Title:
COMPOSITIONS AND METHODS FOR SELECTIVE PROTEIN EXPRESSION
Document Type and Number:
WIPO Patent Application WO/2017/181119
Kind Code:
A3
Abstract:
Provided herein are fusion proteins including two protein domains separated by a heterologous protease cleavage site, wherein a first of the protein domains is a conditional expression domain. Thus, the fusion proteins comprise three essential elements: a conditional expression domain, a domain containing the protein of interest, and a protease cleavage domain separating the two. Also provided herein are methods for treating autoantibody and alloantibody-mediated diseases or conditions in a subject by targeting B cells with anti-B cell modified T cells. In one embodiment, a chimeric antigen receptor (CAR) modified T cell is selectively ablated in a subject after adoptive transfer. Pharmaceutical compositions comprising the temporally regulated CAR modified T cell are also described herein.
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Inventors:
GOLOSOV ANDREI (US)
GUIMARAES CARLA (US)
MOTZ GREGORY (US)
MILONE MICHAEL (US)
ELLEBRECHT CHRISTOPH T (US)
PAYNE AIMEE S (US)
GUIMARAES CARLA (US)
MOTZ GREGORY (US)
MILONE MICHAEL (US)
ELLEBRECHT CHRISTOPH T (US)
PAYNE AIMEE S (US)
Application Number:
PCT/US2017/027778
Publication Date:
January 04, 2018
Filing Date:
April 14, 2017
Export Citation:
Assignee:
NOVARTIS AG (CH)
UNIV PENNSYLVANIA (US)
GOLOSOV ANDREI (US)
GUIMARAES CARLA (US)
MOTZ GREGORY (US)
MILONE MICHAEL (US)
ELLEBRECHT CHRISTOPH T (US)
PAYNE AIMEE S (US)
UNIV PENNSYLVANIA (US)
GOLOSOV ANDREI (US)
GUIMARAES CARLA (US)
MOTZ GREGORY (US)
MILONE MICHAEL (US)
ELLEBRECHT CHRISTOPH T (US)
PAYNE AIMEE S (US)
International Classes:
C12N15/62; C07K14/725
Domestic Patent References:
| WO2000023602A2 | 2000-04-27 | |||
| WO2001057242A2 | 2001-08-09 | |||
| WO2015168613A2 | 2015-11-05 | |||
| WO2014012001A2 | 2014-01-16 | |||
| WO2015134877A1 | 2015-09-11 | |||
| WO2017032777A1 | 2017-03-02 | |||
| WO2017024318A1 | 2017-02-09 |
Other References:
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RIVERA V M ET AL: "REGULATION OF PROTEIN SECRETION THROUGH CONTROLLED AGGREGATION IN THE ENDOPLASMIC RETICULUM", SCIENCE, AMERICAN ASSOCIATION FOR THE ADVANCEMENT OF SCIENCE, vol. 287, 1 January 2000 (2000-01-01), pages 826 - 830, XP000887329, ISSN: 0036-8075, DOI: 10.1126/SCIENCE.287.5454.826
LUIS QUINTINO ET AL: "Functional Neuroprotection and Efficient Regulation of GDNF Using Destabilizing Domains in a Rodent Model of Parkinson's Disease", MOLECULAR THERAPY, vol. 21, no. 12, 1 December 2013 (2013-12-01), US, pages 2169 - 2180, XP055408532, ISSN: 1525-0016, DOI: 10.1038/mt.2013.169
HOKYUNG K CHUNG ET AL: "Tunable and reversible drug control of protein production via a self-excising degron", NATURE CHEMICAL BIOLOGY, vol. 11, no. 9, 27 July 2015 (2015-07-27), Basingstoke, pages 713 - 720, XP055408268, ISSN: 1552-4450, DOI: 10.1038/nchembio.1869
M. R. PRATT ET AL: "Small-molecule-mediated rescue of protein function by an inducible proteolytic shunt", PROCEEDINGS NATIONAL ACADEMY OF SCIENCES PNAS, vol. 104, no. 27, 3 July 2007 (2007-07-03), US, pages 11209 - 11214, XP055408262, ISSN: 0027-8424, DOI: 10.1073/pnas.0700816104
YUSUKE MIYAZAKI ET AL: "Destabilizing Domains Derived from the Human Estrogen Receptor", JOURNAL OF THE AMERICAN CHEMICAL SOCIETY, vol. 134, no. 9, 7 March 2012 (2012-03-07), US, pages 3942 - 3945, XP055387238, ISSN: 0002-7863, DOI: 10.1021/ja209933r
MICHAEL C JENSEN ET AL: "Design and implementation of adoptive therapy with chimeric antigen receptor-modified T cells", IMMUNOLOGICAL REVIEWS., vol. 257, no. 1, Special Issue, 13 December 2013 (2013-12-13), US, pages 127 - 144, XP055156740, ISSN: 0105-2896
