Icosavax Gains Fast Track for VLP Vaccine

The FDA has granted Fast Track designation to Icosavax’s IVX-A12, an innovative investigational bivalent vaccine that targets both respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).

The vaccine uses viral-like particles (VLP), lab-created units that are primarily composed of antigen on a protein scaffold to stimulate a robust immune response.

Icosavax is currently awaiting phase 1 data from a placebo-controlled study in 120 healthy older adults who will be followed over one year. A phase 2 trial should begin later this year.

The platform employs multiple antigens that self-assemble into VLPs when they come into contact with a protein scaffold. The scaffold can support antigens from multiple vaccine candidates and can enable a single vaccine to target several different diseases.