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Alphamab Oncology Initiated KN026 Phase II Clinical Trial

June 06, 2019 17:00 Eastern Daylight Time

SUZHOU, China, June 6, 2019 – Alphamab Oncology announced that KN026, an anti-HER2 bispecific antibody independently developed by the company, has entered phase II clinical trial in patients with advanced gastric or gastroesophageal junction carcinomas in China.


KN026 is an anti-HER2 Fc-based heterodimer bispecific antibody which can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated equivalent or superior efficacy compared with Trastuzumab and Pertuzumab alone or in combination, such as increased binding affinity, as well as better efficacy in tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 also shown inhibitory effect on tumor cells with low HER2 expression or Trastuzumab-resistant cell lines.


At present, the phase I dose-escalating clinical trial of KN026 conducted in China is approaching completion, and the preliminary results have shown good safety and preliminary efficacy. Additionally, KN026 is entering clinical trials in the United States.


The phase II clinical trial aims to evaluate the safety, efficacy and tolerability of KN026 in patients with advanced gastric or gastroesophageal junction carcinomas with HER2 overexpression and medium or low expression. This trial is led by Professor Jianming Xu from the Fifth Medical Center of PLA General Hospital as the leading principle investigator. Eight clinical sites participate in the study, including the Oncology Hospital Affiliated to Harbin Medical University, the First Affiliated Hospital of Zhengzhou University, Zhejiang Oncology Hospital, the First Affiliated Hospital of Medical School of Zhejiang University, the First Affiliated Hospital of Nanchang University and the First People’s Hospital of Changzhou.


Professor Jianming Xu, director of the Gastrointestinal Cancer Center in the Fifth Medical Center of PLA General Hospital, said: “Our study center has extensive experience in conducting clinical trials. We are  confident about this phase II clinical study, and we are looking forward to further exploring KN026 to bring more effective treatment options to patients with advanced gastric or gastroesophageal junction carcinomas.” 


Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology, commented: “We will spare no efforts to advance the clinical development of KN026, and explore the therapeutic potential of KN026 in tumors with different levels of HER2 expression. This phase II clinical trial in patients with advanced gastric or gastroesophageal junction carcinomas will expand a new patient population for KN026. We are looking forward to seeing patients to benefit from KN026.”


About Alphamab Oncology

Alphamab Oncology is a leading biopharmaceutical company in China dedicated to the development of innovative biologics for cancer therapy globally. Thus far, four drug candidates in Alphamab Oncology's pipeline have advanced into clinical development phase. With multiple in-house proprietary platforms for innovative biopharmaceuticals, Alphamab Oncology has built a robust pipeline in oncology and immunology to benefit cancer patients around the world. 

Please feel free to visit the official website: http://www.alphamabonc.com 


Contacts:
Alphamab Oncology
Fengzhang Guan, +86-512-62850800 Extension 8807
fengzhangguan@alphamabonc.com