Title:
METHODS OF TREATMENTS USING CTLA4 ANTIBODIES
Document Type and Number:
WIPO Patent Application WO/2013/142796
Kind Code:
A3
Abstract:
In certain embodiments, the present invention, the present invention provides a method of treating a cancer in a subject, comprising: (a) administering to the subject a predetermined dosage of an anti-CTLA4 antibody; (b) detecting the level of the anti-CTLA4 antibody in a sample of the subject; and (c) increasing the dosage of the anti-CTLA4 antibody in the subject if the level of the anti-CTLA4 antibody from step (b) is below a threshold exposure level, such that the cancer is treated.
Inventors:
ROY AMIT (US)
FENG YAN (US)
STOUFFER BRUCE C (US)
FENG YAN (US)
STOUFFER BRUCE C (US)
Application Number:
PCT/US2013/033513
Publication Date:
December 19, 2013
Filing Date:
March 22, 2013
Export Citation:
Assignee:
BRISTOL MYERS SQUIBB CO (US)
International Classes:
A61K39/395; C07K16/28
Domestic Patent References:
| WO2003086459A1 | 2003-10-23 | |||
| WO2007067959A2 | 2007-06-14 | |||
| WO2001014424A2 | 2001-03-01 |
Other References:
MAKER AJAY V ET AL: "Intrapatient dose escalation of anti-CTLA-4 antibody in patients with metastatic melanoma.", JOURNAL OF IMMUNOTHERAPY (HAGERSTOWN, MD. : 1997) 2006 JUL-AUG, vol. 29, no. 4, July 2006 (2006-07-01), pages 455 - 463, XP009171182, ISSN: 1524-9557
LANGER LEE F ET AL: "Update on anti-CTLA-4 antibodies in clinical trials.", EXPERT OPINION ON BIOLOGICAL THERAPY AUG 2007, vol. 7, no. 8, August 2007 (2007-08-01), pages 1245 - 1256, XP009171143, ISSN: 1744-7682
RIBAS ANTONI ET AL: "Antitumor activity in melanoma and anti-self responses in a phase I trial with the anti-cytotoxic T lymphocyte-associated antigen 4 monoclonal antibody CP-675,206.", JOURNAL OF CLINICAL ONCOLOGY : OFFICIAL JOURNAL OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY 10 DEC 2005, vol. 23, no. 35, 10 December 2005 (2005-12-10), pages 8968 - 8977, XP002702513, ISSN: 0732-183X
F. STEPHEN HODI ET AL: "Improved Survival with Ipilimumab in Patients with Metastatic Melanoma", NEW ENGLAND JOURNAL OF MEDICINE, vol. 363, no. 8, 19 August 2010 (2010-08-19), pages 711 - 723, XP055015428, ISSN: 0028-4793, DOI: 10.1056/NEJMoa1003466
AJAY V MAKER ET AL: "Tumor Regression and Autoimmunity in Patients Treated With Cytotoxic T Lymphocyte-Associated Antigen 4 Blockade and Interleukin 2: A Phase I/II Study", ANNALS OF SURGICAL ONCOLOGY, SPRINGER-VERLAG, NE, vol. 12, no. 12, 1 December 2005 (2005-12-01), pages 1005 - 1016, XP019369612, ISSN: 1534-4681
TARHINI AHMAD A ET AL: "CTLA-4 blockade: therapeutic potential in cancer treatments", ONCOTARGETS AND THERAPY, DOVE MEDICAL PRESS LTD, GB, vol. 3, 1 January 2010 (2010-01-01), pages 15 - 25, XP009167476, ISSN: 1178-6930, [retrieved on 20100624]
CAMACHO LH, RIBAS A, GLASPY JA ET AL.: "Phase 1 clinical trial of anti-CTLA4 human monoclonal antibody CP-675,206 in patients (pts) with advanced solid malignancies", J CLIN ONCOL (MEETING ABSTRACTS), vol. 22, no. 14_SUPPL 2505, July 2004 (2004-07-01), XP002702514
RIBAS ET AL: "Anti-CTLA4 antibody clinical trials in melanoma", UPDATE ON CANCER THERAPEUTICS, ELSEVIER, AMSTERDAM, NL, vol. 2, no. 3, 22 October 2007 (2007-10-22), pages 133 - 139, XP022371752, ISSN: 1872-115X, DOI: 10.1016/J.UCT.2007.09.001
A. RIBAS: "Overcoming Immunologic Tolerance to Melanoma: Targeting CTLA-4 with Tremelimumab (CP-675,206)", THE ONCOLOGIST, vol. 13, no. Supplement 4, 1 October 2008 (2008-10-01), pages 10 - 15, XP055015427, ISSN: 1083-7159, DOI: 10.1634/theoncologist.13-S4-10
PAOLO A ASCIERTO ET AL: "Anti-CTLA4 monoclonal antibodies: the past and the future in clinical application", JOURNAL OF TRANSLATIONAL MEDICINE, vol. 9, no. 1, 1 January 2011 (2011-01-01), pages 196, XP055071066, ISSN: 1479-5876, DOI: 10.1186/1479-5876-8-38
