US-FDA clears OBI Pharma IND application for phase 1/2 study of OBI-992

OBI Pharma, a clinical stage oncology company, announced that the US 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.

OBI plans to enroll patients with advanced solid tumours, 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 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 TROP2 ADC designed and engineered by OBI. It demonstrates outstanding preclinical efficacy, favourable 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.”

OBI-992 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload to kill tumour cells. TROP2 is highly expressed in a variety of solid tumours such as lung, breast, ovarian, and gastric cancer, rendering it an ideal target for cancer therapy.

OBI-992 uses a unique hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumour cells. OBI-992 demonstrates remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favourable safety profile in animal models.

OBI Pharma, Inc., is a clinical stage oncology company that is headquartered in Taiwan and established in 2002. Its mission is to develop novel cancer therapeutic agents for patients with high unmet medical needs.

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