Everest Medicines today announced that the first patient has been enrolled in a global multi-center Phase I clinical trial of its Tumor-Associated Antigen Cancer Vaccine EVM14 at NEXT Oncology Virginia in the United States. Previously, the Investigational New Drug (IND) application for EVM14 has been approved by the National Medical Products Administration (NMPA) in China. EVM14 becomes Everest Medicines’ first internally developed therapeutic mRNA cancer vaccine to receive IND approvals from both China’s NMPA and the U.S. Food and Drug Administration (FDA).
EVM14, an off-the-shelf therapeutic mRNA cancer vaccine, is developed based on Everest Medicines’ proprietary mRNA platform. It is formulated with mRNA encoding 5 tumor-associated antigens (TAAs) and is designed to treat various squamous cell carcinomas, including squamous non-small cell lung cancer (sq-NSCLC) and head and neck squamous cell carcinoma (HNSCC). In the targeted cancer types, 96% of patients with sq-NSCLC and 97% of patients with HNSCC expressed at least one of the five target genes[1]. TTA vaccines offer distinct advantages, including elimination of HLA screening requirements, off-the-shelf availability, lower production costs versus personalized neoantigen vaccines, and applicability across multiple tumor types.
“The cancer burden in China remains substantial. Neither immunotherapy nor targeted therapy can offer long term benefits to cancer patients. EVM14 is designed to treat various squamous cell carcinomas, EVM14’s unique mechanism offers the potential to complement current treatments by enhancing the efficacy via combination therapies and helping delay disease recurrence, aligning with current trends in oncology drug development.” said Professor Lu Shun, the Lead Principal Investigator in China and Director of the Oncology Department at Shanghai Chest Hospital.
“The enrollment of the first patient with EVM14 in the United States marks an important achievement in advancing the global clinical development of our in-house mRNA platform.” said Rogers Yongging Luo, Chief Executive Officer of Everest Medicines. “This progress demonstrates Everest’s continued efforts to translate technological innovation into clinical practice and our first move advantage in developing next-generation immuno-oncology therapies, including therapeutic mRNA cancer vaccines. EVM14 is Everest’s first therapeutic mRNA cancer vaccine to achieve IND approvals in both China and the U.S. The large patient population faces limited options with existing standard-of-care therapies, highlighting an unmet medical need. As a TAA cancer vaccine, EVM14’s unique mechanism offers the potential to complement current treatments by enhancing the efficacy via combination therapies and helping delay disease recurrence, offering hope for long-term cancer-free survival. With EVM14 receiving IND approval from China’s NMPA, we look forward to this innovative therapy demonstrating promising therapeutic potential in global multicenter clinical trials, bringing more treatment options to patients worldwide and enhance their quality of life.”
Everest Medicines’ Jiashan manufacturing site released the first GMP clinical trial batch in June 2025. This batch will support the clinical trials of EVM14 in both China and the United States. The clinical centers involved include NEXT Oncology Virginia, The University of Texas MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center in the U.S., and Shanghai Chest Hospital in China.
Leveraging the company’s industry-leading mRNA therapeutic cancer vaccine platform and mRNA in vivo CAR-T platform, it is building a globally competitive R&D pipeline. EVM18, the in vivo CAR-T program, has completed multiple non-human primates (NHPs) trials and achieved preclinical proof-of-concept, with first-in-human data expected to initiate by the end of 2025. EVM16, the personalized therapeutic mRNA cancer vaccine, has initiated its first-in-human trial in China, with patient dosing completed. In the investigator-initiated trial (IIT), dose escalation in the low- and mid-dose cohorts has been completed, with encouraging preliminary data observed. EVM15, the immune-modulatory cancer vaccine, has completed preclinical proof of concept and identified its clinical candidate.
Looking ahead, Everest Medicines will continue to deepen its “dual-engine” strategy, maintaining a strong focus on advancing innovative drug discovery and development to drive sustainable growth and global expansion. The Company remains committed to delivering innovative therapies to patients, creating long-term value for shareholders, and driving forward with the vision of becoming a leading global biopharmaceutical company.
[1] The Cancer Genome Atlas (TCGA) data