Taiwan FDA clearance of Adagloxad Simolenin (OBI-822) for a Phase III clinical study

Correction on previous announcement: “Clarification on the news article by Commercial Times” to “United Daily News”
September 20, 2018
OBI received notice from patent attorney’s office that product patent for OBI-822 named “Compound and Compositions of Carbohydrate Vaccine and Uses Thereof” has been approved by Taiwan Intellectual Property Office
October 1, 2018
  1. Date of occurrence of the event: Sept 28, 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: Taiwan FDA clearance of Adagloxad Simolenin (OBI-822) for a Phase III clinical study
  6. Countermeasures: N/A
  7. Any other matters that need to be specified:
    (1)Name of the new drug: Active immunotherapeutic agent, Adagloxad Simolenin (OBI-822)
    (2)Uses: OBI-822 is an active immunotherapeutic agent targeting Globo H. Globo H conjugated with KLH, a carrier protein, can trigger the production of anti-Globo H antibodies. The immune response can be used to treat cancer. 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.