1. Date of occurrence of the event: May 13, 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-999 completes its safety evaluation in Phase 1 dose escalation and demonstrates its safety with no major concerns. Safety Review Committee (SRC) suggests proceeding to Phase 2 cohort expansion as planned. Potential subjects’ tumor Globo H expression will be tested via Immunohistochemistry (IHC) as inclusion criteria for the Phase 2 cohort expansion study.
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: An Antibody Drug Conjugate (ADC) treatment for cancer that is based on Globo H, OBI-999, uses to target cancer cells. ADC is by releasing a small molecule payload through the specificity of the antibody, it directly deploys cytotoxicity 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. Clinicaltrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT04084366
(3) Planned development: Phase I, II, III clinical trial, and NDA
(4) Ongoing development stage: Phase 1 dose escalation
A. Clinical trial result:
(A) Study design
a. Study: OBI-999-001
b. Objectives: Primary objective of dose escalation phase is to evaluate the safety and tolerability of OBI-999 when administered intravenously (IV) in patients with solid tumor. Dose rage is from 0.4 mg/kg to 2.0 mg/kg.
c. Phase: Phase 1 dose escalation
d. Name of product: OBI-999
e. Indication: solid tumors
f. Patient number: 15 enrolled for dose escalation
(B) Study Evaluation Result: OBI-999-001 dose escalation phase enrolled 15 patients with advances solids tumors, 4 dose cohorts have been completed for safety evaluation. Safety Review Committee (SRC) has no concerns on OBI-999 safety, tolerability, and recommends the Phase 2 (RP2D) for proceeding to Phase 2 cohort expansion phase.
(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: proceed to Phase 2 cohort expansion
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 cohort expansion
A. Expected timeline: To be completed in 2023. 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-999 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.