Organic compounds -- part of the class 532-570 series – Organic compounds – Carbohydrates or derivatives
Reexamination Certificate
2000-03-24
2002-06-25
Gambel, Phillip (Department: 1644)
Organic compounds -- part of the class 532-570 series
Organic compounds
Carbohydrates or derivatives
C536S023100, C435S069100, C435S455000, C435S471000, C435S235100, C435S252300, C435S320100
Reexamination Certificate
active
06410714
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to canine low affinity IgE receptor (CD23) nucleic acid molecules, proteins encoded by such nucleic acid molecules, antibodies raised against such proteins, compounds capable of regulating, e.g. inhibiting or activating, the function of such proteins, and methods to identify such regulatory compounds. The present invention also includes therapeutic compositions comprising such nucleic acid molecules, proteins, antibodies, or regulatory compounds, as well as methods and kits to detect such proteins.
BACKGROUND OF THE INVENTION
Immunoglobulin E (IgE) is an important molecule in the establishment and progression of allergic disease in an animal. IgE antibody mediates allergy related diseases, for example atopic dermatitis, asthma, inflammation, hay fever, and food sensitivities. The presence of IgE or elevated levels of IgE in an animal is indicative of such diseases.
Recently, it has been shown in humans and in mice that CD23, or low-affinity IgE receptor, has a role in the regulation of IgE levels. For example, CD23 present on B cells, when bound by IgE, transduces a feedback-inhibitory signal that prevents further IgE synthesis. Additionally, CD23 present on antigen presenting cells can interact with antigen IgE complexes, causing internalization of the antigen-IgE complex, more efficient presentation of the antigen to T cells, and an enhanced response to the antigen. This phenomenon is called IgE-mediated antigen presentation, and can be responsible for antigen sensitization and development of allergies. A soluble form of CD23, referred to as sCD23, may regulate immune and/or inflammatory responses. This soluble form of CD23 is capable of binding to IgE-producing B cells, apparently via IgE or a receptor called CD21, and causing up-regulation of IgE production in that B cell. In yet another role, soluble CD23 can interact with inflammatory cells, such as monocytes and macrophages, apparently via the receptors CD11b and CD11c on the surface of the inflammatory cells, causing the inflammatory cells to elaborate proinflammatory cytokines, for example interleukin-1 alpha, interleukin-6, and interferon gamma.
Until the discovery of the present invention, intervention in allergic diseases in canids, or dogs, by manipulating the regulation of IgE levels in dogs or IgE-mediated antigen presentation by CD23 has been hindered by the absence of reagents capable of such action. Additionally, detection of CD23 levels in canids has been hindered by the absence of suitable reagents for detection of CD23.
Prior investigators have disclosed nucleic acid sequences encoding: the human low affinity IgE receptor, also known as human CD23, (Ikuda, et al.,
Proc. Natl. Acad. Sci.
vol. 84, p 819-823, 1987; Kikutani,
Cell,
vol. 47, pp 657-660, 1986; Ludin, C. et al.,
Embo J.
vol. 6, pp 109-113, 1987; and others); the mouse low affinity IgE receptor, also known as mouse CD23, Nunez, et al.
Pathobiology
vol. 61, pp 128-137, 1993; and the rat low affinity IgE receptor, also known as rat CD23, (Genbank accession number X73579, 1993.) Although the human CD23 was known as early as 1986, it has never been used to identify a canine CD23 nucleic acid sequence or protein. Similarly, although nucleic acid sequences encoding rat and mouse CD23 have been known since 1993, they have never been used to identify a nucleic acid sequence, encoding the canine CD23 protein or nucleic acid molecule. Moreover, the determination of the nucleic acid sequences of human, rat and mouse CD23 genes and/or cDNAs does not indicate, suggest or predict the cloning of a novel CD23 gene from a different species, in particular, from a canine species.
Thus, products and processes of the present invention are needed in the art that will provide specific detection of CD23 and treatment of CD23-mediated disease in canids, including, but not limited to, domestic dogs.
