Everest Medicines has dosed the first participant in a Phase I clinical trial of its tumour-associated antigen (TAA) cancer vaccine EVM14 injection at the NEXT Oncology Virginia site in the US.
The participating sites also include the University of Texas MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center in the US, and China’s Shanghai Chest Hospital.
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EVM14 is an off-the-shelf therapeutic messenger ribonucleic acid (mRNA) vaccine designed for treating squamous cell carcinomas, including head and neck squamous cell carcinoma (HNSCC) and squamous non-small cell lung cancer (sq-NSCLC).
It is said to be the company’s first internally developed mRNA vaccine to receive investigational new drug (IND) approvals from both the US Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA).
The Phase I dose-escalation study includes two cohorts: EVM14 as a single agent and combined with a PD-1 monoclonal antibody.
It enrols participants with advanced, unresectable, metastatic or recurrent sq-NSCLC and HNSCC whose disease has progressed after at least two prior systemic therapies.
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By GlobalDataPrimary endpoints of the trial focus on the tolerability and safety of EVM14, with secondary endpoints evaluating preliminary efficacy.
Everest Medicines CEO Rogers Yongqing Luo said: “The first patient dosed with EVM14 in the US marks an important milestone in translating Everest’s internally developed therapeutic mRNA cancer vaccine from technological innovation into clinical development.
“With IND approval also secured in China, we will accelerate clinical progress in both the US and China to build a more robust global evidence base for EVM14’s clinical value.”
“Patients face limited treatment options with the current standard of care, underscoring a significant unmet medical need. As a TAA cancer vaccine, EVM14’s unique mechanism has the potential to complement existing treatments and help delay disease recurrence, offering hope for long-term cancer-free survival.”
The dose escalation for monotherapy is anticipated to conclude in 2026.
In March 2025, Everest Medicines dosed the first subject with EVM16, the company’s mRNA cancer vaccine, in the first-in-human (FIH) trial, EVM16CX01.
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