Compositions comprising immunoreactive reagents and saponins, and methods of use thereof

Abstract

The present invention relates to pharmaceutical compositions that are useful for the prevention and treatment of infectious diseases, primary and metastatic neoplastic diseases (i.e., cancer), neurodegenerative or amyloid diseases, or any other disease wherein the treatment of such disease would be improved by an enhanced immune response, and methods of formulating the compositions. The compositions comprise an immunoreactive reagent (i.e., an antigen binding protein comprising an antigen binding region and a region or regions of an antibody that mediate antibody dependent immunological processes) and a saponin. The present invention also relates to methods of using the compositions of the invention for the prevention and / or treatment of infectious diseases, primary and metastatic neoplastic diseases (i.e., cancer), neurodegenerative or amyloid diseases, or any other disease wherein the treatment of such disease would be improved by an enhanced immune response.

Description

1. FIELD OF THE INVENTION [0001] The present invention relates to pharmaceutical compositions that are useful for the prevention and treatment of infectious diseases, primary and metastatic neoplastic diseases (i.e., cancer), neurodegenerative or amyloid diseases, or any other disease wherein the treatment of such disease would be improved by an enhanced immune response, and methods of formulating the compositions. The compositions comprise an immunoreactive reagent (i.e., an antigen binding protein comprising an antigen binding region and a region or regions of an antibody that mediate antibody dependent immunological processes) and a saponin. Such antibody dependent processes include, but are not limited to, antibody dependent cellular cytotoxicity and phagocytosis. The present invention also relates to methods of using the compositions of the invention for the treatment of infectious diseases, primary and metastatic neoplastic diseases (i.e., cancer), neurodegenerative or amyloid...

AI Technical Summary

Benefits of technology

The present invention is about pharmaceutical compositions that can be used to prevent and treat infectious diseases, cancer, neurodegenerative or amyloid diseases, and any other diseases that would benefit from an enhanced immune response. These compositions contain an immunoreactive reagent and a saponin. They can also include an immunostimulatory oligonucleotide. The invention also provides methods for using these compositions for treatment, including passive immunotherapy. The compositions can be used to generate an immune response against specific antigens associated with these diseases. The invention also provides dosage regimes and kits for the use of these compositions.

Problems solved by technology

The first commercially available Quillaja saponin adjuvants were crude extracts which, because of their variability, were not desirable for use in veterinary practice or in pharmaceutical compositions for man.

However, while Dalsgaard's preparation, “Quil-A,” was a definite improvement over the previously available commercial saponins, it still exhibited considerable heterogeneity.

However, not all of these saponins were active as adjuvants.