Peptide particle formulation

Inventors

Rubsamen, Reid M.Heckerman, David Earl

Assignees

Flow Pharma Inc

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Publication Number

US-9408906-B2

Patent

Publication Date

2016-08-09

Expiration Date


Abstract

A composition as disclosed is comprised of a plurality of groups of particles. The particles are comprised of a biocompatible polymer which maybe a co-polymer such as PLGA combined with a peptide of a sequence of interest, e.g. a sequence which corresponds to a sequence presented on a surface of a cell infected with a virus. A plurality of different groups of particles are provided in the formulation wherein the particles within any single group include peptides of identical amino acid sequence. The particles are sized such that they are sufficiently large so as to prevent more than the contents of a single particle from being presented to a single immune system cell.

Core Innovation

The invention provides peptide particle vaccine formulations that include a pharmaceutically acceptable carrier comprising monophosphoryl lipid A and multiple groups of substantially spherical particles. Each particle group comprises a biocompatible polymer embedding only a single species of an antigen consisting of eight to twenty amino acids, where the antigen species in different groups are different from one another.

The compositions define that each group includes only one antigen or peptide species of identical sequence, embedded in the polymer. The particles are sized so that only a single particle can be consumed by an antigen presenting cell in a range of from 10 microns ±20% to 25 microns ±20%, and this is intended to prevent presentation of multiple antigen species by one antigen presenting cell.

The disclosed compositions apply the multiple particle groups concept with antigen-presenting cell uptake while maintaining substantially spherical biocompatible polymer particles. The polymer is selected from poly(lactic co-glycolic acid), polycaprolactone, polyglycolide, polylactic acid, and poly-3-hydroxybutyrate.

Claims Coverage

Three independent claims are present. Each claim centers on a multi-group peptide particle composition that embeds single-species eight-to-twenty-amino-acid antigens in biocompatible polymer particles, with substantially spherical particles sized so only a single particle is consumed by an antigen presenting cell in a defined diameter range of 10 microns ±20% to 25 microns ±20%.

Two antigen particle groups with single-species eight-to-twenty-amino-acid antigens and single-particle APC consumption

A composition comprising a pharmaceutically acceptable carrier comprising monophosphoryl lipid A; a first group of substantially spherical particles of a biocompatible polymer embedding a first antigen consisting only of a single species consisting of eight to twenty amino acids, and a second group of substantially spherical particles of a biocompatible polymer embedding a second antigen consisting only of a single species consisting of eight to twenty amino acids, wherein the second antigen is different from the first antigen; wherein each particle in both groups is sized so that only a single particle can be consumed by an antigen presenting cell in a range of from 10 microns ±20% to 25 microns ±20%.

Three distinct antigen particle groups with selected biodegradable polymers and single-particle APC consumption

A composition comprising a pharmaceutically acceptable carrier comprising monophosphoryl lipid A; a first, second, and third group of substantially spherical particles of a biocompatible polymer, each group embedding only a single species antigen consisting in each case of a single species embedded in the polymer, wherein the second antigen is different from the first antigen and the third antigen is different from both the first and second antigens; wherein each particle is sized so that only a single particle can be consumed by an antigen presenting cell in a range of from 10 microns ±20% to 25 microns ±20%, and wherein the biocompatible polymer is selected from poly(lactic co-glycolic acid), polycaprolactone, polyglycolide, polylactic acid, and poly-3-hydroxybutyrate.

Multiple additional antigen particle groups with antigen uniqueness across all groups and single-particle APC consumption

A composition comprising a pharmaceutically acceptable carrier comprising monophosphoryl lipid A; a first group and a second group of substantially spherical particles of a biocompatible polymer, each group embedding a single species antigen consisting only of a single species consisting of eight to twenty amino acids, with the second antigen different from the first antigen; and a plurality of additional groups of particles having a diameter such that only a single particle can be consumed by an antigen presenting cell, where additional antigens in each additional group are embedded in the polymer and are different from the antigen in all other groups and the antigens of each group consist only of a single species; wherein each particle has a particle diameter substantially spherical and in a range of from 10 microns ±20% to 25 microns ±20%, and wherein the biocompatible polymer is selected from poly(lactic co-glycolic acid), polycaprolactone, polyglycolide, polylactic acid, and poly-3-hydroxybutyrate.

The claim set covers multi-group peptide particle vaccine compositions with monophosphoryl lipid A, where each particle group embeds a distinct single-species antigen consisting only of eight to twenty amino acids in a selected biocompatible polymer. All independent claims additionally require substantially spherical particles with diameters sized so only a single particle can be consumed by an antigen presenting cell within 10 microns ±20% to 25 microns ±20%, with the third claim expanding to a plurality of additional groups while maintaining antigen uniqueness across all groups.

Stated Advantages

Configured so only a single particle can be consumed by an antigen presenting cell, preventing presentation of multiple antigen species by one antigen presenting cell.

Documented Applications

Therapeutic or prophylactic immune modulation using injection or nasal administration.

Immune modulation using antigen or epitope contexts including viral epitopes such as HIV and CMV.

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