FAST: Towards safe and effective subcutaneous immunotherapy of persistent life-threatening food allergies

Laurian Zuidmeer-Jongejan; Montserrat Fernandez-Rivas; Lars K. Poulsen; Angela Neubauer; Juan Asturias; Lars Blom; Joyce Boye; Carsten Bindslev-Jensen; Michael Stellian Clausen; Rosa Ferrara; Paula Garosi; Hans Huber; Bettina M Jensen; Stef Koppelman; Marek L Kowalski; Anna Lewandowska-Polak; Birgit Linhart; Bernard Maillere; Adriano Mari; Alberto Martinez; Clare En Mills; Claudio Nicoletti; Dirk-Jan Opstelten; Nikos G Papadopoulos; Antonio Portoles; Neil Rigby; Enrico Scala; Heidi J Schnoor; Sigurveig Sigursdottir; Georg Stavroulakis; Frank Stolz; Ines Swoboda; Rudolf Valenta; Rob van den Hout; Serge A Versteeg; Marianne Witten; Ronald van Ree

doi:10.1186/2045-7022-2-5

FAST: Towards safe and effective subcutaneous immunotherapy of persistent life-threatening food allergies

Laurian Zuidmeer-Jongejan, Montserrat Fernandez-Rivas, Lars K. Poulsen, Angela Neubauer, Juan Asturias, Lars Blom, Joyce Boye, Carsten Bindslev-Jensen, Michael Stellian Clausen, Rosa Ferrara, Paula Garosi, Hans Huber, Bettina M Jensen, Stef Koppelman, Marek L Kowalski, Anna Lewandowska-Polak, Birgit Linhart, Bernard Maillere, Adriano Mari, Alberto MartinezClare En Mills, Claudio Nicoletti, Dirk-Jan Opstelten, Nikos G Papadopoulos, Antonio Portoles, Neil Rigby, Enrico Scala, Heidi J Schnoor, Sigurveig Sigursdottir, Georg Stavroulakis, Frank Stolz, Ines Swoboda, Rudolf Valenta, Rob van den Hout, Serge A Versteeg, Marianne Witten, Ronald van Ree

51 Citations (Scopus)

Abstract

The FAST project (Food Allergy Specific Immunotherapy) aims at the development of safe and effective treatment of food allergies, targeting prevalent, persistent and severe allergy to fish and peach. Classical allergen-specific immunotherapy (SIT), using subcutaneous injections with aqueous food extracts may be effective but has proven to be accompanied by too many anaphylactic side-effects. FAST aims to develop a safe alternative by replacing food extracts with hypoallergenic recombinant major allergens as the active ingredients of SIT. Both severe fish and peach allergy are caused by a single major allergen, parvalbumin (Cyp c 1) and lipid transfer protein (Pru p 3), respectively. Two approaches are being evaluated for achieving hypoallergenicity, i.e. site-directed mutagenesis and chemical modification. The most promising hypoallergens will be produced under GMP conditions. After preclinical testing (toxicology testing and efficacy in mouse models), SCIT with alum-absorbed hypoallergens will be evaluated in phase I/IIa and IIb randomized double-blind placebo-controlled (DBPC) clinical trials, with the DBPC food challenge as primary read-out. To understand the underlying immune mechanisms in depth serological and cellular immune analyses will be performed, allowing identification of novel biomarkers for monitoring treatment efficacy. FAST aims at improving the quality of life of food allergic patients by providing a safe and effective treatment that will significantly lower their threshold for fish or peach intake, thereby decreasing their anxiety and dependence on rescue medication.

Original language	English
Journal	Clinical and Translational Allergy
Volume	2
Issue number	1
Pages (from-to)	5
ISSN	2045-7022
DOIs	https://doi.org/10.1186/2045-7022-2-5
Publication status	Published - 9 Mar 2012

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Zuidmeer-Jongejan, L., Fernandez-Rivas, M., Poulsen, L. K., Neubauer, A., Asturias, J., Blom, L., Boye, J., Bindslev-Jensen, C., Clausen, M. S., Ferrara, R., Garosi, P., Huber, H., Jensen, B. M., Koppelman, S., Kowalski, M. L., Lewandowska-Polak, A., Linhart, B., Maillere, B., Mari, A., ... van Ree, R. (2012). FAST: Towards safe and effective subcutaneous immunotherapy of persistent life-threatening food allergies. Clinical and Translational Allergy, 2(1), 5. https://doi.org/10.1186/2045-7022-2-5

