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.

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.


GlobalData’s Chimeric Antigen Receptor Cell Therapy report combines primary research from a cross-specialty panel of oncology experts with in-house analyst expertise to provide an assessment of the development landscape (including regulation), key challenges, and future directions for CAR cell therapies.

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

Table of Contents

1 Table of Contents (PowerPoint Deck)

1. Preface

1.1 Related Reports

1.2 Upcoming Reports

1.3 Abbreviations

2. Executive Summary

3. Introduction

3.1 Chimeric Antigen Receptor Cell Therapy Mechanism of Action

3.2 History of Development of CAR Cell Products

3.3 Approved CAR-T Cell Products

3.4 Late-stage Pipeline CAR-T Cell Therapies

3.5 Preclinical Development of CAR Cell Products

4. Regulatory Pathways for CAR Cell Therapy

4.1 CAR Cell Therapy Regulation Overview in the 8MM

4.2 US CAR Cell Therapy Regulation

4.3 EU CAR Cell Therapy Regulation

4.4 Japan CAR Cell Therapy Regulation

4.5 China CAR Cell Therapy Regulation

5. Challenges for CAR Cell Therapy

5.1 Pricing Issues

5.2 Toxicity

5.3 Manufacturing

5.4 Resistance

6. Future Directions for CAR Cell Therapy

6.1 Allogeneic CAR Cell Therapies

6.2 Armored CARs

6.3 Dual Targeting CAR Cell Therapies

6.4 CAR Cell Therapy Combinations

6.5 CAR Natural Killer Cells

6.6 CAR Cell Therapies for Solid Tumors

7. Appendix

7.1 Primary Research

7.2 Sources

7.3 About the Authors

7.4 About GlobalData

7.5 Contact Us

7.6 Disclaimer


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