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Neihu, Taiwan (October 14, 2020)
Abnova announced today that both Abnova and Leadgene have completed the COVID-19 antibody humanization and validation for its best-in-class 7F7 antibody lead candidate. Abnova developed the monoclonal antibody from mouse hybridoma and Leadgene undertook the human antibody engineering via CDR grafting. 7F7 humanized antibody has been successfully validated using protein receptor-binding assay, pseudovirus neutralization assay, antibody kinetic assay, epitope mapping and LALA Fc mutation. Abnova and Leadgene are now working together to select the pharma partners for out-licensing, GMP manufacturing, and EUA designated clinical trials.
7F7 humanized antibody has one of the highest antibody potency as measured by pseudovirus neutralization assay IC50 at 4ng/ml compared to antibodies in clinical trials ranging from (8.37ng/ml - 79ng/ml). 7F7 also has a high affinity for SARS-CoV-2 RBD (receptor-binding domain) with KD value of 1.34E-10. 7F7 antibody binds to the conserved core domain of the RBD with 86.3% protein sequence homology between SARS-CoV and SARS-CoV-2. Neutralizing antibody targeting the conserved region of the RBD is recognized as broadly neutralizing antibody which is more effective against viral escape mutants causing drug resistance. A precautionary LALA mutation has been also engineered at the Fc domain of the 7F7 antibody to minimize any potential Antibody-Dependent Enhancement (ADE) side effects.
As therapy, 7F7 humanized antibody can be highly useful and effective to reduce the viral load and improve disease deterioration in COVID-19 infected individuals. In immunosuppressed individuals, therapeutic antibody can be applied in the earlier stage of COVID-19 infection to avoid disease complication. As prophylaxis, 7F7 humanized antibody can be given to high-risk individuals such as healthcare workers and people with underlying risk factors or exposure to confirmed COVID-19 cases. The risk of ADE is also lowered for prophylaxis use because of lowered viral load in early viral transmission. |
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Abnova has established a comprehensive portfolio of fully integrated solutions to address the needs of the in vitro diagnostic (IVD) industry. Abnova provides its partners and customers access to the technologies, products, and services relating to circulating rare cells, circulating exosomes, and circulating cell-free RNA for early to metastatic to recurrent disease and treatment diagnosis, prediction, guidance, and monitoring. Abnova facility is for proprietary bioreagent and high-throughput automation development and manufacturing for clinical trials and IVD commercialization. (www.abnova.com)