Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector
Reexamination Certificate
2000-02-22
2003-02-04
Caputa, Anthony C. (Department: 1642)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
C424S190100, C424S197110, C424S236100, C424S240100, C424S277100, C424S278100, C424S094100, C424S094500, C514S002600, C530S350000
Reexamination Certificate
active
06514499
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to the fields of medicine and biology. In particular, the present invention is directed towards compositions exhibiting ADP-ribosyltransferase activity which have prophylactic and/or therapeutic activity (e.g., in preventing cancer metastasis, preventing recurrence or reducing the incidence of cancers), as well as methods for the preparation and use thereof.
The use of surgery and radio- or chemotherapy to treat cancer involves the risk of serious side-effects and even death, yet frequently fails to produce substantive benefit. It is not surprising that these methods are rarely used to prevent cancer. It is clear there is a need for better methods to prevent or cure cancer and/or ameliorate the symptoms thereof in a patient.
Immune responses can effectively kill cells that display antigens that mark cells is harboring a pathogen. Vaccines containing such antigens can stimulate these desired responses and protect against disease with little risk. Coupling this experience with the hypothesis that malignant cells may also present a similar marker has led many investigators to search for vaccines that could prevent or cure various types of cancer [McCall, C. A., Wiemer, L., Baldwin, S., & Pearson, F. C. (1989)
Bio/technology
, 7, 231-240; Rosenburg, S. A. (1992)
J. Clin. Oncol
10, 180-199; Prehn, R. T. (1993)
Proc. Natl. Acad. Sci. U.S.A
. 90, 4332-4333]. The successful development of such a vaccine would involve identifying preparations containing tumor-associated antigens, and learning how to prompt the immune system to properly and specifically kill cells displaying those antigens.
Some vaccines have been spectacularly successful it preventing infectious disease (e.g., smallpox); attempts to make other vaccines have, to date, failed (e.g., AIDS). At times, the lack of success may arise from a failure to elicit a proper response to an antigen, not the unavailaibility of a suitaible antigen. These failures suggest that methods that control immune responses to antigens could greatly benefit the performance of vaccines designed to prevent, treat and/or cure infectious disease.
Similar issues face the development of cancer vaccines. For example, injecting irradiated tumor cells frequently fails to elicit an effective anti-tumor response. However, injecting irradiated tumor cells previously transfected with genes causing production of lymphokines (e.g., GM-CSF) [Dranoff; G., Jaffee, E., Lazenby, A., Golumbeck, P., Levitsky, H., Brose, K., Jackson, V., Hamada, H., Pardoll, D., & Mulligan, R. C. (1993)
Proc. Natl. Acad. Sci. U.S.A
. 90, 3539-3543] can promote anti-tumor responses. Similar results have been obtained with tumor cells transfected to produce foreign major histocompatibility complexes [Plautz, G. E., Yang, Z. Y., Wu, B. Y., Gao, X., Huang, L., & Nabel, G. (1993)
Proc. Natl. Acad. Sci. U.S.A
. 90, 4645-4649], or adhesins, such as B7, normally found on the surface of antigen-presenting cells [Chen, L., Ashe, S., Brady, W. A., Hellstroem, I., Hellstroem, K. E., Ledbetter, J. A., McGowan, P., & Linsley, P. S. (]992)
Cell
71, 1093-1102; Schwarz, R. H. (1992)
Cell
71, 1068-1068; Baskar, S., Ostrand-Rosenburg, S., Nabavi, N., Nadler, L. M., Freeman, G. J., & Glimcher, L. H. (1993)
Proc. Natl. Acad. Sci. U.S.A
. 90, 5687-5690; Townsend, S. E., & Allison, J. P. (1993)
Science
. 259, 368-370]. Yet another approach has been to stimulate the immune system with bacteria or factors derived therefrom [McCall et al., 1989, supra].
