The US Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for Everest Medicines’ tumour-associated antigen (TAA) vaccine, EVM14.
EVM14 is the first messenger RNA (mRNA) therapeutic vaccine developed internally by the company to gain this approval.
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Its mechanism is designed to improve the efficacy of existing treatments through combo therapies and potentially delay disease recurrence.
The sterile, preservative-free mRNA-lipid nanoparticle (LNP) cancer vaccine, EVM14 consists of a solution encoding several TAAs within an LNP system.
Everest Medicines CEO Rogers Yongqing Luo stated: “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 both license-in and in-house research and development innovation.
“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 programmes, will serve as foundational elements of our innovation strategy in oncology and autoimmune diseases.”
The company has established end-to-end capabilities in its mRNA platform, progressing therapies aimed at treating cancer and autoimmune conditions.
These therapies include TAA cancer vaccines, immunomodulatory cancer vaccines, in vivo CAR-T therapies and personalised cancer vaccines (PCVs).
Everest is also developing advanced LNP delivery systems to improve cell-mediated immune responses.
The company has completed the subject dosing in an investigator-initiated trial (IIT) of EVM16 in March 2025.
The company’s mRNA manufacturing facility in China adheres to global current good manufacturing practice (cGMP) standards and is equipped for both clinical and commercial-scale production.
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