Zuidmeer-Jongejan, L, Fernandez-Rivas, M, Poulsen, LK, Neubauer, A, Asturias, J, Blom, L, Boye, J, Bindslev-Jensen, C, Clausen, MS, Ferrara, R, Garosi, P, Huber, H, Jensen, BM, Koppelman, S, Kowalski, ML, Lewandowska-Polak, A, Linhart, B, Maillere, B, Mari, A, Martinez, A, Mills, CE, Nicoletti, C, Opstelten, D-J, Papadopoulos, NG, Portoles, A, Rigby, N, Scala, E, Schnoor, HJ, Sigursdottir, S, Stavroulakis, G, Stolz, F, Swoboda, I, Valenta, R, van den Hout, R, Versteeg, SA, Witten, M & van Ree, R 2012, 'FAST: Towards safe and effective subcutaneous immunotherapy of persistent life-threatening food allergies', Clinical and Translational Allergy, vol. 2, no. 1, pp. 5. https://doi.org/10.1186/2045-7022-2-5

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abstract = "The FAST project (Food Allergy Specific Immunotherapy) aims at the development of safe and effective treatment of food allergies, targeting prevalent, persistent and severe allergy to fish and peach. Classical allergen-specific immunotherapy (SIT), using subcutaneous injections with aqueous food extracts may be effective but has proven to be accompanied by too many anaphylactic side-effects. FAST aims to develop a safe alternative by replacing food extracts with hypoallergenic recombinant major allergens as the active ingredients of SIT. Both severe fish and peach allergy are caused by a single major allergen, parvalbumin (Cyp c 1) and lipid transfer protein (Pru p 3), respectively. Two approaches are being evaluated for achieving hypoallergenicity, i.e. site-directed mutagenesis and chemical modification. The most promising hypoallergens will be produced under GMP conditions. After preclinical testing (toxicology testing and efficacy in mouse models), SCIT with alum-absorbed hypoallergens will be evaluated in phase I/IIa and IIb randomized double-blind placebo-controlled (DBPC) clinical trials, with the DBPC food challenge as primary read-out. To understand the underlying immune mechanisms in depth serological and cellular immune analyses will be performed, allowing identification of novel biomarkers for monitoring treatment efficacy. FAST aims at improving the quality of life of food allergic patients by providing a safe and effective treatment that will significantly lower their threshold for fish or peach intake, thereby decreasing their anxiety and dependence on rescue medication.",

author = "Laurian Zuidmeer-Jongejan and Montserrat Fernandez-Rivas and Poulsen, {Lars K.} and Angela Neubauer and Juan Asturias and Lars Blom and Joyce Boye and Carsten Bindslev-Jensen and Clausen, {Michael Stellian} and Rosa Ferrara and Paula Garosi and Hans Huber and Jensen, {Bettina M} and Stef Koppelman and Kowalski, {Marek L} and Anna Lewandowska-Polak and Birgit Linhart and Bernard Maillere and Adriano Mari and Alberto Martinez and Mills, {Clare En} and Claudio Nicoletti and Dirk-Jan Opstelten and Papadopoulos, {Nikos G} and Antonio Portoles and Neil Rigby and Enrico Scala and Schnoor, {Heidi J} and Sigurveig Sigursdottir and Georg Stavroulakis and Frank Stolz and Ines Swoboda and Rudolf Valenta and {van den Hout}, Rob and Versteeg, {Serge A} and Marianne Witten and {van Ree}, Ronald",

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T2 - Towards safe and effective subcutaneous immunotherapy of persistent life-threatening food allergies

AU - Zuidmeer-Jongejan, Laurian

AU - Fernandez-Rivas, Montserrat

AU - Poulsen, Lars K.

