FDA Clears IND Application for EVM14 Across Cancers
The FDA has cleared EVM14, making it the first mRNA therapeutic cancer vaccine for global clinical trials.
US FDA
- The FDA cleared the investigational new drug (IND) application for EVM14.
- EVM14 is an off-the-shelf tumor-associated antigen (TAA) vaccine designed to treat various cancers, including non–small cell lung cancer (NSCLC) and head and neck cancer.
- Preclinical evidence supports advancing EVM14 into clinical trials, particularly for combination therapy approaches.
The FDA has cleared the IND application for EVM14, an off-the-shelf TAA vaccine, for the potential treatment of various cancers, including NSCLC and head and neck cancer.1
EVM14 is a preservative-free, sterile mRNA-lipid nanoparticle cancer vaccine that is made with mRNA solution encoding multiple TAAs enclosed in a lipid nanoparticle system.1 Once intramuscular injection is completed, EVM14 is taken up by antigen-presenting cells and translated into target antigens that are processed, presented to T cells by major histocompatibility complex molecules, and activated antigen-specific T cells that can recognize and destroy tumor cells that express the target antigens.1
Preclinically, EVM14 showed potent antitumor activity through inducing a dose-dependent, antigen-specific immune response in mice. It also significantly inhibited tumor growth across multiple syngeneic tumor models. Enhanced T-cell response was also seen as EVM14 promoted T-cell infiltration into tumors, increased T-cell activation and cytotoxic function, reduced immunosuppressive regulatory T cells, and decreased cytotoxic T lymphocyte exhaustion.
"With FDA IND approval, EVM14 has become the 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 both license-in and in-house R&D innovation," said Rogers Yongqing Luo, chief executive officer of Everest Medicines, in a press release.
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Additional preclinical data has shown long-term immune memory and prevention of recurrence as EVM14 demonstrated the ability to induce immune memory. This could potentially help prevent tumor recurrence and support long-term cancer-free survival. Further, combining EVM14 with ICIs greatly enhanced antitumor activity, supporting future clinical exploration of combination therapies.
The unique mechanism of action of EVM14 shows its potential in combination with other therapies to enhance efficacy and delay disease recurrence.
In addition to EVM14, Everest Medicines’ first internally developed personalized mRNA cancer vaccine, EVM16, has completed dosing of its first patient in an investigator-initiated clinical trial.2 The first-in-human, dose-escalation and dose-expansion trial plans to evaluate the safety, tolerability, immunogenicity, and initial efficacy of EVM16 injection as a single and in combination with PD-1 antibody for the treatment of patients with advanced or recurrent solid tumors.
Investigators are exploring the primary end points of safety and tolerability of EVM16 monotherapy and EVM16 in combination with PD-1 antibody in patients with advanced or recurrent solid tumors, and aim to determine the recommended phase 2 dose of the agent. Secondary end points will assess the immunogenicity of EVM16, and the initial efficacy of EVM16 in combination with PD-1 antibody in this patient population.
"EVM14, along with EVM16, which is a personalized cancer vaccine in clinical development and in-vivo [chimeric antigen receptor] T programs, will serve as foundational elements of our innovation strategy in oncology and autoimmune diseases,” Luo added in the press release.1 "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 in the near future.”
REFERENCES:
Everest Medicines announces FDA clearance of IND application for tumor-associated antigen vaccine EVM14. News release. Everest Medicines. March 23, 2025. Accessed March 24, 2025. https://tinyurl.com/fzshchh8
Everest Medicines announces first patient dosed with EVM16, its first internally developed personalized mRNA cancer vaccine. News release. Everest Medicines. March 6, 2025. Accessed March 24, 2025. https://tinyurl.com/sewp4n43
