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Article ; Online: Accelerating the development of genetically engineered cellular therapies: a framework for extrapolating data across related products.

2024

Abstract: Background: Significant advancements have been made in the field of cellular therapy as anti-cancer treatments, with the approval of chimeric antigen receptor (CAR)-T cell therapies and the development of other genetically engineered cellular therapies. ...

Abstract	Background: Significant advancements have been made in the field of cellular therapy as anti-cancer treatments, with the approval of chimeric antigen receptor (CAR)-T cell therapies and the development of other genetically engineered cellular therapies. CAR-T cell therapies have demonstrated remarkable clinical outcomes in various hematological malignancies, establishing their potential to change the current cancer treatment paradigm. Due to the increasing importance of genetically engineered cellular therapies in the oncology treatment landscape, implementing strategies to expedite development and evidence generation for the next generation of cellular therapy products can have a positive impact on patients. Methods: We outline a risk-based methodology and assessment aid for the data extrapolation approach across related genetically engineered cellular therapy products. This systematic data extrapolation approach has applicability beyond CAR-T cells and can influence clinical development strategies for a variety of immune therapies such as T cell receptor (TCR) or genetically engineered and other cell-based therapies (e.g., tumor infiltrating lymphocytes, natural killer cells and macrophages). Results: By analyzing commonalities in manufacturing processes, clinical trial designs, and regulatory considerations, key learnings were identified. These insights support optimization of the development and regulatory approval of novel cellular therapies. Conclusions: The field of cellular therapy holds immense promise in safely and effectively treating cancer. The ability to extrapolate data across related products presents opportunities to streamline the development process and accelerate the delivery of novel therapies to patients.
Language	English
Publishing date	2024-03-16
Publishing country	England
Document type	Journal Article
ZDB-ID	2039821-9
ISSN	1477-2566 ; 1465-3249
ISSN (online)	1477-2566
ISSN	1465-3249
DOI	10.1016/j.jcyt.2024.03.009
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Article ; Online: Chimeric Antigen Receptor-T Cell Therapy: Practical Considerations for Implementation in Europe.

Buechner, Jochen / Kersten, Marie José / Fuchs, Miriam / Salmon, Florence / Jäger, Ulrich

HemaSphere

2018 Volume 2, Issue 1, Page(s) e18

Abstract: Chimeric antigen receptor (CAR)-T cell therapy is a new class of cellular immunotherapies that involves ex vivo genetic modification of T cells to incorporate an engineered CAR. After infusion into the patient, the CAR-expressing T cells recognize ... ...

Abstract	Chimeric antigen receptor (CAR)-T cell therapy is a new class of cellular immunotherapies that involves ex vivo genetic modification of T cells to incorporate an engineered CAR. After infusion into the patient, the CAR-expressing T cells recognize specific tumor targets and induce an immune response against them. The technology utilized is fundamentally different from previously available cancer treatments. Currently, most CAR-T cell therapies use autologous T cells. Tisagenlecleucel (formerly CTL019) is an anti-CD19 CAR-T cell therapy that was recently approved in the United States for the treatment of pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). Tisagenlecleucel has shown robust in vivo expansion and long-term persistence, clinically meaningful durable response and remission rates, and overall survival benefit in pediatric and young adult patients with relapsed/refractory B-ALL and in relapsed/refractory diffuse large B-cell lymphoma. Common adverse events (AEs) include cytokine release syndrome, which may require hospitalization and admission to an intensive care unit, neurological toxicities, and B-cell aplasia. These AEs are manageable when treated by an appropriately trained team. Additional research is required to further develop AE management protocols. In this review, we describe regulatory requirements, clinical considerations, and site-level requirements for clinical study implementation of CAR-T cell therapy in Europe. We also provide a case study of the European experience from the first global clinical trial for tisagenlecleucel, which may serve as a useful starting point for investigators and clinicians looking to implement CAR-T cell therapy at their institutions.
Language	English
Publishing date	2018-02-02
Publishing country	United States
Document type	Journal Article ; Review
ISSN	2572-9241
ISSN (online)	2572-9241
DOI	10.1097/HS9.0000000000000018
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Article ; Online: Industry's Giant Leap Into Cellular Therapy: Catalyzing Chimeric Antigen Receptor T Cell (CAR-T) Immunotherapy.

