FDA Clearance of OBI-3424 IND Application for A Phase I/II Study Targeting AKR1C3 Solid Tumors

  1. Date of occurrence of the event: April 19, 2018
  2. Company name: OBI Pharma, Inc.
  3. Relationship to the Company (please enter ”head office” or ”affiliated company”): Head office
  4. Reciprocal shareholding ratios: N/A
  5. Cause of occurrence: FDA clearance of OBI-3424 IND application for a Phase I/II study targeting AKR1C3 solid tumors
  6. Countermeasures: None
  7. Any other matters that need to be specified:
    (1)Name of the new drug: Novel Chemotherapeutic Prodrug OBI-3424
    (2)Uses: OBI-3424 selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3), and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme.
    (3)Planned development: Phase I, II, III clinical trial and NDA
    (4)Ongoing development:
    A.Filed application/ Granted/ Denied: Clearance of IND application for a Phase I/II study
    B.Risk and countermeasures for denied applications: N/A
    C.Outlook for granted applications: N/A
    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: plan to enter Phase II (cohort expansion) after completing Phase I (dose escalation).
    A.Expected timeline: Phase I (does escalation) Clinical Trial of OBI-3424 is scheduled to take 1–2 years after the IND clearance. The timeline may be adjusted based on actual study progress.
    B.Expected obligation: None
    (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. OBI-3424 is still in the early stage of clinical development; the potential indications of OBI-3424 in solid tumors include AKR1C3 over-expressed hepatocellular carcinomas (HCC) and castrate-resistant prostate cancer (CRPC)
    (7)New drug development is a long journey associated with high costs. It is not a guaranteed success, which may increase the risk of investment. Investors shall make prudent judgments and investments.