Immunoglobulin polypeptide fractions from products of domestic animals
Inventors
Bremel, Robert D. • Homan, Jane
Assignees
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Publication Number
US-10799582-B2
Publication Date
2020-10-13
Expiration Date
Abstract
The present invention provides a means to prepare a product from domestic animal milk, blood or eggs which comprises an array of T-cell exposed motifs similar in identity, distribution and concentration to those found in human immunoglobulin variable regions and to prepare and apply the product as an immune modulating agent for administration either as a nutritional supplement or as a pharmaceutical product.
Core Innovation
The invention provides a protein product comprising an immunoglobulin polypeptide fraction derived from a milk product of a domestic animal, including colostrum and whey. The immunoglobulin polypeptide fraction is characterized by a frequency of representation of T-cell exposed motifs that matches at least 60% of the T-cell exposed motifs present in a reference database, and the reference database comprises at least 40,000 unique T-cell exposed motifs selected from human germline immunoglobulin variable region sequences, somatically mutated human immunoglobulin variable region sequences, and immunoglobulin constant chains.
The protein product is formulated as a liquid and comprises greater than about 25% w/w immunoglobulin polypeptides on a dry basis. The invention is directed to immune modulation and immune rebalancing by using immunoglobulin polypeptide fractions whose T-cell exposed motif representation profiles are comparable to human immunoglobulin variable regions, including comparison between bovine and human T-cell exposed motif frequency profiles.
The invention further includes an oral formulation comprising an immunoglobulin polypeptide fraction derived from a domestic animal. The oral formulation contains an immunoglobulin polypeptide fraction with frequency of representation of at least 60% of the same type of reference database and comprises greater than about 25% w/w immunoglobulin polypeptides on a dry basis, and the oral formulation is selected from powder, liquid, capsule and gel.
Claims Coverage
The patent includes two independent claims focused on a liquid protein product derived from domestic animal milk products and an oral formulation with the same T-cell exposed motif frequency-profile requirement relative to a human reference database. Each independent claim combines the TCEM frequency-of-representation criterion, the reference database size and selection, and the immunoglobulin content and formulation constraints.
TCEM-frequency-matched immunoglobulin fraction derived from domestic animal milk product
A protein product comprising an immunoglobulin polypeptide fraction derived from a milk product of a domestic animal, wherein the immunoglobulin polypeptide fraction comprises a frequency of representation of at least 60% of the T-cell exposed motifs found in a reference database selected from human germline immunoglobulin variable region sequences, somatically mutated human immunoglobulin variable region sequences, and immunoglobulin constant chains, and wherein the reference database comprises at least 40,000 unique T-cell exposed motifs.
Liquid formulation with high immunoglobulin w/w content
The immunoglobulin polypeptide fraction is formulated as a liquid and comprises greater than about 25% w/w immunoglobulin polypeptides on a dry basis.
Oral TCEM-frequency-matched immunoglobulin fraction derived from domestic animal
An oral formulation comprising an immunoglobulin polypeptide fraction derived from a domestic animal, wherein the immunoglobulin polypeptide fraction comprises a frequency of representation of at least 60% of the T-cell exposed motifs found in the same reference database of at least 40,000 unique T-cell exposed motifs.
Oral formulation with high immunoglobulin w/w content and selected dosage forms
The immunoglobulin polypeptide fraction comprises greater than about 25% w/w immunoglobulin polypeptides on a dry basis, and the oral formulation is selected from powder, liquid, capsule and gel.
Across both independent claims, the inventive coverage centers on a domestic-animal immunoglobulin polypeptide fraction whose T-cell exposed motif frequency of representation is matched to at least 60% relative to a human reference database containing at least 40,000 unique motifs, together with formulation and immunoglobulin content constraints.
Stated Advantages
Immune modulation and immune rebalancing through oral and/or pharmaceutical/nutritional use.
Immune balancing for autoimmune dysregulation, immunosuppression/transplant contexts, and adjunct to vaccination.
Compatibility with contexts involving antibiotic disruption and antibody therapeutics.
Documented Applications
Nutritional supplement use and/or pharmaceutical product use, including oral formulations (powder, liquid, capsule and gel) for immune modulation and immune rebalancing.
Use in autoimmune dysregulation contexts for immune balancing.
Use in immunosuppression/transplant contexts for immune balancing and reconstitution.
Adjunct to vaccination.
Use in contexts including antibiotic disruption and antibody therapeutics.
Reference database construction and non-human TCEM overlap analysis.
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