FDA Approves Everest Medicines’ First mRNA Cancer Vaccine, EVM14, For NSCLC And Head And Neck Cancer

Everest Medicines has received FDA clearance for its Investigational New Drug (IND) application for EVM14, an mRNA-based Tumor-Associated Antigen (TAA) vaccine. This marks the company’s first internally developed mRNA therapeutic vaccine to advance into clinical trials, representing a significant milestone in its oncology pipeline. EVM14 is designed to treat multiple cancers, including non-small cell lung cancer (NSCLC) and head and neck cancer. The vaccine utilises lipid nanoparticle (LNP) technology to deliver mRNA encoding multiple tumor-associated antigens (TAAs). Once administered, the vaccine stimulates an antigen-specific immune response, activating T cells to target and destroy cancer cells.

“With FDA IND approval, EVM14 has become Everest’s first internally developed mRNA therapeutic vaccine to receive clearance for global clinical development. This marks a critical breakthrough, advancing our mRNA technology from early-stage research to global clinical trials and highlighting our growing capabilities in mRNA technology. It also represents a new chapter in our ‘dual-engine’ strategy, evolving from a license-in model to a balanced integration of license-in and in-house R&D innovation.” Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Through our clinically validated and fully integrated mRNA platform, we have realised synergies with our ‘AI-powered’ pipeline, underscoring Everest’s leadership position in advancing innovation in oncology and immunology. EVM14, along with EVM16, which is a personalised cancer vaccine in clinical development and in-vivo CAR-T programs, will serve as foundational elements of our innovation strategy in oncology and autoimmune diseases. Everest is at the forefront of China’s mRNA and AI-powered therapeutic development, having advanced mRNA cancer therapeutic vaccines to clinical trials. Over the past four years, Everest has utilised its AI- and big data-powered mRNA platform to accelerate target identification, sequence design, and delivery optimisation. Our proprietary algorithm for mRNA design, now in its third generation, has significantly improved target protein expression and continues to evolve through big data-driven modelling.”

Luo also commented, “This approach has enabled key breakthroughs in mRNA technology, expanded our global pipeline, and unlocked potential new opportunities for international collaboration. We look forward to advancing EVM14 into clinical trials and providing new treatment options for cancer patients. Additionally, we will submit the IND application for EVM14 to the China National Medical Products Administration (NMPA) shortly."

The preclinical evidence showed EVM14 achieved three key results: it reduced tumour growth and increased T-cell infiltration and immune response. Studies established that the vaccine could create immune memory to fight off future cancer returns. Studies indicate that EVM14 proved more potent against tumours when combined with immune checkpoint inhibitors (ICIs), showcasing possible uses as part of combination therapies.

In addition to EVM14, Everest Medicines continues the development of a diverse portfolio consisting of mRNA-based treatments for autoimmune diseases and oncology. The first clinical testing of EVM16, a personalised cancer vaccine, began in March 2025, following the start of its evaluation phase. The company is also developing new lipid nanoparticle delivery mechanisms that improve their mRNA-based medicines' immune responses and treatment efficiency.