Ittershagen, Stacie / Ericson, Solveig / Eldjerou, Lamis / Shojaee, Ali / Bleickardt, Eric / Patel, Manisha / Taran, Tetiana / Anak, Oezlem / Hall, Charlene / Leung, Mimi / Roccoberton, Deborah / Salmon, Florence / Fuchs, Miriam / Romanov, Vadim / Lebwohl, David

Current hematologic malignancy reports

2019 Volume 14, Issue 1, Page(s) 47–55

Abstract: Purpose of review: We describe the significant technological leap from bench to bedside that was achieved through a strong academic-industry collaboration between dedicated clinicians and researchers at the University of Pennsylvania, the Children's ... ...

Abstract	Purpose of review: We describe the significant technological leap from bench to bedside that was achieved through a strong academic-industry collaboration between dedicated clinicians and researchers at the University of Pennsylvania, the Children's Hospital of Philadelphia, and Novartis to commercialize the chimeric antigen receptor T cell (CAR-T) therapy tisagenlecleucel (CTL019; Kymriah®; Novartis Pharma AG, Basel, Switzerland). Recent findings: Tisagenlecleucel was the first CAR-T therapy and the first gene therapy to receive US Food and Drug Administration approval in 2017, with an initial indication for pediatric and young adult patients with relapsed or refractory (r/r) acute lymphoblastic leukemia, followed by approval in May 2018 for a second indication in adult patients with r/r diffuse large B cell lymphoma. Subsequent approvals in the European Union, Switzerland, and Canada soon followed. The tisagenlecleucel success story represents the development and commercialization of a first-of-its-kind personalized cellular therapy with a manufacturing process that supports commercial production and ongoing global clinical trials in a growing number of countries.
MeSH term(s)	Genetic Therapy/methods ; Humans ; Immunotherapy/methods ; Receptors, Chimeric Antigen/immunology
Chemical Substances	Receptors, Chimeric Antigen
Language	English
Publishing date	2019-01-21
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2229765-0
ISSN	1558-822X ; 1558-8211
ISSN (online)	1558-822X
ISSN	1558-8211
DOI	10.1007/s11899-019-0498-6
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Book ; Thesis: Untersuchungen zur Charakterisierung der Proteintyrosinphosphatase PTP[Kappa]

Fuchs, Miriam

1996

Author's details	vorgelegt von Miriam Fuchs
Keywords	Zelllinie ; Brustkrebs ; Proteintyrosinphosphatase
Language	German
Size	201 S, Ill., graph. Darst, 21 cm
Document type	Book ; Thesis
Thesis / German Habilitation thesis	Univ., Diss.--München, 1996
Database	Former special subject collection: coastal and deep sea fishing

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Book ; Thesis: Untersuchungen zur Charakterisierung der Proteintyrosinphosphatase PTP[Kappa]

Fuchs, Miriam

1996

Author's details	vorgelegt von Miriam Fuchs
Keywords	Zelllinie ; Brustkrebs ; Proteintyrosinphosphatase
Language	German
Size	201 S, Ill., graph. Darst, 21 cm
Document type	Book ; Thesis
Thesis / German Habilitation thesis	Univ., Diss.--München, 1996
Database	Library catalogue of the German National Library of Science and Technology (TIB), Hannover

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Article: Negative Soziale Unterstützung bei der Bewältigung von Lebensbelastungen

Laireiter, Anton-Rupert / Fuchs, Miriam / Pichler, Maria-Elisabeth

Zeitschrift für Gesundheitspsychologie

2007 Volume 15, Issue 2

Abstract: Zusammenfassung. Neben unterstützendem Verhalten müssen durch Lebensereignisse Belastete immer auch mit belastenden Reaktionen aus ihrer Umwelt rechnen. Die vorliegende Studie ist einer konzeptuellen und empirischen Analyse dieses Phänomens und seiner ... ...

