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Methods and compositions for treating respiratory disease

A composition and virus technology, applied in the field of treatment of respiratory diseases and compositions, can solve the problems of medical resource burden, harmful effects on patients, etc.

Pending Publication Date: 2020-05-12
NOVAVAX
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Exacerbations of COPD have profoundly deleterious effects on patients and place a significant burden on healthcare resources

Method used

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  • Methods and compositions for treating respiratory disease
  • Methods and compositions for treating respiratory disease
  • Methods and compositions for treating respiratory disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0135] Expression and purification of RSV F protein

[0136] The RSV F protein having SEQ ID NO: 8 was expressed in a baculovirus expression system, and recombinant plaques expressing the RSV F protein were selected and confirmed. The recombinant virus was then amplified by infecting Sf9 insect cells. Insect cell cultures were infected with baculovirus at approximately 3 MOI (multiplicity of infection = virus ffu or pfu / cell). Cultures and supernatants were harvested 48-72 hours after infection. Approximately 30 mL of crude cell harvest was clarified by centrifugation at approximately 800 xg for 15 minutes. The resulting crude cell harvest containing RSV F protein was purified as described below.

[0137] Using Nonionic Surfactants in Membrane Protein Extraction Protocols NP-9 (nonylphenol ethoxylate). NP-9 was a crude extract which was further purified by anion exchange chromatography, lentil lectin affinity / HIC and cation exchange chromatography. Washed cells were lys...

Embodiment 2

[0142] Preparation of vaccine composition

[0143]To provide the nanoparticles for administration of the vaccine product, the drug substance is diluted into the drug product with a PS80:RSV protein molar ratio of about 50. Prior to administration, the drug substance is thawed, diluted and filled into glass vials or prefilled syringes for storage at 2°C-8°C. Nanoparticles are combined with alum adjuvant. Alum adjuvant was added and mixed to ensure that about 95% of the nanoparticles were bound to alum, meaning about 0.4 mg per 120 μg dose of RSV F nanoparticles in a volume of 0.5 mL.

Embodiment 3

[0145] RSV F in nanoparticles reduces COPD exacerbation hospitalizations

[0146] In a randomized placebo-controlled study of 11,856 subjects aged over 60 years, a vaccine containing 135 μg of RSV F nanoparticles in the absence of alum reduced all-cause COPD exacerbation hospitalizations (in image 3 and Figure 4 referred to as "E-301"). Subjects were followed for one year to determine the safety, immunogenicity and efficacy of the vaccine. Surprisingly, administration of the RSV F nanoparticle vaccine reduced both the general population of the study (p=0.017) and the subpopulation of the study (p=0.14) in subjects previously identified as having baseline COPD. Hospitalization due to exacerbation.

[0147] In a smaller comparative study consisting of 1600 subjects aged over 60 years, the group given the RSV F nanoparticle vaccine did not experience COPD exacerbation hospitalization ( image 3 referred to as "E-201"). Data show that in the E-201 study, 0 of 798 subjects w...

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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 COPDpatients 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.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to U.S. Provisional Application No. 62 / 536,235, filed July 24, 2017, the disclosure of which is incorporated herein for all purposes. [0003] For all purposes, this application incorporates U.S. Application No. 15 / 257,436, filed September 6, 2016, and the following U.S. provisional application serial numbers: 62 / 213,947, filed September 3, 2015, The disclosures of 62 / 255,786, 62 / 309,216 filed March 16, 2016, and 62 / 350,973 filed June 16, 2016 are incorporated in their entireties. [0004] Instructions for Electronically Submitted Text Files [0005] The contents of the text file filed electronically herewith in its entirety are hereby incorporated by reference in its entirety: Copy of Sequence Listing in Computer Readable Format (File Name: NOVV_075_01WO_SeqList_ST25.txt, Date of Record: July 19, 2018, File Size : about 67 kilobytes). technical field [0006] The present disclosure ge...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/51A61K31/047A61K38/16A61K39/12A61K39/145
CPCA61K39/12A61K9/5115C12N2760/18522C12N2760/18534A61P31/14A61P11/00A61K9/5123A61K39/155C12N2760/16022C12N2760/16034
Inventor G·史密斯Y·刘J·H·田M·马萨尔S·博达帕蒂G·格伦L·弗列斯I·赵
Owner NOVAVAX
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