Lessons learned from, and intervention efforts against SARS coronavirus (CoV), MERS-CoV and other emerging viruses provide invaluable information to accelerate the coordinated response against 2019 novel (2019 -n)CoV and the rapid development and manufacture of new diagnostic, prophylactic and therapeutic intervention strategies. A -promising approach to both patient management of emerging viral infections and to better preparedness and response to emerging epidemics is the use of monoclonal antibodies. MANCO aims at contributing to the rapid international response against 2019-nCoV, through preclinical and clinical evaluation of monoclonal antibodies against 2019-nCoV. MANCO will build on and leverage outstanding results from ongoing IMI-funded project #115760 ZAPI, including recently-discovered broadly cross-reactive H2L2 monoclonal antibodies against betacoronaviruses and an established pipeline for rapid identification of specific H2L2 monoclonal antibodies against 2019-nCoV; antibodies that will be selected to proceed to GMP manufacturing in high-yield CHO cell-lines. This project furthermore builds on ZAPI consortium’s experience and expertise for the development and establishment of relevant animal models, to ensure preclinical efficacy and safety, including absence of antibody-dependent enhancement, an issue seen to occur in some immunization studies against feline and SARS CoVs
Based on the generated preclinical data, MANCO will advance one lead (prophylactic and/or therapeutic) monoclonal antibody into a Phase I clinical trial that can be completed within two years of the start of the project, by leveraging clinical expertise, infrastructure and network currently in place for ongoing CEPI-funded projects on candidate vaccines against MERS-CoV (#INID1801) and Rift Valley Fever virus (#INLA1901), and H2020-funded projects on improved vaccines targeting the elderly (ISOLDA #848166) and on universal influenza vaccines, including in LMICs (ENDFLU #874650).