Institution	Fachbereich Psychologie Österreich Kurmittelhaus Bad Tatzmannsdorf Österreich Landesberufsschule “C. J. Tschugmall“ Brixen Südtirol
Abstract	Zusammenfassung. Neben unterstützendem Verhalten müssen durch Lebensereignisse Belastete immer auch mit belastenden Reaktionen aus ihrer Umwelt rechnen. Die vorliegende Studie ist einer konzeptuellen und empirischen Analyse dieses Phänomens und seiner Effekte gewidmet. Dabei wird über eine retrospektive Lebensereignisstudie berichtet (N = 224), bei der u.a. negative und positive Unterstützungsformen erhoben wurden. Explorative Hauptkomponentenanalysen erbrachten vier gut interpretierbare und mit den konzeptuellen Analysen übereinstimmende Faktoren negativer Unterstützung (Kritik und Abwertung, Diskriminierung und Feindseligkeit, Enttäuschung und nicht ernst nehmen, Einmischung und übertriebene Sorge), wobei übertriebene und mangelnde Unterstützung (Einmischung/übertrieben Sorge, Enttäuschung/nicht ernst nehmen) häufiger vorkommen als die beiden aggressiveren Formen (Kritik und Abwertung, Diskriminierung und Feindseligkeit). Dennoch sind diese aber mit schlechterem Bewältigungserfolg, geringerem Selbstwert und schlechterem Befinden am Ende des Lebensereignisses assoziiert. Mediator- und Moderatoranalysen zeigen, dass diese Effekte zum Teil durch die initiale Reaktion auf das belastende Ereignis vermittelt werden, insofern solche Personen ein hohes Maß an Negativunterstützung erleben, die initial intensiv und eher negativ auf das Ereignis reagieren. Das Ausmaß erhaltener positiver Unterstützung kann diese Effekte puffern. Die Ergebnisse sprechen dafür, negativer Unterstützung bei präventiven Maßnahmen vermehrte Aufmerksamkeit zu schenken. People undergoing stressful life events are in great danger of experiencing negative social support from their social environments. The present study deals with this issue and its consequences on health related measures. After a conceptual analysis of negative support a retrospective life-event study (N = 224) is presented including measures on positive and negative social support. Principal components analyses result into four consistent and conceptually sound factors of negative social support (criticism and devaluation, hostility, disappointment, overinvolvement). The more benign forms (disappointment, overinvolvement) are experienced more often than the more aggressive ones (criticism and devaluation, hostility), which are associated with less effective coping of the life-events and with lower self-esteem and well-being at the end of the stress process. By mediator and moderator analyses it was found that negative social support mediates negative reactions to the life-events from the beginning to the end and is buffered by positive social support. The results support the notion that negative social support should become an important component of preventive interventions for victims of stressful life events.
Keywords	Lebensereignisse ; soziale Unterstützung ; soziale Belastungen ; Puffereffekte ; stressful life-events ; social support ; non support ; buffering effects
Publishing date	2007-05-07
Document type	Article
ZDB-ID	1146931-6
ISSN	2190-6289 ; 0943-8149 ; 0943-8149
ISSN (online)	2190-6289
ISSN	0943-8149
DOI	10.1026/0943-8149.15.2.43
Database	Hogrefe publisher's database

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Article: Negative Soziale Unterstützung bei der Bewältigung von Lebensbelastungen. Eine konzeptuelle und empirische Analyse

Laireiter, Anton-Rupert / Fuchs, Miriam / Pichler, Maria-Elisabeth

Zeitschrift für Gesundheitspsychologie

2007 Volume 15, Issue 2, Page(s) 43–56

Abstract: Neben unterstützendem Verhalten müssen durch Lebensereignisse Belastete immer auch mit belastenden Reaktionen aus ihrer Umwelt rechnen. Dieses Phänomen und seine Effekte wurden konzeptuell und empirisch analysiert. Es wird über eine retrospektive ... ...

