Immune safety challenges facing the preclinical assessment and clinical progression of cell therapies
•Cell therapies can come with an extensive range of immune safety considerations, with different cell therapies presenting different safety risks.•There are limited preclinical models for assessing the immune safety risk of cell therapies.•Experiences with CAR-T therapies in the oncology space can p...
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| Published in: | Drug discovery today p. 104239 |
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| Format: | Journal Article |
| Language: | English |
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Elsevier Ltd
08-11-2024
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| Abstract | •Cell therapies can come with an extensive range of immune safety considerations, with different cell therapies presenting different safety risks.•There are limited preclinical models for assessing the immune safety risk of cell therapies.•Experiences with CAR-T therapies in the oncology space can provide guidance for preclinical and clinical mitigation strategies for broader disease indications.•Preclinical models that better predict the activity and safety profile in humans are critical to avoid unwanted adverse events in the clinic.
The promise of curative outcomes for life-limiting diseases using cell therapies is starting to become a reality, not only for patients with end-stage cancer, but also increasingly for regenerative therapies, including dentistry, ocular, neurodegenerative, and cardiac diseases. The introduction of often genetically modified cells into a patient can come with an extensive range of safety considerations. From an immune perspective, cell-based therapies carry inherent consequences and consideration of factors, such as the cell source (donor-derived autologous cells versus allogeneic cells), the intrinsic cellular nature of the therapy, and engineering/manufacturing methods, all of which influence the likelihood of inducing unwanted immune responses. Here, we provide an overview of the potential immune safety risks associated with cell therapies and explore possible mitigation approaches. |
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| AbstractList | The promise of curative outcomes for life-limiting diseases using cell therapies is starting to become a reality, not only for patients with end-stage cancer, but also increasingly for regenerative therapies, including dentistry, ocular, neurodegenerative, and cardiac diseases. The introduction of often genetically modified cells into a patient can come with an extensive range of safety considerations. From an immune perspective, cell-based therapies carry inherent consequences and consideration of factors, such as the cell source (donor-derived autologous cells versus allogeneic cells), the intrinsic cellular nature of the therapy, and engineering/manufacturing methods, all of which influence the likelihood of inducing unwanted immune responses. Here, we provide an overview of the potential immune safety risks associated with cell therapies and explore possible mitigation approaches.The promise of curative outcomes for life-limiting diseases using cell therapies is starting to become a reality, not only for patients with end-stage cancer, but also increasingly for regenerative therapies, including dentistry, ocular, neurodegenerative, and cardiac diseases. The introduction of often genetically modified cells into a patient can come with an extensive range of safety considerations. From an immune perspective, cell-based therapies carry inherent consequences and consideration of factors, such as the cell source (donor-derived autologous cells versus allogeneic cells), the intrinsic cellular nature of the therapy, and engineering/manufacturing methods, all of which influence the likelihood of inducing unwanted immune responses. Here, we provide an overview of the potential immune safety risks associated with cell therapies and explore possible mitigation approaches. •Cell therapies can come with an extensive range of immune safety considerations, with different cell therapies presenting different safety risks.•There are limited preclinical models for assessing the immune safety risk of cell therapies.•Experiences with CAR-T therapies in the oncology space can provide guidance for preclinical and clinical mitigation strategies for broader disease indications.•Preclinical models that better predict the activity and safety profile in humans are critical to avoid unwanted adverse events in the clinic. The promise of curative outcomes for life-limiting diseases using cell therapies is starting to become a reality, not only for patients with end-stage cancer, but also increasingly for regenerative therapies, including dentistry, ocular, neurodegenerative, and cardiac diseases. The introduction of often genetically modified cells into a patient can come with an extensive range of safety considerations. From an immune perspective, cell-based therapies carry inherent consequences and consideration of factors, such as the cell source (donor-derived autologous cells versus allogeneic cells), the intrinsic cellular nature of the therapy, and engineering/manufacturing methods, all of which influence the likelihood of inducing unwanted immune responses. Here, we provide an overview of the potential immune safety risks associated with cell therapies and explore possible mitigation approaches. |
| ArticleNumber | 104239 |
| Author | Cornish, Georgina Delsing, Louise Wong, Ryan Bahjat, Mahnoush Bates, Stephanie M. Evans, Kelly V. |
| Author_xml | – sequence: 1 givenname: Stephanie M. orcidid: 0000-0003-2708-6118 surname: Bates fullname: Bates, Stephanie M. organization: Safety Innovation, Clinical Pharmacology and Safety Sciences, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK – sequence: 2 givenname: Kelly V. orcidid: 0000-0002-8276-1211 surname: Evans fullname: Evans, Kelly V. organization: Safety Innovation, Clinical Pharmacology and Safety Sciences, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK – sequence: 3 givenname: Louise orcidid: 0000-0003-2899-3801 surname: Delsing fullname: Delsing, Louise organization: Cell and Gene Therapy Safety, Clinical Pharmacology and Safety Sciences, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden – sequence: 4 givenname: Ryan surname: Wong fullname: Wong, Ryan organization: Cell and Gene Therapy Safety, Clinical Pharmacology and Safety Sciences, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK – sequence: 5 givenname: Georgina orcidid: 0000-0002-1984-6677 surname: Cornish fullname: Cornish, Georgina organization: Oncology Safety, Clinical Pharmacology and Safety Sciences, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK – sequence: 6 givenname: Mahnoush orcidid: 0000-0002-0738-1905 surname: Bahjat fullname: Bahjat, Mahnoush email: mahnoush.bahjat@astrazeneca.com organization: Safety Innovation, Clinical Pharmacology and Safety Sciences, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK |
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