Everest Medicines , a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, announced the launch of an Investigator-Initiated Clinical Trial (IIT) for a personalized mRNA cancer vaccine, EVM16, under the study EVM16CX01, at the Peking University Cancer Hospital and Fudan University's Cancer Hospital. This trial is designed to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 injection as a monotherapy and in combination with PD-1 antibody for patients with advanced or recurrent solid tumors. EVM16CX01 is the first-in-human (FIH) trial for EVM16.

EVM16 is a novel personalized therapeutic mRNA cancer vaccine independently developed by Everest. EVM16 contains neoantigens with high immunogenicity potential that are predicted based on the unique tumor mutations of each patient by Everest's proprietary neoantigen prediction algorithm. 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.

"EVM16 is the first personalized mRNA cancer vaccine independently developed by Everest using our proprietary mRNA platform. The initiation of this clinical trial is an important milestone that demonstrates our commitment to discover and develop a new generation of mRNA immunotherapies for cancer and autoimmune diseases." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines."While establishing leadership positions in nephrology, infectious disease, and autoimmune diseases, Everest will also focus on innovative modalities such as therapeutic mRNA vaccines. We look forward to seeing personalized cancer vaccines become a new clinical treatment method to serve more patients."

According to the Globocan's data in 2022, there were 19.976 million new cancer cases globally, with 9.744 million cancer-related deaths^[1]. In the last few decades, 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 development.  

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. Preclinical data also demonstrated that the combination of EVM16 and a PD-1 antibody has synergistic effect, which supports the clinical application of the combination of EVM16 with checkpoint inhibitors. In preclinical toxicity studies, repeated dosing with EVM16 was well tolerated and safe. Taken together, the preclinical immunogenicity, efficacy and safety studies demonstrate that EVM16 is safe and has potential to bring benefits to cancer patients.

Everest has built end-to-end capabilities across its proprietary mRNA platform. Our R&D team is developing multiple mRNA-based therapeutic products, as well as next generation lipid nanoparticle (LNP) delivery systems to enhance cell-mediated immune response. Our mRNA manufacturing facility in Jiashan, Zhejiang Province in China is designed to comply with global cGMP standards and is able to produce at clinical- and commercial-scale. Everest owns full global intellectual property rights to its mRNA therapeutic programs.