Cilgavimab, Tixagevimab Approved Mixture of 2

Aug 25, 2020: AZD7442 is a combination of two mAbs (AZD8895 + AZD1061) derived from convalescent patients with SARS-CoV-2 infection. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the mAbs were optimised by AstraZeneca with half-life extension and reduced Fc receptor binding. The half-life extended mAbs should afford at least six months of protection from COVID-19.(2-5) In a recent Nature publication, the mAbs were shown preclinically to block the binding of the SARS-CoV-2 virus to host cells and protect against infection in cell and animal models of disease.(6) NCT04507256 is a Phase I, first time in human, randomised, double-blind, placebo-controlled, and dose escalation study that aims to evaluate the safety, tolerability and pharmacokinetics of AZD7442 in healthy participants.1 Data readout is anticipated in the second half of 2020. References 1. ClinicalTrials.gov. NCT04507256. https://clinicaltrials.gov/ct2/show/NCT04507256?term=NCT04507256&draw=2&rank=1 2. Robbie, G.J., et al., A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother, 2013. 57(12): p. 6147-53. 3. Griffin, M.P., et al., Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults. Antimicrob Agents Chemother, 2017. 61(3). 4. Yu, X.Q., et al., Safety, Tolerability, and Pharmacokinetics of MEDI4893, an Investigational, Extended-Half-Life, Anti-Staphylococcus aureus Alpha-Toxin Human Monoclonal Antibody, in Healthy Adults. Antimicrob Agents Chemother, 2017. 61(1). 5. Domachowske, J.B., et al., Safety, Tolerability and Pharmacokinetics of MEDI8897, an Extended Half-life Single-dose Respiratory Syncytial Virus Prefusion F-targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants. Pediatr Infect Dis J, 2018. 37(9): p. 886-892. 6. Zost SJ et al. Potently neutralizing human antibodies that block SARS-CoV-2 receptor binding and protect animals. Nature. 2020. DOI: 10.1038/s41586-020-2548-6 July 2020: AZD7442 (neutralising-antibody therapy for the prevention and treatment of COVID-19) AZ's comprehensive pandemic response includes rapid mobilisation of AstraZeneca’s global research efforts to discover novel coronavirus-neutralising antibodies to prevent and treat progression of the COVID-19 disease. During the period, AstraZeneca announced it had licensed coronavirus-neutralising antibodies from Vanderbilt University, US, and plans to advance two of these monoclonal antibodies (AZD8895 and AZD1061) into clinical development as a potential combination therapy (AZD7442) for the prevention and treatment of COVID-19. AstraZeneca has secured support from the Defense Advanced Research Projects Agency, part of the US Department of Defense and BARDA for the Phase I trial and the manufacturing of the potential new medicine for testing in Phase I, which is expected to initiate in the second half of the year. In July 2020, the UK Government announced an agreement in principle with AstraZeneca for the supply of one million doses of AZD7442, with deliveries anticipated to start as early as first half of 2021, should the monoclonal-antibody combination prove to be tolerated and effective in clinical trials. (https://www.sec.gov/Archives/edgar/data/901832/000110465920089187/a20-26252_16ka.htm) Tixagevimab (AZD8895) + Cilgavimab (AZD1061)