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United States Patent (19) 11 Patent Number: 5,866,129 Chang Et Al USOO5866129A United States Patent (19) 11 Patent Number: 5,866,129 Chang et al. (45) Date of Patent: Feb. 2, 1999 54 METHOD OF PRODUCING AN ANTIBODY OTHER PUBLICATIONS WITH A PEPTIDE CORRESPONDING TO MEMBRANE-BOUND IGA Lawton et al., IgA determinants on B-lymphocytes in patients with deficiency of circulating IgA, J. Lab. Clin. (75) Inventors: Tse Wen Chang; Nancy T. Chang, both of Houston, TeX. Med., 80(1):26–33, Jul 1972. Durkin et al., orignin and fate of IgE-bearing lymphocytes. Assignee: Tanox Biosystems, Inc., Houston, Tex. I. Peyer's patches as differentiation site of cell simulta neously bearing IgA and IgE, J. Exp. Med., 154(3):640-648, Appl. No.: 785,565 Sep. 1981. Filed: Nov. 4, 1991 Emancipator et al. IgA Immune Complex Renal disease 1983. Annals of the N.Y. Academy of Science vol. Related U.S. Application Data 409:171-176. Ed. J.R. McGhee and J. Mestecky. 60 Division of Ser. No. 455,080, Dec. 22, 1989, Pat. No. 5,089.603, which is a continuation-in-part of Ser. No. 369, 479, Jun. 21, 1989, Pat. No. 5,079,344. Primary Examiner David L. Fitzgerald ASSistant Examiner-Claire M. Kaufman 51 Int. Cl. ........................ A61K 39/395; CO7K 16/42; Attorney, Agent, or Firm-Eric P. Mirabel CO7K 16/28 52) U.S. Cl. ..................................... 424/185.1; 530/387.2; 57 ABSTRACT 530/388.73; 530/300; 530/350 58 Field of Search ..................................... 530/387, 300, The invention relates to a method of using a peptide which 530/350, 387.3, 388.73, 412; 514/12, 2; has the Sequence of epitopes which are present on B cell 424/185.1 bound but not secreted IgA. This induces production of the antibody itself. These extracellular peptide Segments form, 56) References Cited entirely or in part, antigenic epitopes unique to membrane bound but not Secreted IgA. U.S. PATENT DOCUMENTS 4,636,463 1/1987 Altman et al. .............................. 435/7 2 Claims, No Drawings 5,866,129 1 2 METHOD OF PRODUCING AN ANTIBODY It has been found that individuals with low IgA produc WITH A PEPTIDE CORRESPONDING TO tion are more prone to various infectious diseases and have MEMBRANE-BOUND IGA a higher tendency to develop allergic diseases than those with normal IgA levels. Thus if the levels of either total IgA RELATED APPLICATIONS 5 or antigen-Specific IgA can be increased, the diseases or allergies may be prevented. This application is a divisional of application Ser. No. It is also well known that various allergenic Substances 07/455,080, filed Dec. 22, 1989, now U.S. Pat. No. 5,089, enter through inhalation and food ingestion, causing 603, which is a continuation-in-part of Serial No. 07/369, immediate-type, antibody-mediated hyperSensitivities and 479 filed Jun. 21, 1989, now U.S. Pat. No. 5,079,344. delayed-type, cell-meditated hyperSensitivities. In Sensitized Priority is claimed to both these applications. 1O individuals, the IgE-mediated reactions against pollens, ani mal danders, dust mites, and other allergenic antigens cause FIELD OF THE INVENTION the common allergic Symptoms, Such as allergic rhinitis The invention relates to a method of treating an infectious ("hay fever”) and extrinsic asthma. In Such allergic disease through administering a peptide with a sequence 15 responses, the allergens enter the mucosal layers of the which corresponds to epitopes which are present on B respiratory tracts and nasal linings and bind to allergen Specific IgE which is on the Surface of basophils and mast cell-bound but not Secreted IgA. cells. The binding of IgE by the allergens on the basophils BACKGROUND OF THE INVENTION and mast cell Surface causes croSS-linking of the underlying IgE Fc receptors, and triggers the release of histamines and B lymphocytes produce five classes of immunoglobulins, 2O other pharmacologic mediators, resulting in various allergic which mediate different functions. IgM is most effective in Symptoms. In the cell-mediated hyperSensitivities, certain T complement fixation, IgG causes opSonization and cellular helper cells responsible for delayed-type hyperSensitivity cytotoxicity and can croSS the placenta. IgA functions on the are activated. These T cells recruit and activate mucosal Surface and IgE mediates degranulation of mast 25 macrophages, causing inflammatory Symptoms. cells and basophils. The function of Ig|D is still not well It has been shown that antibodies which bind to epitopes understood. These antibodies are present in the blood of B cell membrane-bound immunoglobulins can be used to circulation, with IgG, IgA, and IgM being the major Serum eliminate B cells producing the immunoglobulins. In components. particular, antibodies Specific for the antigenic epitope In addition to Secreting immunoglobulins, the B cells also located on the transmembrane anchoring peptide of B cell express different isotypes of the immunoglobulins on their membrane-bound (but not Secreted) IgE can be used for cell Surfaces at different Stages of maturation. IgM and Ig) removing IgE Secreted B cells in patients Suffering from are present on the Surface of resting, uncommitted B cells, IgE-mediated allergies, as described the published interna while often only one of the five classes of immunoglobulins tional PCT/US88/04706 patent application, filed Dec. 29, may exist on late Stage, mature B cells, which Secrete the 35 1988. Same immunoglobulin isotype as expressed on their cell Antibodies that belong to certain immunoglobulin classes Surface. Teale, J.M., et al., J. Immunol. 