AbbVie initiates Phase I trial to study SARS-CoV-2 neutralising antibody
AbbVie has licensed the SARS-CoV-2 neutralising antibody, 47D11, from Harbour BioMed and Utrecht University and begun clinical trials.
Harbour BioMed and Utrecht University (UU), the Netherlands, announced that the they have licensed their fully human, SARS-CoV-2 neutralising antibody, 47D11 and programme, for the prevention and treatment of COVID-19 and related coronaviruses, to AbbVie.
AbbVie has also now initiated a Phase I clinical trial of the antibody. The Phase I trial will be a randomised, double-blind, placebo-controlled, study to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending doses of ABBV-47D11 in adults hospitalised 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. The company will start the clinical programme in the US and later expand it into Europe. If successful, the company will manufacture and commercialise the product worldwide.
According to the companies, 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 neutralising nature made it the ideal candidate to take it into development. The antibody targets a conserved region of the SARS-CoV-2 Spike (S) protein. Pre-clinical 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.
AbbVie will pay Harbour BioMed 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.
“The rapid progress we have made to date is a credit to the outstanding research by our teams and university partners, the strength of Harbour BioMed ‘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 Harbour BioMed. “With the clinical program at AbbVie now underway, we are in a position to contribute a new therapeutic option to address this pandemic.”