April 29, 2021/PRNewswire/--Corning Jereh Biopharmaceuticals announced that it has reached a clinical trial and drug supply cooperation with Pfizer to evaluate the combination of KN046 and Inlead® (axitinib) for first-line use The effectiveness and safety of the treatment of non-small cell lung cancer (NSCLC). Lung cancer is one of the most threatening malignant tumors to human health and life. In the past 50 years, many countries have reported that the incidence and mortality of lung cancer have increased significantly. National cancer statistics released by the National Cancer Center show that the incidence and mortality of lung cancer account for 20.03% and 26.99% of all malignant tumors, respectively. Non-small cell lung cancer is the most common type of lung cancer, accounting for 84% of all diagnosed lung cancer cases, and the 5-year overall survival rate is only 24%, ranging from 61% for localized non-small cell lung cancer to 6% for metastatic non-small cell lung cancer. Wait. Although based on experience, platinum-containing dual chemotherapy is still the gold standard for the treatment of advanced NSCLC without genetic mutations, but there is still a huge unmet clinical need. A variety of different concepts in clinical treatment work synergistically, and more and more updated treatment methods and combinations are constantly being explored to improve the prognosis and quality of life of patients.
KN046 is a bispecific antibody that targets both PD-L1 and CTLA-4 immune checkpoints. It can more effectively activate T cells and enhance immune anti-tumor ability. KN046 Phase II clinical study data for advanced non-small cell lung cancer showed good tolerability and safety, as well as the advantages of PFS and OS. Based on the results of this trial, a phase III clinical trial (ENREACH-LUNG-01) has been launched and will explore new standard first-line treatments for lung cancer. In March 2020, Corning Jereh announced a clinical cooperation with Pfizer to advance the trial of the combination of KN026 (anti-HER2 bispecific antibody) and Aiboxin® (pibacillil), and successfully obtained clinical approval in December. In April 2021, Corning Jereh and Pfizer once again joined hands to jointly sign a clinical supply agreement to promote KN046 and a new generation of tyrosine kinase inhibitor (TKI) Inrida® (axitinib) combined drug trial.
The combination drug will first carry out a multi-center, open-label Phase II clinical study to evaluate the effectiveness, safety and tolerability of KN046 combined with axitinib in the treatment of patients with advanced non-small cell lung cancer. Professor Zhang Li from Sun Yat-sen University Cancer Hospital served as the main investigator. The main endpoint of the study was the objective response rate. The trial, as a potential chemotherapy-free regimen, will bring new hope to patients with advanced non-small cell lung cancer.
Dr. Xu Ting, Chairman and President of Corning Jerry, said: “KN046 is the world’s leading PD-L1/CTLA-4 bispecific antibody. We strive to quickly promote its clinical development and marketing layout. At the same time, we are very happy to cooperate with Pfizer. The company once again cooperates. Their deep accumulation in the field of cancer and expertise in drug development will help us fully develop the potential of KN046 for the treatment of patients with advanced lung cancer. It is hoped that this cooperation will produce a new therapeutic combination to solve The unmet clinical needs in this field serve patients worldwide."
About KN046
KN046 is a PD-L1/CTLA-4 bispecific antibody independently developed by Corning Jereh. Its innovative design includes the fusion of CTLA-4 and PD-L1 single domain antibodies with different mechanisms; it can be targeted and enriched in PD- The tumor microenvironment with high expression of L1 and the elimination of Tregs that inhibit tumor immunity. KN046 has carried out nearly 20 clinical trials in different stages covering more than 10 types of tumors such as non-small cell lung cancer, triple negative breast cancer, esophageal squamous cell carcinoma, liver cancer, and pancreatic cancer in Australia and China. The results of the trials show that patients have the advantage of survival benefit. . 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, and granted KN046 the orphan drug designation for the treatment of thymic epithelial tumors in September 2020. Four key registered clinical trials of KN046 are currently in progress.
About Corning Jerry
Corning Jereh Biopharmaceuticals focuses on the research and development, production and commercialization of innovative anti-tumor drugs. On December 12, 2019, the company was listed on the main board of the Hong Kong Stock Exchange, stock code: 9966. Corning Jereh Biopharmaceuticals has a discovery, R&D, and manufacturing platform for the entire industry chain in bispecific antibody and protein engineering. The company's product pipeline includes 15 highly differentiated anti-tumor drug candidates with independent intellectual property rights, mainly double antibodies, and a Covid-19 multifunctional antibody, four of which are in China, the United States, Japan, and Australia In phase I-III clinical. The marketing application of Envolimab Injection (KN035) has been formally accepted by the National Medical Products Administration (NMPA) and included in the priority review.
The company has a number of technical platforms with independent intellectual property rights such as heterodimers and hybrid antibodies, and large-scale production capabilities that meet the cGMP standards of China, the United States and the European Union, and have passed a complete quality system including multiple audits of the European Union QP. . The company is committed to building an internationally leading, multi-dimensional drug development and industrialization platform, focusing on multifunctional biomacromolecule new drugs, benefiting patients in China and around the world.
Source: Corning Jerry
