Preclinical Evaluation Platform for mRNA Cancer Vaccines Based on Human MHC-Restricted Immune Response Assessment

mRNA-based cancer vaccines are an advanced immunotherapeutic strategy designed to generate potent, targeted immune activation against tumor antigens. However, standard mouse models with murine MHC molecules are not suitable for evaluating these MHC-restricted immune responses. To address this gap, GemPharmatech has implemented an integrated preclinical service platform for the evaluation of mRNA vaccine candidates, encompassing in vitro immunogenicity assessment, in vivo efficacy testing, and safety profiling. This platform employs a human immune cell-based co-culture system. For translational in vivo studies, GemPharmatech utilizes a panel of proprietary HLA-humanized mouse models. These human HLA molecules enable accurate evaluation of antigen presentation, immunogenicity, and therapeutic efficacy of mRNA vaccines. Therapeutic studies using TA-1 (mRNA vaccine) or anti-PD-1 in a patient-derived xenograft (PDX) model demonstrated that TA-1 or anti-PD-1 alone inhibited tumor growth, while combination therapy led to greater tumor inhibition.