The first patient has been dosed with EVM16 at Peking University Cancer Hospital, marking a major milestone as Everest's proprietary AI-based tumor neoantigen prediction algorithm and clinically validated mRNA platform progress into human trials.
In preclinical studies, EVM16 demonstrated significant tumor growth inhibition in syngeneic mouse model, with repeated dosing showing favorable safety and tolerability.
Preclinical data also showed a synergistic anti-tumor effect when EVM16 was combined with a PD-1 antibody, supporting its potential use in combination therapies in clinical settings.
SHANGHAI, March 6, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the first patient has been dosed with the Company's internally developed personalized mRNA cancer vaccine EVM16 at Peking University Cancer Hospital in the investigator-initiated clinical trial (IIT) EVM16CX01. EVM16CX01 is the first-in-human (FIH) trial for EVM16, conducted jointly at Peking University Cancer Hospital and Fudan University Shanghai Cancer center, to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 as a monotherapy and in combination with a PD-1 antibody in patients with advanced or recurrent solid tumors.
EVM16 is a novel personalized therapeutic mRNA cancer vaccine internally developed by Everest. It contains neoantigens with high immunogenicity potential, predicted based on the unique tumor mutations of each patient using Everest's proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1. The vaccine is designed to encode dozens of tumor neoantigens. The vaccine uses a lipid nanoparticle (LNP) delivery system to efficiently deliver neoantigen-encoded mRNA in vivo, activating neoantigen-specific tumor-killing T cells and inhibiting tumor growth.
In preclinical studies, vaccination with EVM16 stimulated a strong neoantigen-specific T cell response in different mouse models and showed significant tumor growth inhibition in the syngeneic B16F10 mouse melanoma model. EVER-NEO-1, the AI-based neoantigen prediction algorithm developed in-house by Everest, can identify the majority of reported tumor neoantigens, as well as several previously unreported neoantigens. Furthermore, the neoantigen prediction capability of EVER-NEO-1 was shown to be either comparable to or superior to leading industry algorithms in multiple independent validation studies.
Preclinical data also demonstrated that the combination of EVM16 and a PD-1 antibody has synergistic effects, which supports the combination of EVM16 with checkpoint inhibitors in clinical settings. In preclinical toxicity studies, repeated dosing with EVM16 was well tolerated and safe. Taken together, the preclinical studies show that EVM16 is safe and efficacious and has potential to bring benefits to cancer patients.
"The first patient dosed with the personalized mRNA cancer vaccine EVM16 represents a notable milestone in its clinical development. EVM16 is a customized vaccine based on each patient's tumor-specific mutations, and using the cutting-edge mRNA technology, to activate the patient's tumor-specific immune response to recognize and attack tumor cells." said Professor Shen Lin, Director of the Gastrointestinal Oncology Department at Beijing Cancer Hospital and Chair of the Gastric Cancer Expert Committee of the Chinese Society of Clinical Oncology. " In preclinical studies, we are excited to discover that EVM16, when combined with PD-1 antibodies, demonstrated synergistic anti-tumor effects, further highlighting its broader potential for clinical application. We are confident in achieving positive outcomes in the upcoming clinical trials, bringing hope to cancer patients."
"In recent years, AI has become a major force in drug development, especially in the area of mRNA vaccines. AI is increasingly seen as a crucial tool for boosting research efficiency and accuracy, attracting substantial attention from both the biopharmaceutical industry and governments worldwide. Everest has demonstrated the clinical validation capabilities of its mRNA platform since 2021, with an emphasis on employing AI to identify tumor neoantigens. By continually optimizing its algorithms, the company has enhanced the precision of neoantigen recognition and validation, giving it a strong foundation and a competitive edge in developing mRNA-based cancer vaccines." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "EVM16 is the first personalized mRNA cancer vaccine internally developed by Everest. The first patient dosing marks a significant milestone in its clinical development of EVM16, indicating our proprietary tumor neoantigen AI-based algorithm system and mRNA technology platform have advanced to human trials. As a cancer vaccine candidate developed using our proprietary mRNA platform, we look forward to demonstrating EVM16's therapeutic potential in upcoming clinical trials, with the goal of offering innovative treatment options to cancer patients worldwide and expand choices for those facing life-threatening diseases."
According to the Globocan's data in 2022, there were 19.976 million new cancer cases globally, with 9.744 million cancer-related deaths1. Immunotherapy including checkpoint inhibitors has become an important part of treating some cancer types. However, they are only effective for some patients, and there is an urgent need to develop new generations of immunotherapies, such as personalized mRNA cancer vaccines, that have demonstrated early promise in clinical setting.
Everest Medicines is currently developing a range of mRNA cancer therapeutics, including personalized cancer vaccines (PCVs), tumor-associated antigen (TAA) vaccines, immunomodulatory cancer vaccines, etc. Additionally, the company is working on next-generation lipid nanoparticle (LNP) delivery systems to enhance cell-mediated immune responses. Everest Medicines will submit an investigational new drug application for its TAA vaccines in China and the United States in 2025.
About EVM16
EVM16 is a novel personalized mRNA cancer vaccine independently developed by Everest Medicines. EVM16 contains neoantigens with high immunogenicity potential and predicted by Everest-proprietary algorithm EVER-NEO-1 and uses an LNP delivery system to efficiently deliver neoantigen-expressing mRNAs into the human body. After vaccination with EVM16, neoantigens-encoding mRNAs are delivered into human body to produce neoantigen peptides, which activate neoantigen-specific T cell immune responses to kill tumor cells, thereby inhibiting tumor growth.
About EVM16CX01 study
The study is a FIH, dose escalation and expansion study to evaluate the safety, tolerability, immunogenicity, and initial efficacy of EVM16 injection as a single and in combination with PD-1 antibody in subjects with advanced or recurrent solid tumors. The primary objectives are to evaluate the safety and tolerability of EVM16 monotherapy and EVM16 in combination with PD-1 antibody in subjects with advanced or recurrent solid tumors, and to determine the recommended phase 2 dose (RP2D) of EVM16. The secondary objectives are to evaluate the immunogenicity of EVM16, and the initial efficacy of EVM16 in combination with PD-1 antibody in subjects with advanced or recurrent solid tumors.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.
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