1. Date of occurrence of the event: Apr 7, 2021
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’s application to initiate the Phase III clinical study of the active cancer immunotherapy OBI-822 (Adagloxad Simolenin) has been denied by the Ministry of Health, Argentina.
6. Countermeasures: OBI-822 is a Globo H-targeted therapeutic cancer vaccine classified as an active cancer immunotherapy. OBI-822 Phase III clinical study, intended to treat triple negative breast cancer (TNBC) patients with high Globo H expression, has been approved and active in United States, Australia, China, Taiwan, Hong Kong, South Korea, Ukraine, and Russia. OBI is planning to resubmit the application to the Ministry of Health, Argentina for Phase III clinical study of OBI-822 in the near future.
7. Any other matters that need to be specified:
(1) Name of the new drug: active cancer immunotherapy OBI-822 (Adagloxad Simolenin)
(2) Uses: OBI-822 is a therapeutic cancer vaccine classified as active cancer immunotherapy. Globo H-KLH conjugate triggers immune response against hard-to-treat cancers once injected into the human system.
https://www.clinicaltrials.gov/ct2/show/NCT03562637
(3) Planned development: Phase III clinical study, new drug registration approval
(4) Ongoing development:
A. Filed application/ Granted/ Denied: Denied
B. Risk and countermeasures for denied applications: OBI-822 Phase III clinical study, intended to treat triple negative breast cancer (TNBC) patients with high Globo H expression, has been approved and active in 8 countries. OBI is planning to resubmit the application to the Ministry of Health, Argentina for Phase III clinical study of OBI-822 in the near future.
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:
A. Expected timeline: expected to evaluate primary endpoint in 2025, actual schedule will be adjusted according to the timeline.
B. Expected obligation: Phase III clinical trial has already started. Milestone payment of US$1,000,000 to Optimer will be initiated.
(6) Current market: According to public research report of Fortune Business Insights, the global oncology drugs market size was valued at USD 141.3 billion in 2019 with 11.6 % of compound annual growth rate (CAGR). OBI-822 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 investment.