ExeVir Bio has dosed the first participants in Phase I clinical trial of its llama-derived antibody, XVR011(VHH72-Fc), for Covid-19 prevention and treatment.
Developed by scientists at the VIB-Ghent University in Belgium, XVR011 is a single domain-based anti-SARS-CoV-2 antibody enhanced for stability, safety, wide neutralising ability and greater manufacturability.
The molecule can potentially disable SARS-CoV-2 spike proteins and sterically hinder spike attachment to angiotensin-converting enzyme 2 (ACE2), thereby stopping the virus entry to a human cell and further viral replication.
ExeVir noted that the antibody acts on a peculiar epitope in the conserved region, offering a broad spectrum of binding to spike receptor-binding domains across various sarbecoviruses.
Furthermore, the single-domain antibodies obtained from llamas are smaller than human antibodies and can bind to parts of a virus that are hard for the human immune system to access.
The randomised, double-blinded, single-centre, placebo-controlled Phase I trial will analyse the safety and pharmacokinetics of intravenous (IV) doses of XVR011 in healthy participants.
In addition, the trial will test three ascending doses of the antibody consecutively in a total of three groups of ten healthy adult participants.
ExeVir Bio chief medical officer Dominique Tersago said: “Following the creation of ExeVir a year ago, we are very pleased that our lead compound XVR011 is now in clinical development.
“We are excited by the prospect of bringing a single-dose treatment for patients with Covid-19 to the clinic, first as an IV infusion, which will be rapidly followed by a formulation for subcutaneous injection.”
According to the latest data from the laboratory at the Rega Institute, KU Leuven, Belgium, XVR011 exhibited robust in vitro neutralisation potency against the Delta and Gamma variants.
Furthermore, the researchers found that the antibody’s potency is unlikely to be affected by any presently circulating SAR-CoV-2 variant of concern or interest.
Belgian-based biopharmaceutical company UCB designed and streamlined the therapeutic abilities of XVR011 and produced the drug required for the trial at scale.
In separate hamster and mouse models against SARS-CoV-2, the drug showed significant potent, extensive neutralising activity and protection from infection.