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Chimeric Antigen Receptor Cell Therapy

Chimeric antigen receptor (CAR) cell therapy is an immuno-oncology (IO) approach that has gained increasing momentum in the past few years, with the approval of two new therapies in 2017 (US) and 2018 (EU). Novartis’ Kymriah (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel) demonstrated impressive efficacy, and have both been approved for diffuse large B-cell lymphoma (DLBCL), with Novartis’ product approved for acute lymphocytic leukemia as well. Despite promising efficacy data, several challenges face the integration of CAR cell therapies into the clinic. Complex manufacturing can lead to delayed patient access, as currently approved therapies can take up to three weeks to manufacture. High toxicity is also a key challenge for CAR cell therapies, as high rates of cytokine release syndrome and neurotoxicities (which can be fatal) require constant patient monitoring, potentially limiting CAR cell therapy’s use to centers of excellence. High production cost and hefty pricing are also challenges that CAR cell developers fail, as payers may hold negative perceptions of the nearly $0.5M pricepoint per dose.

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This report provides an overview of the approved and late-stage pipeline CAR cell therapy landscape (including pre-clinical and Phase I CAR-NK cells), as well as a summary of key regulation processes in place in the 8MM (France, Germany, Italy, Spain, UK, US, Japan, China). Key challenges faced by CAR cell therapies are summarized, as well as expected future development trends for the field.

Scope

Components of the slide deck include primary and secondary research –
– Quotes from eight US- and 5EU-based key opinion leaders, payers, and researchers
– Quotes from three Japan-based key opinion leaders
– Summary of CAR-cell therapy mechanism of action and history of development
– Overview of late-stage CAR cell pipeline and two marketed products
– Outline of regulatory pathways in place for CAR cell therapies across the 8MM, challenges that currently face CAR cell therapies, and future directions for CAR cell therapies
– Call-outs of key information and details
– Insight from GlobalData’s specialist oncology analysts.

Reasons to buy

– Develop business strategies by understanding the challenges facing CAR cell therapies.
– Design development strategies by understanding innovative development strategies likely to improve CAR cell therapy perceptions and uptake in the future.
– Be acquainted with regulatory processes relevant to CAR cell therapies across the US, 5EU, Japan and China.
– Develop strategies by understanding expert perceptions of currently approved CAR cell therapies, challenges facing CAR cell therapies, and future directions of CAR cell therapy.

Companies Mentioned:
Amgen Inc
Autolus Therapeutics Plc
Beijing Immunochina Medical Science & Technology Co Ltd
Bellicum Pharmaceuticals Inc
Bristol-Myers Squibb Co
bluebird bio Inc
CARsgen Therapeutics Ltd
Celgene Corp
Cell Medica Ltd
Cellular Biomedicine Group Inc
Celularity Inc
Celyad SA
Daiichi Sankyo Co Ltd
Fosun Pharmaceutical AG
Gilead Sciences Inc
Guangzhou Anjie Biomedical Technology Co Ltd
Hangzhou Converd Co Ltd
Hebei Senlang Biotechnology Inc Ltd
HRAIN Biotechnology Co Ltd
Juno Therapeutics Inc
Kite Pharma Inc
Nanjing Legend Biotech Co Ltd
NantKwest Inc
Nkarta Inc
Novartis AG
Ono Pharmaceutical Co Ltd
Shanghai GeneChem Co Ltd
Shanghai Sinobioway Sunterra Biotechnology Co Ltd
Shanghai Unicar-Therapy Bio-Medicine Technology Co Ltd
Sorrento Therapeutics Inc
Takara Bio Inc

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