Medimmune Limited

Abbvie Inc.

Abbvie Biotherapeutics Inc.

Arexis Ab

Regenerx Biopharmaceuticals, Inc.

Christian B Allan

Cynthia N Oliver

Stephen T Chang

Erica Shane

Benjamin S Isaacs

Herren Wu

Changshou Gao

Anthony Coyle

Peter Kiener

Edward B Reilly

Ling-Ling An

Louie Naumovski

Su-Yau Mao

Daniel E Afar

Jieyi Wang

William Dall'Acqua

Jeffrey S Swers

Stephen Chang

Mark Anderson

William H Walton

Mark G Anderson

Benjamin S Issaacs

The present invention provides liquid formulations of SYNAGIS&#xae; or an antigen-binding fragment thereof that immunospecifically bind to a respiratory syncytial virus (RSV) antigen, which formulations exhibit stability, low to undetectable levels of aggregation, and very little to no loss of the biological activities of SYNAGIS&#xae; or an antigen-binding fragment thereof, even during long periods of storage. In particular, the present invention provides liquid formulations of SYNAGIS&#xae; or an antigen-binding fragment thereof which immunospecifically binds to a RSV antigen, which formulations are substantially free of surfactant, inorganic salts, and/or other common excipients. Furthermore, the invention provides method of preventing, treating or ameliorating symptoms associated with RSV infection utilizing liquid formulations of the present invention.

Stabilized liquid anti-RSV antibody formulations

The present disclosure provides antibody drug conjugates that bind human cMET, their methods of making, and their uses to treat patients having cancer.

Anti-cMet antibody drug conjugates and methods for their use

The present invention provides liquid formulations of SYNAGIS&#xae; or an antigen-binding fragment thereof that immunospecifically bind to a respiratory syncytial virus (RSV) antigen, which formulation exhibit stability, low to undetectable levels of aggregation, and very little to no loss of the biological activities of SYNAGIS&#xae; or an antigen-binding fragment thereof, even during long periods of storage. In particular, the present invention provides liquid formulations of SYNAGIS&#xae; or an antigen-binding fragment thereof which immunospecifically binds to a RSV antigen, which formulation are substantially free of surfactant, inorganic salts, and/or other common excipients. Furthermore, the invention provides method of preventing, treating or ameliorating symptoms associated with RSV infection utilizing liquid formulations of the present invention.

The present invention provides embodiments which involve methods of providing a predetermined concentration of thymosin beta 4 (TB4) at a predetermined time, t, in a body portion of a live human patient. The methods can include determining a thymosin beta 4 treatment dosage (D) using Formula I: C=(A)D&#xb7;t, wherein C is the predetermined concentration at time t, in ng/mL, D is the dosage of thymosin beta 4 administered in mg, t is the time elapsed after administration of dosage D in hours, A is about 30 to about 38, and B is about 0.5 to about 1; and administering the dosage (D) of thymosin beta 4 to the patient. Formula I may be, for example,=(35.6)&#x2003;&#x2003;(Formula II).

Method of achieving a thymosin beta 4 concentration in a human patient

The invention provides method for therapeutic protein drug development that incorporates therapeutic and/or formulation and/or manufacturing considerations in the early screening process. The approach involves screening a plurality of different variants of a domain that have been determined to have the desired therapeutic property to identify one or more variants that have desired therapeutic and/or formulation characteristics, and constructing the full multidomain proteins using the identified domain variants. The present invention also provides a method for determining the shelf life of multidomain proteins in formulations. The method comprises determining a thermal denaturation and/or renaturation curve of a domain of the protein whose unfolding leads to aggregation of the protein in a solution. The method evaluates the shelf life of the multidomain protein based on the denaturation/renaturation curve. The invention also provides methods for engineering multidomain proteins to improve their therapeutic and/or formulation characteristics.

Integrated approach for generating multidomain protein therapeutics

The present invention provides liquid formulations of SYNAGIS&#xae; or an antigen-binding fragment thereof that immunospecifically bind to a respiratory syncytial virus (RSV) antigen, which formulations exhibit stability, low to undetectable levels of aggregation, and very little to no loss of the biological activities of SYNAGIS&#xae; or an antigen-binding fragment thereof even during long periods of storage. In particular, the present invention provides liquid formulations of SYNAGIS&#xae; or an antigen-binding fragment thereof which immunospecifically binds to a RSV antigen, which formulations are substantially free of surfactant, inorganic salts, and/or other common excipients. Furthermore, the invention provides method of preventing, treating or ameliorating symptoms associated with RSV infection utilizing liquid formulations of the present invention.

Compositions and methods are disclosed for inhibiting the release of a proinflammatory cytokine from a vertebrate cell, and for inhibiting an inflammatory cytokine cascade in a patient. The compositions comprise, for example, high affinity antibodies that specifically bind HMG1 and antigenic fragments thereof. The high affinity antibodies of the present invention and pharmaceutical compositions comprising the same are useful for many purposes, for example, as therapeutics against a wide range of inflammatory diseases and disorders such as sepsis, rheumatoid arthritis, peritonitis, Crohn's disease, reperfusion injury, septicemia, endotoxic shock, cystic fibrosis, endocarditis, psoriasis, psoriatic arthritis, arthritis, anaphylactic shock, organ ischemia, reperfusion injury, and allograft rejection. In addition, the high affinity antibodies of the present inventions are useful as diagnostic antibodies.

High affinity antibodies against HMGB1 and methods of use thereof

The present invention provides liquid formulations of antibodies or antibody fragments that immunospecifically bind to an IL-9 polypeptide, which formulations exhibit stability, low to undetectable levels of aggregation, and very little to no loss of the biological activities of the antibodies or antibody fragments, even during long periods of storage. In particular, the present invention provides liquid formulations of antibodies or fragments thereof that immunospecifically bind to an IL-9 polypeptide, which formulations are substantially free of surfactants, sugars, sugar alcohols, amino acids other than histidine (preferably with pKa values of less than 5 and above 7), and/or other common excipients. Furthermore, the invention provides methods of preventing, treating or ameliorating a disease or disorder associated with or characterized by aberrant expression and/or activity of an IL-9 polypeptide, a disease or disorder associated with or characterized by aberrant expression and/or activity of the IL-9R or one or more subunits thereof, an autoimmune disease, an inflammatory disease, a proliferative disease, or an infection (preferably, a respiratory infection), or one or more symptoms thereof, utilizing the liquid formulations of the present invention.

Anti-IL-9 antibody formulations

Growing community of inventors

Brookeville, MD, United States of America

Christian B Allan