T cell epitopes of the major allergens from dermatophagoides...

Organic compounds -- part of the class 532-570 series – Organic compounds – Carbohydrates or derivatives

Reexamination Certificate

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C536S023100, C536S023400, C435S069100, C435S252300, C424S185100, C424S275100

Reexamination Certificate

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06268491

ABSTRACT:

BACKGROUND OF THE INVENTION
Recent reports have documented the importance of responses to the Group I (e.g., Der p I and Der f I) and Group II (e.g., Der p II and Der f II) protein allergens in house dust mite allergy. For example, it has been documented that over 60% of patients have at least 50% of their anti-mite antibodies directed towards these proteins (e.g., Lind, P. et al.,
Allergy
, 39:259-274 (1984); van der Zee, J. S. et al.,
Journal Allergy and Clinical Immunology
, 81:884-896 (1988)). It is possible that children show a greater degree of reactivity to the Group I and Group II allergens (Thompson, P. J., et al., Immunology, 64:301-314 (1988)). Allergy to mites of the genus Dermatophagoides (D.) is associated with conditions such as asthma, rhinitis and ectopic dermatitis. Two species,
D. pteronyssinus
and
D. farinae
, predominate and, as a result, considerable effort has been expended in trying to identify the allergens produced by these two species.
A concerted effort has been made to characterize by gene cloning the major allergens from both
D. pteronyssinus
and
D. farinae
. Consequently, several publications have reported the complete nucleotide sequences of several allergens including Der p I (Thomas, W. R., et al.,
International Archives of Allergy and Applied Immunology
, 85:127-129 (1988); and Chua, K. Y., et al.,
Journal of Experimental Medicine
, 167:175-182 (1988)), Der p II (Chua, K. Y., et al.,
International Archives of Allergy and Applied Immunology
, 91:118-123 (1990)), Der f I (Dilworth, R. J., et al.,
Clinical and Experimental Allergy
, 21:25-32 (1891)), Der f II (Yuuki, T., et al.,
Japan Journal Allergol
., 39:557-461 (1990); and Trudinger, M., et al.,
Clinical and Experimental Allergy
, 21:33-37 (1991)) and a low molecular weight allergen (Ovey, E. R., et al.,
Journal of Experimental Medicine
, 170:1457-1462 (1989)).
The published nucleotide sequences of cDNAs encoding Der p I and Der f I demonstrate that these two proteins are highly homologous at the amino acid level (81% identity) and that the mature protein products are comprised of 222 and 223 residues, respectively (Chua, K. Y., et al.,
Journal of Experimental Medicine
, 167:175-182 (1988); and Dilworth, R. J., et al., supra)). The protein allergens Der p II and Der f II are both comprised of 129 residues, and are also highly homologous (88% identity) in amino acid sequence (Trudinger, M., et al. supra; Yuuki, T., et al. supra); Chua, K. Y., et al,
International Archives of Allergy and Applied Immunology
, 91:118-123 (1990)).
The isolation of cDNAs clones encoding Der p I and Der p II has permitted antibody binding studies on the recombinant antigens (Green, W. K., et al.,
International Archives of Allergy and Applied Immunology
, 92:30-38 (1990); Chua, K. Y., et al.,
International Archives of Allergy and Applied Immunology
, 91:124-129 (1990)). Complementary DNA fragments of Der p I have been expressed in
E. coli
and IgE binding studies with pooled human mite allergic IgE sera have demonstrated binding and non-binding regions throughout the molecule (Thomas, W. R., et al., In:
Epitopes of Atopic Allergens. Proceedings of Workshop from XIV Congress of the European Academy of Allergy and Clinical Immunology
, Berlin, September 1989. pp 77-82). T cell epitopes of Der p I have been reported (O'Hehir, R. E., et al.,
Annual Review Immunology
, 9:67-95 (1991); Stewart, G. A., et al., In:
Epitopes of Atopic Allergens, Proceedings of Workshop from XIV Congress of the European Academy of Allergy and Clinical Immunology, Berlin
, September 1989. pp 41-47; Yessel, H., et al., In: T cell Activation in Health and Disease: Discrimination Between Immunity and Tolerance, Conference Sep. 22-26, 1990, Trinity College, Oxford, U.K. and Hessel, H., et al.,
Journal of Immunology
, 148(3): 738-745 (Feb. 1, 1992).
SUMMARY OF THE INVENTION
The present invention provides isolated peptides of the major protein allergens of the genus Dermatophagoides. Preferred peptides within the scope of the invention comprise at least one T cell epitope, and may comprise at least two T cell epitopes of a protein allergen selected from the allergens Der p I, Der p II, Der f I, or Der f II. The invention further provides peptides comprising at least two regions, each region comprising at least one T cell epitope of a mite protein allergen. The regions are derived from the same or from different protein allergens of the genus Dermatophagoides.
The invention also provides modified peptides having similar or enhanced therapeutic properties as the corresponding, naturally-occurring allergen or portion thereof, but having reduced side effects, as well as modified peptides having improved properties such as increased solubility and stability. Peptides of .the invention are capable of modifying, in a house dust mite-sensitive individual to whom they are administered, the allergic response of the individual to a house dust mite allergen or an allergen immunologically cross-reactive with house dust mite allergen. Methods of treatment or of diagnosis of sensitivity to house dust mite in an individual and therapeutic compositions comprising one or more peptides of the invention are also provided.
The present invention further provides optimized therapeutic compositions and multipeptide formulations comprising “unique” peptides of the invention. Such therapeutic compositions have been optimized to accomodate and maintain the unique characteristics of the “unique” peptides of the invention, and at the same time provide maximum therapeutic effect when used in therapeutic regimens for the treatment of house dust mite allergy in humans.


REFERENCES:
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patent: 5552142 (1996-09-01), Thomas et al.
patent: 50598/90 (1991-02-01), None
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patent: WO88/10297 (1988-12-01), None
patent: WO91/06571 (1991-05-01), None
patent: WO92/04445 (1992-03-01), None
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Chua, et al.,J. Exp. Med.,1988, vol. 167(1): 175-182.
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Chua, et al.,Int. Arch. Allergy Appl. Immunol., 1990, vol. 91: 118-123.
Chua, et al.,Clinical and Exp. Allergy, 1991, vol. 21: 161-166.
Dilworth, et al.,Clinical and Exp. Allergy, 1991, vol. 21: 25-32.
Ford, et al.,Clinical and Exp. Allergy, 1989, vol. 20: 27-31.
Greene, et al.,The Journal of Immunol.,1991, vol. 147: 3766-3773.
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Thomas, et al., Epiotpes of Allergies, Proc. of Workshop XIVth Congress Europe Acad. Allergy and Clinical Immunol., Berlin

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