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On October 14, the CDE official website showed that the clinical application of TJ033721 (TJ-CD4B) injection of CLDN18.
2/4-1BB bispecific antibody was accepted, which was the first in China
.
TJ033721 is the only innovative bispecific antibody that targets the tumor antigen claudin 18 spliceosome 2 (Claudin 18.
2) and the T cell co-stimulatory molecule 4-1BB in the clinical stage, which specifically binds to these two targets at the same time , Can increase lymphocyte tumor infiltration and enhance tumor immune response
.
TJ033721's unique 4-1BB binding epitope allows it to activate T cells only when it binds to Claudin 18.
Pre-clinical studies have shown that even in the case of low expression of Claudin 18.
2, TJ-CD4B can still bind to tumor lesions and produce better immune activity than other 4-1BB monoclonal antibodies
.
In addition, the study also suggests that TJ033721 helps to produce a long-term immune response, so as to obtain a long-lasting therapeutic effect
In July 2018, Tianjing Biotech authorized the development and commercialization rights of TJ033721 outside the Greater China region to South Korea’s ABL Bio.
ABL Bio will pay Tianjing a prepayment of 2.
5 million US dollars and the total amount will be as high as 100 million US dollars.
Milestone payments for R&D, registration and sales
.
This collaboration will also include three other bispecific antibody projects
On July 1, 2021, the first US phase I clinical trial (NCT04900818) of TJ033721 for the treatment of advanced or metastatic solid tumors was completed for the first patient
.
The study is a multi-center dose climbing and dose expansion trial
