English 中文简体 中文繁体

IND Application for Phase Ⅲ Registration Study of KN026 in Combination with Chemotherapy for the First-line Treatment of Breast Cancer Was Approved by CDE

May 09, 2023 09:20 Eastern Daylight Time

Suzhou, May 9, 2023- Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. jointly announced that the IND application was approved in China for the pivotal trial of the anti-HER2 bispecific antibody KN026 combined with Docetaxel (albumin-binding), in the first-line HER2 positive recurrent metastatic breast cancer.


The study is a randomized, controlled, open, multicenter Phase III study to evaluate the efficacy and safety of KN026 in combination with albumin-binding docetaxel versus trastuzumab in combination with pertuzumab and docetaxel in first-line treatment of HER2-positive metastatic breast cancer. The trial plans to enroll 880 patients with PFS assessed by IRC as primary endpoint.


Breast cancer is the most prevalent and deadly cancer among women worldwide. According to the World Health Organization’s report, a new case of breast cancer is diagnosed every 1.8 seconds. In China, the incidence of breast cancer has been rising year by year, resulting in 0.42 million new cases and 0.12 million deaths in 2020. Although medical advancements have significantly improved the survival of patients with early breast cancer, HER2-positive breast cancer remains a highly aggressive and heterogeneous subtype that requires new therapeutic strategies to continuously improve patient outcomes.


KN026 is a HER2 bispecific antibody developed by Alphamab Oncology, it has good tolerance and safety, and has shown significant antitumor activity against HER2-positive breast cancer in a number of clinical studies. An efficacy and safety results of KN026, a HER2-targeted bispecific antibody combined with docetaxel in first-line treatment of HER2-positive recurrent/metastatic breast cancer was published at SABCS in 2022, with an objective response rate (ORR) of 76.4%, median duration of response (mDoR) of 24.0 months, and disease control rate (DCR) of 100%. We will further explore the efficacy and safety of KN026 in combination with docetaxel through this registered clinical trial, in the hope of bringing more effective treatment options to patients with HER2-positive breast cancer.


About KN026

KN026 is an anti-HER2 bispecific antibody invented by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. KN026 has demonstrated potentially superior efficacy to Trastuzumab and Pertuzumab in combination, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines.


KN026 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple clinical trials in China and the United States, for patients with breast cancer, or gastric cancer/gastroesophageal junction cancer, etc. Two phase III pivotal studies of KN026 combined with chemotherapy and the chemo-free regimen of KN026/KN046 combo for the treatment of gastric cancer are ongoing. The results of prior clinical studies showed that KN026 has good efficacy and safety profiles, even in heavily pretreated patients with HER2-positive breast cancer.


In August 2021, the company entered an agreement with JMT-Bio, a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China. According to the terms of the agreement, JMT-Bio will obtain the exclusive license rights of KN026 for the development and commercialization in the indications of breast cancer and gastric or gastroesophageal junction cancers (GC/GEJ) in Mainland China (excluding Hong Kong, Macau and Taiwan).


About Alphamab Oncology

Alphamab Oncology is a leading biopharmaceutical company dedicated to the discovery, development manufacturing and commercialization of world-class innovative biotherapeutics for cancer treatment. On December 12, 2019, Alphamab Oncology was listed on the Main Board of Hong Kong Stock Exchange, with the stock code:9966.


We have converged a professional R&D team led by top scientists, and have a complete industrial chain from early research and development of innovative drugs, process development, commercial production to clinical research.


With multiple in-house proprietary platforms of bispecifics, protein engineering and antibody screening, Alphamab Oncology has established a globally competitive and differentiated pipeline which consists of tumor monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Among them, 2 varieties were selected into the national special project of " New Drug Development", and 3 varieties were granted 4 orphan drug qualifications by FDA. The world's first subcutaneous PD-L1 inhibitor injection (Envafolimab) has been obtained the market approval by the Chinese National Medical Products Administration. More than 30 clinical studies have been carried out in 6 varieties in China, the United States and Australia, among which 8 studies of 3 varieties have entered the critical clinical stage in China and the United States.


To make cancer manageable and curable,Alphamab Oncology has always been guided by clinical value and patient needs, and focuses on the development of innovative, safe and affordable anti-tumor drugs to benefit patients in China and around the world.


Alphamab Oncology Forward-Looking Statements

This press release contains statements related to our future business, financial performance and future events involving Alphamab Oncology that may constitute forward-looking statements. These statements include projections and estimates and relevant assumptions, statements regarding plans and expectations and statements regarding future activities, operations and performance. These statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," or words of similar meaning. Such statements are based on the certain assumptions of Alphamab Oncology’s management and business operations, which are subject to various risks and uncertainties, including but not limited to political, economic, legal and business environment. The actual results, performance or achievements of Alphamab Oncology may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statements. Unless otherwise required by applicable laws, Alphamab Oncology does not undertake obligation to publicly update any forward-looking statement nor liability for the failure to materialize such forward-looking statements, whether because of new information, future events or otherwise.