OBI Pharma, Inc. announced that it has been granted by US FDA to proceed to Phase I/II human clinical trial. 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: (1) Application submission/approval/disapproval/each of clinical trials (include interim analysis): OBI-992 TROP2 ADC has been granted by US FDA to proceed to Phase I/II human clinical trial; (2) Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur: Not applicable; (3) After obtaining official approval or the results of statistically significant sense, the future strategy: Proceed to Phase I/II human clinical trial; (4) 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/II clinical trial ? Phase I Dose Escalation; (1) Estimated date of completion: 2025 second quarter; (2) Estimated responsibilities: The Company is responsible for clinical trial related expenses, including development milestones to be paid to Biosion, Inc. under the terms of the license agreement.