English 中文简体 中文繁体

Alphamab Oncology's HER2 bispecific antibody KN026 gained US IND approval; phase I clinical trial started in China

October 16, 2018 16:00 Eastern Daylight Time

SUZHOU, China, Oct. 16, 2018 /PRNewswire/ -- Alphamab Oncology announced that it has received US FDA's IND approval for its proprietary HER2 bispecific antibody (product code: KN026), and KN026 is anticipated to enter clinical development later in the US.  With the earlier IND approval for KN026 in China, Alphamab Oncology has recently initiated the phase I clinical trial there, and the trial is going well as expected.


Based on the company's proprietary Fc-based bispecific platform (CRIB), Alphamab Oncology developed anti-HER2 heterodimeric antibody KN026, which has the same format of natural IgG antibody. KN026 binds to two separate epitopes on HER2.  KN026 is manufactured through a robust conventional antibody production process. The process has been validated by multiple large-scale (up to 1,000 liters) batches.


KN026 has demonstrated an excellent pre-clinical profile in binding affinity, efficacy, safety, and pharmacokinetics. It showed better efficacy in about 40% of HER2+ tumor cell lines and multiple in vivo tumor models, as compared to the combo of Trastuzumab and Pertuzumab. KN026 is expected to offer cancer patients a new and potentially improved therapeutic option. Currently the global annual sales of Trastuzumab and Pertuzumab is about $10 billion.


"We are very pleased with the FDA's IND approval for KN026, and it shows the agency's initial recognition for the quality of this innovative bispecific biologics. It also represents the first US IND approval for a bispecific antibody discovered and developed by China-based biotech or pharmaceutical companies," said Dr. Ting Xu, Chairman of the Board and CEO of Alphamab Oncology. "With the world-class bispecific platform at Alphamab Oncology, we also look forward to partnering with pharma/biotech companies worldwide to develop more innovative therapeutics."


Alphamab Oncology has been collaborating with leading oncologists and will study KN026 in multiple clinical trials for patients of breast cancer, gastric cancer, and lung cancer with HER2 overexpression.


About Alphamab Oncology

Alphamab Oncology is a clinical-stage biopharmaceutical company dedicated to the discovery, development, manufacturing and commercialization of world-class innovative therapeutics for cancer treatment. With multiple in-house proprietary platforms, including bispecifics, protein engineering and antibody screening, Alphamab Oncology has built a robust pipeline in oncology/immunology. We strive to develop next-generation or best-in-class medicines to address global unmet medical needs.

Visit http://www.alphamabonc.com for more information.


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