EVM14

EVM14 is an off-the-shelf, preservative-free, sterile mRNA cancer vaccine developed by Everest Medicines. It is designed to target multiple tumor-associated antigens (TAAs) and is intended for the treatment of various cancers, including non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma. The vaccine consists of mRNA encoding several TAAs encapsulated in a lipid nanoparticle (LNP) delivery system. Upon intramuscular injection, the LNPs are taken up by antigen-presenting cells where the mRNA is translated into target antigens. These antigens are then processed and presented via major histocompatibility complex molecules to T cells, activating antigen-specific immune responses that enable T cells to recognize and destroy tumor cells expressing these antigens. Preclinical studies demonstrated that EVM14 induces a dose-dependent, antigen-specific immune response in mice, significantly inhibits tumor growth across multiple syngeneic models, promotes T-cell infiltration into tumors, increases T-cell activation and cytotoxic function, reduces immunosuppressive regulatory T cells (Tregs), decreases cytotoxic T lymphocyte exhaustion, induces long-term immune memory, prevents tumor recurrence, and enhances anti-tumor activity when combined with immune checkpoint inhibitors. EVM14 received FDA clearance for its Investigational New Drug (IND) application in March 2025—the first such approval for an internally developed mRNA therapeutic vaccine from Everest Medicines—enabling global clinical development[2][3][6].