1.Date of occurrence of the event: Jul 22, 2020
2.Company name: OBI Pharma Inc.
3.Relationship to the Company (please enter “head office” or “subsidiaries”): Head Office
4.Reciprocal shareholding ratios: No applicable
5.Cause of occurrence:
Active cancer immunotherapy OBI-822 (Adagloxad Simolenin) targets patients of triple negative breast cancer (TNBC) with high Globo H expression. The global Phase III clinical study has started in the States since end of 2018. Please refer to MOPS of Nov 02, 2018 for details.
OBI decided to file an application for clinical study design change to FDA, and officially addressed FDA related questions. OBI will restart recruitment with the new study design and continue the study.
Changes are detailed below:
- Study design changed from randomized, double-blind, placebo-controlled to randomized, open-label.
- Recruitment conditions changed from based on positive results of axillary lymph nodes to based on pathology TNM
Expected changes in the clinical study design will accelerate the recruitment progress for Phase III clinical study of OBI-822, targeting TNBC.
6.Countermeasures: None
7.Any other matters that need to be specified:
(1) Name of the new drug: Adagloxad Simolenin (OBI-822)
(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:
- Filed application/ Granted/ Denied: Granted
- Risk and countermeasures for denied applications: Not applicable
- Outlook for granted applications: Continue phase III human clinical trial with new clinical study design
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:
- Expected completion: expected to evaluate primary endpoint in 2025, the actual schedule will be adjusted according to the timeline.
- Expected obligation: Phase III clinical trial has already started. Milestone royalty of US$1,000,000 to Optimer will be initiated.
(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-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 investments.