Clearance of Adagloxad Simolenin (OBI-822) for a Phase III clinical study in the United States

OBI Pharma Australia Pty Ltd announces the clearance of Adogloxad Simolenin (OBI-822) for a Phase III clinical study in Australia
October 29, 2018
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
November 12, 2018
  1. Date of occurrence of the event: Nov 02, 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: Phase III clinical study of OBI’s active immunotherapeutic drug Adagloxad Simolenin (OBI-822) is planned to target Triple Negative Breast Cancer (TNBC) subjects with high Globo H expression. The Immunohistochemistry (IHC) tests to evaluate Globo H expression has been approved for Investigational Device Exemption (IDE) by the Food and Drug Administration (FDA) on Jul 26, 2018 for its use in OBI-822 Phase III clinical study. In addition, OBI has submitted OBI-822 Phase III protocol amendment to the FDA on Sept 18, 2018 (US time). As of today, no objections or comments have been received. Since the submission the protocol amendment, OBI has completed Phase III related tasks, including the submission of “Pathologist concordance training program: Repeat Concordance Results.” OBI will proceed with Phase III study of OBI-822 in the United States.
  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.
    https://www.clinicaltrials.gov/ct2/show/NCT03562637?cond=OBI-822&rank=1
    (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.