Alphamab Oncology Announces Phase II Clinical Trial of KN046 (PD-L1/CTLA-4 Bispecific Antibody) in Combination with Pfizer’s INLYTA® (axitinib) for First-Line Treatment of Advanced NSCLC

Suzhou, April 29, 2021 /PRNewswire/ -- Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (stock code: 9966.HK) announced that it has entered into a clinical trial and drug supply collaboration with Pfizer Inc. to evaluate KN046 and Inlyta^®(Axitinib) in Combination Therapy: Efficacy and Safety for First-Line Treatment of Non-Small Cell Lung Cancer (NSCLC).

Lung cancer is one of the malignant tumors posing the greatest threat to human health and life. Over the past 50 years, many countries have reported significant increases in both the incidence and mortality rates of lung cancer. According to national cancer statistics released by the National Cancer Center, the incidence and mortality rates of lung cancer account for 20.03% and 26.99%, respectively, of all malignant tumors. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, representing 84% of all diagnosed cases. The overall 5-year survival rate is only 24%, ranging from 61% for localized NSCLC to 6% for metastatic NSCLC.

Although platinum-based doublet chemotherapy remains the gold standard for treating advanced NSCLC without gene mutations based on clinical experience, there is still a significant unmet clinical need. In clinical practice, various therapeutic concepts work synergistically to continuously explore newer treatment modalities and combinations, aiming to improve patient prognosis and quality of life.

KN046 is a bispecific antibody that simultaneously targets the PD-L1 and CTLA-4 immune checkpoints, enabling more effective activation of T cells and enhancing anti-tumor immunity. KN046 for advanced non-small cell lung cancerPhase IIClinical study data demonstrated favorable tolerability and safety, as well as advantages in PFS and OS. Based on these trial results,Phase IIIThe ENREACH-LUNG-01 clinical trial has been initiated and will explore new first-line standard therapies for lung cancer. In March 2020, Jiangsu Alphamab Biopharmaceuticals Co., Ltd. announced a clinical collaboration with Pfizer to advance KN026 (an anti-HER2 bispecific antibody) and Ibrance^® (Palbociclib) combination therapy trial, with clinical trial approval successfully obtained in December. In April 2021, Jiangsu Alphamab Biopharmaceuticals Co., Ltd. and Pfizer, Inc. once again joined hands to jointly sign a clinical supply agreement, advancing the development of KN046 in combination with the next-generation tyrosine kinase inhibitor (TKI) Inlyta.^®(Axitinib) Combination Therapy Trial.

This combination therapy will first initiate a multicenter, open-labelPhase IIClinical Study to Evaluate the Efficacy, Safety, and Tolerability of KN046 in Combination with Axitinib for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer. Professor Zhang Li from Sun Yat-sen University Cancer Center serves as the principal investigator, with the primary endpoint being the objective response rate. As a potential chemotherapy-free regimen, this trial will bring new hope to patients with advanced non-small cell lung cancer.

Dr. Xu Ting, Chairman and President of Jiangsu Alphamab Biopharmaceuticals Co., Ltd., stated, “KN046 is a globally leading PD-L1/CTLA-4 bispecific antibody. We are committed to accelerating its clinical development and market launch strategy. Meanwhile, we are delighted to renew our collaboration with Pfizer. Their extensive expertise in oncology and drug development will help us fully realize the potential of KN046 for treating patients with advanced lung cancer. We hope this partnership will yield a novel therapeutic combination to address unmet clinical needs in this field and benefit patients worldwide.”

About KN046

KN046 is a PD-L1/CTLA-4 bispecific antibody independently developed by Alphamab Oncology. Its innovative design features the fusion of single-domain antibodies targeting CTLA-4 and PD-L1, which operate via distinct mechanisms. This construct enables targeted enrichment in the tumor microenvironment with high PD-L1 expression and facilitates the depletion of regulatory T cells (Tregs) that suppress anti-tumor immunity.

KN046 has undergone nearly 20 clinical trials at various stages in Australia and China, 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. The trial results have demonstrated a survival benefit for patients. Based on the clinical trial outcomes achieved in Australia and China, the U.S. FDA approved KN046 to directly enter Phase II clinical trials in the United States and granted orphan drug designation to KN046 for the treatment of thymic epithelial tumors in September 2020. Currently, four key registrational clinical trials of KN046 are ongoing.

About Alphamab

Alphamab Oncology focuses on the research and development, manufacturing, 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, with stock code: 9966.

Jiangsu Alphamab Biopharmaceuticals Co., Ltd. possesses a full-industry-chain platform for the discovery, research and development, and manufacturing of bispecific antibodies and protein engineering. The company’s product pipeline includes 15 highly differentiated, independently intellectual property-owned anti-tumor candidate drugs, primarily bispecific antibodies, and one multi-functional antibody for COVID-19, among which four products are inStages I–IIIClinical. The marketing application for Envafolimab Injection (KN035) has been officially accepted by the National Medical Products Administration (NMPA) and included in the priority review program.

The Company possesses multiple proprietary technology platforms, including those for bispecific heterodimers and mixed antibodies, along with large-scale manufacturing capabilities compliant with Chinese, U.S., and EU cGMP standards. It has established a comprehensive quality system that has successfully undergone multiple audits, including those by the EU Qualified Person (QP). The Company is committed to building an internationally leading, multidimensional platform for drug development and industrialization, focusing on novel multifunctional biologic drugs to benefit patients in China and worldwide.

Welcome to visit the company website:www.alphamabonc.com