Development of a Stable Lyophilized Formulation of a Quadrivalent Frame-Shift Peptide Vaccine for Cancer Prevention in Lynch Syndrome

A stable lyophilized formulation for a cancer vaccine containing quadrivalent frameshift neo antigen peptides TAFB(-1), AIM2(-1), HT001(-1) and TGFBR2(-1), was obtained through an iterative screening process. To develop a lyophilized formulation, the screening included evaluation of pH, stabilizers, bulking agents, and surfactants. The screening resulted in a scalable formulation and lyophilization process that co-formulated four peptides with 100 mcg/ml each peptide in 10 mM Histidine at pH 5.5, 260 mM trehalose, and 0.02% polysorbate 20 as a clinical formulation. Based on peptide content and peptide purity from a three-month stability study, the lyophilized formulation is estimated to be stable at ambient temperatures for 18 months.