Methods and compositions for treating respiratory disease

Inventors

Smith, Gale • Liu, Ye • Tian, Jing-Hui • MASSARE, Michael J. • BODDAPATI, Sarathi • Glenn, Gregory • Fries, Louis • CHO, Iksung

Assignees

Novavax Inc

Abstract

Disclosed herein are methods and nanoparticles suitable for use in reducing exacerbations in COPD patients. The methods and compositions advantageously reduce the incidence of hospitalization in COPD patients that occurs in response to environmental insults such as exposure to or infection by RSV. Dosages, formulations, and methods for preparing the vaccines and nanoparticles are also disclosed.

Core Innovation

The invention relates to a nanoparticle vaccine for reducing exacerbations of chronic obstructive pulmonary disease (COPD) in a human subject. The nanoparticle comprises a non-ionic detergent core and a viral glycoprotein associated with the core, and the detergent is present at about 0.03% to about 0.05%. The viral glycoprotein is an RSV F protein.

The RSV F glycoprotein is configured as a selected protein associated with the non-ionic detergent core. In some implementations, the RSV F protein comprises a 1–10 amino acid deletion corresponding to positions 137–146 of SEQ ID NO:2, and an inactivated primary furin cleavage site achieved by mutations in amino acids 131–136 of SEQ ID NO:2. In related implementations, the RSV F protein is selected from SEQ ID NOS:2–13 or variants of SEQ ID NOS:2–13 missing part or all of the N-terminal signal peptide.

The invention also covers immunogenic compositions for COPD exacerbations in response to an environmental insult. The composition comprises a first nanoparticle with a PS80 non-ionic detergent core and an RSV F glycoprotein associated with the core at about 0.03% to about 0.05%, and in some compositions a second nanoparticle includes a PS80 non-ionic detergent core and an influenza HA protein as an additional viral glycoprotein.

Claims Coverage

The partial content identifies two independent claims. Across these independent claims, the coverage centers on administering a nanoparticle vaccine or immunogenic composition with a non-ionic or PS80 detergent core associated with an RSV F glycoprotein and having the detergent present at about 0.03% to about 0.05%.

The claim set covers COPD exacerbation reduction by administering nanoparticle vaccine or immunogenic compositions built from a non-ionic or PS80 detergent core associated with an RSV F glycoprotein, constrained by detergent presence at about 0.03% to about 0.05%. Dependent claims further narrow RSV F protein sequence or variant choices and enable combination with influenza HA via additional nanoparticle components.

Stated Advantages

Documented Applications

No documented applications found