OBI Pharma Starts Phase 1/2 Study of OBI-992 for Cancer Therapy

June 12, 2024—OBI Pharma, a clinical-stage oncology firm, has commenced a Phase 1/2 clinical study for OBI-992, an antibody-drug conjugate (ADC) aimed at TROP2, an antigen found in several tumor types. This trial marks an important step in evaluating the safety and efficacy of OBI-992 in patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and gastric cancer (GC), among others.

OBI Pharma plans to enroll patients diagnosed with these advanced cancers to determine the safety, pharmacokinetics, and preliminary efficacy of OBI-992. Dr. M. Wayne Saville, OBI Pharma's Chief Medical Officer, emphasized that preclinical data suggests OBI-992 offers advantages over other TROP2 ADCs. Key benefits include high serum stability, a strong bystander effect, potential to overcome drug resistance, and significant activity in animal and organoid cancer models. Dr. Leia Tsimberidou of MD Anderson Cancer Center in Houston, Texas, serves as the lead investigator for the study.

OBI Pharma's CEO, Dr. Heidi Wang, expressed excitement about the initiation of this first human trial for OBI-992, describing it as a pivotal company milestone. She highlighted the company's dedication to expanding its innovative oncology pipeline and thanked both patients and investigators for their contributions.

OBI-992 is an ADC that targets TROP2, which is extensively expressed in various solid tumors, including those of the lung, breast, ovary, and stomach. The ADC contains a potent topoisomerase I inhibitor payload known as exatecan, which has been shown to kill tumor cells effectively. OBI-992 employs a hydrophilic, enzyme-cleavable linker designed to remain stable in circulation but release its cytotoxic payload inside tumor cells. Preclinical studies have demonstrated OBI-992’s impressive antitumor activity, enhanced pharmacokinetics, and favorable safety profile compared to other ADCs.

The TROP2 targeting antibody utilized in OBI-992 was licensed from Biosion, Inc. in December 2021. OBI Pharma holds commercial rights for OBI-992 outside of China.

Established in 2002 and headquartered in Taiwan, OBI Pharma is a clinical-stage oncology company committed to developing novel cancer therapies for patients with significant unmet medical needs. The company’s first-in-class immuno-oncology portfolio includes Globo H active immunotherapy vaccines, adagloxad simolenin (formerly OBI-822) and OBI-833. Additionally, OBI Pharma has developed an innovative ADC pipeline using its proprietary GlycOBI™ platform, which includes OBI-992, OBI-902, and OBI-904, targeting TROP2 and Nectin-4, respectively. The company also has a pioneering AKR1C3-targeted small-molecule prodrug, OBI-3424, designed to release a potent DNA-alkylating agent in the presence of the AKR1C3 enzyme.

GlycOBI™ is a registered trademark of OBI Pharma, Inc. The company continually strives to advance cancer treatment options and improve outcomes for patients worldwide.

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