Antengene's PD-L1/4-1BB dual antibody ATG-101 for injection was approved for clinical use

Recently, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that ATG-101 for injection declared by Antengene has been approved for clinical use, and the proposed indications are advanced/metastatic solid tumors and mature B-cell non-Hodge.

Screenshot source: CDE official website

According to the earlier public information of Antengene, ATG-101 is a drug specially designed and developed to combine the effect of PD-1 inhibition with the immune activation effect of 4-1BB

As a novel PD-L1/4-1BB bispecific antibody, ATG-101 forms a trimer based on cell-antibody-cell structure, blocks PD-L1/PD-1 binding and activates 4-1BB co-stimulatory signals, thereby activating anti-tumor immune effector cells, and effectively reducing hepatotoxicity

In in vitro studies, ATG-101 activated depleted immune cells, showing its potential to reverse T cell dysfunction and cell depletion (under PD-1 cross-linking conditions)

Previously, ATG-101's Phase 1 clinical trial applications for the treatment of metastatic or advanced solid tumors and B-cell non-Hodgkin's lymphoma have been approved in Australia and the United States, respectively, and the first Phase 1 will be completed in Australia in December 2021.

The clinical approval of ATG-101 in China this time means that the drug will soon start relevant clinical trials in China

References:

[1] The official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China.

[3] Antengene has been approved by the US FDA for ATG-101 (PD-L1/4-1BB dual antibody) for the treatment of solid tumors and non-Hodgkin lymphoma Phase I trials.