|
Everest Medicines, a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, announced the Investigational New Drug (IND) application for EVM14, a tumour-associated antigen (TAA) cancer vaccine, has been approved by the National Medical Products Administration (NMPA) in China. This achievement marks a key milestone in the company’s efforts to develop innovative mRNA therapeutics in oncology. EVM14 becomes Everest Medicines’ first internally developed therapeutic mRNA cancer vaccine to receive IND approvals from both China’s National Medical Products Administration (NMPA) and the US 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 tumour-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). EVM14 previously received IND clearance from the US Food and Drug Administration (FDA) in March 2025.
“The cancer burden in China remains substantial. Neither immunotherapy nor targeted therapy can offer long term benefits to cancer patients. As a tumour-associated antigen cancer vaccine, EVM14 is designed to treat various squamous cell carcinomas,” Professor Lu Shun, the Lead Principal Investigator in China and director of the oncology Department at Shanghai Chest Hospital, stated: " 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. In preclinical studies, EVM14 demonstrated the ability to induce immune memory and prevent tumour recurrence,offering hope for long-term cancer-free survival. We look forward to EVM14 demonstrating promising therapeutic potential in clinical trials, bringing new hope to more patients.”
“EVM14 is Everest's first therapeutic mRNA cancer vaccine to achieve IND approvals in both China and the US. The approvals reinforces our leadership in developing therapeutic cancer vaccine as a novel immuno-oncology modality.” said Rogers Yongqing Luo, chief executive officer of Everest Medicines. “Tumour-associated antigen 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 tumour types.
The NMPA approval marks another important milestone that will accelerate clinical development in both countries. Ongoing global multicenter trials will generate valuable clinical evidence to support indication expansion and bring more treatment options to cancer patients worldwide.”
The primary endpoints of the EVM14 phase I trial are safety and tolerability, with secondary endpoints assessing preliminary efficacy. 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. This broad expression profile, coupled with the limited efficacy of existing standard-of-care therapies, highlights a substantial unmet medical need within these patient populations.
In preclinical studies, EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumour growth in multiple syngeneic tumour models. Notably, EVM14 demonstrated the ability to induce immune memory and prevent tumour recurrence, offering hope for long-term cancer-free survival. Furthermore, preclinical data demonstrated that the combination of EVM14 with immune checkpoint inhibitors (ICIs), such as anti-PD-1 or anti-CTLA-4 antibodies, greatly enhanced the anti-tumour activity, reduced recurrence and metastasis, and supports clinical exploration of combination therapies.
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 centres involved include NEXT Oncology Virginia, The University of Texas MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center in the US, and Shanghai Chest Hospital in China.
EVM14 Injection is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) cancer vaccine. It is formulated with mRNA solution encoding 5 tumour-associated antigens (TAAs), encapsulated in a lipid nanoparticle system. After intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs) and translated into target antigens. These antigens are processed, presented to T cells by major histocompatibility complex (MHC) molecules and activated antigen-specific T cells. The activated T cells can migrate to tumour tissues, recognize, and kill the tumour cells expressing the target antigens.
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets.
|