- Date of occurrence of the event: Jun 15, 2019
- 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-888 completed safety evaluation in a phase I dose escalation phase. Trial results demonstrated OBI-888’s safety and tolerability with no major safety concerns. Safety Review Committee suggests to proceed to phase 2 Cohort Expansion Phase as planned.
- Countermeasures: None
- Any other matters that need to be specified:
(1)Name of the new drug: passive immunotherapeutic monoclonal antibody OBI-888
(2)Uses: An immunotherapeutic monoclonal antibody targeting Globo H for the treatment of cancer.
(3)Planned development: Phase I, II, III clinical trial and NDA
A.Filed application/ Granted/ Denied: OBI-888 completed safety evaluation in a phase I dose escalation phase with 12 last stage patients with solid tumor. The trial evaluated three dose levels of OBI-888 at 5 mg/kg, 10 mg/kg and 20 mg/kg. Results indicates the safety of OBI-888 at all dose levels tested and are well tolerated. No dose limiting toxicity (DLT) nor OBI-888-related AE were observed. Safety Review Committee suggests to proceed to phase 2 Cohort Expansion Phase as planned. Single clinical trial result may not accurately reflect the possibility of drug commercialization. Investors shall make prudent judgments and investments.
B.Risk/impact and countermeasures for clinical trial (include interim analysis) results not meeting statistical significance or other key events: N/A
C.Company outlook for clinical trial (include interim analysis) results meeting statistical significance or other key events: Phase 2 clinical trial—cohort expansion phase
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: Phase II Cohort Expansion Phase
A.Expected timeline: To be completed in 2019. Actual project timeline will be adjusted based on the actual study plans.
B.Expected obligation: None
(6)Current market: According to IQVIA, the global market for anti-tumor drugs is about US$150 billion in 2018, the largest among the top 10 categories. OBI-888 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.