On October 14, EVEREST MED (01952) announced that its universal off-the-shelf therapeutic cancer vaccine EVM14 injection successfully enrolled its first patient in the global multi-center Phase I clinical trial at NEXT Oncology Virginia in the United States. Just one day earlier (October 13), the Investigational New Drug (IND) application for this vaccine received approval from China's National Medical Products Administration. This milestone of simultaneous breakthroughs in China and the US not only marks the innovative vaccine's formal entry into a new stage of synchronized clinical development between China and the US, but also highlights Chinese pharmaceutical companies' enhanced competitiveness in the global mRNA cancer treatment landscape.
As a product of EVEREST MED's proprietary mRNA technology platform, EVM14 is a universal off-the-shelf therapeutic cancer vaccine targeting five tumor-associated antigens (TAA), intended for treating various squamous cell cancers including non-small cell lung squamous carcinoma and head and neck squamous cell carcinoma.
The development of EVM14 directly addresses current clinical pain points in squamous carcinoma treatment. Currently, the squamous carcinoma patient population is substantial, but existing standard treatments have not achieved satisfactory therapeutic outcomes, presenting significant unmet medical needs. As a universal off-the-shelf vaccine, EVM14 offers advantages including no HLA screening requirement, ready availability, lower production costs, and applicability across multiple tumor types, demonstrating broad application prospects in cancer treatment.
Preclinical trial results further validate EVM14's potential. It induced dose-dependent antigen-specific immune responses in mice and significantly inhibited tumor growth in multiple mouse syngeneic tumor models. More notably, it can simultaneously induce immune memory, demonstrating effective capability in reducing tumor recurrence. Preclinical studies also proved that combining EVM14 with immune checkpoint inhibitors can significantly enhance anti-tumor activity, supporting clinical exploration of combination therapy.
Regarding EVM14's clinical potential, Professor Lu Shun, Director of Oncology at Shanghai Chest Hospital and China's Principal Investigator, stated: "Currently, tumors in China remain in a high-incidence trend, while existing immunotherapies and targeted therapies often struggle to form lasting immune memory. Tumor-associated antigen vaccines can not only serve as powerful supplements to existing therapies, playing synergistic roles, but may also reduce recurrence, aligning with global cancer drug development trends. In preclinical studies, EVM14 can induce immune memory and demonstrates effective capability in reducing tumor recurrence, potentially helping patients achieve 'long-term cancer-free survival' benefits. This innovative exploration has groundbreaking significance in the field of cancer treatment."
From an industry perspective, the mRNA field is currently experiencing an explosive period, with frequent global pharmaceutical company positioning moves. Domestically, Simcere Pharmaceutical entered the mRNA track through acquisition in August, while Suzhou Shali Biotechnology completed over 600 million yuan in Series C funding in October, with its R&D pipeline covering in vivo CAR-T therapy based on LNP delivery platforms and tumor neoantigen mRNA vaccines.
In international markets, Bristol Myers Squibb spent $1.5 billion in October to acquire Orbital, gaining access to its preclinical candidate drug in vivo CAR-T therapy OTX-201 and proprietary RNA technology platform. Earlier in June, BioNTech spent $1.25 billion to acquire CureVac to integrate mRNA technology advantages, while AbbVie also acquired Capstan for $2.1 billion to strengthen its layout in the in vivo CAR-T field, demonstrating leading pharmaceutical companies' fierce competition for mRNA-related cutting-edge technologies.
According to predictions, the mRNA cancer vaccine market could reach $40.651 billion under neutral scenarios, with universal vaccines achieving much higher penetration rates than personalized products due to cost advantages. EVM14, with its differentiated advantages, has achieved leadership in clinical development progress amid intense industry competition.
The current EVM14 global multi-center Phase I clinical trial brings together top institutions from China and the US, including 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. The trial will focus on observing the vaccine's safety and efficacy.
EVM14's rapid development progress is inseparable from EVEREST MED's internationally leading, fully integrated and localized AI+mRNA platform. This platform has built a complete industrial chain covering antigen design, sequence optimization, delivery system development to large-scale production, and enhances mRNA expression levels through third-generation AI algorithms, laying the foundation for vaccine development.
Notably, EVM14 is just one highlight in EVEREST MED's mRNA pipeline. In its pipeline, the autologous CAR-T project EVM18 is expected to initiate clinical trials before year-end, personalized therapeutic cancer vaccine EVM16 has launched first-in-human clinical trials in China and completed patient dosing, while off-the-shelf immunomodulatory vaccine EVM15 has completed preclinical proof-of-concept studies.
Comments