Harbour BioMed, and Utrecht University today 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.

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."

About Harbour BioMed
Harbour BioMed is a clinical-stage biopharmaceutical company engaged in the discovery and development of differentiated antibody therapeutics in immunology and oncology disease areas. The company is building its pipeline through internal R&D programs and collaborations with co-discovery and co-development partners.

The company's internal discovery programs are centered around its two patented transgenic mouse platforms (Harbour Mice®) for generating both fully human monoclonal antibodies and heavy chain only antibodies (HCAb) and HBICE™ immune cell engager technology for developing bispecific antibodies. Harbour BioMed also licenses the platforms to companies and academic institutions. The company has operations in Cambridge, Massachusetts; Rotterdam, The Netherlands; and Suzhou & Shanghai, China. 

About Utrecht University
Founded in 1636, Utrecht University is one of the largest research universities in Europe, with over thirty thousand students and a staff of more than six thousand. We invest in creating the leaders of the future through innovative education of the highest quality, as reflected by the University's consistently high position in international rankings. Dedicated to performing groundbreaking research aimed at resolving large global issues, our culture of cooperation is a breeding ground for innovation, new insights, and social impact.