Human Monoclonal Antibodies for Prevention and Treatment of Influenza Virus Infections

Background

Seasonal influenza, also referred to as influenza or flu, is a contagious respiratory viral illness. Influenza infection varies in severity, causing asymptomatic infection to fatal disease, particularly for high-risk patient populations such as the elderly (over 65 years of age), young children (under five years of age), pregnant women, and people with chronic health conditions like asthma, diabetes, or heart disease. Although a licensed vaccine has been available for over seventy years, influenza infections still remain a major public health concern. Annually, in the United States (US) alone, influenza leads to an average of ~30,000 deaths and ~300,000 hospitalizations, with ~3 to 5 million severe cases and 200,000 to 500,000 deaths per year globally. Due to the propensity of the virus for mutations, and its tendency to elicit predominantly strain specific antibodies, humanity remains susceptible to waves of new strains of seasonal viruses and at the risk of viruses with pandemic potential for which limited or no immunity may exist. Current seasonal vaccinations and anti-viral treatments are sub-optimal with increasing incidence of drug resistant viral mutants and a limited therapeutic window. Subsequently new preventive and therapeutic interventions for both seasonal and potential pandemic influenza are being sought.

Technology Overview

We have developed a cocktail of high affinity fully human monoclonal antibodies (hmAbs) that target the hemagglutinin (HA) protein expressed on the surface of the virion. This cocktail has neutralizing activity against influenza A (IAV), influenza B (IBV), H1 and H3 viruses and will confer universal protective and therapeutic activity against seasonal and potentially pandemic influenza viruses.

Benefits

A high degree of specificity, limited off-target effects, and superb safety profile. Can be used as prophylaxis and treatment for influenza infection. As hmAbs can be delivered via subcutaneous or intramuscular injection and can be modified to achieve half-lives of greater than 6 months. Widespread prophylactic use is feasible.