Announcement on behalf of AP Biosciences to file
application for Phase I human clinical trial of
Bispecific Antibody, AP203, to US FDA
Date of events
2022/08/12
To which item it meets
paragraph 10
Statement
1.Date of occurrence of the event:2022/08/12
2.New drug name or code:Bispecific Antibody, AP203
3.Indication:Bispecific antibody AP203 is a second-generation cancer
immunotherapy developed by AP Biosciences (hereinafter referred to as
APBio). It binds to PD-L1 and CD137, and induces T-cell activation, as
well as cancer cell killing, in a target-dependent manner with reduced
systemic cytokine release.
4.Planned development stages:Phase I, II, III clinical trial, and Biologics
License Application (BLA).
5.Current development stage:
(1)Application submission/approval/disapproval/each of clinical
trials(include interim analysis):
APBio has filed the application to US FDA for Phase I human 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:Not applicable.
(4)Accumulated investment expenditure incurred:
For negotiation on potential licensing deals in the future, and for the
best interest of shareholders, this information is kept confidential
temporarily.
6.Upcoming development plan:Phase I human clinical trial
(1)Estimated date of completion:2024
(2)Estimated responsibilities:None
7.Market situation:According to public research report of Fortune Business
Insights, the global oncology drug market size was valued at USD 141.3
billion in 2019, with 11.6 % of compound annual growth rate (CAGR). While
AP203 is intended to target unmet medical needs where a meaningful clinical
benefit to the patients is identified, advancement of AP203 in further
studies will be determined eventually as part of the development strategy
for the entire product pipeline.
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.:
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OBI Pharma Inc. published this content on 12 August 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 August 2022 06:49:06 UTC.
OBI Pharma, Inc. is a Taiwan-based company principally engaged in the development of new pharmaceuticals. The Company mainly operates its businesses through the research and development of novel cancer and infectious disease therapies. It also develops next generation active immunotherapies to treat cancers, including lung, prostate, pancreatic, stomach and ovarian cancers. It is engaged in the development of OBI-822 (formerly OPT-822/821), an active immunotherapy new drug for metastatic breast cancer; the research and development of therapeutic vaccine OBI-833 for the treatment of new generation of cancers, as well as the development of cancer testing reagent OBI-868.
OBI PHARMA, INC. 
