- Date of occurrence of the event: Aug 31, 2019
- Company name: OBI Pharma Inc.
- Relationship to the Company (please enter “head office” or “subsidiaries”): Head Office
- Reciprocal shareholding ratios: Not applicable
- Cause of occurrence: FDA clearance of IND Phase I/II Study Application of Globo-H Antibody-Drug Conjugate, OBI-999.
- Countermeasures: None
- Any other matters that need to be specified:
(1) Name of the new drug: Globo-H Antibody Drug Conjugate, OBI-999
(2) Uses: OBI-999 uses a Globo H antibody to target cancer cells of high Globo H expression. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. Antibody linked payload binds with the receptor on tumor cell to deploy endocytosis, followed by degradation of ADC in lysosomes releases small molecule payload to prevent tumor cell differentiation, to achieve the goal of anti-tumor.
(3) Planned development: Phase I/II Study, phase III study and inspection registration review of new drug
(4) Ongoing development:
A. Filed application/ Granted/ Denied: Granted Phase I/II Study Application
B. Risks/impact and countermeasures for clinical trial (include interim analysis) results not meeting competent authorities: Not Applicable
C. Company outlook for clinical trial (include interim analysis) results meeting competent authorities: Execution of Phase I/II Study according to the plan
D. Total invested capital: To be kept confidential to avoid complications in future negotiation of licensing deals, and as for the best interest of shareholders.
(5) Next phase of development: Expected to finish Phase I Study, Dose Escalation Phase, before proceeding to Phase II Study, Cohort Expansion Phase.
A. Expected timeline: Expected to finish OBI-999 Phase I Study, Dose Escalation Phase, in 1-2 years. The actual schedule will be adjusted according to the progress of execution.
B. Expected obligation: None
(6) Current market: According to IQVIA, the global market for anti-tumor drugs is about US$150 billion in 2018, the largest among the top 10 categories. OBI-999, Globo-H Antibody-Drug Conjugate, is still in clinical development; its indications will be evaluated based on unmet medical needs, product opportunities, and company portfolio.
(7) New drug development is a long process associated with high costs. It is not a guaranteed success, which may increase the risk of investment. Investors shall make prudent judgments and investments.