On October 11, Jiangsu Corning Jerry Biopharmaceutical Co., Ltd. ("Jiangsu Corning Jerry") announced that its independent research and development of the world's first recombinant humanized PD-L1-CTLA-4 bispecific antibodies (product code: KN046) has recently conducted Phase I clinical trials in Australia, and has received clinical approval from the State Drug Administration of China, which is about to enter clinical trials in China.
The success of the development of cancer immunoantibodies drugs over the past decade marks a major breakthrough in the history of anti-cancer research, and the 2018 Nobel Prize in Medical Physiology has been awarded to two scientists who have made outstanding contributions to research and development in this field.
PD-(L)1 and CTLA-4 are currently the only two cancer immunopharmaceutical targets that have been proven to be effective in clinical trials, but the approved PD-(L)1 and CTLA-4 antibody drugs are only effective in some cancer patients;
Jiangsu Corning Jerry from the safety of the in-depth consideration, screening out a new generation of CTLA-4 antibodies, improve their safety, and pD-L1 antibody fusion to form a dual-target antibody KN046.
through protein engineering, KN046 is targeted and concentrated in the pD-L1 high-expression tumor microenvironment, thereby further reducing the possible toxic side effects of the human peripheral system.
in preclinical studies, KN046 showed good anti-tumor efficacy, and compared with existing CTLA-4 antibodies, the toxic side effects were greatly reduced. "KN046 is the world's first-of-its-kind tumor immuno-immune dual-target therapy antibody, and we target it at the cornerstone of second-generation tumor immunotherapy," said Dr. Xu Wei, chairman of the
Jiangsu Corning Jerry's.
we are very pleased to see that THE FIRST phase of the TRIAL of KN046 in Australia is progressing well and has reached the expected therapeutic dose.
we expect the overall treatment indicators of KN046 to be better than pD-(L) 1 or CTLA-4 antibody monodrug, as well as the combination of these two antibody drugs. Dr. Xu,
", added: "Based on KN046's unique mechanism of action, excellent preclinical research and CMC testing indicators, it took 3 months for the China Pharmaceutical Review Center to approve and approve the clinical approval."
We are very grateful to the National Drug Administration for its recognition and support for the KN046 project and have communicated and discussed the KN046 clinical trial plan with international oncologists.
we plan to develop multiple tumor indications simultaneously in the near future, and push the KN046 project at full speed to reach cancer patients in China and around the world at an early date.
" Source: BioBAY.