- Date of occurrence of the event: Jul 27, 2018
- Company name: OBI Pharma Inc.
- Relationship to the Company (please enter “head office” or “subsidiaries”): Head office
- Reciprocal shareholding ratios: N/A
- Cause of occurrence: OBI received a letter from the US Food and Drug Administration（FDA）on July 26 (US time) that the Investigational Device Exemption (IDE) for the development of Adogloxad Simolenin (OBI-822) was approved for its use in OBI-822 Phase III Clinical Trial. OBI-822. In the Phase III study, Globo H expression on potential subjects’ tumor will be tested by Immunohistochemistry (IHC) to determine the subject’s eligibility. Immunohistochemistry (IHC), an in vitro Companion Diagnostic Devices, is a testing method to determine patient’s Globo H expression on tumors, in which an Investigational Device Exemption (IDE) needs to be submitted before the start of the clinical trial.
- Countermeasures: N/A
- 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 that is classified into active immunotherapy of cancer. Globo H-KLH conjugate triggers immune response against hard-to-treat cancers once injected into the human system.
(3)Planned development: Phase III clinical trial and NDA
A.Filed application/ Granted/ Denied: granted
B.Risk and countermeasures for denied applications: N/A
C.Outlook for granted applications: Testing of Globo H expression on tumors via immunohistochemistry (IHC) for its use in OBI-822 Phase III Clinical Trial
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: expect to evaluate the primary endpoint by 2023. The actual study timeline will be based on the progress of the clinical trial.
B.Expected obligation: Upon initiation of Phase III clinical trial, milestone royalty of US$500,000 and US$1,000,000 to MSKCC and Optimer, respectively.
(6)Current market: According to EvaluatePharma, the global market for anti-tumor drugs is about US$100.9 billion in 2017, the largest among the top 10 categories. However, OBI-822 is still in the clinical phase. The development of indications is based on the unmet medical needs where future development of the drug will be determined after a comprehensive consideration of the company’s overall product pipeline and strategy.
(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.