MedPath

EVM-16

Generic Name
EVM-16

FDA Clears Everest Medicines' IND Application for Novel mRNA Cancer Vaccine EVM14

• EVM14, Everest Medicines' first internally developed mRNA therapeutic vaccine, has received FDA clearance for its IND application, marking a significant milestone in the company's oncology innovation strategy. • Preclinical studies demonstrated EVM14's ability to induce antigen-specific immune responses, inhibit tumor growth in multiple models, and prevent tumor recurrence, offering potential for long-term cancer-free survival. • The off-the-shelf mRNA vaccine targets multiple tumor-associated antigens and is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer, with plans for NMPA submission in China.

Everest Medicines Initiates First-in-Human Trial of Personalized mRNA Cancer Vaccine EVM16

• Everest Medicines has dosed the first patient with EVM16, its proprietary personalized mRNA cancer vaccine, in a first-in-human trial at Peking University Cancer Hospital in China. • The trial will evaluate EVM16's safety, immunogenicity, and efficacy both as monotherapy and in combination with PD-1 antibody in patients with advanced or recurrent solid tumors. • Preclinical studies demonstrated synergistic anti-tumor effects when EVM16 was combined with PD-1 antibodies, suggesting potential clinical benefits for cancer patients with limited treatment options.

Everest Medicines Advances mRNA Tumor Vaccine Pipeline Amidst Financial Growth

• Everest Medicines is focusing on mRNA-based therapeutic vaccines, with its first personalized mRNA tumor vaccine, EVM16, now in clinical trials. • Nefecon, Everest's drug for IgA nephropathy, achieved substantial sales of 167 million yuan shortly after launch, highlighting its market potential. • The company's financial performance is strong, with a 158% revenue increase in the first half of the year and expectations to achieve cash break-even by the end of 2025.
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