Pertussis toxin is a protein released from the bacterium
Bordetella pertussis
. The administration of pertussis toxin along with a proper antigen markedly enhances antigen-specific autoimmune disease [Munoz, J. J. (1988) in
Pathogenesis asid Immunity in Pertussis
(Wardlaw, A. C., & Parton, R., Eds.) Chapter 8, pp. 173-192, John Wiley & Sons Ltd., New York; Kamradt, T., Soloway, P. D., Perkins, D. L., & Gefter, M. L. (1991)
J. Immunol
. 147, 3296-3302] and antigen-specific delayed-type hypersensitivity reactions, but not antigen-independent inflammatory responses [Sewell, W. A., Munoz, J. J., & Vadas, M. A. (1983)
J. Exp. Med
. 157, 2087-2096; Sewell, W. A., Munoz, J. J., Scollay, R., & Vadas, M. A. (1984)
J. Immunol
. 133, 1716-1722]. There are reports [Likhite, V. V. (1983) U.S. Pat. No. 4,372,945; Minagawa, H., Kakamu, Y., Yoshida, H., Tomita, F., Oshima, H., & Mizuno, D. I. (1988)
Jpn. J. Cancer Res
. 79, 384-389; Minagawa, H., Kobayashi, H., Yoshida, H., Teranishi, M., Morikawa, A., Abe, S., Oshima, H., & Mizuno, D. I. (1990)
Br. J. Cancer
62, 372-375] that crude preparations of
B. pertussis
can cause anti-tumor responses; the factor in these preparations causing this effect was not identified. Others have shown that lipopolysaccharides from
B. pertussis
can stimulate anti-tumor responses [Ohnishi, M., Kimura, S., Yarnazaki, M., Abe, S., & Yamaguchi, H. (1994)
Microbiol. Immunol
. 38, 733-739; Olinishi.M, Kimura, S., Yamazaki, M., Oshimna, H., Mizuno, D.-I., Abe, S., & Yamaguchi, H. (1994)
Br. J. Cancer
69, 1038-1042].
It is an object of the present invention to provide compositions and methods which do not suffer from the drawbacks attendant to the heretofore-available compositions and methods. In particular, it is an object of the present invention to provide compositions which increase the efficacy of other compositions and methods.
SUMMARY OF THE INVENTION
In accordance with the present invention, there are provided compositions characterized by ADP-ribosyltransferase activity. These compositions are useful in promoting prophylactic and/or therapeutic responses as are promoted by, e.g., pertussis toxin but directed against another target antigen (e.g., a cancer-related antigen) in a mammalian patient.
REFERENCES:
G. Ada, “The coming of age of tumour immunotherapy”, Immunology and Cell biology, vol. 77, pp. 180-185. 1999.*
Hiraki et al, “Loss of HLA haplotype in lung cancer . . . ”, Clinical Cancer Research, vol. 5, pp. 933-936. Apr. 1999.*
Paul et al, “HLA-G expression in melanoma: a way for tumor cells to escape . . . ”, PNAS, vol. 95, pp. 4510-4515. Apr. 1998.*
Becker et al, “Tumor escape mechanisms from immunosurveillance . . . ”, International Immunology, vol. 5, pp. 1501-1508. 1993.*
Welt and Ritter, “Antibodies for the therapy of colon carcinoma”, Seminars in Oncology, vol. 26, pp. 683-690. Dec. 1999.*
Blumenthal et al, “Physiological factors influencing radioantibody uptake . . . ”, International Journal of Cancer, vol. 51, pp. 935-941. 1992.*
V. Likhite, “The delayed and long-lasting rejection of mammary adenocarcinoma . . . ”, Cancer Research, vol. 34, pp. 1027-1030. May 1974.*
Yoo et al, “Effect ofBordetella pertussisvaccine on growth of hepatoma”, The Lancet, pp. 402-403. Feb. 1975.*
Black et al, “ADP-ribosyltransferase activity of pertussis toxin . . . ”, Science, vol. 240, pp. 656-659. (abstract). Apr. 1988.*
Wilson et al, “Adjuvant action of . . . pertussis toxin in the induction of IgA antibody response . . . ”, Vaccine, vol. 11, pp. 113-118. 1993.*
Chirgos et al, “Chemical and biological adjuvents capable of potentiating tumor cell vaccine”, Cancer Research, vol. 38, pp. 1085-1091. Apr. 1978.*
Gonzalo et al, “Pertussis Toxin Interferes with Superantigen-Induced Deletion of Peripheral T Cells . . . ”, Journal of Immmunology, vol. 152, No. 9, pp. 4291-4299. May 1994.*
Lycke et al, “The adjuvant effect ofVibro choleraeandEscherichia coliheat-labile enterotoxins is linked to their ADP-ribosyltransferase activity”, Eur Journal of Immunology, vol. 22, No. 9, pp. 2277-2281. 1992.
Canella Karen A.
Caputa Anthony C.
Fulbright & Jaworski LLP
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