Modulation of gene expression in a human bioreactor
Inventors
Barron, Annelise E. • Haase, David • McClure, Joshua
Assignees
Publication Number
US-11697834-B2
Publication Date
2023-07-11
Expiration Date
2040-01-27
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Abstract
A method is provided for treating a recipient with a biological product obtained from at least one donor that may be the same as, or different from, the recipient. The method includes identifying a targeted level of gene expression of a first gene in a biological product to be transferred from at least one donor to a recipient; treating the at least one donor to achieve the targeted level of gene expression of the first gene in the biological product; and transferring the biological product from the at least one donor to the recipient.
Core Innovation
The invention provides a method for treating a recipient with a biological product obtained from at least one donor. The method involves identifying a targeted level of gene expression of a first gene in a biological product to be transferred, treating the donor to achieve that targeted gene expression in the product, and transferring the biological product from the donor to the recipient. The donor and recipient may be the same person or different individuals, and the process can be applied to single donors or mixtures from multiple donors to achieve desired gene expression profiles in the final administered product.
The system allows for various biological products to be used, including blood components, organs, cells, and tissues. Treatments to induce targeted gene expression in the donor include administering pharmaceutical compositions, enforcing specific diets, exercise regimens, exposure to stimuli, or direct genome or RNA modifications. The approach also includes donor selection based on criteria like gene expression, hormones, genomic analysis, or age difference relative to the recipient.
The problem addressed is the lack of control over gene expression levels in donated biological products, which may affect therapeutic outcomes. Prior transfusion work has not clearly determined how donor characteristics or gene modulation impacts recipient benefit. By modulating donor gene expression before collection, the invention aims to achieve more optimal or therapeutic levels of desired agents in the biological product, potentially improving treatment outcomes for recipients.
Claims Coverage
There is one independent claim in this patent, focusing on the method for treating a recipient with a biological product involving targeted modulation of gene expression.
Method for treating a recipient via targeted gene expression modulation in donor-derived biological products
This inventive feature includes: 1. Identifying a targeted level of gene expression of a first gene in a biological product to be transferred from at least one donor to a recipient. 2. Treating the at least one donor to achieve the targeted level of gene expression of the first gene in the biological product. 3. Transferring the biological product from the at least one donor to the recipient. The process is general to any biological product and any donor-recipient relationship, encompassing both autologous and allogeneic transfers.
The independent claim broadly covers methods for modulating gene expression in donor-derived biological products prior to administration to a recipient, encompassing a range of donors, biological products, and treatment modalities for gene expression modulation.
Stated Advantages
The methods allow beneficial effects in donor/recipient therapies by achieving more optimal levels of one or more therapeutic agents in the biological product or recipient's body than may be possible without gene expression modulation in the donor.
The invention enables control of gene expression levels in biological products, potentially leading to improved therapeutic outcomes.
Documented Applications
Use in CAR (Chimeric Antigen Receptor) T cell therapy for subjects suffering from cancer, involving upregulation of CAMP gene expression in donors and enhanced efficacy of therapeutic T cells.
Treatment of recipients with blood, blood plasma, or cells from donors (including autologous or multiple donors) where gene expression (such as the CAMP gene) is upregulated prior to product collection and transfusion.
Treatment of recipients having degenerative conditions, including Alzheimer’s disease, amyotrophic lateral sclerosis, cancers, cardiovascular diseases, multiple sclerosis, Parkinson’s disease, and various other listed degenerative diseases.
Treatment of recipients having toxigenic conditions, such as diphtheria, anthrax infections, and Clostridium difficile infections.
Treatment of recipients having pathogenic conditions, including ocular neurodegenerative diseases such as age-related macular degeneration, glaucoma, ocular hypertension, and diabetic retinopathy.
Use in veterinary applications and laboratory or research settings for non-human subjects.
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