New Cell Study Presents Ground-breaking Pre-Clinical Work: Developing Immune Therapy to Potentially Treat Serious Influenza A

A paper published by renowned scientific journal cell Cell presents pre-clinical work to develop a promising new antibody, MEDI8852, as a potential therapy to treat influenza caused by numerous type A strains – the source of seasonal and pandemic outbreaks. The findings also highlight the mechanisms of action of MEDI8852, which along with its unique binding properties, point to valuable implications for the design of a universal influenza vaccine that can address the unpredictable nature of the flu virus.

“The results of this study confirm how MEDI8852’s unique molecular features have the potential to differentiate it from current treatment options for influenza, with the potential to become an important anti-influenza candidate during pandemic periods,” said JoAnn Suzich, Vice President, R&D, MedImmune.

The paper results from international collaboration among researchers at MedImmune, the global biologics research and development arm of AstraZeneca; Humabs BioMed; the Institute for Research in Biomedicine (Università della Svizzera italiana); and, the Francis Crick Institute in London.

Study highlights include:

• MEDI8852 exhibits multiple mechanisms of action, including blocking essential steps of the viral lifecycle; it also engages the immune system to eliminate virus-infected cells.
• MEDI8852 provides an extended therapeutic window in animal models when compared to the standard of care.
• Structural analyses reveal that MEDI8852 targets a unique and highly conserved epitope in the stem region of influenza in two distinct hemagglutinin (HA) subtypes, H5 and H7, distinguishing it from other structurally characterized cross-reactive antibodies.

“We compared the binding activity of MEDI8852 with other antibodies, as well as its precursor, and found it has the highest activity and the widest breadth of coverage,” said co-author Davide Corti, Chief Scientific Officer, Humabs BioMed. “This antibody targets a unique epitope in the stem of the influenza HA and can attack the virus’ entry and exit by blocking multiple mechanisms.”

John Skehel, one of the lead authors from the Francis Crick Institute, said: “This new antibody binds to numerous different influenza viruses to block their infectivity. Our studies show how this is achieved and highlight differences between this and other antibodies to explain its potential as an anti-influenza therapeutic.”

MEDI8852: Potential for high unmet medical need for influenza treatment

Despite advances in vaccines and antiviral therapeutics, a high unmet medical need remains for additional treatment options of influenza in populations at high risk for morbidity and mortality. In these patients, influenza infection can lead to severe complications and causes a significant burden to the overall healthcare system. The current standard of care for the treatment of influenza, the neuraminidase inhibitors (NAIs) oseltamivir and zanamivir, have many limitations, including a limited therapeutic window and the potential for resistance.

MEDI8852 received Fast Track designation from the US Food and Drug Administration (FDA) in March 2016. 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.

MEDI8852 is currently being evaluated in a Phase Ib/IIa clinical trial to investigate the safety and preliminary 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 prior to studying it in hospitalized patients. A recently completed Phase I study in healthy adult subjects demonstrated that MEDI8852 had an acceptable safety and pharmacokinetics profile, which supported continued development in patients with influenza.