The "Chimeric Antigen Receptor Cell Therapy", 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.
Chimeric Antigen Receptor (CAR) cell therapy is an Immuno-Oncology (IO) approach that has gained increasing momentum in the past few years. Despite having demonstrated impressive efficacy in terms of response rates, CAR-T cell therapies are faced with several issues. Complex manufacturing leads to delayed patient access, high toxicity requires constant patient monitoring, and high cost of production means therapies are costing close to $0.5M.
Many new methods are being tested to improve CAR cell efficacy and overcome these challenges, in a broad range of indications Allogeneic CAR cell therapies may reduce manufacturing delays; however these are likely to be associated with additional toxicities versus autologous cells, and may demonstrate lower persistence.
Combinatorial approaches may improve CAR cell therapy efficacy and prevent resistance, but no single strategy stands out as the most promising. Armored' CARs, CARs in combination with other immunotherapies, and dual-targeting CARs may be some of the ways in which CARs can be enhanced, however there are concerns that these may drive up cost of already very costly therapies.
CAR cell therapies are still very new, and specific guidance for regulation is not available on a global scale. Improved regulatory guidance may enhance integration of CAR cell therapies as developers feel more confident in their strategic approaches.
There is global consensus that cell therapies should be regulated in a different way to small molecules or other less complex biologic therapies, however, to date, CAR cell-specific guidance exists only in Europe. Nevertheless, the European, American, Japanese, and Chinese healthcare regulatory agencies all appreciate that cell therapies have huge therapeutic potential, and accelerated pathways for approval of cell therapies are in place in these markets.
Currently, two CAR-T cell products are approved in the US and EU, Gilead Sciences' Yescarta for diffuse large B-cell lymphoma (DLBCL) and Novartis' Kymriah for acute lymphocytic leukemia and DLBCL, while several late-stage candidates are being developed for a broad range of blood cancers and solid tumors.
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.
Key Topics Covered:
1.1 Related Reports
1.2 Upcoming Reports
2. Executive Summary
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
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
- 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 Bi
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