GLOFF C A ET AL: "Pharmacokinetics and protein therapeutics", ADVANCED DRUG DELIVERY REVIEWS, ELSEVIER BV, AMSTERDAM, NL, vol. 4, no. 3, 1 January 1990 (1990-01-01), pages 359 - 386, XP023756086, ISSN: 0169-409X, [retrieved on 19900101], DOI: 10.1016/0169-409X(90)90027-P
RICARDO J. SOLĂ ET AL: "Glycosylation of Therapeutic Proteins", BIODRUGS, vol. 24, no. 1, 1 February 2010 (2010-02-01), pages 9 - 21, XP055016446, ISSN: 1173-8804, DOI: 10.2165/11530550-000000000-00000
CONSTANTINOU A ET AL: "Modulating the pharmacokinetics of therapeutic antibodies", BIOTECHNOLOGY LETTERS, SPRINGER NETHERLANDS, DORDRECHT, vol. 32, no. 5, 4 February 2010 (2010-02-04), pages 609 - 622, XP019787094, ISSN: 1573-6776
LANGER LEE F ET AL: "Update on anti-CTLA-4 antibodies in clinical trials.", EXPERT OPINION ON BIOLOGICAL THERAPY AUG 2007, vol. 7, no. 8, August 2007 (2007-08-01), pages 1245 - 1256, XP009171143, ISSN: 1744-7682
RIBAS ANTONI ET AL: "Antitumor activity in melanoma and anti-self responses in a phase I trial with the anti-cytotoxic T lymphocyte-associated antigen 4 monoclonal antibody CP-675,206.", JOURNAL OF CLINICAL ONCOLOGY : OFFICIAL JOURNAL OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY 10 DEC 2005, vol. 23, no. 35, 10 December 2005 (2005-12-10), pages 8968 - 8977, XP002702513, ISSN: 0732-183X
F. STEPHEN HODI ET AL: "Improved Survival with Ipilimumab in Patients with Metastatic Melanoma", NEW ENGLAND JOURNAL OF MEDICINE, vol. 363, no. 8, 19 August 2010 (2010-08-19), pages 711 - 723, XP055015428, ISSN: 0028-4793, DOI: 10.1056/NEJMoa1003466
AJAY V MAKER ET AL: "Tumor Regression and Autoimmunity in Patients Treated With Cytotoxic T Lymphocyte-Associated Antigen 4 Blockade and Interleukin 2: A Phase I/II Study", ANNALS OF SURGICAL ONCOLOGY, SPRINGER-VERLAG, NE, vol. 12, no. 12, 1 December 2005 (2005-12-01), pages 1005 - 1016, XP019369612, ISSN: 1534-4681
TARHINI AHMAD A ET AL: "CTLA-4 blockade: therapeutic potential in cancer treatments", ONCOTARGETS AND THERAPY, DOVE MEDICAL PRESS LTD, GB, vol. 3, 1 January 2010 (2010-01-01), pages 15 - 25, XP009167476, ISSN: 1178-6930, [retrieved on 20100624]
CAMACHO LH, RIBAS A, GLASPY JA ET AL.: "Phase 1 clinical trial of anti-CTLA4 human monoclonal antibody CP-675,206 in patients (pts) with advanced solid malignancies", J CLIN ONCOL (MEETING ABSTRACTS), vol. 22, no. 14_SUPPL 2505, July 2004 (2004-07-01), XP002702514
RIBAS ET AL: "Anti-CTLA4 antibody clinical trials in melanoma", UPDATE ON CANCER THERAPEUTICS, ELSEVIER, AMSTERDAM, NL, vol. 2, no. 3, 22 October 2007 (2007-10-22), pages 133 - 139, XP022371752, ISSN: 1872-115X, DOI: 10.1016/J.UCT.2007.09.001
A. RIBAS: "Overcoming Immunologic Tolerance to Melanoma: Targeting CTLA-4 with Tremelimumab (CP-675,206)", THE ONCOLOGIST, vol. 13, no. Supplement 4, 1 October 2008 (2008-10-01), pages 10 - 15, XP055015427, ISSN: 1083-7159, DOI: 10.1634/theoncologist.13-S4-10
PAOLO A ASCIERTO ET AL: "Anti-CTLA4 monoclonal antibodies: the past and the future in clinical application", JOURNAL OF TRANSLATIONAL MEDICINE, vol. 9, no. 1, 1 January 2011 (2011-01-01), pages 196, XP055071066, ISSN: 1479-5876, DOI: 10.1186/1479-5876-8-38
GLOFF C A ET AL: "Pharmacokinetics and protein therapeutics", ADVANCED DRUG DELIVERY REVIEWS, ELSEVIER BV, AMSTERDAM, NL, vol. 4, no. 3, 1 January 1990 (1990-01-01), pages 359 - 386, XP023756086, ISSN: 0169-409X, [retrieved on 19900101], DOI: 10.1016/0169-409X(90)90027-P
RICARDO J. SOLĂ ET AL: "Glycosylation of Therapeutic Proteins", BIODRUGS, vol. 24, no. 1, 1 February 2010 (2010-02-01), pages 9 - 21, XP055016446, ISSN: 1173-8804, DOI: 10.2165/11530550-000000000-00000
CONSTANTINOU A ET AL: "Modulating the pharmacokinetics of therapeutic antibodies", BIOTECHNOLOGY LETTERS, SPRINGER NETHERLANDS, DORDRECHT, vol. 32, no. 5, 4 February 2010 (2010-02-04), pages 609 - 622, XP019787094, ISSN: 1573-6776
Attorney, Agent or Firm:
GUO, Z. Angela et al. (P.O. Box 4000Princeton, New Jersey, US)
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