Everest Medicines Announces Successful Release of First Clinical Batch of Tumor-Associated Antigen Vaccine EVM14 at Jiashan Manufacturing Site

Everest Medicines Announces Successful Release of First Clinical Batch of Tumor-Associated Antigen Vaccine EVM14 at Jiashan Manufacturing Site

SHANGHAI, June 20, 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 the successful release of the first clinical batch of EVM14, a Tumor-Associated Antigen (TAA) vaccine, from its Jiashan manufacturing site, Zhejiang Province in China.  This batch will support the clinical trials of EVM14 in both China and the United States (US). EVM14 received US FDA clearance for its Investigational New Drug (IND) application in March 2025. This release marks another milestone in advancing Everest's proprietary mRNA platform with end-to-end capabilities spanning antigen design, lipid nanoparticle (LNP) based delivery, CMC process development and GMP manufacturing, laying a solid foundation for future pipeline progression and commercialization.

The released batch was manufactured at Everest's Jiashan manufacturing site using the Company's proprietary mRNA platform, in compliance with global GMP standards.

EVM14 is an off-the-shelf therapeutic mRNA cancer vaccine targeting multiple tumor-associated antigens (TAAs) and is designed to treat various squamous cell carcinomas, including non-small cell lung cancer and head and neck cancer. 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 and metastasis, offering hope for long-term cancer-free survival. Furthermore, preclinical data demonstrated that the combination of EVM14 with immune checkpoint inhibitors (ICIs), such as PD-1 or PD-L1 inhibitors, greatly enhanced the anti-tumor activity, reduced recurrence and metastasis, and supports clinical exploration of combination therapies.

In March 2025, Everest received FDA Clearance of IND Application for EVM14, marking the Company's first internally developed mRNA therapeutic vaccine to enter early-stage global clinical development. The Company also plans to submit the IND application for EVM14 to the China's National Medical Products Administration Center for Drug Evaluation (CDE) in the near future.

"The release demonstrates Everest's end-to-end capabilities across the whole value chain of our mRNA platform," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Off-the-shelf mRNA therapeutic cancer vaccines such as EVM14 can significantly shorten production cycles, improve scalability, and lower manufacturing costs, ultimately benefiting more patients. Through our clinically validated and fully-integrated mRNA platform, we have realized synergies with our 'AI-powered' pipeline to significantly enhanced the efficiency of mRNA vaccine development. This not only provides strong support for the development of EVM14 and other pipeline assets, but also establishes differentiated competitive advantages as we deepen our strategic focus on mRNA-based cancer therapies and in vivo CAR-T programs. We are fully committed to advancing EVM14 into clinical trials in both China and the U.S., and we look forward to offering more diverse treatment options to cancer patients around the world."

EVM14 utilizes mRNA encoding multiple TAAs encapsulated in a lipid nanoparticle (LNP) delivery system. Following intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs), where the mRNA is translated into target antigens. These antigens are then processed and presented by major histocompatibility complex (MHC) molecules to T cells, triggering an antigen-specific immune response. The activated T cells migrate to tumor tissues, recognize and kill the cancer cells expressing the target antigens, while also inducing long-term immune memory.

Everest has successfully localized its clinically validated mRNA platform, establishing a fully integrated end-to-end infrastructure covering antigen design, mRNA sequence optimization, LNP delivery, and industrial-scale manufacturing. This platform enables significant improvements in the efficiency of target selection, sequence design, delivery system optimization, and production.

The platform has previously been clinically validated. In a global Phase II clinical trial enrolling 374 subjects, Everest's mRNA COVID-19 vaccine candidate PTX-COVID19-B was directly compared with Comirnaty^®, Pfizer/BioNTech's U.S. FDA-approved mRNA vaccine. PTX-COVID19-B demonstrated non-inferiority compared to Comirnaty^®. Additionally, it was generally well-tolerated, with a safety and tolerability profile similar to Comirnaty^®. 

Everest is currently advancing multiple mRNA therapies targeting cancer and autoimmune diseases through its proprietary mRNA technology platform. These include personalized cancer vaccines (PCVs) EVM16, tumor-associated antigen (TAA) cancer vaccines EVM14, immunomodulatory cancer vaccines, and in vivo CAR-T programs. Additionally, the Company is working on next-generation LNP delivery systems to further boost cell-mediated immune responses.

Everest's mRNA manufacturing facility in Jiashan, Zhejiang Province in China, spanning 58,000 square meters and built with an investment of over RMB 900 million, is equipped with advanced production facilities that meet both global and China GMP standards.

About EVM14
EVM14 Injection is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) cancer vaccine. It is formulated with mRNA solution encoding multiple 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.

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SOURCE Everest Medicines