Everest Medicines announced that the first patient has been enrolled in a global multi-centre Phase I clinical trial of its Tumour-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, was developed based on Everest Medicines' proprietary mRNA platform. It is formulated with mRNA encoding 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). In the targeted cancer types, 96 per cent of patients with sq-NSCLC and 97 per cent of patients with HNSCC expressed at least one of the five target genes. TTA vaccines offer distinct advantages, including elimination of HLA screening requirements, off-the-shelf availability, lower production costs versus personalised neoantigen vaccines, and applicability across multiple tumour 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-mover 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 enhancing their quality of life.”