Everest Medicines launches personalized mRNA cancer vaccine trial

Preclinical studies have shown positive results, with EVM16 stimulating a strong T cell response. Image credit: Max Acronym/Shutterstock.

Everest Medicines has initiated an investigator-initiated clinical trial (IIT) of its personalized mRNA cancer vaccine EVM16.

The study, called EVM16CX01, is being conducted at Peking University Cancer Hospital and Fudan University Cancer Hospital in China.

The objective is to evaluate the tolerability, safety, immunogenicity and preliminary efficacy of EVM16 both as a single agent and in combination with a PD-1 antibody in patients with advanced or recurrent solid tumors.

EVM16 is a new therapeutic vaccine that contains neoantigens predicted by a proprietary algorithm. These neoantigens are selected based on individual tumor mutations and are designed to induce a robust immune response.

The vaccine uses a lipid nanoparticle delivery system to enhance the in vivo delivery of neoantigen-encoded mRNA, which is expected to activate tumor-killing T cells and inhibit tumor growth.

Rogers Yongqing Luo, CEO of Everest Medicines, said: “EVM16 is the first personalized mRNA cancer vaccine independently developed by Everest using our proprietary mRNA platform.

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“While Everest builds leadership positions in nephrology, infectious diseases and autoimmune diseases, it will also focus on innovative modalities such as therapeutic mRNA vaccines.”

Preclinical studies have shown positive results, with EVM16 stimulating a strong T cell response and inhibiting tumor growth in mouse models.

The combination of EVM16 and a PD-1 antibody also showed a synergistic effect, supporting the potential clinical benefit of this therapy.

Repeated dosing in toxicity studies showed that EVM16 is well tolerated and safe.

In 2022, Everest Medicines received approval from the Center for Drug Evaluation of the National Medical Products Administration of China for its Investigational New Drug application to conduct a Phase Ib clinical trial of EVER001 for the treatment of glomerular disease.