1. Date of occurrence of the event: Oct 06, 2020
2. Company name: OBI Pharma Inc.
3. Relationship to the Company (please enter “head office” or “subsidiaries”): head office
4. Reciprocal shareholding ratios: not applicable
5. Cause of occurrence: OBI filed the application to FDA of investigational device exemption (IDE) for ‘testing immunohistochemistry (IHC) of AKR1C3 expression on tumor cells.’ IHC will be used in Phase I/II Cohort Expansion Phase human clinical trial for first-in-class novel prodrug OBI-3424. Potential subjects will be tested with IHC to investigate the expression of AKR1C3 on tumor to decide whether to be included into Cohort Expansion Phase.
6. Countermeasures: none
7. Any other matters that need to be specified:
(1) Name of the new drug: first-in-class novel prodrug, OBI-3424
(2) Uses: OBI-3424 releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme on cancer cells to treat cancers.
(3) Planned development: Phase I, II, III clinical trial and NDA
(4) Ongoing development:
A. Filed application/ Granted/ Denied: Filed application of Investigational Device Exemption (IDE) for Phase I/II Cohort Expansion human clinical studies to FDA
B. Risk and countermeasures for denied applications: Not applicable
C. Outlook for granted applications: Not applicable
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: Expect to finish Dose Escalation Phase for Phase I/II human clinical studies before Cohort Expansion Phase
A. Next phase of development: Dose Escalation Phase for OBI-3424 phase I/II human clinical studies are expected to complete by end of 2020, the actual schedule will be adjusted according to the timeline.
B. Expected obligation: None
(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-3424, first-in-class novel prodrug, is still in clinical development; the indications of solid tumor will include overexpression of AKR1C3 enzyme on hepatocellular carcinoma (HCC) and castration-resistant prostate cancer (CRPC).
(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.