Title translation	Negative social support in the adaptation to life stress: A conceptual and empirical analysis
Abstract	Neben unterstützendem Verhalten müssen durch Lebensereignisse Belastete immer auch mit belastenden Reaktionen aus ihrer Umwelt rechnen. Dieses Phänomen und seine Effekte wurden konzeptuell und empirisch analysiert. Es wird über eine retrospektive Lebensereignisstudie mit 224 Teilnehmerinnen und Teilnehmern berichtet, bei der u. a. negative und positive Unterstützungsformen erhoben wurden. Explorative Hauptkomponentenanalysen erbrachten vier gut interpretierbare und mit den konzeptuellen Analysen übereinstimmende Faktoren negativer Unterstützung (Kritik und Abwertung, Diskriminierung und Feindseligkeit, Enttäuschung und nicht ernst nehmen, Einmischung und übertriebene Sorge), wobei übertriebene und mangelnde Unterstützung (Einmischung/übertriebene Sorge, Enttäuschung/nicht ernst nehmen) häufiger vorkamen als die beiden aggressiveren Formen (Kritik und Abwertung, Diskriminierung und Feindseligkeit). Letztere waren mit schlechterem Bewältigungserfolg, geringerem Selbstwert und schlechterem Befinden am Ende des Lebensereignisses assoziiert. Mediator- und Moderatoranalysen zeigten, dass diese Effekte zum Teil durch die initiale Reaktion auf das belastende Ereignis vermittelt wurden, insofern solche Personen ein hohes Maß an Negativunterstützung erlebten, die initial intensiv und eher negativ auf das Ereignis reagierten. Das Ausmaß erhaltener positiver Unterstützung konnte diese Effekte puffern. Die Ergebnisse sprechen dafür, negativer Unterstützung bei präventiven Maßnahmen vermehrte Aufmerksamkeit zu schenken.
Keywords	Aggressionsverhalten ; Aggressive Behavior ; Bewältigungsverhalten ; Coping Behavior ; Criticism ; Feindseligkeit ; Hostility ; Interpersonal Interaction ; Interpersonale Interaktion ; Kritik ; Lebensereignisse ; Life Experiences ; Selbstwert ; Self-Esteem ; Self-Worth ; Social Stress ; Social Support ; Soziale Unterstützung ; Sozialer Stress ; Wertschätzung der eigenen Person
Language	German
Document type	Article
ZDB-ID	1146931-6
ISSN	2190-6289 ; 0943-8149
ISSN (online)	2190-6289
ISSN	0943-8149
DOI	10.1026/0943-8149.15.2.43
Database	PSYNDEX

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Article: Homeotic transformations of the axial skeleton that accompany a targeted deletion of E2f6.

Storre, Jörg / Elsässer, Hans-Peter / Fuchs, Miriam / Ullmann, Diana / Livingston, David M / Gaubatz, Stefan

EMBO reports

2002 Volume 3, Issue 7, Page(s) 695–700

Abstract: E2F transcription factors play an important role in regulating mammalian cell proliferation. E2F6, the most recently identified E2F family member, is a transcriptional repressor. In an effort to ascertain the in vivo biological function of E2F6, we have ... ...

