1.Date of occurrence of the event: 2021/11/12
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.Name of the reporting media: Commercial Times page B4, etc.
6.Content of the report:
The initial result of interim analysis for breast cancer therapy A is expected to come out no later than the first half of 2023. On the other hand, the Company’s COVID-19 vaccine targeting the coronavirus Delta variant is expected to reveal the results of animal testing at the end of December. OBI-999, the Globo-H Antibody Drug Conjugate, is now at the stage of Phase II Clinical trial and will be open for enrollment in Taiwan soon. As for OBI-833/821, OBI expects to file the application of Phase II Clinical trial for non-small cell lung cancer to TFDA recently and starts the clinical trial in the first half of next year.
7.Cause of occurrence: Supplementary explanation on news article.
8.Countermeasures:
(1) The current experimental design of phase III Clinical Trial of triple negative breast cancer for Active Cancer Immunotherapy OBI-822, Adagloxad Simolenin, has been changed from a randomized, double-blinded, placebo-controlled trial to a randomized, open-labelled, standard-of-care (SOC) controlled design. It has been granted by the health authorities in Taiwan, the United States, China Hong Kong, Australia, Ukraine, Russia, South Africa, and South Korea. The schedule mentioned in the news to receive the initial result of interim analysis in 2023 is based on the assumption that the recruitment proceeds as planned and all the requirements for interim analysis were achieved. For progress of all the clinical trials, please refer to the Company’s material information announcement on MOPS website.
(2) Globo H Antibody Drug Conjugate, OBI-999, has been granted by TFDA to proceed to Phase II Clinical Trial. Potential subjects will be tested via IHC to investigate the expression of Globo H on tumor to decide whether to be included into Phase II clinical trial. The application of Investigational Device Exemption (IDE) for IHC applied to Phase II Clinical Trial of OBI-999, has also been granted by FDA. Please refer to the Company’s material information announcement on 2021/10/21 and 2021/10/25. For progress of all the clinical trials, please refer to the Company’s material information announcement on MOPS website.
(3) Active Cancer Immunotherapy, OBI-833, has completed its Phase I Cohort Expansion Trial and planned to proceed to Phase II Clinical Trial for non-small cell lung cancer. OBI expects to file the application to TFDA recently. Please refer to the Company’s material information announcement on 2021/5/5. For progress of all the clinical trials, please refer to the Company’s material information announcement on the MOPS website.
(4) The Company’s COVID-19 vaccine targeting the coronavirus Delta variant is still at the stage of preclinical development of animal study. Announcement will be made once the results come out. The Company devote its resources to develop the COVID-19 vaccine under the consideration of public welfare. Based on our expertise of protein and patents, we hope to develop a more beneficial, effective, and convenient vaccine and is willing to collaborate with research institutes and other biotechnology companies. The Company will adjust the R&D strategy and schedule of all the products mentioned in the news according to the patient enrollment and completion of therapy timeline for the best interest of shareholders. For development progress of all the products, please refer to the Company’s material information announcement on MOPS website.
9.Any other matters that need to be specified: 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 decisions.