Abstract: The present invention is directed in part to pharmaceutical compositions for storage and administration comprising a) a HER2/neu antibody (“margetuximab”), b) buffering agents, and c) stabilizers, wherein said margetuximab is stable. The invention in part provides, containers and kits comprising such pharmaceutical compositions. The invention is directed in part to the use of such pharmaceutical compositions, containers, and kits containing margetuximab in the treatment of HER2/neu-positive cancer (i.e., a cancer that expresses HER2), including breast cancer or gastric cancer or GEJ cancer.

Abstract: The present disclosure is provides pharmaceutical compositions, for storage and administration, comprising a human PD-1 (“hPD-1”) antibody (“retifanlimab”) and buffering agents. The disclosure further provides containers and kits comprising such pharmaceutical compositions. The disclosure further provides the use of such pharmaceutical compositions, containers, and kits containing retifanlimab in the treatment of a cancer, and in certain aspects treatment of a cancer expressing PD-L1.

Abstract: The present invention is directed to stable aqueous pharmaceutical formulations that comprise a bispecific monovalent diabody (“Diabody formulation”), and to aqueous stabilizer solutions for stabilizing and administering said diabody. The invention particularly concerns such pharmaceutical formulations that comprise a diabody drug product (DART-A DP formulations) that comprise a sequence-optimized CD 123×CDS bispecific diabody (DART-A) that is capable of simultaneously binding to CD 123 and CDS. The invention further concerns the use of such DART-A DP formulations in the treatment of hematologic malignancies such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in patients.

Abstract: The present invention is directed in part to pharmaceutical compositions for storage and administration comprising a) a HER2/neu antibody (“margetuximab”), b) buffering agents, and c) stabilizers, wherein said margetuximab is stable. The invention in part provides, containers and kits comprising such pharmaceutical compositions. The invention is directed in part to the use of such pharmaceutical compositions, containers, and kits containing margetuximab in the treatment of HER2/neu-positive cancer (i.e., a cancer that expresses HER2), including breast cancer or gastric cancer or GEJ cancer.

Abstract: The present invention is directed to a dosing regimen for administering a CD 123×CDS bispecific diabody to patients with a hematologic malignancy such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The present invention is also directed to a dosing regimen for administering a CD 123×CDS bispecific diabody in combination with a molecule capable of binding PD-1 or a natural ligand of PD-1 (a “PD-1 or PD-1 ligand binding molecule”) to patients with a hematologic malignancy such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The invention particularly concerns the use of such regimens for administering the sequence-optimized CD 123×CDS bispecific diabody, “DART-A,” which is capable of simultaneous binding to CD 123 and CDS.

Abstract: The present invention is directed in part to pharmaceutical compositions for storage and administration comprising a) a HER2/neu antibody (“margetuximab”), b) buffering agents, and c) stabilizers, wherein said margetuximab is stable. The invention in part provides, containers and kits comprising such pharmaceutical compositions. The invention is directed in part to the use of such pharmaceutical compositions, containers, and kits containing margetuximab in the treatment of HER2/neu-positive cancer (i.e., a cancer that expresses HER2), including breast cancer or gastric cancer or GEJ cancer.