TFDA clearance for Phase 1 clinical study for active immunotherapeutic cancer vaccine, OBI-866

1.Date of occurrence of the event: Aug 25, 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: TFDA has approved to proceed Phase 1 human clinical study for active immunotherapeutic cancer vaccine, OBI-866.
6.Countermeasures: None
7.Any other matters that need to be specified:
(1) Name of the new drug: active immunotherapy, OBI-866
(2) Uses: OBI-866 is an active immunotherapeutic cancer vaccine targeting SSEA-4, conjugating SSEA-4 and carrier protein KLH. OBI-866 is designed to elicit SSEA4 specific antibodies immune responses after human injection as anti-cancer therapy.
(3) Planned development: Phase I, II, III clinical trial and NDA
(4) Ongoing development:
A. Filed application/ Granted/ Denied: TFDA granted Phase 1 human clinical studies
B. Risk and countermeasures for denied applications: Not applicable
C. Outlook for granted applications: phase 1 human clinical study is proceeding as planned
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: Phase 1 human clinical study
A. Next phase of development: expected to complete in 2021, 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-866, active immunotherapeutic cancer vaccine, 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.