1.Date of occurrence of the event:2022/07/01
2.New drug name or code:Passive Immunotherapeutic Monoclonal Antibody, OBI-888
3.Indication:An immunotherapeutic monoclonal antibody targeting Globo H for the treatment of cancer.
Clinicaltrials.gov:
https://www.clinicaltrials.gov/ct2/show/NCT03573544
https://www1.cde.org.tw/ct_taiwan/search_case2.php?caseno_ind%5B1%5D=6213
4.Planned development stages:Phase I, II, III clinical trial, and New Drug Application (NDA)
5.Current development stage:
(1)Application submission/approval/disapproval/each of clinical trials(include interim analysis):
OBI-888 is now at the stage of Phase II clinical trial. Although it didn’t show the expected result, preliminary findings did show the anti-cancer activity of OBI-888.
Among subjects enrolled in the clinical trial, there are four patients whose overall survival extends more than six months, two of them even extends to ten months. Observation of tumor shrinkage demonstrates the preliminary clinical effect of OBI-888 and the potential of further development.
The yield of Lonza’s manufacturing of DS is lower than expected when the reactor is scaled up to 1000L or 2000L and causes high manufacturing cost. Even if the clinical study proceeds, the treatment costs are far beyond patients’ means and therefore, under the consideration of manufacturing costs and long-term development of the Company, we decided to discontinue the Phase II Clinical Trial of OBI-888. The new strategy will be designed after production optimization of next-gen antibody.
Although OBI-888 is an important ingredient of OBI-999, Globo H Antibody Drug Conjugate, the amount of monoclonal antibody needed during the manufacture of OBI-999 and the frequency of treatments are less then OBI-888. The Company decides to dedicate our organizational focus on development of OBI-999, Globo H Antibody Drug Conjugate, which bears lower manufacturing costs and is more affordable and marketable.
(2)Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur:Not applicable.
(3)After obtaining official approval or the results of statistically significant sense, the future strategy:Not applicable.
(4)Accumulated investment expenditure incurred:As the information is involved in future negotiation of licensing deals, to avoid influence on licensing deals and for best interest of shareholders, it will be kept confidential temporary.
6.Upcoming development plan:
(1)Estimated date of completion:The new strategy will be designed after production optimization of next-gen antibody.
(2)Estimated responsibilities:None
7.Market situation:According to public research report of Fortune Business Insights, the global oncology drugs market size was valued at USD 141.3billion in 2019 with 11.6 % of compound annual growth rate (CAGR). While OBI-888 is still in the phase of clinical trial, its indications will be targeted at the unmet medical needs where meaningful clinical benefit is observed. The future development will be determined after comprehensive consideration of product development strategy.
8.Any other matters that need to be specified:None
9.New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks.The investors are advised to exercise caution and conduct thorough evaluation.