OBI Pharma Australia Pty Ltd announces the clearance of Adogloxad Simolenin (OBI-822) for a Phase III clinical study in Australia

  1. Date of occurrence of the event: Oct 29, 2018
  2. Company name: OBI Pharma Australia Pty Ltd
  3. Relationship to the Company (please enter “head office” or “subsidiaries”): subsidiary
  4. Reciprocal shareholding ratios: 100%
  5. Cause of occurrence: An application of a P3 clinical study for Adogloxad Simolenin (OBI-822), an investigational drug in development by OBI, was submitted by OBI Pharma Australia Pty Ltd, an OBI Pharma Inc.’s subsidiary. The application was granted by Therapeutic Goods Administration (TGA) for the commencement of a P3 clinical study at St Vincent’s Hospital, Sydney, Australia.
  6. Countermeasures: N/A
  7. Any other matters that need to be specified:
    (1)Name of the new drug: Adagloxad Simolenin (OBI-822)
    (2)Uses: OBI-822 is a therapeutic cancer vaccine classified as active cancer immunotherapy. Globo H-KLH conjugate triggers immune response against hard-to-treat cancers once injected into the human system.
    (3)Planned development: Phase III clinical trial and NDA
    (4)Ongoing development:
    A.Filed application/ Granted/ Denied: Granted
    B.Risk and countermeasures for denied applications: N/A
    C.Outlook for granted applications: Phase III Clinical Trial
    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:
    A.Expected timeline: expect to evaluate the primary endpoint by 2023. The actual study timeline will be based on the progress of the clinical trial.
    B.Expected obligation: Upon initiation of Phase III clinical trial, milestone royalty of US$500,000 and US$1,000,000 to MSKCC and Optimer, respectively.
    (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.