Core Insights - CloudTop New Medicine (01952.HK) has initiated the first patient dosing in a global multi-center Phase I clinical trial for its universal on-demand tumor therapeutic vaccine EVM14, marking a significant milestone in the company's mRNA technology platform and its global clinical development efforts [1] Group 1: Product Development - EVM14 is developed based on CloudTop's proprietary mRNA technology platform and targets five tumor-associated antigens (TAA), intended for treating various squamous cell carcinomas, including non-small cell lung squamous carcinoma (sq-NSCLC) and head and neck squamous cell carcinoma (HNSCC) [1] - Approximately 96% of sq-NSCLC patients and 97% of HNSCC patients express at least one TAA gene, indicating a strong potential patient population for EVM14 [1] Group 2: Clinical Trial Details - The Phase I clinical trial design includes both EVM14 monotherapy and EVM14 in combination with PD-1 monoclonal antibodies, with primary endpoints focusing on safety and tolerability, and secondary endpoints on efficacy [2] - The project is expected to complete the dose escalation for monotherapy by 2026, providing initial safety and tolerability data [2] - Clinical centers involved include NEXT Oncology Virginia, The University of Texas MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and Shanghai Chest Hospital in China [2] Group 3: Preclinical Results - Preclinical trials demonstrated that EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumor growth in various mouse tumor models [2] - EVM14 also showed the ability to induce immune memory and effectively reduce tumor recurrence, supporting the exploration of combination therapy with immune checkpoint inhibitors (ICIs) [2] Group 4: Broader Pipeline - CloudTop is developing a range of tumor and other therapeutic mRNA drugs, leveraging its leading self-developed mRNA tumor therapeutic vaccine platform and autologous CAR-T platform, with full intellectual property rights and global rights for its pipeline [3] - In addition to EVM14, the pipeline includes autologous CAR-T project EVM18, personalized tumor therapeutic vaccine (PCV) EVM16, and on-demand immune modulation vaccine EVM15 [3]