– MedImmune Receives U.S. Fast Track Designation for MEDI8852 Antibody Developed Under a Collaboration with Humabs for the Treatment of Influenza A
Humabs BioMed SA, a leading Swiss antibody therapeutics company, today announced that a novel antibody developed using its proprietary Cellclone technology has received Fast Track designation from the US Food and Drug Administration (FDA). The investigational human monoclonal antibody MEDI8852 is being clinically developed by MedImmune, the global biologics research and development arm of AstraZeneca, for the treatment of patients hospitalized with Type A strain influenza.
The antibody with broad influenza-neutralizing properties is a human IgG1 kappa monoclonal antibody administered via infusion. The precursor to MEDI8852 was isolated from human memory B cells by Humabs BioMed and further optimized for enhanced neutralization activity at MedImmune. MEDI8852 binds to a region within the stalk of the hemagglutinin protein that is highly conserved amongst all influenza A subtypes. MEDI8852 is being developed as a treatment for patients hospitalized with seasonal influenza caused by Type A strains in conjunction with local standard of care. It is anticipated that it could also be used in the pandemic setting.
MEDI8852 is currently being evaluated in a Phase Ib/IIa clinical trial to investigate the safety and efficacy of a single intravenous dose in combination with oseltamivir, and as a monotherapy in adult patients with confirmed acute, uncomplicated influenza caused by Type A strains. A recently completed Phase I study in healthy adult subjects demonstrated that MEDI8852 had an acceptable safety and pharmacokinetics profile, which supports continued development in patients with influenza.
The FDA’s Fast Track program is designed to expedite the development and review of drugs to treat serious conditions and fill an unmet medical need.
“We are very pleased that our partner MedImmune received Fast Track designation for the antibody we jointly identified only five years ago,” said Filippo Riva, CEO of Humabs BioMed. “This is a validation of our technology and also of our strategy to rapidly discover and develop human-derived antibodies in life-threatening infectious diseases.”