CEACAM5 antibody-drug conjugate formulation

A method of treating a cancer, comprising administering to a subject in need thereof an effective amount of a pharmaceutical formulation comprising:

• an antibody-drug conjugate (ADC) comprising an anti-human carcinoembryonic antigen-related cell adhesion molecule 5 (hCEACAM5) antibody bound to a maytansinoid derivative 4 (DM4) by a N-succinimidyl-4-(2-pyridyldithio) butanoic acid (SPDB) linker;
• wherein the antibody comprises a variable heavy (VH) domain of amino acid sequence of SEQ ID NO:
• 6 and a variable light (VL) domain of amino acid sequence of SEQ ID NO:7;
• the formulation consisting of the following excipients:
• i) sodium acetate at a concentration of about 10 mM;
• ii) sorbitol at a concentration of about 5% w/v;
• iii) polysorbate 80 at a concentration of about 0.04% w/v;
• and
• iv) disodium EDTA at a concentration of between about 1 μM and about 50 μM;
• wherein the formulation has a pH of about 5.5.

A liquid pharmaceutical formulation consisting of:

• i) 5 mg/mL anti-human carcinoembryonic antigen-related cell adhesion molecule 5 (hCEACAM5) antibody-drug conjugate (ADC);
• ii) sodium acetate at a concentration of 10 mM;
• iii) sorbitol at a concentration of 5% w/v;
• iv) polysorbate 80 at a concentration of 0.04% w/v;
• and
• v) disodium EDTA at a concentration of 10 μM;
• wherein the liquid dosage form has a pH of 5.5, and
• wherein the ADC consists of huMAb2-3-SPDB-DM4.