New Cancer Vaccine, EVM14, Cleared for Investigational Drug Application

EVM14, an mRNA cancer vaccine, gained FDA clearance for clinical trials, advancing Everest Medicines’ efforts in oncology drug development.

EVM14, a tumor-associated antigen vaccine, has received U.S. Food and Drug Administration (FDA) clearance for its investigational new drug application in various cancer types, according to a news release from the drug’s manufacturer, Everest Medicines.

"With FDA [investigational new drug] approval, EVM14 has become the Everest's first internally developed mRNA therapeutic vaccine to receive clearance for global clinical development.” the CEO of Everest Medicines, Rogers Yongqing Luo, said in the news release. “This marks a critical breakthrough, advancing our mRNA technology from early-stage research to global clinical trials and highlighting our growing capabilities in mRNA technology. It also represents a new chapter in our 'dual-engine' strategy, evolving from a license-in model to a balanced integration of both license-in and in-house R&D innovation."

The company plans to submit the investigational new drug application for EVM14 to the China National Medical Products Administration in the near future.

An investigational new drug application is a request submitted to the FDA by a sponsor to obtain an exemption from federal law requiring approved marketing before interstate transport or distribution of a drug, allowing clinical trials.

Preclinical findings showed that EVM14 induced a dose-dependent, antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic models. As a therapeutic vaccine, EVM14 promoted immune memory and prevented tumor recurrence. In combination with immune checkpoint inhibitors, EVM14 enhanced anti-tumor activity, supporting further evaluation in clinical trials.

According to the release, EVM14 and its distinct mechanism may improve treatment by boosting efficacy in combination therapies and delaying disease recurrence, reflecting trends in oncology drug development.

Furthermore, the company’s mRNA manufacturing facility in Jiashan, Zhejiang Province in China, is designed to comply with global cGMP standards and to produce at clinical- and commercial-scale.

EVM14 is an off-the-shelf mRNA cancer vaccine targeting multiple tumor-associated antigens to treat cancers such as non-small cell lung and head and neck cancer. It uses mRNA encapsulated in a lipid nanoparticle delivery system. After intramuscular injection, antigen-presenting cells translate the mRNA into target antigens, which are processed and presented via major histocompatibility complex molecules to T cells. The activated T cells then migrate to tumors, recognize cancer cells expressing the target antigens and initiate cell destruction.

GLOBOCAN 2022 estimates reported nearly 20 million new cancer cases worldwide and about 9.7 million cancer-related deaths, according to the release. Lung cancer remains the most common, with nearly 2.5 million new cases and 1.8 million deaths. Non-small cell lung cancer accounts for 85% to 90% of cases, with squamous non-small cell lung cancer making up 25% to 30%. Targetable genetic alterations occur in fewer than 10% of squamous non-small cell lung cancer cases, highlighting the need for new treatments.

Head and neck squamous cell carcinoma is the seventh most common cancer, with 890,000 new cases and 450,000 deaths annually. More than half of patients with locally advanced disease experience recurrence.

“Over the past four years, Everest has utilized its AI- and big data-powered mRNA platform to accelerate target identification, sequence design and delivery optimization,” Luo continued. “Our proprietary algorithm for mRNA design, now in its third generation, has significantly improved target protein expression and continues to evolve through big data-driven modeling. This approach has enabled key breakthroughs in mRNA technology, expanded our global pipeline, and unlocked potential new opportunities for international collaboration. We look forward to advancing EVM14 into clinical trials and providing new treatment options for [patients with cancer].”

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