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

OBI Pharma, a clinical-stage oncology company based in TAIPEI, Taiwan, announced the launch of a Phase 1/2 clinical trial for OBI-992, a novel antibody-drug conjugate (ADC). This ADC specifically targets TROP2, an antigen that is overexpressed in various tumor types. The announcement was made on June 12, 2024. The clinical trial aims to assess the safety, pharmacokinetics, and preliminary efficacy of OBI-992 in patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), gastric cancer (GC), and potentially other malignancies.

Dr. M. Wayne Saville, Chief Medical Officer of OBI Pharma, emphasized the advantages that OBI-992 holds over other TROP2 ADCs currently in development. He cited its high serum stability, excellent bystander effect, potential to overcome drug resistance, and impressive activity in both animal and organoid models of cancer. The trial will be led by Dr. Leia Tsimberidou from MD Anderson Cancer Center in Houston, Texas.

OBI Pharma’s Chief Executive Officer, Dr. Heidi Wang, expressed enthusiasm about the initiation of the first human study of OBI-992, describing it as a significant milestone for the company. She highlighted the company's commitment to advancing its oncology pipeline and extended gratitude to both the patients participating in the trial and the investigators.

OBI-992 is a TROP2-targeted ADC armed with a potent topoisomerase I inhibitor known as exatecan, which is effective in killing tumor cells. TROP2 is predominantly expressed in a wide array of solid tumors, including those in the lung, breast, ovary, and stomach, making it an ideal target for cancer treatment. The ADC uses a novel hydrophilic, enzyme-cleavable linker that remains stable in circulation but releases its cytotoxic payload once inside tumor cells. In preclinical animal studies, OBI-992 demonstrated significant antitumor activity, improved pharmacokinetic properties, and a favorable safety profile in comparison to other ADCs.

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

Founded in 2002 and headquartered in Taiwan, OBI Pharma focuses on developing innovative cancer treatments to meet high unmet medical needs. The company has developed a first-in-class immuno-oncology portfolio targeting Globo H, which includes two active immunotherapy vaccines: adagloxad simolenin (formerly OBI-822) and OBI-833. Additionally, OBI Pharma has created an antibody-drug conjugate pipeline using its proprietary ADC platforms, such as GlycOBI™. This pipeline includes OBI-992, OBI-902, and OBI-904, which target TROP2 and Nectin-4, respectively. Moreover, the company is developing the first-in-class AKR1C3-targeted small-molecule prodrug OBI-3424, designed to release a potent DNA-alkylating antitumor agent in the presence of the enzyme aldo-keto reductase 1C3 (AKR1C3).

GlycOBI™ is a trademark of OBI Pharma, Inc. The company's dedication to innovation and developing cutting-edge treatments continues to drive its efforts to provide effective cancer therapies for patients worldwide.