1. Date of occurrence of the event: Nov 23, 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 received a notification from FDA about the investigational device exemption (IDE) for ‘testing immunohistochemistry (IHC) of AKR1C3 expression on tumor cells.’ IHC was used in Phase I/II Cohort Expansion Phase human clinical trial for first-in-class novel prodrug OBI-3424. After FDA investigation on subjects with high AKR1C3 expression hepatocellular carcinoma (HCC), nonsignificant risk was observed; therefore, no further approval is required to proceed the study.
Potential subjects as previous described will be investigated AKR1C3 expression on tumor via IHC to decide whether to enter in 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: FDA replied that subjects were observed nonsignificant risk, therefore no further approval was required and able to proceed Phase I/II Cohort Expansion Phase human clinical trial
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.