US FDA Nods OBI Pharma's IND Application For Phase 1/2 Study of OBI-992 | India Pharma Outlook

US FDA Nods OBI Pharma's IND Application For Phase 1/2 Study of OBI-992

India Pharma Outlook Team | Friday, 05 January 2024

 India Pharma Outlook Team

The US Food and Drug Administration (FDA) has approved OBI Pharma's investigational new drug (IND) application for OBI-992, allowing the company to move forward with a phase 1/2 study of its innovative antibody-drug conjugate (ADC) cancer therapy that targets TROP2. OBI Pharma is a clinical stage oncology startup.

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, as per pharmabiz.

Utilizing a special hydrophilic, enzyme-cleavable linker, OBI-992 releases the deadly payload into tumor cells while remaining stable in circulation. In animal models, OBI-992 exhibits exceptional anticancer activity, enhanced pharmacokinetic properties, and a favorable safety profile.

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