TJBio announces that its bispecific antibody TJ-CD4B has been approved for Phase 1 clinical trials in China

On December 16, 2021, Horizon Biotech announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has officially approved the bispecific antibody TJ-CD4B (also known as ABL111) for the treatment of solid tumors (including gastric cancer, Phase 1 clinical study of esophageal-gastric junction adenocarcinoma, esophageal adenocarcinoma and pancreatic duct adenocarcinoma
.
TJ-CD4B, as the first clinically innovative bispecific antibody targeting the tumor antigen claudin 18 splice body 2 (Claudin 18.
2) and T cell costimulatory molecule 4-1BB, it specifically binds to these two targets at the same time It can increase lymphocyte tumor infiltration and enhance tumor immune response, and has the potential to treat gastric cancer, pancreatic cancer and a variety of malignant solid tumors
.
Preclinical 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 immune activity superior to other 4-1BB monoclonal antibodies
.
The pre-clinical research data published at the just-concluded 2021 Society for Cancer Immunotherapy (SITC) annual meeting showed that TJ-CD4B has a unique 4-1BB binding epitope and mechanism of action, which reduces the risk of systemic immune response and has long-lasting resistance.
Advantages of tumor curative effect
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TJBio has been approved in the United States in June this year to initiate a phase 1 clinical trial of TJ-CD4B for the treatment of advanced solid tumors (NCT04900818).
The phase 1 clinical trial approved in China this time will be used as a dose extension for the US study Partially launched to speed up the global clinical development process of TJ-CD4B in an all-round way
.