Harbio BioMed Public Relations
December 15, 2020
CAMBRIDGE, Mass., SUZHOU, China, UTRECHT, The Netherlands, December 14, 2020 – Harbour BioMed (HBM)(HKEX:02142) and Utrecht University (UU) today announced that they licensed to AbbVie, their fully human, SARS-CoV-2 neutralizing antibody, 47D11 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 a compelling 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 has worldwide rights for development, manufacture, and commercialization of ABBV-47D11. AbbVie will pay HBM and UU a one-time license fee; payments upon achievement of certain development, regulatory and sales-based milestone;, 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 is 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 (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on oncology and immunology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions.
The Company’s proprietary antibody technology platforms Harbour Mice® generate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) are capable of delivering tumor killing effects unachievable by traditional combination therapies. Integrating Harbour Mice® with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies.
For further information, please refer to www.harbourbiomed.com
About Utrecht University
Founded in 1636, Utrecht University is one of the largest research universities of 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.www.uu.nl.
Phone: +31 6 48 43 47 84
Harbio BioMed Public Relations