Investigational Device Exemption (IDE) for the development of OBI-888 was approved by the US Food and Drug Administration (FDA) for its use in OBI-888 Phase I cohort expansion phase

Clearance of Adagloxad Simolenin (OBI-822) for a Phase III clinical study in the United States
November 2, 2018
Department of Health (DOH) clearance of Adagloxad Simolenin (OBI-822) for a Phase III clinical study in Hong Kong
November 15, 2018
  1. Date of occurrence of the event: Nov 12, 2018
  2. Company name: OBI Pharma Inc.
  3. Relationship to the Company (please enter “head office” or “subsidiaries”): Head office
  4. Reciprocal shareholding ratios: N/A
  5. Cause of occurrence: OBI received a letter from the US Food and Drug Administration (FDA) on Nov 10 (US time) that the Investigational Device Exemption (IDE) for the development of OBI-888 was approved for the immunohistochemistry (IHC) to be used in cohort expansion phase of a Phase I clinical trial for OBI-888, an immunotherapeutic monoclonal antibody. In the Phase III study, Globo H expression on potential subjects’ tumor will be tested by Immunohistochemistry (IHC) to determine the subject’s eligibility in the study.
  6. Countermeasures: N/A
  7. Any other matters that need to be specified:
    (1)Name of the new drug: OBI-888, an immunotherapeutic monoclonal antibody
    (2)Uses: OBI-888 is a passive immunotherapy monoclonal antibody that specifically targets Globo H in cancer therapy.
    https://www.clinicaltrials.gov/ct2/show/NCT03573544?term=OBI-888&rank=1
    (3)Planned development: Phase I, II, III clinical trial and NDA
    (4)Ongoing development:
    A.Filed application/ Granted/ Denied: granted by the US Food and Drug Administration (FDA) for its use in OBI-888 Phase I cohort expansion phase
    B.Risk and countermeasures for denied applications: N/A
    C.Outlook for granted applications: N/A
    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: expect to submit next stage of clinical study after completion of phase I dose escalation and cohort expansion phase.
    A.Expected timeline: ongoing phase I cohort expansion studies are expected to complete in 2019. The actual study timeline will be based on the progress of the clinical trial.
    B.Expected obligation: none.
    (6)Current market: According to EvaluatePharma, the global market for anti-tumor drugs is about US$100.9 billion in 2017, the largest among the top 10 categories.
    However, OBI-822 is still in the clinical phase. The development of indications is based on the unmet medical needs where future development of the drug will be determined after a comprehensive consideration of the company’s overall product pipeline and strategy.
    (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.