Alphamab Oncology (stock code: 9966.HK), a biopharmaceutical company based in Suzhou, China, announced that it will present updated data from a phase II clinical trial (KN026-203) of KN026 (an anti-HER2 bispecific antibody) in combination with KN046 (a PD-L1/CTLA-4 bispecific antibody) for the treatment of HER2-positive solid tumors. The data will be displayed as a poster at the 2023 American Society of Clinical Oncology (2023 ASCO) Annual Meeting, which will take place from June 2 to June 6 in Chicago.
Title: Efficacy and Safety of KN026 in combination with KN046 in Patients with Locally Advanced Unresectable or Metastatic HER2-positive Other Solid Tumors
Abstract Number: 3621
Presentation Format: Poster
First author: Professor Jifang Gong, Beijing Cancer Hospital
Corresponding Author: Professor Lin Shen, Beijing Cancer Hospital
Poster released time: June 5, 2023, at 08:00-11:00(Central Daylight Time)
KN026-203 is a single-arm, open-label, multicenter, multi-cohort, phase II study to evaluate the efficacy and safety of KN026 in combination with KN046 for HER2-positive solid tumors. Three different cohorts of HER2-positive cancers were in this study, including gastric/gastroesophageal junction cancer(GC/GEJ), breast cancer(BC), and other HER2-positive solid tumors. The primary endpoint is the objective response rate (ORR) assessed by the investigators based on RECIST 1.1 criteria.
The combination therapy of KN026 and KN046 showed promising efficacy for patients with HER2-positive advanced or metastatic solid tumors other than gastric/gastroesophageal junction (GC/GEJ) and breast cancer (BC) who had received at least one prior line of systemic therapy. The initial clinical data of this cohort was presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2022. The updated efficacy and safety results will be displayed at this ASCO Annual Meeting.
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 is in multiple clinical trials in China and the United States, which results showed that KN026 has 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 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. Four 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 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.
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