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Alphamab Oncology Initiates the US Phase I Clinical Trial for KN026

June 26, 2019 18:00 Eastern Daylight Time

SUZHOU, China, June 26, 2019 - Alphamb Oncology announced that KNO26, an anti-HER2 bispecific antibody independently developed by the company, has entered phase I clinical trial in the United States and completed dosing of the first patient, marking an important step forward in global development.


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. In pre-clinical studies, KN026 has demonstrated potentially equivalent or superior efficacy compared with Trastuzumab and Pertuzumab alone or 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 will be developed for multiple solid tumors with HER2 expression in multiple clinical trials to be conducted in China and the United States.


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. Moreover, KN026 has entered phase II clinical trial in China for gastric cancer patients with HER2 over-expressing and medium or low expressing tumor cells.


The US phase I clinical trial is an open-label, dose-escalation and cohort-expansion study designed to evaluate the safety and tolerability of KN026 in patients with advanced solid tumors with HER2 over-expression and medium or low expression to determine the maximum tolerated dose and the recommended dose for phase II trials. The trial is led by Dr. W. Jeffrey Edenfield from Greenville Hospital System as the leading principal investigator. Five clinical sites participate in the study, including Greenville Hospital System, Mary Crowley Cancer Research, the University of Toledo Medical Center, Indiana University Melvin and Bren Simon Cancer Center, and Karmanos Cancer Institute. The trial has been recently launched at the University of Toledo Medical Center and Mary Crowley Cancer Research.


Dr. Nemunaitis, as the Principal Investigator of the University of Toledo Medical Center says: “KN026 is an exciting precision therapeutic discovery explained in early phase clinical trial involving HER2 expression cancer. It is a bispecific antibody with both ligand dependent and independent mechanisms of anti-cancer activity. As a result, it reveals not only significant activity in HER2 high positive cancer but also downstream effect in low positive HER2 expression cancer. A population of patients are in huge need for this new targeted treatment. We are excited to be working with Alphamab as their first site in the USA for open phase I trial of KN026.” 


Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology, commented: “It is the persistent pursuit of Alphamab Oncology to develop next-generation multi-functional biologics therapy for cancer treatment globally and to improve the quality of patients’ lives. The initiation of the US clinical trial for KN026, one of the company’s key products, has demonstrated the growing global development capabilities of Alphamab Oncology. We hope to work with the US oncology experts to advance the follow-up clinical studies and explore the efficacy and therapy mode of KN026 so as to benefit more patients as soon as possible.”

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