Abstract	E2F transcription factors play an important role in regulating mammalian cell proliferation. E2F6, the most recently identified E2F family member, is a transcriptional repressor. In an effort to ascertain the in vivo biological function of E2F6, we have generated an E2f6 mutant mouse strain. Mice lacking E2F6 are viable and healthy. Surprisingly, E2f6-/- embryonic fibroblasts proliferate normally. However, E2f6-/- animals display overt homeotic transformations of the axial skeleton that are strikingly similar to the skeletal transformations observed in polycomb mutant mice. This observation is compatible with the recent finding that endogenous E2F6 and one or more mammalian polycomb proteins are components of the same multiprotein complex. The accumulated evidence suggests that, during development, E2F6 participates in the recruitment of polycomb proteins to specific target promoters.
MeSH term(s)	Animals ; Body Patterning ; Bone and Bones/abnormalities ; Bone and Bones/embryology ; Bone and Bones/physiology ; Cell Cycle Proteins/genetics ; Cell Cycle Proteins/metabolism ; Cells, Cultured ; Cellular Senescence/physiology ; E2F6 Transcription Factor ; Embryo, Mammalian/abnormalities ; Embryo, Mammalian/anatomy & histology ; Embryo, Mammalian/physiology ; Fibroblasts/cytology ; Fibroblasts/physiology ; Gene Targeting ; Genes, Homeobox ; In Situ Hybridization ; Male ; Mice ; Morphogenesis ; Polycomb-Group Proteins ; Promoter Regions, Genetic ; Repressor Proteins/metabolism ; Skeleton ; Testis/abnormalities ; Testis/cytology ; Transcription Factors
Chemical Substances	Cell Cycle Proteins ; E2F6 Transcription Factor ; E2f6 protein, mouse ; Polycomb-Group Proteins ; Repressor Proteins ; Transcription Factors
Language	English
Publishing date	2002-05-20
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	2020896-0
ISSN	1469-3178 ; 1469-221X
ISSN (online)	1469-3178
ISSN	1469-221X
DOI	10.1093/embo-reports/kvf141
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Article: E2F-dependent histone acetylation and recruitment of the Tip60 acetyltransferase complex to chromatin in late G1.

Taubert, Stefan / Gorrini, Chiara / Frank, Scott R / Parisi, Tiziana / Fuchs, Miriam / Chan, Ho-Man / Livingston, David M / Amati, Bruno

Molecular and cellular biology

2004 Volume 24, Issue 10, Page(s) 4546–4556

Abstract: E2F proteins can either activate or repress transcription. Following mitogenic stimulation, repressive E2F4-p130-histone deacetylase complexes dissociate from, while activating species (E2F1, -2, and -3) associate with, target promoters. Histones H3 and ... ...

Abstract	E2F proteins can either activate or repress transcription. Following mitogenic stimulation, repressive E2F4-p130-histone deacetylase complexes dissociate from, while activating species (E2F1, -2, and -3) associate with, target promoters. Histones H3 and H4 simultaneously become hyperacetylated, but it remains unclear whether this is a prerequisite or a consequence of E2F binding. Here, we show that activating E2F species are required for hyperacetylation of target chromatin in human cells. Overexpression of a dominant-negative (DN) E2F1 mutant in serum-stimulated T98G cells blocked all E2F binding, H4 acetylation, and, albeit partially, H3 acetylation. Target gene activation and S-phase entry were also blocked by DN E2F1. Conversely, ectopic activation of E2F1 rapidly induced H3 and H4 acetylation, demonstrating a direct role for E2F in these events. E2F1 was previously shown to bind the histone acetyltransferases (HATs) p300/CBP and PCAF/GCN5. In our hands, ectopically expressed E2F1 also bound the unrelated HAT Tip60 and induced recruitment of five subunits of the Tip60 complex (Tip60, TRRAP, p400, Tip48, and Tip49) to target promoters in vivo. Moreover, E2F-dependent recruitment of Tip60 to chromatin occurred in late G(1) following serum stimulation. We speculate that the activities of multiple HAT complexes account for E2F-dependent acetylation, transcription, and S-phase entry.
MeSH term(s)	Acetylation ; Acetyltransferases/metabolism ; Cell Cycle Proteins ; Cell Line ; Chromatin/metabolism ; DNA-Binding Proteins/genetics ; DNA-Binding Proteins/metabolism ; E2F Transcription Factors ; E2F1 Transcription Factor ; E2F4 Transcription Factor ; G1 Phase ; Gene Expression Regulation ; Histone Acetyltransferases ; Histones/metabolism ; Humans ; Kinetics ; Lysine Acetyltransferase 5 ; Mutation ; Protein Binding ; S Phase ; Transcription Factors/genetics ; Transcription Factors/metabolism ; Transcriptional Activation
Chemical Substances	Cell Cycle Proteins ; Chromatin ; DNA-Binding Proteins ; E2F Transcription Factors ; E2F1 Transcription Factor ; E2F1 protein, human ; E2F4 Transcription Factor ; E2F4 protein, human ; Histones ; Transcription Factors ; Acetyltransferases (EC 2.3.1.-) ; Histone Acetyltransferases (EC 2.3.1.48) ; KAT5 protein, human (EC 2.3.1.48) ; Lysine Acetyltransferase 5 (EC 2.3.1.48)
Language	English
Publishing date	2004-02-17
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	779397-2
ISSN	1098-5549 ; 0270-7306
ISSN (online)	1098-5549
ISSN	0270-7306
DOI	10.1128/MCB.24.10.4546-4556.2004
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Article: MYC recruits the TIP60 histone acetyltransferase complex to chromatin.

