Everest Medicine’s IND Application for EVM14 Cleared by FDA

The U.S. Food and Drug Administration (FDA) has cleared Everest Medicines’ 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 targets multiple tumor-associated antigens and is designed to treat various cancers. In preclinical studies, EVM14 induced a dose-dependent immune response, inhibited tumor growth, and demonstrated potential for long-term cancer-free survival.

“With FDA IND approval, EVM14 has become 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. “We look forward to advancing EVM14 into clinical trials and providing new treatment options for cancer patients. Additionally, we will submit the IND application for EVM14 to the China National Medical Products Administration (NMPA) in the near future.”