EVEREST MED (01952) mRNA tumor vaccine EVM14 continues to break through: after being approved for clinical trials in China, the first patient in the United States successfully enrolled in Phase I.

On October 14th, EVEREST MED (01952) announced that the global multicenter Phase I clinical trial of its universal off-the-shelf tumor therapeutic vaccine EVM14 injection was successfully enrolled in the first patient in the United States at NEXT Oncology Virginia. Just the day before (October 13th), the new drug clinical trial application (IND) for the vaccine was approved by the China National Medical Products Administration. This milestone event of simultaneous breakthrough in China and the United States not only marks the official entry of this innovative vaccine into a new stage of simultaneous clinical development in China and the United States but also highlights the competitive strength of Chinese pharmaceutical companies in the global mRNA tumor therapeutic race. As a product based on EVEREST MED's self-developed mRNA technology platform, EVM14 is a universal off-the-shelf tumor therapeutic vaccine targeting 5 tumor-associated antigens (TAA), intended for the treatment of various squamous cell carcinomas such as non-small cell lung squamous cell carcinoma and head and neck squamous cell carcinoma. The development of EVM14 directly addresses the clinical pain points in the treatment of squamous cell carcinomas. Currently, there is a large population of patients with squamous cell carcinomas, but existing standard treatments have not yet achieved satisfactory therapeutic effects, representing a significant unmet medical need. As a universal off-the-shelf vaccine, EVM14 has advantages such as no need for HLA screening, availability as a ready-made product, low production costs, and suitability for multiple tumor types, demonstrating broad application prospects in the field of tumor therapy. Preclinical trial results further confirm the potential of EVM14. It induced dose-dependent antigen-specific immune responses in mice and significantly inhibited tumor growth in multiple mouse syngeneic tumor models. Of particular note, it also induced immune memory while demonstrating the ability to effectively reduce tumor recurrence. Preclinical studies have also shown that the combination of EVM14 and immune checkpoint inhibitors can significantly enhance anti-tumor activity, supporting exploration of combination therapy in clinical settings. Regarding the clinical potential of EVM14, Professor Lu Shun, the lead researcher from China and Director of the Department of Oncology at Shanghai Chest Hospital, said, "Cancer is still prevalent in our country, and existing immune therapies and targeted therapies often fail to generate lasting immune memory. Tumor-associated antigen vaccines not only can serve as a powerful supplement to existing therapies, synergizing to enhance efficacy, but also have the potential to reduce recurrence, fitting in with the global trend of cancer drug development. In preclinical studies, EVM14 was able to induce immune memory, showing the ability to effectively reduce tumor recurrence, and is expected to help patients achieve 'long-term cancer-free survival.' This innovative exploration has groundbreaking significance in the field of cancer therapy." From an industry perspective, the mRNA field is currently experiencing an explosive period, and global pharmaceutical companies are making frequent moves. On the domestic front, in August, SIMCERE PHARMA entered the mRNA race through acquisition, while gravel Biosciences completed a super 600 million yuan Series C financing in October, with its research pipeline covering in vivo CAR-T therapy based on the LNP delivery platform and mRNA vaccines for new tumor antigens. In the international market, in October, Pfizer spent $1.5 billion to acquire Orbital, obtaining its in vivo CAR-T therapy OTX-201 in the preclinical stage, and a proprietary RNA technology platform; earlier in June, BioNTech spent $1.25 billion to acquire CureVac to integrate mRNA technology advantages, while AbbVie spent $2.1 billion to acquire Capstan, increasing its presence in the in vivo CAR-T field. The competition among leading pharmaceutical companies for mRNA-related cutting-edge technologies is evident. It is predicted that the mRNA tumor vaccine market could reach $40.651 billion in a neutral scenario, with universal vaccines expected to have a much higher penetration rate than personalized products due to cost advantages. With its differentiation advantage, EVM14 has taken the lead in clinical development in the fiercely competitive industry. The global multicenter Phase I clinical trial of EVM14 has brought together top institutions in China and the United States, including NEXT Oncology Virginia in the U.S., The University of Texas MD Anderson Cancer Center, Memorial Sloan-Kettering Cancer Center, and Shanghai Chest Hospital in China. The trial will focus on observing the safety and efficacy of the vaccine. The rapid development of EVM14's research is attributed to EVEREST MED's internationally leading, fully integrated, and localized AI+mRNA platform. The platform has built a complete industrial chain covering antigen design, sequence optimization, delivery system development, and large-scale production, and has enhanced mRNA expression levels through third-generation AI algorithms to lay the foundation for vaccine development. It is worth noting that EVM14 is just one of the highlights in EVEREST MED's mRNA pipeline. In its pipeline, the autologous CAR-T project EVM18 is expected to start clinical trials before the end of the year, personalized tumor therapeutic vaccine EVM16 has initiated the first human clinical trial in China and completed patient dosing, and the off-the-shelf immune modulation vaccine EVM15 has completed preclinical proof of concept studies.