On August 24, 2021 Alphamab Oncology (stock code: 9966 HK) reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab" or "the Company"), a wholly-owned subsidiary of Alphamab Oncology, signed a contract with JMT-Bio, a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), for the development and commercialization of the company’s proprietary anti-HER2 bispecific antibody KN026 in Mainland China (Press release, Alphamab, AUG 24, 2021, View Source [SID1234586905]). The totaldeal size reaches 1 billion RMB, and the Company will receive a double-digit royalty based on sales revenue.
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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), and bear the cost of all planed clinical trials in territory; In addition, JMT-Bio will devote joint efforts with Alphamab to develop more potential indications of KN026 single agent or combo treatment in other solid tumors . Alphamab Oncology will receive 150 million RMB upfront payment, with up to 850 million RMB development and sales milestone payments, and will receive a double-digit royalty based on sales revenue.
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). It can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated equivalent efficacy compared with the combination of Trastuzumab and Pertuzumab and was superior to either single agent in HER2-positive tumor cell lines. Data from several clinical studies have shown that in patients with HER2-positive GC/GEJ or breast cancer, even after first-line or multi-line treatment, KN026 still demonstrated positive data, especially for patients with GC/GEJ.
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.