Abnova has successfully identified four mouse neutralizing antibodies to SARS-CoV-2 through a series of antibody generation, selection, and validation. To improve the similarity to natural human antibodies, Leadgene Biomedical Inc. will further proceed with antibody humanization and analyze the pharmacokinetics within the following two months. Afterward, Abnova will examine the neutralizing activity of the potential antibody candidates in a BSL-3 laboratory.

Leadgene Biomedical is a company that possesses both research expertise and manufacturing capacity. Leadgene Biomedical is dedicated to generating and engineering antibodies and cytokines for IVD and is experienced in antibody humanization. There are several steps to develop human monoclonal antibodies from non-human species. First, the CDR regions (complementarity-determining regions) are inserted into a human antibody acceptor. The next step is to graft the SDRs (specificity determining residues) upon the human frameworks to the humanized antibody for minimizing the anti-V region responses.

The Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of remdesivir to treat patients with COVID-19 on 1ST May 2020. Besides anti-viral drugs like remdesivir, therapeutic antibodies help patients form severe infections in an efficient way. Now Abnova has identified four promising antibodies, and Leadgene Biomedical Inc. will further perform antibody humanization. Together Biomedical Inc. and Abnova will develop the therapeutic antibody for COVID-19 and then initiate the out-license agreement, GMP manufacturing, and EUA designated clinical trial.



Related information
Abnova: http://www.abnova.com/aboutus/news_detail.asp?CTID={A8F0A11B-00AC-4BC4-BC86-12D9161A0A08}
FDA: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19