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bioRxiv · 10.1101/2025.08.14.670419

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

Gupta, S.·Misra, B.·Javeri, I.·Nellaiappan, K.·Fouts, T.·Shoemaker, R. H.
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Abstract

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 {micro}g/ml each peptide in10 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.

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Gupta, S., Misra, B., Javeri, I., Nellaiappan, K., Fouts, T., Shoemaker, R. H.. 2025-08-20. Development of a Stable Lyophilized Formulation of a Quadrivalent Frame-Shift Peptide Vaccine for Cancer Prevention in Lynch Syndrome. https://doi.org/10.1101/2025.08.14.670419

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