- Date of occurrence of the event: Jun 23, 2020
- Company name: OBI Pharma Inc.
- Relationship to the Company (please enter “head office” or “subsidiaries”): head office
- Reciprocal shareholding ratios: Not applicable
- Name of the reporting media: Commercial Time page A4, Economic Daily Page A13, and MoneyDJ, etc. (electronic media)
- Content of the report:
(1) Phase 3 clinical study of breast cancer therapy OBI-822 as open-label trial accelerates the recruitment progress. The initial data will be ready as quick as by the end of 2021. Additionally, the authorizations of partial product and the platform have been negotiated with several venders. Expecting results in the next 18 months OBI-822 initially targeted patients with indications of triple-negative breast cancer and with high Globo H expression. The study was designed as double-blind experiment for 2-year of study; however, due to the difficulty of recruitment, after communicating with FDA, the study was modified to open-label trial. Expected to expand the area of patient screening to South Korea, Europe, and China. Based on the recruitment plan, the initial result for interim analysis will come out as quick as by the end of 2021.
(2) After completing safety evaluation of Phase 1 human clinical study in Taiwan in 2021, botulinum toxin preparation, OBI-858, is expected to have the opportunity to receive international authorization. Triple-negative breast cancer therapy, OBI-822, recruiting for Phase 3 clinical study in multiple countries is expected to accelerate the process, and to have initial data by the end of next year.
- Cause of occurrence: Supplementary explanation on news article
(1) Triple-negative Phase 3 clinical study for active immunotherapy, OBI-822 (Adagloxad Simolenin) has been approved to proceed in Taiwan, the U.S., Australia, Hong Kong, Ukraine, Russia, and South Korea. The applications for EU and China clinical study are now under preparation and will file them as soon as possible.
(2) Company is currently communicating with U.S FDA about the change of Phase 3 clinical study design for OBI-822 triple negative breast cancer. Study design will be modified from randomized, double-blind, and placebo-controlled to randomized and open-label. Company is currently working on modification of clinical study proposal based on FDA suggestions and will file the final version to FDA for approval. The study will proceed following the updated clinical study design and expected to accelerate recruitment process. The news about receiving the initial clinical data by the end of 2021 is the assumption if the recruitment proceeds as planned. Please refer to MOPS for latest updates.
(3) On Jun 10, 2020, company has filed application of Phase 1 clinical study for the novel botulinum toxin OBI-858 to TFDA. Currently under review. Please refer to MOPS of Jun 10, 2020 for details.
(4) The timeline of each product will be adjusted based on the specificity of each product and RD development progress, in order to maximize shareholders’ profit. Please refer to MOPS for all updates.
- Any other matters that need to be specified: 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.