Pharmaceutical compositions comprising anti-191p4d12 antibody drug conjugates and methods of use thereof

#Provided herein are pharmaceutical compositions comprising anti-191P4D12 antibody drug conjugates. Methods of using the pharmaceutical compositions are also provided herein.

#Drug substances are usually administered as part of a formulation in combination with one or more other agents that serve varied and specialized pharmaceutical functions. Pharmaceutical excipients have various functions and contribute to the pharmaceutical formulations in many different ways, e.g., solubilization, dilution, thickening, stabilization, preservation, coloring, flavoring, etc. Properties that may be considered when formulating an active drug substance include bioavailability, ease of manufacture, ease of administration, and stability of the dosage form. Due to the varying properties of active drug substances being formulated, dosage forms typically require pharmaceutical excipients that are uniquely tailored to the active drug substance in order to achieve advantageous physical and pharmaceutical properties.

#Thus, a need exists as to pharmaceutical compositions of anti-191P4D12 antibody drug conjugates having advantageous physical and pharmaceutical properties. The present invention satisfies this need and provides related benefits.

#FIGS. 1A, 1B, 1C, and 1D depict the results of SDS-PAGE analysis for the 14-day stability study for the formulations F1-F14 at 40° C.

#FIG. 1E depicts the summary of the PR-HPLC study described in Section 6.1.

#FIGS. 1F, 1G, and 1H depicts the results of the SE-HPLC analysis for the formulations F1-F14 at 40° C.

#Before the present disclosure is further described, it is to be understood that the disclosure is not limited to the particular embodiments set forth herein, and it is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

#Techniques and procedures described or referenced herein include those that are generally well understood and/or commonly employed using conventional methodology by those skilled in the art, such as, for example, the widely utilized methodologies described in Sambrook et al., Molecular Cloning: A Laboratory Manual (3d ed. 2001); Current Protocols in Molecular Biology (Ausubel et al. eds., 2003); Therapeutic Monoclonal Antibodies: From Bench to Clinic (An ed. 2009); Monoclonal Antibodies: Methods and Protocols (Albitar ed. 2010); and Antibody Engineering Vols 1 and 2 (Kontermann and Dübel eds., 2d ed. 2010).

#Unless otherwise defined herein, technical and scientific terms used in the present description have the meanings that are commonly understood by those of ordinary skill in the art. For purposes of interpreting this specification, the following description of terms will apply and whenever appropriate, terms used in the singular will also include the plural and vice versa. In the event that any description of a term set forth conflicts with any document incorporated herein by reference, the description of the term set forth below shall control.