December 15, 2020 -- Harbour BioMed and Utrecht University have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, to AbbVie. AbbVie has initiated a phase I clinical trial of the antibody for the prevention and treatment of COVID-19, initially in the U.S. with the goal of expanding into Europe.
The antibody was discovered using fully human transgenic Harbour mice. The antibody targets a conserved region of the SARS-CoV-2 spike protein and the preclinical data indicate that the antibody can target current strains but also potential escape mutants.
The phase I trial will be a randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics, and pharmacodynamics of single ascending doses of the antibody in adults hospitalized with COVID-19. Three different doses will be testing on 24 patients.
Under the license agreement, AbbVie will conduct clinical development of ABBV-47D11, and if successful, will manufacture and commercialize the product worldwide. AbbVie will pay Harbour and Utrecht a one-time license fee, certain development, regulatory, and sales milestone payments, and tiered royalties on commercial net sales of the antibody.
Erasmus University Medical Center (Erasmus MC) was involved in the fundamental science but is not involved in the license agreement. Financial terms were not disclosed.
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