The active cancer immunotherapy OBI-822, Adagloxad Simolenin, has been granted by Ministry of Food and Drug Safety of South Korea to proceed Phase III human clinical study

Due to the tense situation of Novel Coronavirus Disease (COVID-19), company decided to pause the recruitment of Global Phase III clinical study for 3 months and will restart recruitment when epidemic gets controlled.
April 6, 2020
Supplementary statement for 2020 Shareholders’ Meeting (Change in location and new items)
May 8, 2020
  1. Date of occurrence of the event: Apr 10, 2020
  2. Company name: OBI Pharma Inc.
  3. Relationship to the Company (please enter “head office” or “subsidiaries”): Head Office
  4. Reciprocal shareholding ratios: No applicable
  5. Cause of occurrence: The active cancer immunotherapy OBI-822, Adagloxad Simolenin, has been granted by Ministry of Food and Drug Safety of South Korea to proceed Phase III human clinical study.
  6. Countermeasures: None
  7. Any other matters that need to be specified:
    (1) Name of the new drug: active cancer immunotherapy OBI-822 (Adagloxad Simolenin)
    (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
    (3) Planned development: Phase III clinical study, new drug registration approval
    (4) Ongoing development:
    A. Filed application/ Granted/ Denied: Granted
    B. Risk and countermeasures for denied applications: Not applicable
    C. Outlook for granted applications: Phase III human clinical trial in progress
    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 to evaluate primary endpoint in 2025, the actual schedule will be adjusted according to the timeline.
    B. Expected obligation: Phase III clinical trial has already started. Milestone royalty of US$1,000,000 to Optimer will be initiated.
    (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-822 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.