Announcement of phase II clinical trial result for ovarian cancer on OBI and Mackay Memorial Hospital cooperated Adagloxad Simolenin, OBI-822

Announcement on change of research and development officer
September 6, 2019
  1. Date of occurrence of the event: Sep 16, 2019
  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: Announced phase II clinical trial result for ovarian cancer on OBI and Mackay Memorial Hospital.
  6. Countermeasures: None
  7. Any other matters that need to be specified:
    (1) Name of the new drug: Adagloxad Simolenin (OBI-822)
    (2) Uses: OBI-822 is a therapeutic cancer vaccine classified as active cancer immunotherapy. Globo H-KLH conjugate triggers immune response against hard-to-treat cancers once injected into the human system.
    https://www.clinicaltrials.gov/ct2/show/NCT02132988
    (3) Planned development: This study is for IIT (Investigator initiated trial), which is led by doctor not company; therefore, it is not applicable.
    (4) Ongoing development:
    A. Results of clinical trial (include interim analysis)/ Critical events occurred to affect new drug development:
    Phase II clinical trial for ovarian cancer of OBI and Mackay Memorial Hospital cooperated Adagloxad Simolenin, OBI-822, is a case-control and non-blind trial study design. Recruited patients are diagnosed as stage II and higher or first-time relapse of ovarian carcinoma, tubal cancer, and peritoneal cancer. Therapeutic results are obtained from patients receiving OBI-822 under stable condition after evaluating surgical and standard chemotherapies.
    This study recruited 77 stage II and higher of ovarian carcinoma, tubal cancer, and peritoneal cancer patients. Compared clinical therapeutic results between patients participated in this clinical study and patients receiving “Angiogenesis Inhibitor” or “PARP Inhibitor”: 55 patients who got diagnosed for the first time have similar Progression-Free Survival (PFS) as who received “Angiogenesis Inhibitor” do; 22 first-time relapse patients after receiving OBI-822 therapy have no clinical effectiveness, compared to patients who received “PARP Inhibitor”. The overall safety and tolerance of this vaccine are within acceptance.
    Additionally, the concentration of antibody against Globo H after vaccine injection seems to have positive correlation with Progress-Free Survival (PFS). Further investigation is needed. This observation is same as the result of OBI-822 phase II clinical trial for metastatic breast cancer.
    A single clinical trial result cannot sufficiently present success or failure of new drug development. Investors shall make prudent judgment and investments.
    B. Risks/impact and countermeasures for clinical trial (include interim analysis) results not meeting competent authorities:
    This study is for IIT (Investigator initiated trial), which is led by doctor not company; therefore, it is not applicable.
    C. Company outlook for clinical trial (include interim analysis) results meeting competent authorities: Not applicable
    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: not applicable
    A. Expected timeline: Not applicable
    B. Expected obligation: None
    (6) Current market: According to public research report of IQVIA, the global market for anti-tumor drugs is about US$150 billion in 2018, the largest among the top 10 categories. OBI-822 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.