Gene switches have garnered significant attention from drug developers owing to their ability to control the activity of genetically modified cell products in vivo
Driven by numerous developmental breakthroughs and encouraging study results demonstrating the vast potential of adoptive cell therapies (ACT), including CAR-T cell therapies, TCR therapies, TILs and natural killer cell therapies, in the treatment of various complex disorders, this therapeutic modality has garnered considerable attention from the players engaged in the pharmaceutical industry. Driven by the increasing adoption of gene switches to overcome the safety-related concerns associated with engineered cell therapies, the gene switch market is likely to witness significant growth in the future.
In fact, in the past few years, close to 30 cell and gene therapies have been approved by the US FDA. Moreover, over 1,220 cell therapies are currently being evaluated across various clinical stages of development. Further, the recent approvals of more than five CAR-T cell therapies have further fueled the interest in the broader development of such cellular therapies.
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However, despites several advantages, adverse events associated with genetically modified T-cell therapies, including neurotoxicity, cytokine release syndrome (CRS), on-target / off-tumor toxicity and graft-versus-host-disease (GVHD), form the major limitation of such therapeutic modality. As a result, the industry is actively seeking various tools / methods to mitigate this challenge. Amongst the various approaches to enhance safety profiles of ACTs, safety switch / gene switch / kill switch systems (which are the regulatory sites on genes capable of switching on / off transcription and translation process) have gained sufficient attention from drug developers owing to their ability to control the activity of genetically modified cell products in vivo while sparing host immune activity.
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