Phase 3 clinical just started! Corning Jerry PD-L1/CTLA-4 double resistance was re-approved clinically.

China's State Drug Administration Drug Review Center (CDE) recently announced that Corning Jerry's recombinant humanized PD-L1/CTLA-4 dual-specific monomedia antibody Fc fusion protein injection obtained a clinical trial implied license to develop the adaptation: combined toluene sulfonate donafini tablets for the treatment of advanced digestive tract solid tumors.
, according to Corning Jerry's official information, this is a research and development code-named KN046 in the study of new drugs.
two days ago, KN046's clinical study of stage IV squamous non-small cell lung cancer was officially entered into phase 3 trial phase, which will be used to declare the product's new drug on the market in China.
screenshot Source: CDE.com According to public information, KN046 is Corning Jerry's first recombinant humanized PD-L1/CTLA-4 dual-specific antibody.
through its original drug design, the company uses THELA-4 monolithic antibodies with significantly improved safety to fuse with PD-L1 antibodies to form a dual-specific antibody KN046, blocking PD-(L)1 and CTLA-4, effectively activating and activating T cells and enhancing anti-tumor immunity.
KN046's innovative design includes: 1) the use of a significantly improved safety of CTLA-4 monolithic antibodies;
preclinical and clinical trial results show that the product can significantly reduce the possible toxic side effects on the human perivirus system, and is expected to become a new generation of breakthrough tumor immunological drugs.
, KN046 has shown good safety and initial efficacy in Phase 1 clinical trials conducted simultaneously in Australia and China.
according to The Chinese drug clinical trial registration and information publicity platform information, the product is currently in China to carry out non-small cell lung cancer, triple-yin breast cancer, esophageal squamous cancer and many other Phase 2 clinical trials.
2020, the FDA approved KN046 to go directly to Phase 2 clinical trials in the United States based on clinical trial results obtained in Australia and China.
KN046 was approved clinically in China to be developed for the treatment of advanced gastroesophedic solid tumors with toluene sulfonate donaphine tablets.
is an oral multi-target, multi-kinase inhibitor-type small-molecule anti-tumor drug developed by Zetam Pharmaceuticals, which belongs to class 1 new drug.
, combination therapy is one of KN046's research and development strategies.
previously, its clinical trials with toluene sulfonate nigtinib for solid and blood system tumors were approved in China in May this year.
(CT053) is a multi-target small molecule inhibitor developed by Dongsian, which mainly targets c-Met/Axl/MER/VEGFR2.
: China's State Drug Administration. Retrieved Aug 14, 2020, from the 2nd Corning Jerry's dual-specific antibody KN046 initiated a Clinical PHASE III. Phase III trial, and the researchers' meeting was successfully held. Retrieved Aug 16, 2020, from #rd.com and public information.