Clearance of Adagloxad Simolenin (OBI-822) for a Phase III clinical study in the United StatesNovember 2, 2018
Department of Health (DOH) clearance of Adagloxad Simolenin (OBI-822) for a Phase III clinical study in Hong KongNovember 15, 2018
- Date of occurrence of the event: Nov 12, 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 Nov 10 (US time) that the Investigational Device Exemption (IDE) for the development of OBI-888 was approved for the immunohistochemistry (IHC) to be used in cohort expansion phase of a Phase I clinical trial for OBI-888, an immunotherapeutic monoclonal antibody. In the Phase III study, Globo H expression on potential subjects’ tumor will be tested by Immunohistochemistry (IHC) to determine the subject’s eligibility in the study.
- Countermeasures: N/A
- Any other matters that need to be specified:
(1)Name of the new drug: OBI-888, an immunotherapeutic monoclonal antibody
(2)Uses: OBI-888 is a passive immunotherapy monoclonal antibody that specifically targets Globo H in cancer therapy.
(3)Planned development: Phase I, II, III clinical trial and NDA
A.Filed application/ Granted/ Denied: granted by the US Food and Drug Administration (FDA) for its use in OBI-888 Phase I cohort expansion phase
B.Risk and countermeasures for denied applications: N/A
C.Outlook for granted applications: N/A
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: expect to submit next stage of clinical study after completion of phase I dose escalation and cohort expansion phase.
A.Expected timeline: ongoing phase I cohort expansion studies are expected to complete in 2019. The actual study timeline will be based on the progress of the clinical trial.
B.Expected obligation: none.
(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.