Everest Medicines Starts Investigator-Initiated Trial for Personalized mRNA Cancer Vaccine EVM16

Everest Medicines has recently announced the start of an Investigator-Initiated Clinical Trial (IIT) for EVM16, a cutting-edge personalized mRNA cancer vaccine. This trial, named EVM16CX01, will take place at Peking University Cancer Hospital and Fudan University’s Cancer Hospital. The objective is to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 both as a standalone treatment and in combination with a PD-1 antibody for patients suffering from advanced or recurrent solid tumors. Notably, EVM16CX01 marks the first human trial of EVM16.

EVM16 represents a novel approach in personalized therapeutic mRNA cancer vaccines, independently developed by Everest Medicines. The vaccine contains neoantigens with high immunogenicity potential, designed based on the unique tumor mutations of each patient via Everest's proprietary neoantigen prediction algorithm. Utilizing a lipid nanoparticle (LNP) delivery system, EVM16 efficiently delivers neoantigen-encoded mRNA in vivo, which then activates neoantigen-specific tumor-killing T cells, inhibiting tumor growth.

Rogers Yongqing Luo, the Chief Executive Officer of Everest Medicines, highlighted the significance of this trial. According to Luo, the initiation of this clinical trial represents a vital milestone, demonstrating the company's dedication to developing new generations of mRNA immunotherapies for cancer and autoimmune diseases. Luo also emphasized Everest’s focus on innovative modalities like therapeutic mRNA vaccines, aiming to establish new clinical treatment methods for cancer patients.

According to the 2022 data from Globocan, there were approximately 19.976 million new cancer cases globally, alongside 9.744 million cancer-related deaths. Over recent decades, immunotherapy, including checkpoint inhibitors, has become a crucial element in treating certain types of cancer. However, these treatments are only effective for a subset of patients, underscoring the urgent need for new-generation immunotherapies, such as personalized mRNA cancer vaccines, which have shown early promise in clinical development.

Preclinical studies of EVM16 have demonstrated a strong neoantigen-specific T cell response in various mouse models and significant tumor growth inhibition in the syngeneic B16F10 mouse melanoma model. Additionally, combining EVM16 with a PD-1 antibody produced a synergistic effect, thereby supporting its clinical application with checkpoint inhibitors. Preclinical toxicity studies revealed that repeated dosing with EVM16 was well tolerated and safe, collectively indicating that EVM16 has the potential to benefit cancer patients.

Everest Medicines has developed comprehensive capabilities across its proprietary mRNA platform. The company's R&D team is working on multiple mRNA-based therapeutic products and advanced lipid nanoparticle (LNP) delivery systems to enhance cell-mediated immune responses. Their mRNA manufacturing facility in Jiashan, Zhejiang Province, China, adheres to global cGMP standards and is capable of producing at both clinical and commercial scales. Everest also holds full global intellectual property rights to its mRNA therapeutic programs.

EVM16 is a groundbreaking personalized mRNA cancer vaccine developed by Everest Medicines. It incorporates neoantigens predicted by Everest's proprietary algorithm and utilizes an LNP delivery system to deliver mRNAs that express tumor neoantigens into the body. Following vaccination, these neoantigen-encoding mRNAs are delivered into cells to produce neoantigen peptides, which then activate neoantigen-specific T cell immune responses to kill tumor cells, thus inhibiting tumor growth.

The EVM16CX01 study is a first-in-human, dose escalation and expansion study aimed at evaluating the safety, tolerability, immunogenicity, and initial efficacy of EVM16 injection as a single agent and in combination with a PD-1 antibody in patients with advanced or recurrent solid tumors. The primary objectives are to assess the safety and tolerability of EVM16 monotherapy and its combination with a PD-1 antibody, and to establish the recommended phase 2 dose (RP2D) of EVM16. Secondary objectives include evaluating the immunogenicity and initial efficacy of EVM16 in combination with a PD-1 antibody in subjects with advanced or recurrent solid tumors.

Everest Medicines is dedicated to discovering, developing, manufacturing, and commercializing transformative pharmaceutical products and vaccines to address critical unmet medical needs for patients in Asian markets. The management team has extensive expertise from leading global and Chinese pharmaceutical companies, enabling high-quality discovery, clinical development, regulatory affairs, and operations. Everest has built a robust portfolio of potentially global first-in-class or best-in-class molecules in renal diseases, infectious diseases, and autoimmune disorders.