Investigational Device Exemption (IDE) for the development of Adagloxad Simolenin (OBI-822) was approved by the US Food and Drug Administration (FDA) for its use in OBI-822 Phase III Clinical Trial

OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC)
July 8, 2018
Clarification on the news article by Commercial Times
July 30, 2018
  1. Date of occurrence of the event: Jul 27, 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 July 26 (US time) that the Investigational Device Exemption (IDE) for the development of Adogloxad Simolenin (OBI-822) was approved for its use in OBI-822 Phase III Clinical Trial. OBI-822. In the Phase III study, Globo H expression on potential subjects’ tumor will be tested by Immunohistochemistry (IHC) to determine the subject’s eligibility. Immunohistochemistry (IHC), an in vitro Companion Diagnostic Devices, is a testing method to determine patient’s Globo H expression on tumors, in which an Investigational Device Exemption (IDE) needs to be submitted before the start of the clinical trial.
  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 that is classified into active immunotherapy of cancer. 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: Testing of Globo H expression on tumors via immunohistochemistry (IHC) for its use in OBI-822 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.