Research & Development
Alphamab Oncology announces US FDA approval for cancer therapy KN026
17 October 2018 -

Biopharmaceutical company Alphamab Oncology revealed on Tuesday the receipt of US FDA IND approval for its proprietary HER2 bispecific antibody (KN026) in anticipation of clinical development in the US.

Following the prior IND approval for KN026 in China, the company has initiated the phase I clinical trial in the country and the trial is going well as expected.

The company will study KN026 in multiple clinical trials in patients with breast cancer, gastric cancer and lung cancer with HER2 overexpression. It is expected to offer cancer patients a new and potentially improved therapeutic option.

In addition,the company's anti-HER2 heterodimeric antibody KN026 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 that has been validated by multiple large-scale (up to 1,000 liters) batches.

According to the company, KN026 has demonstrated and shown better efficacy activity in about 40% of HER2+ tumour cell lines and multiple in vivo tumour models, as compared to the combo of Trastuzumab and Pertuzumab. Currently the global annual sales of Trastuzumab and Pertuzumab is about USD10bn.