TFDA has granted the approval for the active cancer immunotherapy OBI-833 to proceed to a Phase II clinical trial

1.Date of occurrence of the event: 2022/02/23
2.New drug name or code: Active cancer immunotherapy, OBI-833
3.Indication: OBI-833 is a therapeutic cancer vaccine against Globo H, which is classified as an active cancer immunotherapy. Once injected into the human body, the Globo H-CRM197 conjugate can elicit anti-Globo H antibodies to treat cancers. Potential subjects will be tested by IHC to assess the expression of Globo H in the tumor to decide whether they can be enrolled into this Phase II NSCLC clinical trial.
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): TFDA has granted the approval for OBI-833 to proceed to a Phase II clinical trial.
(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: Phase II clinical trial in progress.
(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: Phase II human clinical trial
(1)Estimated date of completion: Expected to evaluate primary endpoint in 2024, 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-833 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.