SUMMARY OF THE INVENTION
The present invention relates to a novel product and process for protection of canids from diseases mediated by canine low affinity IgE receptor, also known as canine CD23. Identification of a CD23 of the present invention is unexpected because initial attempts using the primers containing the most similar nucleic acid sequences identified by previous investigators failed.
According to the present invention there are provided canine CD23 proteins, and derivatives thereof; canine CD23 nucleic acid molecules, including those that encode such proteins; antibodies raised against such CD23 proteins (i.e. anti-CD23 antibodies); and compounds that regulate, i.e. inhibit or activate, CD23 production or activity.
The present invention also includes methods to obtain such proteins, derivatives, nucleic acid molecules, antibodies and regulatory compounds. Also included in the present invention are therapeutic compositions comprising a protective compound derived from a protein of the present invention that inhibits or activates the activity of canine CD23 as well as methods to use such therapeutic compositions to reduce allergy or inflammation. Also included in the present invention are novel methods to detect canine CD23, and an assay kit for detecting the presence of canine CD23.
One embodiment of the present invention is an isolated nucleic acid molecule having a length greater than or equal to about 150 nucleotides which hybridizes under conditions that allow less than or equal to about a 10% base pair mismatch with a nucleic acid sequence selected from the group consisting of SEQ ID NO:1, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:12, SEQ ID NO:13, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:21, SEQ ID NO:24, and/or SEQ ID NO:26; or a fragment thereof having at least about 47 nucleotides.
Another embodiment of the present invention is an isolated nucleic acid molecule selected from the group consisting of a nucleic acid comprising a nucleic acid sequence selected from the group consisting of SEQ ID NO:1, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:12, SEQ ID NO:13, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:21, SEQ ID NO:24, and/or SEQ ID NO:26; and a nucleic acid molecule comprising an at least 30 nucleotide portion identical in sequence to a consecutive 30 nucleotide portion of at least one of the sequences named above.
The present invention also relates to recombinant molecules, recombinant viruses and recombinant cells that include a canine CD23 nucleic acid molecule of the present invention. Also included are methods to produce such nucleic acid molecules, recombinant molecules, recombinant viruses and recombinant cells.
Another embodiment of the present invention includes an isolated canine CD23 protein selected from the group consisting of (a) a protein comprising an amino acid sequence that is at least about 70% identical to an amino acid sequence selected from the group consisting of SEQ ID NO:2, SEQ ID NO:5, SEQ ID NO:8, SEQ ID NO:1, SEQ ID NO:14, SEQ ID NO:17, SEQ ID NO:20 and/or SEQ ID NO:25, wherein said protein is at least about 80 amino acids in length; (b) a protein comprising an amino acid sequence having SEQ ID NO:2, SEQ ID NO:5, SEQ ID NO:8, SEQ ID NO:11, SEQ ID NO:14, SEQ ID NO:17, SEQ ID NO:20 and/or SEQ ID NO:25, or a protein comprising a fragment thereof, wherein said fragment is capable of binding to IgE;(c) a protein comprising an amino acid sequence having SEQ ID NO:2, SEQ ID NO:5, SEQ ID NO:8, SEQ ID NO:11 SEQ ID NO:14, SEQ ID NO:17, SEQ ID NO:20 and/or SEQ ID NO:25, or a protein comprising a fragment thereof, wherein said fragment is capable of binding to a receptor selected from the group consisting of CD21, CD11b and CD11c; and (d) a protein encoded by an allelic variant of a nucleic acid molecule encoding any protein of (a), (b), and/or (c).
The present invention also relates to derivatives of canine CD23 proteins as well as to isolated antibodies that selectively bind to canine CD23 proteins or derivatives thereof. Also included are
McCall Catherine A.
Weber Eric R.
Gambel Phillip
Heska Corporation
Heska Corporation
Roark Jessica H.
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