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

OBI Pharma Inc. to attend Credit Suisse Asian Investment Conference
March 19, 2018
Announcement based on the procedures for acquisition or disposal of assets
April 20, 2018
  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.