Junshi Biotechnology completed the world's first anti-PD-1/TGF-β bifunctional fusion protein JS201 clinical trial for the first patient administration

Beijing 2021 Nian 7 Yue 30 days, Jun real biological ( 1877.
HK , 688180.
SH ) announced that the company developed the world's first recombinant PD-1 monoclonal antibody / TGF-β RⅡ bifunctional fusion protein (Project Code: JS201 ) Phase I clinical trial ( NCT04956926 ) has completed the first patient administration recently
.

This study aims to evaluate the safety, tolerability, pharmacokinetic characteristics and initial efficacy of JS201 in the treatment of patients with advanced malignant tumors in dose escalation, dose expansion and clinical expansion

Beijing 2021 Nian 7 Yue 30 days, Jun real biological ( 1877.

Due to factors such as the environment and the prolonged life expectancy of human beings, cancer has become the main cause of death in our country, and it is a major problem in the field of public health

In recent years, tumor immunotherapy represented by PD-1 inhibitors has developed rapidly, and has shown significant clinical anti-tumor activity and survival benefits in a variety of malignant tumors, but there are still a certain number of patients who cannot respond to them.
.
How to further expand the beneficiary population of immunotherapy and improve the therapeutic effect has become the focus of drug development in this field .

Related studies have found that immune checkpoint inhibitors only act on a certain aspect of the tumor and its microenvironment complex system, while many other factors in the tumor microenvironment can still mediate the immune escape of tumors ^[2] [2]

JS201 is a recombinant PD-1 monoclonal antibody /TGF-β R Ⅱ bifunctional fusion protein.

Preclinical data show that JS201 can specifically bind to recombinant human PD-1 and TGF-β proteins with high affinity , and effectively block PD-1/PD-L1 or PD-1/PD-L2 and TGF-β signaling pathways , Thereby activating the human immune system, improving the tumor microenvironment, effectively enhancing the immune response, and reducing immune escape and the occurrence of drug resistance

The conduct of the NCT04956926 study is an I period, open, multi-center clinical study, by the Cancer Center of Sun Yat-sen tension Jiaoshou led leadership, to evaluate the tension JS201 Late effective treatment regimens in the treatment of advanced standard or non-standard by vicious Safety, tolerability, pharmacokinetic characteristics, pharmacodynamic characteristics, immunogenicity and preliminary effectiveness in cancer patients

 

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About J S201

About About J J S201 S201

JS201 is a bifunctional fusion protein independently developed by Junshi Biologics that can simultaneously target PD-1 and TGF-β (transforming growth factor- β )
.

PD-1 and TGF-β are usually highly expressed in the tumor microenvironment at the same time.
TGF-β mediates the primary drug resistance of anti- PD-1 monoclonal antibodies

JS201 is a bifunctional fusion protein independently developed by Junshi Biologics that can simultaneously target PD-1 and TGF-β (transforming growth factor- β )

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