Suzhou, August 10, 2023 - Alphamab Oncology (stock code: 9966.HK) announced that posters to highlight the company's core pipeline products, PD-L1/CTLA-4 bispecific antibody KN046 and HER2 bispecific antibody KN026, will be announced at the 2023 European Society for Medical Oncology (ESMO) Congress.
KN046
KN046, a BsAb immune checkpoint inhibitor simultaneously targeting two clinically-validated immune checkpoints, PD-L1 and CTLA-4, representing a potential breakthrough, next-generation immuno-oncology blockbuster drug. Currently, there are approximately 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, TNBC, ESCC, HCC, PDAC and Thymic carcinoma in China, the United States and Australia. The results of these clinical trials have demonstrated a preliminary profile of good safety and promising efficacy of KN046.The ESMO Conference will present four clinical research results of KN046.
Title: Preliminary efficacy and safety of KN046 (a bispecific anti-PD-L1/CTLA-4) in patients with metastatic non-small cell lung cancer who previously treated with immune checkpoint inhibitor(s)
Abstract Number: 2155
Poster ID: 1459P
Corresponding Author：Prof. Caicun Zhou, Shanghai Pulmonary Hospital
First author: Prof. Caicun Zhou, Shanghai Pulmonary Hospital
Title: Updated results of the efficacy and safety of KN046 (a bispecific anti-PD-L1/CTLA-4) in patients with metastatic non-small cell lung cancer (NSCLC) who failed prior EGFR-TKI(s)
Abstract Number: 2230
Poster ID: 1330P
Corresponding Author：Prof. Caicun Zhou, Shanghai Pulmonary Hospital
First author: Prof. Caicun Zhou, Shanghai Pulmonary Hospital
Title:The preliminary data from a single-arm, open-label, multicenter phase 2 clinical trial：KN046 combined with axitinib as first-line (1L) treatment for NSCLC
Abstract Number: 3226
Poster ID: 1449P
Corresponding Author：Prof. Li Zhang, Sun Yat-Sen University Cancer Center
First author: Prof. Yuanyuan Zhao, Sun Yat-Sen University Cancer Center
Title:KN046 in Patients with Thymic Carcinoma: a prospective, single-arm, multi-center, phase 2 study
Abstract Number: 5843
Poster ID: 1449P
Corresponding Author：Prof. Xiaolong Fu, Shanghai Chest Hospital
First author: Prof. Wentao Fang, Shanghai Chest Hospital
KN026
KN026 is an anti-HER2 bispecific antibody that can bind two non-overlapping epitopes of HER2 simultaneously, leading to potentially superior efficacy. KN026 has superior anti-tumor activity and good safety than the combination of trastuzumab and pertuzumab, and is currently undergoing a number of clinical trials in different stages in China and the United States. The ESMO Conference will present two clinical research results of KN026.
Title: Two-year follow-up data on the efficacy and safety of KN026, a HER2-targeted bispecific antibody combined with docetaxel as first-line treatment for HER2-positive recurrent /metastatic breast cancer
Abstract Number: 3575
Poster ID: 418P
Corresponding Author：Prof. Qingyuan Zhang, Harbin Medical University Cancer Hospital
First author: Prof. Qingyuan Zhang, Harbin Medical University Cancer Hospital
Title: KN026 in combination with docetaxel as neoadjuvant treatment for HER2+ early or locally advanced breast cancer (BC): A single arm, multicenter, phase 2 study
Abstract Number: 1300
Poster ID: 247P
Corresponding Author：Prof. Jiong Wu, Fudan University Shanghai Cancer Center
First author: Dr. Linxiaoxi Ma, Fudan University Shanghai Cancer Center
About KN046
KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a novel mechanism - CTLA-4 fused with PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg (suppress tumor immunity) clearing function.
There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, pancreatic cancer, thymic cancer, HCC, ESCC and TNBC in Australia, the US and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab Oncology has received FDA clearance to enter phase II trial of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA's orphan drug designation for thymic epithelial tumor in September 2020. Several pivotal clinical trials are currently being conducted, among which the interim analysis of the phase III clinical study of KN046 combined with chemotherapy as the first-line treatment of NSCLC successfully met the prespecified PFS endpoint.
About KN026
KN026 is an anti-HER2 bispecific antibody that 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.
Alphamba already initiated multiple clinical trials for KN026 in China and the United States. KN026 showed good efficacy and safety profiles, even in heavily pretreated patients with HER2-positive breast cancer and gastric cancer. Currently, several phase III pivotal studies of KN026 are ongoing for patients with breast cancer, or gastric cancer/gastroesophageal junction cancer, etc.
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 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.
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.
We have created a biological macromolecule drug discovery, research and development, manufactured technology platform with independent intellectual property rights such as protein/antibody engineering, antibody screening, multi-module/multi-functional antibody modification.
With multiple in-house proprietary technology platforms, Alphamab Oncology has established a globally competitive and differentiated pipeline which consists of tumor single domain antibody/monoclonal antibodies, multi-functional antibodies, and antibody-drug conjugates. Among them, The world's first subcutaneous PD-L1 inhibitor injection (Envafolimab) has been obtained the market approval by the Chinese National Medical Products Administration, several varieties have entered the critical clinical stage in China and the United States, 2 varieties were selected into the national special project of " New Drug Development", and 3 varieties were granted 4 orphan drug qualifications by FDA.
Alphamab Oncology Forward-Looking Statements
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