Pre-clinical safety evaluation of heat shock protein 65–MUC1 peptide fusion protein

With a goal of developing a medication for the treatment of MUC1 expressing human cancers, a recombinant heat shock protein 65–MUC1 fusion protein (HSP65–MUC1) between BCG derived heat shock protein 65 (HSP65) and MUC1 derived peptide (MUC1) was developed. To move the HSP65–MUC1 into a phase I clinical trial, a comprehensive non-clinical safety evaluation was conducted. The evaluation comprised of single-dose toxicity and repeat-dose toxicity studies both in mice and rhesus monkeys. The data from the study indicates that the treatment with HSP65–MUC1 is not associated with obvious toxicity in the tested animals. The changes in clinical chemistry and hematology in both the mice and monkeys were considered to be mild because there were no indications of overt toxicity after administering HSP65–MUC1. The data provided here contributed to the approval of initiating a phase I clinical trial with HSP65–MUC1 for the treatment of patients with MUC1-positive breast cancer in China.