EVM14 received U.S. FDA clearance for its IND application, becoming Everest's first internally discovered program, and the first mRNA therapeutic cancer vaccine to be cleared for global clinical development.
Preclinical highlights：
EVM14 induced a dose-dependent, antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models.
As a therapeutic vaccine, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence.
In combination with immune checkpoint inhibitors (ICIs), EVM14 significantly enhanced anti-tumor activity, supporting exploration of combination therapies in clinical trials.
EVM14, EVM16 and in-vivo CAR-T programs are the core pillars of Everest's oncology and autoimmune disease innovation strategy.
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EVM14, a Tumor-Associated Antigen (TAA) vaccine. EVM14 is Everest's first internally developed mRNA therapeutic vaccine to receive FDA IND approval, marking a significant milestone in the Company's efforts to develop innovative mRNA therapeutics in oncology.
EVM14 is an off-the-shelf mRNA cancer vaccine targeting multiple TAAs and is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer. It utilizes mRNA encoding multiple TAAs encapsulated in a lipid nanoparticle (LNP) delivery system. Following intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs), where the mRNA is translated into target antigens. These antigens are then processed and presented by major histocompatibility complex (MHC) molecules to T cells, triggering an antigen-specific immune response. The activated T cells migrate to tumor tissues, recognize and kill the cancer cells expressing the target antigens.
In preclinical studies, EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. EVM14 promoted T cell infiltration into tumor tissues, increased T cell activation and cytotoxic function, decreased the Treg population and cytotoxic T lymphocyte (CTL) exhaustion - all well correlated with its anti-tumor activity. 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 ICIs greatly enhanced the anti-tumor activity, supporting clinical exploration of combination therapies.
"With FDA IND approval, EVM14 has become the Everest's first internally developed mRNA therapeutic vaccine to receive clearance for global clinical development. 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." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Through our clinically validated and fully-integrated mRNA platform, we have realized synergies with our 'AI-powered' pipeline, underscoring Everest's leadership position in advancing innovation in oncology and immunology. EVM14, along with EVM16, which is a personalized cancer vaccine in clinical development and in-vivo CAR-T programs, will serve as foundational elements of our innovation strategy in oncology and autoimmune diseases. Everest is at the forefront of China's mRNA and AI-powered therapeutic development, having advanced mRNA cancer therapeutic vaccines to the clinical trials. Over the past fou...
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