Combination of plasma immunoglobulin and antigen-specific immunoglobulin for the modification of the immune system and the treatment or prevention of allergic diseases
Inventors
Hoffmann, Geoffrey William • Gorczynski, Reginald M.
Assignees
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Publication Number
US-12090202-B2
Publication Date
2024-09-17
Expiration Date
Abstract
A method of use of plasma immunoglobulin, such as intramuscular immunoglobulin, in combination with polyclonal antigen-specific immunoglobulin in the treatment or prevention of allergic disease is provided. Also provided is a pharmaceutical composition including plasma immunoglobulin in combination with polyclonal antigen-specific immunoglobulin.
Core Innovation
The invention relates to a pharmaceutical composition for the treatment or prevention of allergic disease in a mammalian subject. The composition comprises a combination of pooled plasma immunoglobulin and additional antigen specific immunoglobulin, and the concept is also described using pooled plasma immunoglobulin as intramuscular immunoglobulin, including human IMIG.
The described approach combines pooled plasma immunoglobulin with an antigen-specific polyclonal immunoglobulin to modulate allergic responses. In the document, combined intramuscular immunoglobulin and antigen-specific polyclonal immunoglobulin attenuate allergen-specific IgE and IL-4 responses while not attenuating IgG/IL-2 responses.
The disclosed formulation and product concepts include pharmaceutically acceptable carriers, and kit options that provide separate or mixed aliquots of the immunoglobulin components. The document also supports the concept with mouse and dog experiments and measurements such as ELISA and splenocyte assays including ConA stimulation, reporting changes consistent with attenuation of allergen-specific IgE and IL-4.
Claims Coverage
The independent claim set comprises pharmaceutical composition and method claims, with three independent claim families directed to allergic disease, and to ovalbumin allergy or peanut allergy. Across these independent claims, the coverage centers on a combined administration of pooled plasma immunoglobulin together with an additional antigen-specific immunoglobulin, with inventive features defined by specific antigen-specific polyclonal immunoglobulin selections and, in some cases, injection or intramuscular injection as the administration format.
Pooled plasma immunoglobulin plus antigen-specific polyclonal immunoglobulin for allergic disease composition
A pharmaceutical composition for the treatment or prevention of allergic disease in a mammalian subject comprising a combination of pooled plasma immunoglobulin and additional antigen specific immunoglobulin selected from polyclonal anti-tetanus toxoid immunoglobulin, polyclonal anti-hepatitis B immunoglobulin, polyclonal anti-rabies immunoglobulin, and polyclonal anti-varicella immunoglobulin.
Administer pooled plasma immunoglobulin plus antigen-specific immunoglobulin to treat or prevent allergic disease
A method of treating or preventing an allergic disease comprising administering to a mammalian subject in need thereof a combination of pooled plasma immunoglobulin and additional antigen-specific immunoglobulin.
Treat or prevent ovalbumin allergy or peanut allergy using pooled plasma immunoglobulin plus antigen-specific immunoglobulin
A method of treating or preventing an ovalbumin allergy or peanut allergy comprising administering to a mammalian subject in need thereof a pharmaceutical composition comprising a combination of pooled plasma immunoglobulin and antigen-specific immunoglobulin.
Overall, the independent claims cover administering pooled plasma immunoglobulin together with an additional antigen-specific immunoglobulin, including composition and method formats, and in specific claim sets directed to ovalbumin allergy or peanut allergy and to injection or intramuscular injection refinements.
Stated Advantages
Attenuation of allergen-specific IgE and IL-4 responses.
No attenuation of IgG/IL-2 responses.
Dose-response effects are described.
Documented Applications
Treatment or prevention of allergic disease in a mammalian subject.
Treatment or prevention of an ovalbumin allergy or peanut allergy.
Mouse and dog experimental support including beagle dog peanut-butter sensitization studies.
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