Everest Medicines Doses First Patient with EVM16, Its First Personalized mRNA Cancer Vaccine

Everest Medicines has reached a significant milestone in cancer treatment by dosing the first patient with its customized mRNA cancer vaccine, EVM16, at Peking University Cancer Hospital. This marks the commencement of the investigator-initiated clinical trial, EVM16CX01, which is the first human trial for EVM16. The trial is being conducted in collaboration with Peking University Cancer Hospital and Fudan University Shanghai Cancer Center, aiming to evaluate the vaccine's safety, tolerability, immunogenicity, and initial effectiveness, both as a standalone treatment and in combination with a PD-1 antibody for patients suffering from advanced or recurring solid tumors.

EVM16 represents an innovative approach to cancer immunotherapy, tailored specifically to each patient's unique tumor mutations. Developed using Everest's proprietary AI-based neoantigen prediction algorithm known as EVER-NEO-1, the vaccine is designed to encode multiple tumor neoantigens, which are delivered using a lipid nanoparticle (LNP) system. This system enhances the delivery of neoantigen-expressing mRNAs into the body, triggering the body's immune system to generate tumor-specific T cells that target and destroy cancer cells, thereby inhibiting tumor growth.

In preclinical studies, EVM16 has shown promise, demonstrating significant inhibition of tumor growth in various mouse models, particularly in the B16F10 mouse melanoma model. The EVER-NEO-1 algorithm has been instrumental in identifying most known tumor neoantigens and has also discovered several previously unreported ones. Its precision in predicting neoantigens has been validated as comparable to or even superior to other leading industry algorithms through multiple independent studies.

A notable discovery from the preclinical studies is the synergistic effect observed when EVM16 is combined with a PD-1 antibody, suggesting the potential for enhanced efficacy in combination therapies. This combination could play a critical role in expanding treatment options for cancer patients. The safety profile of EVM16 has also been a focal point, with repeated dosing in preclinical toxicity studies proving to be safe and well-tolerated.

Professor Shen Lin from Beijing Cancer Hospital, who is a leading figure in gastrointestinal oncology, highlighted the importance of the first dosing event as a pivotal step in EVM16's clinical journey. He expressed optimism about the vaccine's potential, especially when used alongside PD-1 antibodies, as it could offer broader applications in clinical settings and provide new hope for effective cancer treatments.

The development of EVM16 underlines the growing role of AI in drug development, particularly concerning mRNA vaccines. Rogers Yongqing Luo, CEO of Everest Medicines, emphasized the significance of AI in enhancing the accuracy of tumor neoantigen identification, which has been a cornerstone of Everest's mRNA platform since 2021. The company's focus on optimizing its algorithms has established a firm foundation for advancing mRNA-based cancer vaccines.

Everest is actively engaged in developing a range of mRNA cancer therapeutics beyond EVM16, such as personalized cancer vaccines (PCVs), tumor-associated antigen (TAA) vaccines, and immunomodulatory cancer vaccines. The company is also working on next-generation LNP delivery systems to boost immune response efficacy. With plans to submit investigational new drug applications for its TAA vaccines in China and the U.S. in 2025, Everest is poised to make significant contributions to cancer therapeutics.

The advent of personalized mRNA cancer vaccines like EVM16 reflects a promising frontier in cancer treatment, aiming to address the urgent need for effective immunotherapies. With immunotherapy becoming increasingly crucial, especially for cancer types where traditional treatments may fall short, innovations like EVM16 offer hope for improved patient outcomes and expanded treatment choices in the fight against cancer.