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MPL and AS02/AS04 adjuvant patents

MPL patent

MPLTM, patented by Corixa Corp., is protected by patents in quite a few countries.  Patents are found in Australia, China, European countries of Austria, Germany, Denmark, Hungary, Norway, Poland, Portugal, Spain,  Turkey; Hong Kong, New Zealand and the United States.  Applications were also filed in Brazil, Canada, and Israel. 

The patents are drawn to an attenuated form of the lipid A component of bacterial lipopolysaccharide (LPS).  LPS, and lipid A, are potent immunostimulators but have deleterious side effects, such as pyrogenicity (fever).  The modifications described in Corixa's patents abate the side effects but do not disable the immunostimulatory effects of lipid A. 

PATENT INFO

SUBJECT MATTER OF THE CLAIMS

LEAD CLAIM

EP 0 971 739 B

expires 01 Apr 2018

Adjuvant composition comprising MLA / 3D-MLA and a surfactant.  Methods for making the adjuvant composition and use of adjuvant for making medicament. 

An adjuvant composition comprising an adjuvant in water which further contains a surfactant, characterised in that the adjuvant consists of an attenuated lipid A derivative selected from monophosphoryl lipid A (MLA) or 3-O-deacylated monophosphoryl lipid A (3D-MLA), the water is free of co-solvent and in that the molar ratio of the MLA or 3D-MLA to the surfactant is from 10:1 1 to 2:1.

EP 1 194 166 B1

expires 14 Jun 2020

Adjuvant composition comprising MLA  or 3D-MLA, a surfactant, and glycero in aqueous or lyphilized forms.  Methods for making the aqueous adjuvant and use of the adjuvant for making a medicament.

An aqueous immunostimulatory adjuvant composition comprising an attenuated lipid A derivative, which is mono-phophoryl lipid A or 3-O-deacylated monophosphoryl lipid A, one or more non-immuostimulatory surfactants, and glycerol

US 6,491,919

expires 1 Apr 2017

Formulation of adjuvant composition comprising MLA or 3D-MLA, surfactant and glycerol.

A dry formulation of an immunostimulatory adjuvant, said formulation comprising: (a) an immunostimulatory adjuvant which is a member selected from monophosphoryl lipid A, 3-O-deacylated monophosphoryl lipid A and combinations thereof; (b) a non-immunostimulatory surfactant; and (c) glycerol in an amount sufficient to provide a clear suspension of particles of said immunostimulatory adjuvant upon contacting said formulation with water without sonication.

AS04 patents

Patents have issued in Australia, Europe (Austria, Germany, Denmark, Spain, Hungary, Luxembourg, Norway, Poland, Turkey) New Zealand, Taiwan, and the United States.  Patent applications were filed in Brazil, Canada, Israel, India, Japan, and there is a divisional patent application pending in Europe. 

PATENT INFO

SUBJECT MATTER OF THE CLAIMS

LEAD CLAIM

EP 1 126 876 B1
expires 08 Oct 2019

Methods for making vaccine comprising an antigen and 3D-MLA adsorbed onto alum; a vaccine made by the method, a vaccine comprising an antigen adsorbed onto alum and 3D-MLA adsorbed onto alum. 

A process for the manufacture of a vaccine composition comprising the admixture of a) an adjuvant composition comprising an immunostimulant which is 3-de-O-acylated monophosphoryl lipid A, adsorbed onto an aluminium salt particle, characterised in that not more than 20% by mass of the total material capable of adsorbing to the aluminium salt particle is an antigen, and b) an antigen.

US 7,357,936
expires 08 Oct 2019

Vaccine composition and method for making it in which the composition comprises an immunostimulant (e.g., MLA) adsorbed onto a metallic salt (e.g. alum) and antigen adsorbed onto a metallic salt (e.g. alum).  In other claims the antigen is not adsorbed onto a metallic salt.  Vaccine composition comprising an antigen and MLA or derivative, or immunostimulatory nucleotide or immunostimulatory cytokine adsorbed onto metallic salt.  In other claims the immunostimulant may be oligonucleotides, block copolymers, and the like. 

A vaccine composition comprising two major populations of complexes, (a) a first complex containing an immunostimulant adsorbed onto a metallic salt particle which is substantially free of antigen; and (b) a second complex containing antigen adsorbed onto a metallic salt particle which is optionally substantially free of immunostimulant; wherein the metallic salt from the first complex may be identical to or different from the metallic salt of the second complex.

AS02 patents

A patent family directed to vaccine compositions comprising 3D-MLA and QS21 is owned by GlaxoSmithKline.  In this very large family, patents have been granted in Australia, Canada, China, Czech Republic, Hong Kong, Israel, Japan, New Zealand, Russia, Singapore, the United States and Europe (Austria, Germany, Kenmark, Spain, Finland, Great Briatain, Greece, Hungary, Norway, Poland, Portugal, Slovenia, Slovakia).  Some of the patents claim specific vaccines, such as a vaccine comprising an HIV antigen, QS21 and 3D-MPL.  The claims in the table below are not constrained to a particular antigen. 

PATENT INFO

SUBJECT MATTER OF THE CLAIMS

LEAD CLAIM

EP 0 671 948 B1
expires 15 Jun 2013

Vaccine composition comprising an antigen, 3D-MPL and QS21.  Antigen can be derived from virus, such as HIV, FeIV, HSV, CMV, HepA, HepB, HebC, HepE, RSV, Papilloma virus, influenza virus or from a microorganism, such as Salmonella, Neisseria, Chlamydia, Plasmodium, Bordetella, or Toxoplasma.

A vaccine composition comprising an antigen and/or antigenic composition, QS21 and 3 De-O-acylated monophosphoryl lipid A (3D-MPL).

EP 0 761 231 B1
expires 15 Jun 2013

Composition comprising QS21 and 3D-MPL. Vaccine compositions comprising QS21, 3D-MPL, and gp120 from HIV, gD2t from Herpes Simplex Virus, RTS,S from Plasmodium, HBsAg from HepB.

A composition comprising QS21 and 3-de-O-acylated monophosphoryl lipid A (3D-MPL)

US 5,750,110
expires 12 May 2015

Vaccine composition comprising antigen, QS21 and 3D-MPL.  Vaccine composition in which the antigen is from a virus or microorganism.  Method of treating mammals by administering a vaccine composition. 

A vaccine composition comprising:(a) an antigen;(b) QS21; and(c) 3-De-O-acylated monophosphoryl lipid A (3D-MPL).

The information contained in this page was believed to be correct at the time it was collated. New patents and patent applications, altered status of patents, and case law may have resulted in changes in the landscape. CAMBIA makes no warranty that it is correct or up to date at this time and accepts no liability for any use that might be made of it. Corrections or updates to the information are welcome. Please send an email to info@bios.net.

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