Suzhou, March 9, 2022 - Alphamab Oncology (stock code: 9966.HK) announced that data from phase II clinical study (KN026-203) of KN026 (HER2 bispecific antibody) combined with KN046 (PD-L1/CTLA-4 bispecific antibody) will be presented by E- poster at the 113th American Association for Cancer Research (AACR 2022) held from April 8-13, 2022.
Founded in 1907, the American Association for Cancer Research (AACR) is one of the largest cancer meetings in the world and widely considered by the global cancer community to be the bellwether that sets the cancer research agenda. It attracts nearly 20,000 professionals from all over the world each year with its spectrum of cancer science and excellent reputation, accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the public understanding of cancer.
Title: Preliminary Safety and Efficacy Results of KN046 in combination with KN026 in Patients with Locally Advanced Unresectable or Metastatic HER2-positive Solid Cancer
First author: Professor Jifang Gong, Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China
Poster launch time: April 8, 2022, 1:00 p.m.ET, U.S. time
HER2 gene amplification or overexpression is common in breast cancer and gastric cancer but has also been seen in other solid tumors, including colorectal cancer, non-small cell lung cancer, gallbladder cancer, renal pelvis cancer, pancreatic cancer, etc. Anti-HER2-targeted therapy combined with chemotherapy improves survival outcomes in metastatic HER2-positive malignancies, while the reports of immunotherapy combined with HER2-targeted therapy are still very limited.
KN026-203 is an open-label, phase II, multi-center clinical study to evaluate the efficacy and safety of KN026 combined with KN046 in the treatment of HER2-positive solid tumors, the primary endpoint is the objective response rate (ORR) assessed by the investigator according to RECIST 1.1.
About KN026
KN026 is an anti-HER2 bispecific antibody developed 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 equivalent efficacy compared with Trastuzumab and Pertuzumab in combination, and was superior to either single agent, 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 phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has good safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.
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, thymic cancer, pancreatic 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.
About Alphamab Oncology
Alphamab Oncology is focusing on innovation, including discovery, development, production and commercialization of anti-tumor drugs. On December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966.
Alphamab has a fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline includes fifteen anticancer monoclonal antibodies and bispecific antibodies and a Covid-19 bispecific antibody. Five products have advanced into phase I-III clinical trials in China, the United States, Japan and Australia and in November 2021, one of these products, the unique PD-L1 antibody for subcutaneous administration, Envafolimab, received marketing authorization from the Chinese National Medical Products Administration (NMPA) for the treatment of previously treated MSI-H/dMMR advanced solid tumors.
The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA’s cGMP standards and a complete quality system which has passed the on-site inspection of a European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in China and around the world.
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