OBI has filed application of Phase I/II human clinical studies for passive immunotherapeutic monoclonal antibody OBI-888 to TFDA

OBI has signed a non-binding MOU to form a strategic partnership to develop novel bispecific antibody cancer treatments
May 26, 2020
OBI filled application of Phase 1 human clinical study for Novel Botulinum Toxin preparation, OBI-858, to TFDA
June 10, 2020
  1. Date of occurrence of the event: May 29, 2020
  2. Company name: OBI Pharma Inc.
  3. Relationship to the Company (please enter “head office” or “subsidiaries”): Head office
  4. Reciprocal shareholding ratios: Not applicable
  5. Cause of occurrence: OBI has filed the application of phase I/II human clinical studies for passive immunotherapeutic monoclonal antibody OBI-888 to TFDA.
    OBI-888 has completed safety evaluation for phase I/II human clinical studies: Dose Escalation Phase. The study result demonstrated that OBI-888’s safety and tolerance have no major safety concerns. Please refer to Jun 15,2019 MOPS for details. OBI-888 is currently under phase I/II human clinical studies: Cohort Expansion Phase at M.D. Anderson Cancer Center.
  6. Countermeasures: None
  7. Any other matters that need to be specified:
    (1) Name of the new drug: passive immunotherapeutic monoclonal antibody OBI-888
    (2) Uses: An immunotherapeutic monoclonal antibody targeting Globo H for the treatment of cancer.
    https://www.clinicaltrials.gov/ct2/show/NCT03573544
    (3) Planned development: Phase I, II, III clinical trial and NDA
    (4) Ongoing development:
    A. Filed application/ Granted/ Denied: Filed application of phase I/II human clinical studies to TFDA
    B. Risk and countermeasures for denied applications: Not applicable
    C. Outlook for granted applications: Not applicable
    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: Phase I/II human clinical studies: Cohort Expansion Phase
    A. Next phase of development: expected to complete in 2020, the actual schedule will be adjusted according to the timeline.
    B. Expected obligation: None
    (6) Current market: According to public research report of IQVIA, the global market for anti-tumor drugs is about US$150 billion in 2018, the largest among the top 10 categories. OBI-888 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.