Everest Medicines Limited (HKEX: 1952.HK) has announced the launch of an Investigator-Initiated Clinical Trial (IIT) for its innovative personalized mRNA cancer vaccine, EVM16. The trial, designated EVM16CX01, is set to take place at Peking University Cancer Hospital and Fudan University’s Cancer Hospital. This groundbreaking study will be the first-in-human (FIH) trial for EVM16, designed to evaluate its safety, tolerability, immunogenicity, and preliminary efficacy both as a standalone treatment and in combination with a PD-1 antibody for patients with advanced or recurrent solid tumors.

Overview of EVM16

EVM16 represents a novel approach in cancer immunotherapy, developed entirely by Everest Medicines. This personalized mRNA cancer vaccine is engineered to target neoantigens—unique tumor-specific antigens—using a proprietary prediction algorithm developed by Everest. These neoantigens are delivered through a lipid nanoparticle (LNP) system, which efficiently introduces the mRNA encoding these neoantigens into the body. The aim is to activate specific T cells that target and destroy tumor cells, potentially offering a new line of defense against cancer.

Chief Executive Officer Rogers Yongqing Luo expressed enthusiasm about the trial, stating, “The initiation of the EVM16 clinical trial marks a significant milestone for Everest Medicines. It underscores our commitment to advancing a new era of mRNA-based immunotherapies. While we continue to excel in fields like nephrology and autoimmune diseases, our focus on pioneering therapeutic mRNA vaccines aims to address critical unmet needs and offer novel treatment options for cancer patients.”

Details of the Clinical Trial

The EVM16CX01 study is structured as a dose escalation and expansion trial to thoroughly assess the safety and tolerability of EVM16. This study will explore EVM16’s effects both as a monotherapy and in combination with a PD-1 antibody. The primary objectives of the trial include evaluating the safety profile and determining the recommended phase 2 dose (RP2D) of EVM16. Secondary goals are to assess the vaccine’s immunogenicity and its preliminary efficacy when combined with the PD-1 antibody in patients with advanced or recurrent solid tumors.

Insights from Preclinical Research

Preclinical studies have demonstrated that EVM16 stimulates a potent T cell response specific to neoantigens in various mouse models. Notably, it has shown significant tumor growth inhibition in the B16F10 melanoma model. Additionally, EVM16, in combination with a PD-1 antibody, has displayed a synergistic effect, suggesting potential enhanced efficacy for cancer treatment. Safety evaluations in preclinical toxicity studies revealed that EVM16 is well-tolerated, even with repeated dosing, supporting its potential as a safe and effective treatment option.

Everest Medicines’ mRNA Capabilities

Everest Medicines has developed a comprehensive mRNA platform, encompassing both research and development and advanced lipid nanoparticle (LNP) delivery systems. The company’s state-of-the-art mRNA manufacturing facility in Jiashan, Zhejiang Province, China, adheres to global cGMP standards, ensuring the capability to produce both clinical and commercial quantities. Everest Medicines holds full global intellectual property rights for its mRNA therapeutic programs, reinforcing its leadership in this innovative field.

Cancer Treatment Landscape

Globocan’s 2022 statistics highlight a global incidence of approximately 19.976 million new cancer cases, with 9.744 million cancer-related deaths. While immunotherapy, including checkpoint inhibitors, has become integral in treating certain cancers, it remains effective for only a subset of patients. The development of personalized mRNA cancer vaccines like EVM16 offers a promising alternative, potentially enhancing treatment efficacy and expanding options for patients with complex cancer types.

  advanced cancer treatment, Cancer immunotherapy, Everest Medicines, EVM16, Investigator-Initiated Clinical Trial, lipid nanoparticle delivery, neoantigen, PD-1 antibody, personalized mRNA vaccine, preclinical research