Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Monoclonal antibody or fragment thereof
Reexamination Certificate
2007-12-11
2007-12-11
Rawlings, Stephen L. (Department: 1643)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Monoclonal antibody or fragment thereof
C530S387700, C530S351000, C424S085200, C514S012200
Reexamination Certificate
active
09855342
ABSTRACT:
Methods for treating a subject with a cancer that is characterized by overexpression of HER2 receptor protein using a combination of interleukin-2 (IL-2) or variant thereof and at least one anti-HER2 antibody or fragment thereof are provided. These anti-tumor agents are administered as two separate pharmaceutical compositions, one containing IL-2 (or variant thereof), the other containing at least one anti-HER2 antibody (or fragment thereof), according to a dosing regimen. Administering of these two agents together potentiates the effectiveness of the anti-HER2 antibody alone, resulting in a positive therapeutic response that is improved with respect to that observed with this anti-tumor agent.
REFERENCES:
patent: 4894227 (1990-01-01), Stevens et al.
patent: 2003/0185796 (2003-10-01), Wolin et al.
patent: 2003/0235556 (2003-12-01), Wolin et al.
patent: 0 256 714 (1988-02-01), None
patent: WO 89/06692 (1989-07-01), None
Hank JA, et al. Cancer Res Sep. 1, 1990; 50 (17): 5234-9.
Silwkowski MX, et al. Semin Oncol Aug. 1999; 26 (4 Suppl 12): 60-70.
Keler T, et al. Cancer Res Sep. 15, 1997; 57 (18): 4008-14.
Repka T, et al. Clin Cancer Res. Jul. 2003;9(7):2440-6.
Repp et al. (J Hematother. Oct. 1995; 4 (5): 415-421).
DeGeorge et al. (Cancer Chemother. Pharmacol. 1998; 41 (3): 173-185).
Fleming et al. (Clin. Cancer Res. Dec. 2002; 8: 3718-3727).
Shak (Semin. Oncol. Aug. 1999; 26 (4 Suppl. 12): 71-77).
Soiffer et al. (Clin. Cancer Res. Mar. 1996; 2 (3): 493-499).
Meropol et al. (Cancer Immunol. Immunother. 1998; 46: 318-326).
Kim et al. (Int. J. Cancer. 2002; 102: 428-434).
Kawase et al. (Cancer Res. Mar. 1, 1988; 48 (5): 1173-1179).
Vuist et al. (Cancer Res. Sep. 15, 1990; 50 (18): 5767-5772).
Cooley et al. (Exp. Hematol. Oct. 1999 ; 27 (10): 1533-1541).
Skog et al. (Cancer Immunol. Immunother. Nov. 1999; 48 (8): 463-470).
Caron et al. (Clin. Cancer Res. Jan. 1995; 1 (1): 63-70).
Chachoua et al. (J. Immunother. Emphasis Tumor Immunol. Aug. 1994; 16 (2): 132-141).
Keilholz et al. (Leuk. Lymphoma. Nov. 1999; 35 (5-6): 641-642).
Vlasveld et al. (Cancer Immunol. Immunother. Jan. 1995; 40 (1): 37-47).
Sosman et al. (J. Clin. Oncol. Aug. 1993; 11 (8): 1496-1505).
Repka et al. (Clin. Cancer Res. Jul. 2003; 9: 2440-2446).
Baselga et al. (J. Clin. Oncol. Mar. 1996; 14 (3): 737-744).
Jiang et al. (J. Biol. Chem. Feb. 11, 2005; 280 (6): 4656-4662).
Riemer et al. (J. Immunol. 2004; 173: 394-401).
Masui et al. (Cancer Res. Nov. 1986; 46 (11): 5592-5598).
Baselga et al. (Semin. Oncol. Aug. 1999; 26 (4 Suppl. 12): 78-83).
Kossman et al. (Clin. Cancer Res. Oct. 1999; 5: 2748-2755).
Caligiuri et al. (J. Clin. Invest. Jan. 1993; 91: 123-132).
Greenspan et al. (Nature Biotechnology. 1999; 7: 936-937).
Caldas et al. (Mol. Immunol. May 2003; 39 (15): 941-952).
Dennis (Nature. Aug. 7, 2006; 442: 739-741).
Kelland (Eur. J. Cancer. Apr. 2004; 40 (6): 827-836).
