Abstract: The present invention is directed to a method for preventing and/or treating melanoma such as superficial spreading melanoma, nodular melanoma, lentigo maligna melanoma, and acral lentiginous melanoma. The method comprises administering to a subject in need thereof an effective amount of dapansutrile. The method optionally comprising co-administering anti-PD-1 antibody with dapansutrile. A preferred route of administration is oral administration.

Abstract: The present invention is directed to a method for preventing or treating lung infection and/or lung inflammation. The present invention provides a method for preventing or treating macrophage activation syndrome in an infected patient. The present invention also provides a method preventing or treating pneumonitis. The present invention further provides a method for treating COVID-19 patients with SAR-CoV-2 viral infection having mild or moderate respiratory symptoms or fever. The method comprises administering to a subject in need thereof dapansutrile, or a pharmaceutically acceptable solvate thereof, in an effective amount. The present method treats early cytokine release syndrome and arrests the initiation of the IL-1? and IL-18 mediated “cytokine storm” and/or pneumonitis in a patient, without causing a negative effect to his heart condition, type II diabetes, and other issues. Oral administration is a preferred route of administration.

Abstract: The present invention is directed to a method for treating cardiovascular diseases such as acute myocardial infarction, atherosclerosis, heart failure, stroke, thrombosis, carditis (including acute myocarditis, acute pericarditis and complicated pericarditis), cardiac allograft rejection, cardiomyopathy, and peripheral vascular diseases. The method comprises administering to a subject in need thereof dapansutrile, in an effective amount. A preferred route of administration is oral administration.

Abstract: The present invention is directed to a method for treating cardiovascular diseases such as acute myocardial infarction, atherosclerosis, heart failure, stroke, thrombosis, carditis (including acute myocarditis, acute pericarditis and complicated pericarditis), cardiac allograft rejection, cardiomyopathy, and peripheral vascular diseases. The method comprises administering to a subject in need thereof dapansutrile, in an effective amount. A preferred route of administration is oral administration.

Abstract: The present invention is directed to a method for treating diabetes. The method comprises administering to a subject in need thereof dapansutrile, or a pharmaceutically acceptable solvate thereof, in an effective amount. Oral administration is a preferred route of administration.

Abstract: The disclosure provides interleukin 37 (IL-37) fusion proteins, methods of making IL-37 fusion proteins including constructs used to express IL-37 fusion proteins, and methods of using IL-37 fusion proteins. In some embodiments, the IL-37 fusion protein includes amino acids 46-206 of isoform B of IL-37 and a heavy chain portion of an antibody.

Abstract: The present invention is directed to a method for preventing and/or treating Alzheimer's disease. The method comprises administering to a subject in need thereof an effective amount of dapansutrile. The method reduces neuroinflammation and improves the cognitive functions such as learning and memory processes of the subject. Dapansutrile can be administered to the subject orally at a dose of 100-2000 mg/day for 3 months to 5 years or longer.

Abstract: The present invention is directed to a method of treating breast cancer. The method comprises administering to a subject in need thereof an effective amount of dapansutrile, or a pharmaceutically acceptable solvate thereof. The method optionally comprises further administering to the subject an effective amount of a checkpoint inhibitor.

Abstract: Embodiments herein report compositions of alpha-1 antitrypsin fusion polypeptides or peptide derivatives thereof. In certain embodiments, compositions and methods relate to generating a construct of use in pharmaceutically acceptable compositions to treat a subject in need of alpha-1 antitrypsin therapy or treatment. In other embodiments, compositions and methods disclosed herein concern linking alpha-1 antitrypsin or derivative thereof to an immune fragment.

Abstract: The present invention is directed to a method for treating Asthma. The method comprises administering to a subject in need thereof 3-methanesulfonylpropionitrile (dapansutrile), or a pharmaceutically acceptable solvate thereof, in an effective amount. The preferred route of administration is oral administration or local administration.

