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Alphamab’s recombinant HER2 bispecific antibody approved for clinical test

time:04/27/2018 page views: resource:BioBAY

Bispecific antibody is an artificial antibody containing two specific antigen binding sites and can identify and bind two different antigens. It is therefore able to bind immune cells, and virus molecules among others with tumor cells to enhance the killing effect of target cells. Meanwhile, it can also bind different antigens on the same tumor cell to enhance its binding specificity and thereby reducing off-target toxicity and other side effects. This recombinant antibody with dual functions has better curative effect than the monoclonal antibody. Due to difficulties in process scale-up and druggability, there are only two bispecific antibodies available in the market.

The recombinant HER2 bispecific antibody injection (KN026) developed by Alphamab Co. Ltd. (Alphamab) was recently approved by China Food and Drug Administration (CFDA) for clinical test. 

Alphamab developed KN026 with global independent intellectual property rights by using the proprietary Fc based bispecific platform (CRIB) and common light chain. This antibody retains complete Fc functions and can efficiently identify two different HER2 epitopes. Compared with Roche’s Herceptin + Perjeta, the pre-clinical pharmacodynamic studies indicate that KN026 has better or equivalent efficacy, and has inhibitory effect to the HER2 low expression and Herceptin resistant tumor strains, and excellent tumor suppression in the non-clinical studies. KN026 is produced with conventional antibody production technology and boasts the world's leading product yield, purity and quality. The successful development of KN026 will provide new options for patients with HER2-positive tumors. In the near future, an IND application will be submitted in the United States.

Alphamab’s CRIB is a dual-function drug discovery technology with independent property rights. The company plans to develop more dual/multiple function antibody therapies based on this technology.

Dr. Xu, president of Alphamab, said “the progress of bispecific biologics development started in the early 1990s. Due to challenges in product PK and CMC scale-up, only two bispecific antibodies have been marketed globally. Alphamab has developed a cutting-edge CRIB platform and validated it through the development of KN026. We look forward to partnering with pharma/biotech companies on this leading platform.”

About Suzhou Alphamab Co., Ltd.

Founded in 2009, Alphamab has established a more than 6000m2 R&D center in BioBay and post-doctoral stations. Since its founding, the company has created several biomacromolecule drug development platforms, including antibody screening, bispecific and antibody screening as well as bispecific and mixed antibodies, and is able to complete the whole process from antibody/protein drug screening and engineering, efficacy evaluation, cell strain structuring to small-scale test process, pilot scale-up and analysis and quality control. It has several cGMP pilot production lines and aseptic filling workshops. The company has more than a dozen new biomacromolecule drugs under development, with nine of them having been submitted for clinical test applications, four under the clinical study (one under international multi-center development). Alphamab’s Jiangsu production base is under construction, and strives to provide patients with more efficient and quality therapies in the near future.