Everest Medicines has commenced an investigator-initiated clinical trial (IIT) of its personalised mRNA cancer vaccine, EVM16.
The trial, named EVM16CX01, is being conducted at the Peking University Cancer Hospital and Fudan University’s Cancer Hospital in China.
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It aims to evaluate the tolerability, safety, immunogenicity, and preliminary efficacy of EVM16 as both a single agent and along with a PD-1 antibody in advanced or recurrent solid tumour patients.
EVM16 is a new therapeutic vaccine containing neoantigens that are predicted by the company’s proprietary algorithm. These neoantigens are selected based on individual tumour mutations, aiming to trigger 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 tumour-killing T-cells and inhibit the growth of tumours.
Everest Medicines CEO Rogers Yongqing Luo said: “EVM16 is the first personalised mRNA cancer vaccine independently developed by Everest using our proprietary mRNA platform.
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By GlobalData“While establishing leadership positions in nephrology, infectious disease, and autoimmune diseases, Everest 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 tumour growth in mouse models.
The combination of EVM16 and a PD-1 antibody also demonstrated a synergistic effect, supporting the potential clinical benefits of this therapy.
Repeated dosing in toxicity studies indicated that EVM16 was well-tolerated and safe.
In 2022, Everest Medicines secured approval from the China National Medical Products Administration’s Centre for Drug Evaluation for its investigational new drug application to carry out a Phase Ib clinical trial of EVER001 for glomerular disease.
mRNA vaccine coverage on Pharmaceutical Technology (Or Clinical Trials Arena) is supported by Trilink. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
