OBI filled application of Phase 1 human clinical study for active immunotherapeutic cancer vaccine, OBI-866, to TFDA

Supplementary statements on news article
June 23, 2020
  1. Date of occurrence of the event: Jun 29, 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 filled application of Phase 1 human clinical study for active immunotherapeutic cancer vaccine, OBI-866, to TFDA.
  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: Filed application of Phase 1 human clinical studies to TFDA

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: 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.