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Icosavax - Model IVX-A12 - RSV/hMPV Bivalent VLP Vaccine Candidate
IVX-A12 is a bivalent combination of IVX-121 and IVX-241, a human metapneumovirus (hMPV) VLP vaccine candidate. IVX-A12 is being designed to target both RSV and hMPV in a single vaccine candidate. hMPV is being increasingly recognized as a major contributor to acute respiratory infection and pneumonia with rates of pneumonia (Clinics in Chest Medicine 2017) and hospitalization (JID 2012) similar to that of RSV and influenza. RSV, hMPV, and influenza seasons show high seasonal overlap and have similar clinical presentation; as such, hMPV is underdiagnosed and often mistaken for RSV or influenza given the similarity in clinical presentation. There are no FDA approved vaccines for hMPV. Similar to RSV, prospective cohort studies have shown that higher baseline hMPV nAbs are associated with reduced risk of hMPV symptomatic virus infection (Vaccine 2010), so the goal of vaccination is to increase hMPV nAbs.
Our hMPV candidate IVX-241 incorporates a pre-fusion stabilized F protein antigen and was selected based on its stability profile and ability to induce high nAb titers in preclinical studies.
We believe combining two VLP vaccine candidates, IVX-121 and IVX-241, into a single combination vaccine, IVX-A12 will provide potential benefit to vaccinators and patients over monovalent vaccines in clinical development.
Respiratory syncytial virus (RSV) causes infection of the respiratory tract, with symptoms that can sometimes be confused with influenza. It is a ubiquitous pathogen that infects 100% of the population by age 2. With outbreaks each year during the Northern Hemisphere winter, RSV is a major viral cause of pneumonia, which is most severe in infants and young children and in older adults (NEJM 2005). Worldwide, RSV disease affects an estimated 64 million people and causes 160,000 deaths each year (NIAID). There are no specific antiviral therapies or vaccines for RSV.
In the United States, it is estimated that more than 177,000 older adults are hospitalized, and 14,000 of them die due to RSV infection (CDC). The highest burden of RSV healthcare costs in the United States are in those aged ≥65 years (PLOS ONE 2017). Estimates of total RSV-attributable healthcare costs for all elderly aged ≥65 years in the United States range $150 million–$680 million to $1 billion (BMC Health Services Research, 2018).
The global cost in lives and health care expenditures is significant, especially amongst the very young and very old, and a vaccine solution is desperately needed.