AbbVie begins trials of COVID-19 antibody therapy

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University.

In a joint statement, the biotech and the university said that the antibody, dubbed ABBV-47D11, will be developed for prevention and treatment of COVID-19 and related coronaviruses.

AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

The antibody has been developed by Harbour using transgenic mice, which enabled the quick discovery and development of several candidates.

From these ABBV-47D11 was selected because of its cross-reactive neutralising nature.

The antibody targets a conserved region of the SARS-CoV-2 spike protein and has been developed through a collaboration between Harbour (HBM) and Utrecht University (UU).

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 the related SARS-CoV-1 virus that caused an outbreak in Asia in 2003.

AbbVie will conduct clinical development of ABBV-47D11, and if successful, will manufacture and market the product worldwide.

AbbVie will pay HBM and UU an undisclosed one-time license fee and will also make payments upon achievement of certain development, regulatory and sales-based milestones.

The pharma will also pay tiered royalties on commercial net sales of the antibody.

Erasmus University Medical Center, based in Rotterdam, Netherlands, was involved in the fundamental science but is not involved in the license agreement.

The phase 1 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 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.

Regeneron and Eli Lilly have been leading the charge to develop antibody-based therapies against the coronavirus.

Regeneron’s cocktail, REGN-COV2 and Eli Lilly’s bamlanivimab have emergency approvals from the FDA and AstraZeneca has begun clinical development of its rival antibody cocktail last month.

Harbour BioMed is a clinical-stage biotech specialising in antibody therapeutics with operations in Cambridge, MassachusettsRotterdam, The Netherlands; and Suzhou and Shanghai, China.

Feature image courtesy of Rocky Mountain Laboratories/NIH

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.