Frank, Scott R / Parisi, Tiziana / Taubert, Stefan / Fernandez, Paula / Fuchs, Miriam / Chan, Ho-Man / Livingston, David M / Amati, Bruno

EMBO reports

2003 Volume 4, Issue 6, Page(s) 575–580

Abstract: The transcription factor MYC binds specific DNA sites in cellular chromatin and induces the acetylation of histones H3 and H4. However, the histone acetyltransferases (HATs) that are responsible for these modifications have not yet been identified. MYC ... ...

Abstract	The transcription factor MYC binds specific DNA sites in cellular chromatin and induces the acetylation of histones H3 and H4. However, the histone acetyltransferases (HATs) that are responsible for these modifications have not yet been identified. MYC associates with TRRAP, a subunit of distinct macromolecular complexes that contain the HATs GCN5/PCAF or TIP60. Although the association of MYC with GCN5 has been shown, its interaction with TIP60 has never been analysed. Here, we show that MYC associates with TIP60 and recruits it to chromatin in vivo with four other components of the TIP60 complex: TRRAP, p400, TIP48 and TIP49. Overexpression of enzymatically inactive TIP60 delays the MYC-induced acetylation of histone H4, and also reduces the level of MYC binding to chromatin. Thus, the TIP60 HAT complex is recruited to MYC-target genes and, probably with other other HATs, contributes to histone acetylation in response to mitogenic signals.
MeSH term(s)	Acetyltransferases/metabolism ; Adenoviridae/genetics ; Animals ; Cell Line ; Chromatin/metabolism ; DNA/metabolism ; Genetic Vectors ; Histone Acetyltransferases ; Histones/metabolism ; Humans ; Lysine Acetyltransferase 5 ; Precipitin Tests ; Protein Binding ; Proto-Oncogene Proteins c-myc/metabolism ; Proto-Oncogene Proteins c-myc/physiology ; Rats
Chemical Substances	Chromatin ; Histones ; Proto-Oncogene Proteins c-myc ; DNA (9007-49-2) ; Acetyltransferases (EC 2.3.1.-) ; Histone Acetyltransferases (EC 2.3.1.48) ; KAT5 protein, human (EC 2.3.1.48) ; Lysine Acetyltransferase 5 (EC 2.3.1.48)
Language	English
Publishing date	2003-05-29
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2020896-0
ISSN	1469-3178 ; 1469-221X
ISSN (online)	1469-3178
ISSN	1469-221X
DOI	10.1038/sj.embor.embor861
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