Abnova Accelerates its COVID-19 Therapeutic Antibody Humanization with Leadgene Biomedical

Neihu, Taiwan (June 11, 2020)

Abnova announced today that it has identified four COVID-19 neutralization antibodies and initiated therapeutic antibody humanization with Leadgene. Abnova’s COVID-19 mouse monoclonal antibodies have been generated, selected, and validated for neutralization activity via receptor-binding assays. In order to expedite and maximize the best outcome, Leadgene will undertake human antibody engineering for all four antibody candidates and compare their pharmacokinetic profiles within 2 months. Abnova will perform the final COVID-19 virus testing in a BSL3 (P3) containment laboratory. Both Abnova and Leadgene will then select the best-in-class candidate for out-licensing, GMP manufacturing, and EUA designated clinical trial via collaboration with a big pharma.

Leadgene is a Taiwan-based biotech company specializing in monoclonal antibody humanization. Leadgene uses a two-step humanization process to generate a therapeutic antibody. First step is the grafting of the mouse hypervariable antibody domain known as the complementarity-determining region (CDR) onto the variable domain of human antibody template. COVID-19 CDR antibody domain is responsible binding and neutralizing the sub-region of the COVID-19 Spike (S) protein which directly interacts with the ACE2 receptor epithelial protein for viral entry. Second step is a specificity-determining residue (SDR) grafting performed on the CDR framework to further minimize immunogenicity while maintaining antigen binding.

Currently remdesivir is the EUA (Emergency Use Authorization) treatment against COVID-19 infection granted by the FDA on May 1 2020. In a severe infection, COVID-19 therapeutic antibody can be highly useful and effective to reduce the viral load and improve disease deterioration. In immunosuppressed individuals, therapeutic antibody can be applied in the earlier stage of COVID-19 infection to avoid disease complication. On the other hand, another major effort is the development of COVID-19 vaccines to generate protective antibody in healthy population as a safeguard against future infection.