FDA Clearance of IND Application for A Phase 1 Study of A Monoclonal Antibody Cancer Immunotherapy (OBI-888)

Shilin District Court deny OBI’s request to submit the case for trial
January 8, 2018
Clarification on the news articles by Commercial Times, United Daily, etc.
February 23, 2018
  1. Date of occurrence of the event: January 17, 2018
  2. Company name: OBI Pharma, Inc.
  3. Relationship to the Company (please enter ”head office” or ”affiliated company”): Head office
  4. Reciprocal shareholding ratios: N/A
  5. Cause of occurrence: FDA clearance of IND application for a Phase 1 study of a monoclonal antibody cancer immunotherapy (OBI-888)
  6. Countermeasures: None
  7. Any other matters that need to be specified:
    (1) Name of the new drug: Passive Immunotherapy, Monoclonal Antibody OBI-888
    (2) Uses: OBI-888 is a passive immunotherapy monoclonal antibody that specifically targets Globo H in cancer therapy.
    (3) Planned development: Phase I, II, III clinical trial and NDA
    (4) Ongoing development:
    A. Filed application/ Granted/ Denied: Clearance of IND application for a Phase 1 study
    B. Risk and countermeasures for denied applications: N/A
    C. Outlook for granted applications: N/A
    D. Total invested capital: To be kept as confidential for avoidance of complications in future international licensing deals, and the protection of investor interests.
    (5) Next phase of development: Application for Phase II clinical trial will be filed after completing Phase I trial.
    A. Expected timeline: Phase I Clinical Trial of OBI-888 is scheduled to take 1–2 years after the study clearance. The timeline may be adjusted based on actual study progress.
    B. Expected obligation: None
    (6) Current market: According to EvaluatePharma, the global market for anti-tumor drugs is about US $89.9 billion in 2016, the first among the top 10 categories in the world. However, OBI-888, passive immunotherapy monoclonal antibody, is still in clinical trials. Its indications is geared towards unmet medical needs. The overall development plan will be based on the Company’s overall product line and business strategy.
    (7) New drug development is a long journey associated with high cost. It is not a guaranteed success, which may increase the risk of investment. Investors shall make prudent judgments and investments.