Everest Medicines Announces First Patient Enrolled in a Global Multi-Center Phase I Clinical Trial of Tumor-Associated Antigen Cancer Vaccine EVM14
Everest Medicines Announces First Patient Enrolled in a Global Multi-Center Phase I Clinical Trial of Tumor-Associated Antigen Cancer Vaccine EVM14 |
| [14-October-2025] |
SHANGHAI, Oct. 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 therapeutics, today announced that the first patient has been enrolled in a global multi-center Phase I clinical trial of its Tumor-Associated Antigen Cancer Vaccine EVM14 at NEXT Oncology Virginia in the United States. This marks an important clinical achievement following EVM14's Investigational New Drug (IND) approvals by both the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA). EVM14, an off-the-shelf 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). In the targeted cancer types, 96% of patients with sq-NSCLC and 97% of patients with HNSCC expressed at least one of the five target genes[1]. "The enrollment of the first patient with EVM14 in the United States marks an important achievement in advancing the global clinical development of our in-house mRNA platform." said Rogers Yongging Luo, Chief Executive Officer of Everest Medicines. "This progress demonstrates Everest's continued efforts to translate technological innovation into clinical practice and our first move advantage in developing next-generation immuno-oncology therapies, including therapeutic mRNA cancer vaccines. The large patient population faces limited options with existing standard-of-care therapies, highlighting an unmet medical need. As a TAA cancer vaccine, EVM14's unique mechanism offers the potential to complement current treatments by enhancing the efficacy via combination therapies and helping delay disease recurrence, offering hope for long-term cancer-free survival. With EVM14 receiving IND approval from China's NMPA, we look forward to this innovative therapy demonstrating promising therapeutic potential in global multicenter clinical trials, bringing more treatment options to patients worldwide and enhance their quality of life." In the global multi-center 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 multiple syngeneic tumor models. Notably, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence, offering hope for long-term cancer-free survival. Furthermore, preclinical data demonstrated that the combination of EVM14 with immune checkpoint inhibitors (ICIs), such as anti-PD-1 or anti-CTLA-4 antibodies, greatly enhanced the anti-tumor activity, reduced recurrence, and supports clinical exploration of combination therapies. About EVM14 EVM14 Injection is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) cancer vaccine. It is formulated with 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. The activated T cells can migrate to tumor tissues, recognize, and kill the tumor cells expressing the target antigens. 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. References:
SOURCE Everest Medicines | ||
Company Codes: HongKong:1952 |
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