre-clinical studies. It is a solid validation of the unique advantages of Biosion's SynTracer® platform to identify fit-for-purpose antibodies for the development of novel ADC therapies. We are excited about this innovative treatment and making a meaningful difference for patients worldwide."

OBI Pharma plans to enroll patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and gastric cancer (GC), although several other cancers are also potential targets. OBI Pharma's Chief Medical Officer, Wayne Saville, M.D. noted, "The clinical trial intends to evaluate the safety, pharmacokinetics, and preliminary efficacy of OBI-992, a novel anti-TROP2 ADC with best-in-class potential. We look forward to dosing the first patient in our Phase 1/2 clinical study of OBI-992, which is expected to begin in early 2024."

Heidi Wang, Ph.D., OBI Pharma's Chief Executive Officer, added, "OBI-992 is a novel anti-TROP2 ADC designed and engineered by OBI Pharma. It demonstrates outstanding preclinical efficacy, favorable safety, and high stability in numerous in-vivo studies compared to other TROP2 ADCs. We are excited to commence the first-in-human clinical trial of OBI-992. OBI Pharma strives to advance our promising therapeutics to the clinic for cancer patients."

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