SHANGHAI, October 14, 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 therapeutic products, today announced that the first patient has been enrolled in a global multicenter Phase I clinical trial of its antigen-based cancer vaccine associated with EVM14 tumor at NEXT Oncology Virginia. in the United States. This is a significant clinical achievement following the investigational new drug (IND) approval of EVM14 by the US Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA) of China.
EVM14, a commercially available therapeutic mRNA cancer vaccine, is developed based on Everest Medicines’ proprietary mRNA platform. It is formulated with mRNA encoding 5 tumor-associated antigens (TAAs) and is designed to treat various squamous cell carcinomas, including squamous non-small cell lung cancer (SQ-NSCLC) and head and neck squamous cell carcinoma (HNSCC). Across targeted cancer types, 96% of sq-NSCLC patients and 97% of HNSCC patients expressed at least one of five target genes.[1].
“The recruitment of the first patient with EVM14 in the United States marks a significant achievement in advancing the global clinical development of our internal mRNA platform. said Rogers Yongging Luo, CEO of Everest Medicines. “This progress demonstrates Everest’s continued efforts to translate technological innovation into clinical practice and our leading advantage in the development of next-generation immuno-oncology therapies, including therapeutic mRNA cancer vaccines. combination therapies and help delay disease recurrence, offering hope for long-term cancer-free survival. As EVM14 has received IND approval from the Chinese NMPA, we look forward to this innovative therapy demonstrating promising therapeutic potential in global multicenter clinical trials, providing more treatment options to patients around the world and improving their quality of life.
In the global multicenter Phase I clinical trial of EVM14, participating clinical sites include NEXT Oncology Virginia, MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center in the United States and Shanghai Chest Hospital in China, among others.
In preclinical studies, EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumor growth in several syngeneic tumor models. Notably, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence, thus offering hope for long-term cancer-free survival. Furthermore, preclinical data demonstrated that combining EVM14 with immune checkpoint inhibitors (ICIs), such as anti-PD-1 or anti-CTLA-4 antibodies, greatly enhanced antitumor activity, reduced recurrence, and supports clinical exploration of combination therapies.
About EVM14
EVM14 Injection is a sterile, preservative-free cancer vaccine based on mRNA-lipid nanoparticles (mRNA-LNPs). It is formulated with an mRNA solution encoding 5 tumor-associated antigens (TAAs), encapsulated in a lipid nanoparticle system. After intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs) and translated into target antigens. These antigens are processed, presented to T cells by major histocompatibility complex (MHC) molecules and activated antigen-specific T cells. Activated T cells can migrate to tumor tissues, recognize and kill tumor cells expressing target antigens.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of transformative pharmaceuticals and vaccines that address the critical unmet medical needs of patients in Asian markets. Everest Medicines’ management team has deep expertise and extensive experience with 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 or best-in-class molecules in the Company’s core therapeutic areas of kidney disease, infectious diseases and autoimmune diseases. For more information, please visit his website at www.everestmedicines.com.
Forward-looking statements
This press release may contain statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its management with respect to the business operations and financial condition of the Company, which may be identified by terminology such as “will”, “expects”, “anticipates”, “future”, “intends”, “plans”, “believes ”, “esteem”, “confident” and similar statements. These forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the Company’s control and are unpredictable. Therefore, actual results may differ from those in the forward-looking statements due to 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 undertakes no obligation to revise any forward-looking statements to reflect new information, future events or circumstances after the date of this press release, except as required by law.
References:
- Data from the Cancer Genome Atlas (TCGA)
SOURCE Everest Medicines
