• The first patient had received the first dose of EVM14 injection in a global, multi-center Phase I clinical trial of Everest Medicines' Tumor-Associated Antigen (TAA) Cancer Vaccine EVM14 at NEXT Oncology Virginia in the United States, marking an important milestone in its global clinical development.
• The primary endpoints of the EVM14 Phase I trial are safety and tolerability, with secondary endpoints evaluating preliminary efficacy. EVM14 is Everest Medicines' first internally developed therapeutic mRNA cancer vaccine to obtain IND approvals from both China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA).
• EVM14, an off-the-shelf therapeutic mRNA cancer vaccine, is developed based on the Company's proprietary mRNA platform. It 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).
• Patients with these cancers face limited treatment options within the current standard of care, underscoring a significant unmet medical need. As a TAA cancer vaccine, EVM14's unique mechanism offers the potential to complement existing therapies and help delay disease recurrence, providing hope for long-term cancer-free survival.

Everest Medicines  a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, announced that the first patient had received the first dose of EVM14 injection in a global, multi-center Phase I clinical trial of its Tumor-Associated Antigen (TAA) Cancer Vaccine EVM14 at NEXT Oncology Virginia in the United States, marking an important milestone in its clinical development globally. EVM14 is Everest Medicines' first internally developed therapeutic mRNA cancer vaccine to obtain IND approvals from both China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA).

EVM14, an off-the-shelf therapeutic mRNA cancer vaccine, is developed based on the Company's proprietary mRNA platform. It 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 

The EVM14 Phase I trial is a dose-escalation study with two cohorts: EVM14 monotherapy and EVM14 in combination with PD-1 monoclonal antibody. The trial enrolls patients with pathologically confirmed unresectable, advanced, recurrent, or metastatic squamous non-small cell lung cancer (sq-NSCLC) and head and neck squamous cell carcinoma (HNSCC), who have experienced disease progression after receiving at least two prior lines of standard systemic therapy for advanced or metastatic disease. The primary endpoints are the safety and tolerability of EVM14, with secondary endpoints assessing preliminary efficacy. Monotherapy dose escalation is expected to be completed in 2026, with initial safety and tolerability data anticipated. The participating clinical sites include NEXT Oncology Virginia, The University of Texas MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center in the United States, and Shanghai Chest Hospital in China.

"The first patient dosed with EVM14 in the United States 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 U.S. and China to build a more robust global evidence base for EVM14's clinical value," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "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. We look forward to seeing this innovative therapy demonstrate promising potential in upcoming clinical trials, driving breakthroughs in cancer treatment and bringing new hope to patients worldwide."

In preclinical studies, EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. Notably, EVM14 demonstrated the ability to induce immune memory and prevent tumor 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-tumor activity, reduced recurrence, and supports clinical exploration of combination therapies.

Everest Medicines continues to focus on achieving key breakthroughs in its core proprietary pipeline while accelerating the clinical development and global expansion of innovative assets with global rights. Leveraging its industry-leading mRNA therapeutic cancer vaccine platform, the Company is building a globally competitive R&D pipeline.

EVM 14 injection used in this trial was manufactured at Jiashan manufacturing site with the Company's proprietary mRNA platform and in full compliance with global GMP standards. This demonstrates the Company's end-to-end capabilities across the entire mRNA value chain, from proprietary antigen design, LNP delivery system, CMC process development to in-house manufacturing, laying a solid foundation for future pipeline advancement and commercialization.

Reference:

1. The Cancer Genome Atlas (TCGA) data