- Date of occurrence of the event: Dec 24, 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: OBI received the letter of notification from the U.S. FDA about the approval on qualifying Globo H antibody-drug conjugate, OBI-999, for Orphan Drug Designation targeting pancreatic cancer indication. The U.S. FDA approves potential medical therapy of rare diseases with “Orphan Drug Designation” to encourage medical research authorities to develop rare diseases medication. In the states, rare disease is defined as disease with not more than 200,000 patients. The FDA qualified “Orphan Drug” medicines can acquire more logistics help from the U.S competent medical authorities and protection period of exclusive market sale.
- 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: An Antibody Drug Conjugate (ADC) treatment for cancer that is based on Globo H, OBI-999, uses to target cancer cells. ADC is by releasing a small molecule payload through the specificity of the antibody, it directly deploys cytotoxicity 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 clinical trial, phase III clinical trial and inspection registration review of new drug
(4) Ongoing development:
A. Filed application/ Granted/ Denied: the U.S. FDA granted qualification of “Orphan Drug” targeting pancreatic cancer.
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: phase I/II human clinical trials are still ongoing as planned
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 after completing phase I human clinical trial- dose escalation phase, following phase II human clinical trial- cohort expansion phase.
A. Expected timeline: OBI-999 phase I human clinical trial- dose escalation phase, is expected to finish in 1-2 years. The actual time will be adjusted according to the progress.
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.