1.Date of occurrence of the event:2021/10/25
2.New drug name or code: Immunohistochemistry (IHC) applied to Phase II Cohort Expansion Human Clinical Trial of OBI-999
3.Indication: Application of Investigational Device Exemption (IDE) for Immunohistochemistry (IHC) applied to Phase II cohort expansion human clinical trial of Globo H Antibody Drug conjugate, OBI-999, has been granted by FDA. Subjects will be tested via IHC to investigate the expression of Globo H on tumor to decide whether to be included into cohort expansion phase.
OBI-999 is an Antibody Drug Conjugate (ADC) treatment for cancer that is based on Globo H to target cancer cells. ADC releases a small molecule payload through the specificity of the antibody and directly deploys cytotoxic 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 activity.
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):
Application of Immunohistochemistry (IHC) has been granted by FDA and will be used in Phase II cohort expansion clinical trial for OBI-999.Subjects will be tested via IHC to investigate the expression of Globo H on tumor to decide whether to be included into cohort expansion phase.
(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:
Subjects will be tested via IHC granted by FDA to investigate the expression of Globo H on tumor to decide whether to be included into OBI-999 cohort expansion phase.
(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: Expected to evaluate primary endpoint in 2023, actual schedule will be adjusted according to the patient enrollment and completion of therapy timeline.
(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 USD141.3 billion in 2019 with 11.6 % of compound annual growth rate (CAGR). While OBI-999 is still in the proof-of-concept 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.