Everest Medicines Announces the Initiation of an Investigator-Initiated Clinical Trial (IIT) for Personalized mRNA Cancer Vaccine Program EVM16

SHANGHAI, Aug. 22, 2024 /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 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.

About EVM16

EVM16 is a novel personalized mRNA cancer vaccine independently developed by Everest Medicines Limited.. EVM16 contains neoantigens with high immunogenicity potential which are predicted by Everest-proprietary algorithm and uses an LNP delivery system to efficiently deliver mRNAs that express tumor neoantigens into the human body. After vaccination with EVM16, neoantigens-encoding mRNAs are delivered into cells 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 withPD-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.

Forward-Looking Statements:

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

source: Everest Medicines