AU - Neubauer, Angela

AU - Asturias, Juan

AU - Blom, Lars

AU - Boye, Joyce

AU - Bindslev-Jensen, Carsten

AU - Clausen, Michael Stellian

AU - Ferrara, Rosa

AU - Garosi, Paula

AU - Huber, Hans

AU - Jensen, Bettina M

AU - Koppelman, Stef

AU - Kowalski, Marek L

AU - Lewandowska-Polak, Anna

AU - Linhart, Birgit

AU - Maillere, Bernard

AU - Mari, Adriano

AU - Martinez, Alberto

AU - Mills, Clare En

AU - Nicoletti, Claudio

AU - Opstelten, Dirk-Jan

AU - Papadopoulos, Nikos G

AU - Portoles, Antonio

AU - Rigby, Neil

AU - Scala, Enrico

AU - Schnoor, Heidi J

AU - Sigursdottir, Sigurveig

AU - Stavroulakis, Georg

AU - Stolz, Frank

AU - Swoboda, Ines

AU - Valenta, Rudolf

AU - van den Hout, Rob

AU - Versteeg, Serge A

AU - Witten, Marianne

AU - van Ree, Ronald

PY - 2012/3/9

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N2 - The FAST project (Food Allergy Specific Immunotherapy) aims at the development of safe and effective treatment of food allergies, targeting prevalent, persistent and severe allergy to fish and peach. Classical allergen-specific immunotherapy (SIT), using subcutaneous injections with aqueous food extracts may be effective but has proven to be accompanied by too many anaphylactic side-effects. FAST aims to develop a safe alternative by replacing food extracts with hypoallergenic recombinant major allergens as the active ingredients of SIT. Both severe fish and peach allergy are caused by a single major allergen, parvalbumin (Cyp c 1) and lipid transfer protein (Pru p 3), respectively. Two approaches are being evaluated for achieving hypoallergenicity, i.e. site-directed mutagenesis and chemical modification. The most promising hypoallergens will be produced under GMP conditions. After preclinical testing (toxicology testing and efficacy in mouse models), SCIT with alum-absorbed hypoallergens will be evaluated in phase I/IIa and IIb randomized double-blind placebo-controlled (DBPC) clinical trials, with the DBPC food challenge as primary read-out. To understand the underlying immune mechanisms in depth serological and cellular immune analyses will be performed, allowing identification of novel biomarkers for monitoring treatment efficacy. FAST aims at improving the quality of life of food allergic patients by providing a safe and effective treatment that will significantly lower their threshold for fish or peach intake, thereby decreasing their anxiety and dependence on rescue medication.

AB - The FAST project (Food Allergy Specific Immunotherapy) aims at the development of safe and effective treatment of food allergies, targeting prevalent, persistent and severe allergy to fish and peach. Classical allergen-specific immunotherapy (SIT), using subcutaneous injections with aqueous food extracts may be effective but has proven to be accompanied by too many anaphylactic side-effects. FAST aims to develop a safe alternative by replacing food extracts with hypoallergenic recombinant major allergens as the active ingredients of SIT. Both severe fish and peach allergy are caused by a single major allergen, parvalbumin (Cyp c 1) and lipid transfer protein (Pru p 3), respectively. Two approaches are being evaluated for achieving hypoallergenicity, i.e. site-directed mutagenesis and chemical modification. The most promising hypoallergens will be produced under GMP conditions. After preclinical testing (toxicology testing and efficacy in mouse models), SCIT with alum-absorbed hypoallergens will be evaluated in phase I/IIa and IIb randomized double-blind placebo-controlled (DBPC) clinical trials, with the DBPC food challenge as primary read-out. To understand the underlying immune mechanisms in depth serological and cellular immune analyses will be performed, allowing identification of novel biomarkers for monitoring treatment efficacy. FAST aims at improving the quality of life of food allergic patients by providing a safe and effective treatment that will significantly lower their threshold for fish or peach intake, thereby decreasing their anxiety and dependence on rescue medication.

U2 - 10.1186/2045-7022-2-5

DO - 10.1186/2045-7022-2-5

M3 - Journal article

C2 - 22409908

SN - 2045-7022

VL - 2

SP - 5

JO - Clinical and Translational Allergy

JF - Clinical and Translational Allergy

IS - 1

ER -

FAST: Towards safe and effective subcutaneous immunotherapy of persistent life-threatening food allergies

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