Saijo et al. (Cancer Sci. Oct. 2004; 95 (10): 772-776).
Kipps et al. (J. Exp. Med. Jan. 1, 1985; 161 (1): 1-17).
Campbell et al. (Blood Reviews. 2003; 17:143-152).
De Santes et al. (Cancer Research 1992; 52: 1916-1923).
Mariuzza et al (Annu. Rev. Biophys. Biophys. Chem. 16: 139-159, 1987).
Gussow et al. (Methods in Enzymology. 1991; 203: 99-121).
Giusti et al. (Proc. Natl. Acad. Sci. USA. May 1987; 84 (9): 2926-2930).
Chien et al. (Proc. Natl. Acad. Sci. USA. Jul. 1989; 86 (14): 5532-5536).
Dierksheide et al. (1999) “Fc Receptor Cross-Linking in the Presence of Interleukin-12 is a Potent Stimulus to Natural Killer Production of Interferon-gamma: Implications for Anti-Her2 Antibody Therapy,”Proceedings of the American Association for Cancer Research40: 77 (XP002171956).
Fleming et al. (1999) “Phase I Trial of Recombinant Human Anti-Her2 Monoclonal Antibody (H) Plus Low-Dose Interleukin-2 (IL-2) in Patients with Solid Tumors,”Proceedings of the Annual Meeting of the American Society for Clinical Oncology18: A710 (XP001010378).
Kopreski et al. (1996) “Growth Inhibition of Breast Cancer Cell Lines by Combinations of Anti-P185Her2Monoclonal Antibody and Cytokines,”Anticancer Research16: 433-436 (XP000973070).
Li et al. (1999) “Preparation and Characterization of a Human Interleukin-2 and Anti-Human Her2 ScFv Fusion Protein,”Proceedings of the American Association for Cancer Research40: 358 (XP002171954).
Li et al. (2000) “Chemical Conjugation of a Novel Antibody-Interleukin 2 Immunoconjugate Against c-erbB-2 Product,”Chinese Medical Journal113: 151-153 (XP000925246).
Tagliaferri et al. (1996) “Differential Sensitivity to Non-Major Histocompatibility Complex-Restricted Recombinant Interleukin 2-Activated Lymphocyte Killing of Human Mammary Epithelial MCF-10A Cells Overexpressing Oncogenes or Protein Kinase A Subunits,”Clinical Cancer Research2: 207-214 (XP002171953).
Weiner et al. (1995) “Clinical Development of 2B1, A Bispecific Murine Monoclonal Antibody Targeting c-erbB-2 and Fc-gamma-RIII,”Journal of Hematotherapy4: 453-456 (XP002048529).
“Questions and Answers about NCI's Expanded Research with Herceptin (R),”National Cancer Institute, Backgrounders, Online! Bethesda, MD (Sep. 28, 1998).
Meropol et al. (1996) “Daily Subcutaneous Injection of Low-Dose Interleukin 2 Expands Natural Killer Cells in Vivo Without Significant Toxicity,”Clin. Cancer Res. 2: 669-677.
Meropol et al. (1998) “Evaluation of Natural Killer Cell Expansion and Activation on Vivo with Daily Subcutaneous Low-Dose Interleukin-2 Plus Periodic Intermediate-Dose Pulsing,”Cancer Immunol. Immunother46: 318-326.
Burgess et al., “Possible Dissociation of the Heparin-Binding and Mitogenic Activities of Heparin-Binding (Acidic Fibroblast) Growth Factor-1 From Its Receptor-Binding Activities by Site-Directed Mutagenesis of a Single Lysine Residue,” The Journal of Cell Biology, 111:2129-2138 (1990).
Lazar et al., “Transforming Growth Factor α: Mutation of Aspartic Acid 47 and Leucine 48 Results in Different Biological Activities”, Molecular and Cellular Biology, 8(3):1247-1252 (1988).
Leyland-Jones, “Dose Scheduling-Herceptin,” Oncology, 61(2):31-36 (2001).
Caligiuri Michael A.
Meropol Neal J.
Schilsky Richard L.
ARCH Development
Health Research , Inc.
Rawlings Stephen L.
Robins & Pasternak LLP
LandOfFree
Methods of therapy for cancers characterized by... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Methods of therapy for cancers characterized by..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Methods of therapy for cancers characterized by... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3895338