GHORASHIAN SARA ET AL: "CD19 chimeric antigen receptor T cell therapy for haematological malignancies", BRITISH JOURNAL OF HAEMATOLOGY, BLACKWELL PUBLISHING LTD, vol. 169, no. 4, 1 May 2015 (2015-05-01), pages 463 - 478, XP002762697, ISSN: 1365-2141
JIE SUN ET AL: "The quest for spatio-temporal control of CAR T cells", CELL RESEARCH - XIBAO YANJIU, vol. 25, no. 12, 17 December 2015 (2015-12-17), GB, CN, pages 1281 - 1282, XP055361929, ISSN: 1001-0602, DOI: 10.1038/cr.2015.131
ANTONIO DI STASI ET AL: "Inducible Apoptosis as a Safety Switch for Adoptive Cell Therapy", NEW ENGLAND JOURNAL OF MEDICINE, vol. 365, no. 18, 3 November 2011 (2011-11-03), pages 1673 - 1683, XP055181696, ISSN: 0028-4793, DOI: 10.1056/NEJMoa1106152
LIHUA E. BUDDE ET AL: "Combining a CD20 Chimeric Antigen Receptor and an Inducible Caspase 9 Suicide Switch to Improve the Efficacy and Safety of T Cell Adoptive Immunotherapy for Lymphoma", PLOS ONE, vol. 8, no. 12, 17 December 2013 (2013-12-17), pages e82742, XP055213511, DOI: 10.1371/journal.pone.0082742
RIVERA V M ET AL: "REGULATION OF PROTEIN SECRETION THROUGH CONTROLLED AGGREGATION IN THE ENDOPLASMIC RETICULUM", SCIENCE, AMERICAN ASSOCIATION FOR THE ADVANCEMENT OF SCIENCE, vol. 287, 1 January 2000 (2000-01-01), pages 826 - 830, XP000887329, ISSN: 0036-8075, DOI: 10.1126/SCIENCE.287.5454.826
LUIS QUINTINO ET AL: "Functional Neuroprotection and Efficient Regulation of GDNF Using Destabilizing Domains in a Rodent Model of Parkinson's Disease", MOLECULAR THERAPY, vol. 21, no. 12, 1 December 2013 (2013-12-01), US, pages 2169 - 2180, XP055408532, ISSN: 1525-0016, DOI: 10.1038/mt.2013.169
HOKYUNG K CHUNG ET AL: "Tunable and reversible drug control of protein production via a self-excising degron", NATURE CHEMICAL BIOLOGY, vol. 11, no. 9, 27 July 2015 (2015-07-27), Basingstoke, pages 713 - 720, XP055408268, ISSN: 1552-4450, DOI: 10.1038/nchembio.1869
M. R. PRATT ET AL: "Small-molecule-mediated rescue of protein function by an inducible proteolytic shunt", PROCEEDINGS NATIONAL ACADEMY OF SCIENCES PNAS, vol. 104, no. 27, 3 July 2007 (2007-07-03), US, pages 11209 - 11214, XP055408262, ISSN: 0027-8424, DOI: 10.1073/pnas.0700816104
YUSUKE MIYAZAKI ET AL: "Destabilizing Domains Derived from the Human Estrogen Receptor", JOURNAL OF THE AMERICAN CHEMICAL SOCIETY, vol. 134, no. 9, 7 March 2012 (2012-03-07), US, pages 3942 - 3945, XP055387238, ISSN: 0002-7863, DOI: 10.1021/ja209933r
MICHAEL C JENSEN ET AL: "Design and implementation of adoptive therapy with chimeric antigen receptor-modified T cells", IMMUNOLOGICAL REVIEWS., vol. 257, no. 1, Special Issue, 13 December 2013 (2013-12-13), US, pages 127 - 144, XP055156740, ISSN: 0105-2896
GHORASHIAN SARA ET AL: "CD19 chimeric antigen receptor T cell therapy for haematological malignancies", BRITISH JOURNAL OF HAEMATOLOGY, BLACKWELL PUBLISHING LTD, vol. 169, no. 4, 1 May 2015 (2015-05-01), pages 463 - 478, XP002762697, ISSN: 1365-2141
JIE SUN ET AL: "The quest for spatio-temporal control of CAR T cells", CELL RESEARCH - XIBAO YANJIU, vol. 25, no. 12, 17 December 2015 (2015-12-17), GB, CN, pages 1281 - 1282, XP055361929, ISSN: 1001-0602, DOI: 10.1038/cr.2015.131
ANTONIO DI STASI ET AL: "Inducible Apoptosis as a Safety Switch for Adoptive Cell Therapy", NEW ENGLAND JOURNAL OF MEDICINE, vol. 365, no. 18, 3 November 2011 (2011-11-03), pages 1673 - 1683, XP055181696, ISSN: 0028-4793, DOI: 10.1056/NEJMoa1106152
LIHUA E. BUDDE ET AL: "Combining a CD20 Chimeric Antigen Receptor and an Inducible Caspase 9 Suicide Switch to Improve the Efficacy and Safety of T Cell Adoptive Immunotherapy for Lymphoma", PLOS ONE, vol. 8, no. 12, 17 December 2013 (2013-12-17), pages e82742, XP055213511, DOI: 10.1371/journal.pone.0082742
Attorney, Agent or Firm:
COLLAZO, Diana, M. et al. (US)
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