OBI Pharma Announces US FDA Clearance of IND Application for a Phase 1/2 Study of OBI-992
OBI Pharma recently announced the US 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 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, MD, 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, PhD, OBI Pharma’s Chief Executive Officer, added “OBI-992 is a novel TROP2 ADC designed and engineered by OBI. 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.”
OBI-992 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload to kill tumor cells. TROP2 is highly expressed in a variety of solid tumors 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 tumor cells. OBI-992 demonstrates remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety profile in animal models.
The TROP2 targeting antibody was in-licensed from Biosion, Inc. www.Biosion.com, in December 2021. OBI Pharma owns ex-China commercial rights for OBI-992.
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. The company’s novel first-in-class immuno-oncology portfolio targeting Globo H includes: two Globo H active immunotherapy vaccines, Adagloxad Simolenin (formerly OBI-822) and OBI 833. Using the company’s unique ADC platforms, including GlycOBI, OBI created its novel ADC pipelines, OBI-992, OBI-902, OBI-904, and OBI-905, targeting TROP2, Nectin4, and HER2, respectively. OBI’s pipeline also includes the first-in-class AKR1C3-targeted small-molecule prodrug OBI-3424, which selectively releases a potent DNA-alkylating antitumor agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme. For more information, visit www.obipharma.com.
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