Everest Medicines Receives FDA Clearance for Investigational Cancer Vaccine EVM14
Monday, March 24, 2025
Everest Medicines has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for EVM14.
Lung cancer remains one of the most prevalent cancers worldwide, with nearly 2.5 million new cases reported annually. NSCLC accounts for the majority of lung cancer cases, with squamous NSCLC representing 25% to 30% of cases.
EVM14 is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) cancer vaccine formulated with mRNA sequences encoding multiple tumor-associated antigens. After intramuscular injection, the vaccine is taken up by antigen-presenting cells, where the mRNA is translated into target antigens.
These antigens are then processed and presented to T cells, triggering an immune response against tumor cells expressing the target antigens.
This milestone marks the company’s first internally developed mRNA therapeutic vaccine to receive FDA IND approval, advancing its efforts in oncology drug development.
EVM14 is an off-the-shelf mRNA cancer vaccine targeting multiple tumor-associated antigens (TAAs). It is designed to treat various cancers, including non-small cell lung cancer (NSCLC) and head and neck cancer.
The vaccine uses an mRNA sequence encoding multiple TAAs, encapsulated in a lipid nanoparticle (LNP) delivery system. Once injected, the vaccine is taken up by antigen-presenting cells, where the mRNA is translated into target antigens. These antigens are then processed and presented to T cells, activating an immune response that enables them to identify and destroy cancer cells expressing the target antigens.
These advances have strengthened the company’s pipeline of mRNA-based cancer vaccines and immunotherapies.
EVM14 is expected to enter clinical trials following FDA clearance. Everest Medicines also plans to submit an IND application to China’s National Medical Products Administration (NMPA) in the near future.
The company’s mRNA manufacturing facility in Jiashan, Zhejiang Province, China, operates in compliance with global good manufacturing practice (cGMP) standards and is capable of producing mRNA therapeutics at both clinical and commercial scales.
The company is further developing next-generation LNP delivery systems to improve immune responses.
Source: everestmedicines.com
