OBI Pharma Announces U.S. FDA Clearance of IND Application for a Phase 1/2 Study of OBI-992

TAIPEI, Taiwan, Jan. 03, 2024 (GLOBE NEWSWIRE) -- OBI Pharma, a clinical stage oncology company (4174.TWO), today 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.

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, 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, 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."

About OBI-992

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.

About OBI Pharma

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 GlycOBItm, 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. Additional information can be found at www.obipharma.com.

Forward-Looking Statements

Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma's reports and presentations, including OBI Pharma's filings with the Taiwan Securities and Futures Bureau.

COMPANY CONTACT:
Kevin Poulos
OBI Pharma, Inc.
1.619.537.7698 Ext. 102
[email protected]