Pharma Focus Asia

OBI-992 Secures FDA Approval to Commence Phase I/II Clinical Trials

Thursday, January 04, 2024

Taiwan's Halogen Biotech (4174.TWO) has announced the independent development of a new antibody-drug complex (ADC) drug, OBI-992, targeting TROP2. The U.S. Food and Drug Administration (FDA) has granted approval for a Phase I/II clinical trial to evaluate its safety and efficacy.

OBI-992's clinical trial aims to treat patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), gastric cancer (GC), and other potential targets. Dr. Wayne Saville, MD, Chief Medical Officer of Taiwan Haoding, highlighted the trial's purpose of assessing the safety, pharmacokinetics, and preliminary efficacy of OBI-992, expressing belief in its potential as a leading-class drug. Phase I/II trials for TROP2 ADC are set to begin in early 2024, with the first patient scheduled to be dosed.

Dr. Wang Huijun, CEO of Taiwan's Haoding, explained that OBI-992 is a new TROP2 ADC designed and produced in-house, demonstrating superior efficacy and safety in preclinical trials compared to other TROP2 ADCs. Dr. Huijun expressed excitement about OBI-992 entering human clinical trials for the first time, emphasizing Haoding's commitment to advancing potential cancer therapies into the clinic promptly.

OBI-992, an Antibody Drug Conjugate (ADC), is designed to target TROP2, highly expressed in various solid tumors. It utilizes a hydrophilic linker to connect antibodies and potent TOP1 (topoisomerase I) inhibitors, ensuring stability in the bloodstream. Once bound to TROP2 on cancer cell surfaces, OBI-992 releases small molecule drugs internally to induce cell death. Preclinical studies with animal models have demonstrated OBI-992's effective anti-tumor activity, favorable pharmacokinetics, and safety.

The TROP2 antibody, introduced by Taiwan's Haoding Biotechnology in December 2021 with authorization from Boaoxin Company, is part of Haoding's responsibility for ADC construction, research and development, and commercialization rights outside of China.



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