Compositions and methods for treatment in broad-spectrum, undifferentiated or mixed clinical applications
Inventors
Assignees
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Publication Number
US-10611828-B2
Publication Date
2020-04-07
Expiration Date
Abstract
The disclosure provides improved compositions and methods for passive immunization. In embodiments, a composition comprising a synergistic combination of specific polyclonal antibodies in a carrier matrix is provided. The disclosure provides effective, economical compositions and methods for the treatment of diarrhea and enteric infections in broad-spectrum, undifferentiated, or mixed clinical applications.
Core Innovation
A composition is provided for administration to a non-neonate human in need thereof. The composition comprises a non-neonate effective amount of at least one antigen specific antibody, or antigen binding fragment thereof, obtained from a first nonhuman animal, together with a carrier matrix comprising full fat colostrum obtained from a second nonhuman animal, where the antibody or fragment and the colostrum are obtained from different non-human animals.
The carrier matrix comprises at least two components selected from enzymes, lactoferrin, transferrin, nonspecific immunoglobulins, cytokines, white blood cells, complement components, interferons, growth factors, and fibronectin. The disclosed embodiments describe formulations using dried or solid formats, and the carrier matrix is characterized as a multi-component immune composition together with antigen specific antibodies.
The disclosure addresses treatment or prevention of pathogenic infection and undesirable strain of microorganisms in a non-neonate human, including broad-spectrum infectious/diarrheal diseases such as undifferentiated pediatric diarrhea. The compositions are positioned for oral, mucosal, or topical delivery and are described as maintaining antigen specific activity and controlled cross-reactivity among related antigen clusters.
Claims Coverage
The partial content includes two independent claims. Across them, the core coverage centers on combining an antigen specific antibody, or antigen binding fragment, obtained from a first nonhuman animal with a full fat colostrum-derived carrier matrix obtained from a second nonhuman animal, with different-animal sourcing and at least two defined innate immune components in the carrier matrix.
Non-neonate composition with two-animal sourcing and full fat colostrum carrier
A non-neonate effective amount of at least one antigen specific antibody, or antigen binding fragment thereof, obtained from a first nonhuman animal, in a composition comprising a carrier matrix comprising full fat colostrum obtained from a second nonhuman animal, where the carrier matrix comprises at least two components selected from enzymes, lactoferrin, transferrin, nonspecific immunoglobulins, cytokines, white blood cells, complement components, interferons, growth factors, and fibronectin, and wherein the at least one antigen specific antibody or antigen binding fragment thereof and the colostrum are obtained from different non-human animals.
Method of treatment or prevention with two-animal sourcing and full fat colostrum carrier
A method for the treatment or prevention of a pathogenic infection or undesirable strain of microorganisms in a non-neonate human in need thereof, comprising administration of a composition comprising a non-neonate effective amount of at least one antigen specific antibody, or antigen binding fragment thereof, obtained from a first nonhuman animal, and a carrier matrix comprising full fat colostrum obtained from a second nonhuman animal, where the carrier matrix comprises at least two components selected from enzymes, lactoferrin, transferrin, nonspecific immunoglobulins, cytokines, white blood cells, complement components, interferons, growth factors, and fibronectin, and wherein the at least one specific binding molecule and the colostrum of the carrier matrix are obtained from different non-human animals.
Both independent claims cover a non-neonate administration approach that pairs antigen specific binding molecules obtained from a first nonhuman animal with a full fat colostrum-derived carrier matrix obtained from a second nonhuman animal. The carrier matrix includes at least two components selected from a defined group of immune-related components, in both composition and method contexts.
Stated Advantages
Maintaining antigen specific activity and controlled cross-reactivity among related antigen clusters.
Rapid improvement in stool frequency and consistency and physician well-being is reported in field clinical outcomes.
No added polymers, liposomes, microspheres, or added exogenous antigen.
Documented Applications
Treatment or prevention of a pathogenic infection or undesirable strain of microorganisms in a non-neonate human.
Treatment or prevention in connection with broad-spectrum infectious/diarrheal diseases, including undifferentiated pediatric diarrhea.
Typhoid fever is described as having an unexpected efficacy observation.
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