1. Date of occurrence of the event: May 5, 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: Assessment of the primary endpoint of safety and secondary endpoints of immune response and tumor response in the Phase 1 cohort expansion study of OBI-833 has been completed. A Phase 2 study is in planning
6. Countermeasures: None
7. Any other matters that need to be specified:
(1) Name of the new drug: active cancer immunotherapy OBI-833
(2) Uses: OBI-833 is a therapeutic cancer vaccine classified as active cancer immunotherapy. Globo H-CRM197 conjugate triggers immune response against hard-to-treat cancers once injected into the human system.
(3) Planned development: Phase I, II, III clinical trial, and NDA
(4) Ongoing development stage: Phase 1 cohort expansion
A. Clinical trial result:
(A) Study design
a. Study: OBI-833-001
b. Objectives: The objectives of the cohort expansion study were to assess the safety and tolerability, and immune response and tumor response of patients with non-small cell lung cancer who received subcutaneous OBI-833 injections.
c. Phase: Phase 1 Cohort Expansion
d. Name of product: OBI-833
e. Indication: non-small cell lung cancer (NSCLC)
f. Patient number: 14 enrolled for Cohort Expansion
(B) Study Evaluation Result: Total of 14 patients with non-small cell lung cancer (NSCLC) were enrolled during the cohort expansion phase of OBI-833-001 study. OBI-833 demonstrated a favorable safety profile. It elicited a beneficial immune response in NSCLC patients and rendered some TKI-treated patients durable stable disease status. The median progression-free survival was 38.1 weeks.
11 of the 14 patients were co-treated with an EGFR TKI in the study. Eight of them remained in stable disease status for over 6 months. Two patients were treated with OBI-833 for over 2 years; one of the patient showed tumor size reduction by 27% after 16 months of OBI-833 treatment.
(C) If it is a Phase 3 clinical trial result, brief the marketing plan: Not applicable
(D) 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: Not applicable
C. Company outlook for clinical trial (include interim analysis) results meeting statistical significance or other key events: Not applicable, proceed to Phase 2 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) Upcoming development plan: Phase 2
A. Expected timeline: To be completed in 2024. Actual project timeline will be adjusted based on the actual study plans.
B. Expected obligation: None
(6) 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). OBI-833 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 investment.