Core Insights - Cloud-based innovative pharmaceutical company, CloudTop New Horizon, has successfully enrolled its first patient in a global multi-center Phase I clinical trial for its universal on-demand tumor therapeutic vaccine EVM14 in the United States, following the approval of its Investigational New Drug (IND) application by the National Medical Products Administration of China [1][2] Group 1: Vaccine Development - EVM14 targets five tumor-associated antigens (TAA) and is intended for the treatment of various squamous cell carcinomas, including non-small cell lung squamous carcinoma and head and neck squamous cell carcinoma [2] - The vaccine is based on CloudTop's self-developed mRNA technology platform, addressing unmet medical needs in current squamous carcinoma treatments [2] Group 2: Clinical and Market Potential - EVM14 has shown the ability to induce immune memory in preclinical studies, potentially reducing tumor recurrence and offering patients the possibility of "long-term cancer-free survival" [2] - As a universal on-demand vaccine, EVM14 has advantages such as no need for HLA screening, on-demand supply, lower production costs, and applicability to multiple tumor types, indicating a broad application prospect in tumor treatment [2] Group 3: Future Developments - Besides EVM14, CloudTop has several other promising products, including the autologous CAR-T project EVM18, which is expected to initiate clinical trials by the end of the year, and the personalized tumor therapeutic vaccine EVM16, which has already started its first human clinical trial in China [2]
云顶新耀mRNA肿瘤疫苗EVM14实现中美同步临床开发