OBI Filed an Application of Investigational Device Exemption (IDE) for Phase II Cohort Expansion Human Clinical Trial for Globo H Antibody Drug Conjugate, OBI-999, to FDA

1.Date of occurrence of the event: September 29, 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 filed the application of investigational device exemption (IDE) for “testing immunohistochemistry (IHC) of Globo H expression on tumor cells” to FDA. IHC will be used in Phase II cohort expansion clinical trial for Globo H Antibody Drug Conjugate, OBI-999. Potential subjects will be tested via IHC to investigate the expression of Globo H on tumor to decide whether to be included into cohort expansion phase.

6.Countermeasures: None

7.Any other matters that need to be specified:
(1)Name of the new drug: Globo H Antibody Drug Conjugate, OBI-999
(2)Uses: OBI-999 is an Antibody Drug Conjugate (ADC) treatment for cancer that is based on Globo H to target cancer cells. ADC releases a small molecule payload through the specificity of the antibody and directly deploys cytotoxic therapy at the targeted cancer cells. Antibody linked payload binds with the receptor on tumor cell to deploy endocytosis, followed by degradation of ADC in lysosomes releases small molecule payload to prevent tumor cell differentiation, to achieve the goal of anti-tumor activity.
(3)Planned development: Phase I, II, III clinical trial, and New Drug Application (NDA)
(4)Ongoing development stage:
A.Filed application/ Granted/ Denied: Filed application
B.Risk and countermeasures for denied applications: Not applicable
C.Outlook for granted applications: Not applicable
D.Total invested capital: As the information is involved in future negotiation of licensing deals, to avoid influence on licensing deals, it will be kept confidential temporary.
(5)Next phase of development: Phase II cohort expansion human clinical trial
A.Expected timeline: expected to evaluate primary endpoint in 2023, actual schedule will be adjusted according to the patient enrollment and completion of therapy timeline.
B.Expected obligation: None
(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). While OBI-999 is still in the proof-of-concept phase of clinical trial, its indications will be targeted at the unmet medical needs where meaningful clinical benefit is observed. The future development will be determined after comprehensive consideration of product development 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 investment decisions.