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Everest Medicines Announces FDA Clearance of IND Application for Tumor-Associated Antigen Vaccine EVM14
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 significa
About this update from Everest Medicines Ltd.
[{"type":"list","items":[{"val":[{"type":"text","content":"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.","length":211,"tagName":"p"}]},{"val":[{"type":"text","content":"Preclinical highlights：","length":23,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"EVM14 induced a dose-dependent, antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models.","length":154,"tagName":"p"}]},{"val":[{"type":"text","content":"As a therapeutic vaccine, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence.","length":110,"tagName":"p"}]},{"val":[{"type":"text","content":"In combination with immune checkpoint inhibitors (ICIs), EVM14 significantly enhanced anti-tumor activity, supporting exploration of combination therapies in clinical trials.","length":174,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":438,"olType":false}]},{"val":[{"type":"text","content":"EVM14, EVM16 and in-vivo CAR-T programs are the core pillars of Everest's oncology and autoimmune disease innovation strategy.","length":130,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":802,"olType":false},{"type":"text","content":"SHANGHAI, March 24, 2025 /PRNewswire/ -- 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.","length":665,"tagName":"p"},{"type":"text","content":"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....