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. 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.
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.
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