1126:1952-1957 and Subclasses, Such as murine IgG and human IgG and (1981); Gathings, W. E., et al., Immunol. Rev. 57:107-126 that bind with an appropriately high affinity to Surface (1981); Teale, J. M., Fed. Proc. 41:5-9 (1982). antigens of target cells can lyse those target cells. However, Numerous pathogenic microorganisms, Such as bacteria 40 as noted above, not all antibodies Specific for target cells will and viruses, enter the body through the respiratory, cause cytolysis, and Some in fact cause isotype Switching, gastrointestinal, and genitourinary tracts during air proliferation, and increased or decreased antibody produc inhalation, food and liquid intake, and Sexual contact. The tion. See Vitetta, E. D., et al., Immunol. Rev. 52:211-231 potentially allergenic Substances, e.g., tree, grass, and flower (198); Cooper, M.D., et al., Immunol. Rev. 52:29-53 (1980). pollens, dust mites, fungal particles and animal dander, also 45 In numerous Studies, polyclonal antibodies have also been enter the body through the respiratory tract. Secretory IgA shown to induce B cell proliferation. See Sell, S. and Gell, antibodies help to defend against these pathogens and aller P.G.H., J. Exp. Med 122:423–44 (1965); Kishimoto, T., et genS. al., J. Immunol. 115:1179–1184 (1975); Parker, D. C., IgA is produced by plasma cells located along the Nature 258:361-363 (1975); Sieckmann, D. G., et al., J. mucosal linings of the aforementioned tracts, which are all 50 Exp. Med. 147:814–829; Pure, E. and Vitetta, E. S., J. exposed to the external environment. The C. chain and light Immunol. 125:1240–1242 (1980). Unlike antibody chain immunoglobulins produced by plasma cells combine dependent cellular cytotoxicity and complement-mediated with a Secretory component produced by the epithelial cells cytolysis, this proliferative response does not seem to in the mucosal tissues, forming Secretory IgA molecules that involve the Fc of the antibodies. It has been shown that are Secreted to the Surface of mucosal layers. See generally 55 F(ab') is more effective than whole antibody in inducing the J. G. Nedrud et al., “Adjuvants and the Mucosal Immune proliferative effect, Vitetta, E. S. et al., Immunol. Rev. System”, Topics in Vaccine Adjuvant Research, (Spiggs, D. 52:211-231 (1980), indicating the absence of Fc involve E., Koff, W. C., Eds.) CRC Press, Boca Raton, Fla. (1990). ment. These Secretory IgA molecules bind to the invading patho Numerous investigators have Studied effects of anti-Ig gens and weaken their ability to penetrate the mucosal layer 60 antibodies on the activity of B cells. A review article, and to enter the inner tissue and blood stream of the host. See “Effects of anti-immunoglobulin sera on B lymphocyte generally J. G. Nedrud et al., “Adjuvants and the Mucosal function”, Immunol. Rev. Vol. 52, ed. by Moller, G. (1980), Immune System”, Topics in Vaccine Adjuvant Research, States that anti-Ig antibodies have a variety of effects on B (Spiggs, D. E., Koff, W. C., Eds.) CRC Press, Boca Raton, cells, including the ability to cause proliferation of B cells. Fla. (1990). IgA can also bind allergenic substances, thereby 65 In addition, anti-IgM and anti-IgED antibodies appear to be preventing the allergens from binding IgE or activating the able to Switch the resting uncommitted B cells to producers T cells responsible for delayed-type hyperSensitivity. of IgG and IgA. These studies show that divalent antibodies 5,866,129 3 4 which cross-link the Surface Ig are required to Stimulate B J. et al., Cell, 26:19-27 (1981); Yamawaki-Kataoka, Y. et al., cell proliferation. These effects do not require Fc portions of Proc. Natl. Acad. Sci., USA, 79:2008–2012 (1982); the antibodies and, in fact, the F(ab')2 fragments appear to be Kamaromy, M. et al., Nucleic Acids Res., 11:6775-6785 more effective than whole IgG in stimulating B cell prolif (1983); Rogers, J. et al., Cell, 20:303-312 (1980); Bernstein, eration. K. E., J. Immunol. 132:490–495 (1984); Cheng, H. et al., Nature, 296:410–415 (1982); Robbitts, T. H. et al., Nucleic Proliferating B cell with anti-Ig antibodies seem highly Acids Res. 9:4509-4524. These sequences indicate certain desirable for enhancing antibody production in Vivo.
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