1. Date of occurrence of the event: April 21, 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-3424 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 AKR1C3 expression will be tested via Immunohistochemistry (IHC) as inclusion criteria of the Phase 2 cohort expansion study.
6. Countermeasures: None
7. Any other matters that need to be specified:
(1) Name of the new drug: First-in-class novel prodrug, OBI-3424
(2) Uses: OBI-3424 treats cancer by releasing a potent DNA alkylating agent in the presence AKR1C3 overexpressed cancer cells.
Clinicaltrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT03592264
(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-3424-001
b. Objectives: Primary objective of dose escalation phase is to evaluate the safety and tolerability of OBI-3424 when administered intravenously (IV) in patients with solid tumor. Dose rage is from 1 mg/m2 to up to 14 mg/m2.
c. Phase: Phase 1 Dose Escalation
d. Name of product: OBI-3424
e. Indication: Solid Tumors
f. Patient number: 39 enrolled for Dose Escalation
(B) Study Evaluation Result: Total 39 patients with solid tumors were enrolled for OBI-3424-001 dose escalation phase, in which safety evaluation among 10 dose cohorts have been completed. Safety Review Committee (SRC) has no concern on the safety and tolerability of OBI-3424, and provided the recommended Phase 2 does (RP2D) for proceeding to Phase 2 cohort expansion study.
(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-3424 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.