Harbour BioMed and Utrecht University announced that they licensed to AbbVie their fully human, SARS-CoV-2 neutralizing antibody, 47D11 and program, for the prevention and treatment of COVID-19 and related coronaviruses, and that AbbVie has initiated a Phase 1 clinical trial of the antibody. AbbVie will initially conduct the initial clinical program in the U.S. and expand it into Europe.
The fully human H2L2 transgenic Harbour Mice® platform enabled the quick discovery and development of several potent candidates of which ABBV-47D11's cross-reactive neutralizing nature made it the ideal candidate to take it into development. The antibody targets a conserved region of the SARS-CoV-2 spike protein. Preclinical work to date through the collaboration strongly suggests this antibody against the target can potentially address the ongoing pandemic including a wide range of potential escape mutants.
The license agreement will help advance the development of ABBV-47D11, which in pre-clinical research, demonstrated potential against SARS-CoV-2, as well as a related virus, SARS-CoV-1. 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 HBM and UU a one-time license fee; payments upon achievement of certain development, regulatory and sales-based milestones; and tiered royalties on commercial net sales of the antibody. Erasmus MC was involved in the fundamental science but is not involved in the license agreement. Additional terms were not disclosed.
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The Phase 1 trial will be a randomized, double-blind, placebo-controlled, study to evaluate the safety, pharmacokinetics, and pharmacodynamics of single ascending doses of ABBV-47D11 in adults hospitalized with COVID-19. The antibody will be tested in three different doses on 24 patients across global study sites to evaluate study-drug related adverse events as primary endpoints, and several other secondary outcomes. Additional details for the trial can be found here.
"The rapid progress we have made to date is a credit to the outstanding research by our teams and university partners, the strength of HBM's fully human antibody discovery platform and AbbVie's world leading expertise in antibody and antiviral drug development," said Dr. Jingsong Wang, Principal Founder, Executive Director, Chairman & Chief Executive Officer of HBM. "With the clinical program at AbbVie now underway, we are in a position to contribute a new therapeutic option to address this pandemic."