In August 2024 Everest Medicines announced the launch of an Investigator-Initiated Clinical Trial (IIT) assessing the safety, tolerability, immunogenicity, and preliminary efficacy of a personalised mRNA cancer vaccine. EVM16 will be considered as a monotherapy and in combination with PD-1 antibody for patients with advanced or recurrent solid tumours. This is the first-in-human trial for EVM16 and will take place at the Peking University Cancer Hospital and Fudan University Cancer Hospital.
EVM16
EVM16 is a novel personalised therapeutic mRNA cancer vaccine containing neoantigens with “high immunogenicity potential”. These antigens are predicted based on the unique tumour mutations of each patient through Everest’s proprietary neoantigen prediction algorithm. The vaccine “efficiently” delivers neoantigen-encoded mRNA in vivo through a lipid nanoparticle (LNP) delivery system to activate neoantigen-specific tumour-killing T cells and inhibit tumour growth.
Preclinical studies found that vaccination with EVM16 stimulated a “strong” neoantigen-specific T cell response in different mouse models and showed “significant” tumour growth inhibition in the syngeneic B16F10 mouse melanoma model. Preclinical data also revealed a synergistic effect in the combination of EVM16 and a PD-1 antibody, supporting the clinical application of the combination of EVM16 with checkpoint inhibitors. Repeated dosing with EVM16 was “well tolerated and safe” in preclinical toxicity studies. Thus, Everest believes that the vaccine is safe and “has potential to bring benefits to cancer patients”.
An important milestone
Chief Executive Officer of Everest Medicines, Rogers Yongqing Luo, described the initiation of the trial as an “important milestone that demonstrates our commitment to discover and develop a new generation of mRNA immunotherapies for cancer and autoimmune diseases”. The vaccine is the first personalised mRNA cancer vaccine developed “independently” by Everest using the proprietary mRNA platform.
“While establishing leadership positions in nephrology, infectious disease, and autoimmune diseases, Everest will also focus on innovative modalities such as therapeutic mRNA vaccines. We look forward to seeing personalised cancer vaccines become a new clinical treatment method to serve more patients.”
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