OBI Pharma, Inc. has filed the application of Phase I/II human clinical trial for OBI-992 TROP2 ADC to US FDA. Indication: OBI-992 is an Antibody Drug Conjugate (ADC) for cancer treatment that is based on TROP2 to target cancer cells. ADC releases a small molecule payload through the specificity of the antibody and directly deploys cytotoxic molecule at the targeted cancer cells.

Antibody that is linked with a payload binds to the targets on tumor cells followed by entering into cells via internalization. The small molecule payload will then be released through enzymatic cleavage to achieve the goal of killing tumor. Planned development stages: Phase I, II, III clinical trial, and Biologics License Application (BLA).

Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): OBI has filed the application of Phase I/II human clinical trial for OBI-992 TROP2 ADC to US FDA. Accumulated investment expenditure incurred: For negotiation on potential licensing deals in the future, and for the best interest of shareholders, this information is kept confidential temporarily. Upcoming development plan: Phase I clinical trial.

Estimated date of completion: 2024.