Developed for advanced solid tumors, EVM16 represents a significant advancement in the field of mRNA-based cancer immunotherapy. As the company’s first internally developed personalized mRNA cancer vaccine, EVM16 has now entered human clinical trials with the first patient dosed, marking an important milestone in the development of innovative cancer treatments.

EVM16 is a personalized mRNA cancer vaccine designed to stimulate a patient’s immune system to recognize and attack tumor-specific antigens. It is developed using an AI-based neoantigen prediction algorithm, EVER-NEO-1.The vaccine encodes multiple neoantigens and is delivered using lipid nanoparticles (LNPs) to enhance cellular uptake and immune response activation.

EVM16 is designed to generate a strong, patient-specific immune response against cancer cells. By encoding neoantigens—mutated proteins that are unique to a patient’s tumor—the vaccine aims to enhance the body’s ability to recognize and eliminate cancerous cells. Preclinical studies have demonstrated that EVM16 stimulates robust neoantigen-specific T-cell responses and significantly inhibits tumor growth in mouse models. When combined with a PD-1 inhibitor like tislelizumab, the vaccine’s effectiveness may be further enhanced, as immune checkpoint inhibitors help counteract tumor-induced immune suppression.

The first-in-human clinical trial for EVM16, known as EVM16CX01, is being conducted at Peking University Cancer Hospital and Fudan University Shanghai Cancer Center. The study aims to evaluate the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 both as a monotherapy and in combination with the PD-1 antibody tislelizumab. The trial will focus on patients with advanced or recurrent solid tumors, particularly those who have exhausted standard treatment options or are intolerant to conventional therapies.

Clinical trial.