There are nearly 50 dual antibodies under development in China, and Corning Jereh KN046 is expected to be listed in 2022; Kangfang Biology, Hengrui Medicine...
June 18, 2021
On June 7, Corning Jerry, the global leader in the development of PD-(L)1/CTLA-4 dual antibodies, announced PD-L1/CTLA-4 in the form of a poster at the 2021 American Society of Clinical Oncology (ASCO2021) annual meeting Multiple clinical data of bispecific antibody KN046. In advanced non-small cell lung cancer, the ORR is 51% and the mPFS is 5.9 months, showing good results; in the first-line treatment of unresectable locally advanced recurrent/metastatic ESCC phase II trials, it is safe and tolerable and has outstanding efficacy. It is one of the potential options for the first-line treatment of this indication; and the PD-L1/CTLA-4 double antibody KN046 combined with the AG regimen achieved an objective response rate of 55.6% in patients with advanced pancreatic ductal adenocarcinoma, which is compared with the history of AG regimen chemotherapy ORR has more than doubled...
Corning Jerry KN046 related clinical trial data
20 items related to KN046 clinical trials in different stages
KN046 is designed for the two proven immuno-oncology targets of PD-L1 and CTLA-4. It is the world’s first recombinant humanized PD-L1/CTLA-4 bispecific antibody independently developed by Corning Jereh. The single drug targets two important immune regulation targets at the same time, and relieves the inhibition of tumor-specific lymphocytes at two different levels of immune regulation, thereby more effectively activating T cells and enhancing immune anti-tumor ability.
PD-L1/CTLA-4 mechanism of action
Image source: Corning Jerry's official website
According to Corning Jerry’s official website, KN046 has carried out nearly 20 clinical trials at different stages covering more than 10 types of tumors including non-small cell lung cancer, triple negative breast cancer, esophageal squamous cell carcinoma, liver cancer, and pancreatic cancer in Australia and China. The test results show that Good safety and effectiveness. Based on the clinical trial results obtained in Australia and China, the US FDA approved KN046 to directly enter Phase II clinical trials in the United States. KN046 has been granted orphan drug qualification for the treatment of thymic epithelial tumors. Currently, a phase III clinical trial aimed at evaluating the efficacy and safety of KN046 combined with platinum-containing chemotherapy in patients with locally advanced unresectable or metastatic squamous non-small cell lung cancer has been launched in China.
KN046 global clinical progress in research details
Image source: Corning Jerry's official website
It is worth mentioning that the results of preclinical and clinical trials of KN046 showed good curative effects and showed that it can significantly reduce the possible toxic and side effects on the human peripheral system. Corning Jerry believes that KN046 is expected to become a breakthrough tumor immune drug. According to the Industrial Securities Research Report, KN046 is expected to submit an initial listing application in the first half of 2022.
The clinical data of PD-(L)1 double antibody drugs attract attention
According to Southwest Securities, at this ASCO conference, not only Corning Jerry's PD-(L)1/CTLA-4 double antibody released the latest clinical data, many domestic companies have announced their PD-(L)1 at the ASCO conference. Clinical data of double antibodies. Among them, CTLA-4 has the largest number of clinical projects from the perspective of the targets that partner with PD-(L)1 double antibodies.
Domestic PD-(L)1 double anti-drug related clinical trials
Kangfang Bio's AK104 is the same as Kangning Jerry, and its PD-1/CTLA-4 dual anti-drugs. In addition, the latest clinical research data was also published on ASCO this time. According to the official news of Kangfang Bio, Kangfang Bio Cadonilimab (AK104) was included in a phase II clinical trial of combined lenvatinib in the first-line treatment of unresectable liver cancer. The group of patients was planned to receive high and low doses of Cadonilimab, respectively. Among the 18 patients in the low-dose group with evaluable efficacy, the ORR reached 44.4%. Cadonilimab showed good anti-tumor activity. The incidence of TRAE above grade 3 was 26.7%. The drug toxicity is controllable. The PD-(L)1/CTLA-4 double antibody is expected to improve the limitation of ipilimumab's high toxicity and narrow therapeutic window when combined with PD-1 monoclonal antibody by virtue of its mechanism advantages, so as to achieve better curative effects.
A hundred flowers bloom in domestic double antibody research and development
Nearly 50 research projects
Dual antibody drugs are an important direction for the development of antibody drugs. At present, only 3 dual antibody drugs have been approved for marketing in the world, namely Trion/Neovii's Removab, Roche/Chukai's Hemlibra, and Amgen/AstraZeneca's Blincyto. Among them, Hemlibra has been approved for listing in China and is currently the only dual antibody approved in China. In fact, in recent years, domestic companies have successively stepped into the research and development of dual-antibody-specific antibodies. According to incomplete statistics, there are currently about 50 dual-antibody drugs in the clinical stage in China, and most of them are in the clinical phase 1 research stage. Jereh and Kangfang are currently the companies with the fastest progress in double antibody research, and both have entered clinical phase III.
Overview of the development progress of domestic double-antibody drugs
Data source: Yaozhi data
Judging from the current development trend of double antibodies, the development of bispecific antibodies in my country has gradually entered the deep water area, and the process of industrialization will accelerate, especially from the clinical data of ASCO’s domestic PD-(L)1 double antibodies. The PD-(L)1/CTLA-4 double antibody of Kangning Jereh and Kangfang Biology has obtained excellent data in a number of phase II clinical trials. In the future, it is expected to further broaden and deepen the indications of immunotherapy by virtue of its mechanism advantages. At the same time, the era of domestic dual resistance is about to begin.
Sources of news and data: public information such as Corning Jereh’s corporate announcement, Yaozhi data, and Yuekai Securities.
Editor in charge: Sanqi