Abstract: Embodiments herein illustrate methods and compositions for treating medical disorders. In certain embodiments, compositions and methods relate to reducing, inhibiting or treating graft rejection, transplant rejection or diabetes in a subject. Other embodiments herein relate to compounds including naturally occurring and synthetic mutant compositions of alpha-1 antitrypsin, wherein the alpha-1 antitrypsin has no significant serine protease inhibitor activity.

Abstract: The present invention is directed to a method for preventing and/or treating melanoma such as superficial spreading melanoma, nodular melanoma, lentigo maligna melanoma, and acral lentiginous melanoma. The method comprises administering to a subject in need thereof an effective amount of dapansutrile. The method optionally comprising co-administering anti-PD-1 antibody with dapansutrile. A preferred route of administration is oral administration.

Abstract: The present invention is directed to a method for preventing and/or treating Alzheimer's disease. The method comprises administering to a subject in need thereof an effective amount of dapansutrile. The method reduces neuroinflammation and improves the cognitive functions such as learning and memory processes of the subject. Dapansutrile can be administered to the subject orally at a dose of 100-2000 mg/day for 3 months to 5 years or longer.

Abstract: Embodiments of the present invention illustrate methods of preventing transplantation rejection. In certain embodiments, a subject in need of an organ or non-organ transplantation can be pretreated with an AAT composition to reduce the incidence of transplantation rejection in the subject. Other embodiments include treating a subject with a composition including AAT before, during or after plastic surgery.

Abstract: Embodiments herein report methods and compositions for treating cardiac conditions. In certain embodiments, compositions and methods relate to reducing, inhibiting or treating a subject having or suspected of undergoing cardiac remodeling after a cardiac event. Other embodiments herein relate to compounds including naturally occurring and synthetic compositions of alpha-1 antitrypsin and fragments thereof.

Abstract: Embodiments herein report compositions of and methods for making and using alpha-1 antitrypsin (AAT) fusion molecules or peptide derivatives thereof. In certain embodiments, compositions and methods relate to generating an AAT fusion molecule of use in pharmaceutically acceptable compositions to treat a subject in need of AAT therapy or treatment. In other embodiments, compositions and methods disclosed herein concern linking AAT or derivative thereof to an immune fragment.

Abstract: Embodiments of the present invention relate to compositions and methods for treatment of subjects in need of or having a bone marrow transplant. Certain embodiments describe compositions and methods for treatment of conditions associated with bone marrow transplantations in a subject, for example, Graft versus Host Disease (GvHD) or bone marrow transplantation rejection. Some embodiments concern early or immediate bone marrow transplantation rejection. Certain embodiments relate to compositions and uses of alpha1-antitrypsin (?1-antitrypsin, AAT) and carboxyterminal peptide derivatives thereof and/or compositions and uses of serine protease inhibitors, immunomodulators or anti-inflammatory agent activity similar to that of AAT.

Abstract: The present invention is directed to a method for treating Schnitzler's syndrome. The method comprises administering to a subject in need thereof dapansutrile, or a pharmaceutically acceptable solvate thereof, in an effective amount. Oral administration is a preferred route of administration.

Abstract: Embodiments herein report compositions of alpha-1 antitrypsin fusion polypeptides or peptide derivatives thereof. In certain embodiments, compositions and methods relate to generating a construct of use in pharmaceutically acceptable compositions to treat a subject in need of alpha-1 antitrypsin therapy or treatment. In other embodiments, compositions and methods disclosed herein concern linking alpha-1 antitrypsin or derivative thereof to an immune fragment.

Abstract: The disclosure provides interleukin 37 (IL-37) fusion proteins, methods of making IL-37 fusion proteins including constructs used to express IL-37 fusion proteins, and methods of using IL-37 fusion proteins. In some embodiments, the IL-37 fusion protein includes amino acids 46-206 of isoform B of IL-37 and a heavy chain portion of an antibody.