AEMPS of Spain revokes previous approval for the Active Cancer Immunotherapy, OBI-822, to proceed to Phase III Clinical Trial

1.Date of occurrence of the event:2022/04/06
2.New drug name or code:Active Cancer Immunotherapy OBI-822 (Adagloxad Simolenin)
3.Indication: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.
Clinical trial info:
4.Planned development stages:Phase III clinical trial and New Drug Application (NDA)
5.Current development stage:
(1)Application submission/approval/disapproval/each of clinical trials(include interim analysis):
AEMPS of Spain revokes previous approval for the Active Cancer Immunotherapy, OBI-822, to proceed to TNBC Phase III 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:
(a)The Company was informed by The Spanish Agency of Medicines and Medical Devices (hereinafter referred to as “ AEMPS”) on 2022/1/25 of the approval for the Active Cancer Immunotherapy, OBI-822, to proceed to Phase III Clinical Trial. The Company announced the material information on the same date in accordance with the rules related. However, at the beginning of February, 2022, AEMPS informed the Company that due to procedural errors, the review of Phase III Clinical Trial was not completed and supplementary information was needed. Despite that the Company responded immediately to the inquiry, AEMPS informed the Company on 2022/4/6 that previous approval for OBI-822 to proceed to Phase III Clinical Trial had been revoked.
(b)According to the letter missive, AEMPS revokes the approval of Phase III Clinical Trial as the information integrity of Keyhole Limpet Hemocyanin (KLH) and Chemistry, Manufacturing and Controls (CMC), is considered not satisfactory. OBI-822 with its Phase I Clinical Trial finished was transferred from MSKCC and completed its Phase II Clinical Trial by the Company itself. The results of hundreds of patients revealed that OBI-822 had no safety or tolerability concerns. Health authorities in 13 countries, including the United States, Australia, Taiwan, and China, have granted OBI-822 to proceed to Phase III Clinical Trial.
(c)The Company will continue to conduct Phase III Clinical Trial while the trial was granted by several countries in South Africa and South America recently to increase the enrollment. It is estimated that the withdrawal of AEMPS’s previous approval will not cause material impact to the progress of OBI-822 Phase III Clinical Trial.
(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:Expected to perform interim analysis in 2023, actual schedule will be adjusted according to the patient enrollment and completion of therapy timeline.
(2)Estimated responsibilities:Phase III clinical trial already started. Milestone payment of US$1,000,000 to Optimer will be initiated.
7.Market situation:According to public research report of Fortune Business Insights, the global oncology drugs market size was valued at USD 141.3 billion in 2019 with 11.6 % of compound annual growth rate (CAGR). While OBI-822 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.