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Name

Cyclic di-Nucleotides, PQS-Hydroxyquinolon, Hexosylceramides and Glycolipides as adjuvants in vaccines

Organization name

ascenion GmbH

Profile

Challenge

Mucosal delivery of vaccines allows concerted combat of diseases caused by pathogens that either invade through, or cause disease at mucosal surfaces. A novel vaccination approach is to combine systemic response and local mucosal immune response in order to induce specific protection in distant mucosal sites. Easy application of vaccines as e.g. a nasal spray or nebuliser for inhalation increases patient acceptance and convenience of administration. In developing countries ease of use and low costs of these vaccines are important prerequisites for mass vaccinations. Moreover, injections are a potential risk for infections and disease transmission e.g. HIV, especially in developing countries.

In addition many new mucosal vaccine candidates do not elicit sufficiently strong immune responses. The vaccination through mucosal membranes requires potent adjuvants in order to enhance the immunogenicity of the vaccine antigen, to decrease the rate of its degradation and to target the vaccine to the site of immune function. There are only very few adjuvants such as Alum that are approved for the use in humans. Thus the demand for new adjuvants is high and still unmet.

Cyclic di-Nucleotides as adjuvants

Technology

Cyclic di-nucleotides, such as c-di-GMP or c-di-AMP, are key regulators in the bacterial metabolism. In eukaryotic organisms these cyclic di-nucleotides serve as signalling molecules. The presence of this bacterial signalling cue seems to simulate an upcoming infection and therefore provokes a corresponding reaction of the immune system. The cyclic di-nucleotides are particularly useful not only as systemic, but preferably as mucosal adjuvants. Co-administration of cyclic di-nucleotides evokes antigen-specific immune responses with a mixed Th1/Th2 and Th17 phenotype following intra nasal application.

Commercial Opportunity

The technology is offered for co-development or in-licensing.

Developmental Status

Proof of principle with a variety of disease relevant antigens obtained in vivo.

Patent Situation

Pending patent applications based on WO2007054279 in Europe, USA, Canada, Australia and India.

Further Reading

Pedersen et al.: Evaluation of the sublingual route for administration of influenza H5N1 virosomes in combination with the bacterial second messenger c-di-GMP. 2011; 6(11):e26973.

Ebensen et al.: Bis-(3',5')-cyclic dimeric adenosine monophosphate: strong Th1/Th2/Th17 promoting mucosal adjuvant. Vaccine. 2011 Jul 18;29(32):5210-20.

PQS-Hydroxyquinolon as adjuvant

Technology

2-Heptyl-3-hydroxy-4quinolon (PQS) is a bacterial messenger molecule that mainly plays a role in bacterial communication. The family of quinolones are used for various therapeutic purposes (e.g. antibiotics). Fluoroquinolones are known to activate the cellular immune response through the stimulation of cytokine secretion. The bacterial messenger molecule PQS-Hydroxquinolon as well seems to provoke an immune reaction by the simulation of a bacterial infection. Mucosal and parenteral administration of PQS-Hydroxquinolon evokes antigen specific Th2 immune responses. Therefore PQS-Hydroxquinolon is useful as systemic as well as mucosal adjuvant. Increased stability, increased tolerance and decelerated renal excretion are achieved by the linkage of the molecule to PEG (Polyethylenglycol).

Commercial Opportunity

The technology is offered for co-development or in-licensing.

Developmental Status

Proof of principle with variety of disease relevant antigens obtained in vivo.

Patent Situation

Pending patent applications based on WO2007054283 in Europe, USA, Canada, Australia and India.

Hexosylceramides as adjuvants

Technology

α-Galactosylceramid (α-GalCer) is a membrane lipid that originally derives from the marine sponge Agelas mauritianus. Bound to methoxypolyethylene glycol (MPEG) solubility and activity of α-GalCer is improved. α-GalCerMPEG interacts with CD1d on antigen presenting cells which communicates the linkage between NK-cells or iNKT-cells and the antigen presenting cells at the very beginning of the induced immune response (before the specific immune reaction is initiated). Co-administration triggers antigen-specific immune responses with a dominant Th2 phenotype. α-GalCerMPEG is particularly useful not only as systemic, but preferably as mucosal adjuvant.

Commercial Opportunity

The technology is offered for co-development or in-licensing.

Developmental Status

Proof of principle with variety of disease relevant antigens obtained in vivo.

Patent Situation

Granted patents in Europe, USA and Hong Kong, pending patent applications based on WO 27045469 in Canada, Australia and India.

Further Reading

Knothe et al.:The NKT cell ligand α-galactosylceramide suppresses allergic airway inflammation by induction of a Th1 response. Vaccine. 2011 Jun 6;29(25):4249-55.

Ebensen et al.:A pegylated derivative of alpha-galactosylceramide exhibits improved biological properties. J Immunol. 2007 Aug 15;179(4):2065-73.

Glycolipides as adjuvants

Technology

The artificially synthesised glycolipids Mal-1,3-C14 and Mel-1,3-C14, consisting of a unit maltose or melibiose representing the polar part of the molecule and an unpolar tail consisting of two glycerine bound fatty acids, provoke a strong immune response in combination with an antigen. The natural counterpart of these glycolipids is a component of biological membranes. There is strong evidence that these molecules can be used as adjuvants for subcutaneous and mucosal vaccination.

Commercial Opportunity

The technology is offered for co-development or in-licensing.

Developmental Status

Proof of principle with a variety of disease relevant antigens obtained in vivo.

Patent Situation

Pending patent applications based on WO 28028667 in Europe, USA, Canada, Australia, India and Hong Kong.

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