FDA Clears Everest Medicines' IND for Tumor Antigen Vaccine EVM14

Everest Medicines, a biopharmaceutical firm headquartered in Shanghai, has achieved a significant milestone in its ongoing cancer research. On March 23, 2025, the company announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EVM14, a novel mRNA cancer vaccine. This clearance marks the first time Everest's internally discovered program has received approval, setting the stage for global clinical development of this innovative therapeutic approach.

EVM14 is an mRNA-based cancer vaccine designed to target a variety of tumor-associated antigens (TAAs). It is intended for the treatment of several cancer types, including non-small cell lung cancer and head and neck cancer. This off-the-shelf vaccine encapsulates mRNA within a lipid nanoparticle delivery system. When administered via intramuscular injection, the vaccine is absorbed by antigen-presenting cells (APCs). The mRNA is then translated into target antigens, which are presented by major histocompatibility complex (MHC) molecules to T cells. This process activates T cells, which subsequently migrate to tumor sites to identify and destroy cancer cells exhibiting the target antigens.

Preclinical studies of EVM14 have demonstrated promising results. In laboratory tests involving mice, the vaccine elicited a dose-dependent, antigen-specific immune response and significantly suppressed tumor growth across various tumor models. EVM14 also enhanced T cell infiltration into tumors, boosted T cell activation and cytotoxic functions, and reduced the population of regulatory T cells—key factors associated with its anti-tumor efficacy. Notably, EVM14 was shown to induce immune memory, potentially preventing cancer recurrence and offering a pathway to prolonged survival free of disease. Furthermore, experimental data indicated that combining EVM14 with immune checkpoint inhibitors (ICIs) significantly increased its anti-tumor effects, suggesting that combination therapies could be a valuable area for future clinical trials.

Rogers Yongqing Luo, the CEO of Everest Medicines, highlighted the importance of this development, stating that the FDA's clearance of EVM14 not only advances their mRNA technology to clinical testing stages but also marks a shift in the company's strategic approach. Moving from a predominantly license-in model to incorporating in-house research and development, Everest is leveraging its AI-enhanced mRNA platform to accelerate innovation in oncology and immunology. EVM14, along with EVM16—a personalized cancer vaccine—and the company's in-vivo CAR-T programs, are central to Everest's strategy for advancing treatments for cancer and autoimmune diseases.

Globocan 2022 statistics underscore the urgent need for new cancer treatments, with nearly 20 million new cancer cases and approximately 9.7 million cancer-related deaths reported worldwide. Lung cancer remains the most prevalent, contributing to 2.5 million new cases and 1.8 million deaths annually. Non-small cell lung cancer (NSCLC) comprises a significant portion of these cases, yet targetable genetic alterations are identified in fewer than 10% of squamous NSCLC cases, indicating a pressing demand for innovative treatment options.

Simultaneously, head and neck squamous cell carcinoma (HNSCC) ranks as the seventh most common cancer, with a high rate of recurrence or metastasis post-treatment. Current immunotherapies and targeted therapies often fail to provide sustained benefits, emphasizing the potential of EVM14's approach to enhance efficacy and delay disease return, aligning with evolving trends in cancer drug development.

Everest is also investing in next-generation delivery systems to improve immune responses and has advanced its personalized mRNA cancer vaccine, EVM16, into early clinical trials. Their manufacturing facility in Jiashan, Zhejiang Province, is equipped to produce these vaccines to global standards, supporting both clinical and commercial demands.

In conclusion, the FDA's clearance of EVM14 marks a landmark achievement for Everest Medicines in its quest to develop groundbreaking cancer therapies. This advancement not only strengthens the company's position in the field of mRNA therapeutics but also offers hope for new treatment options to improve outcomes for cancer patients worldwide.