Vertex Pharmaceuticals (01952) announces the first patient dosing of the novel mRNA personalized cancer treatment vaccine EVM16 developed independently.

On March 6th, China New Shine (01952) announced that its independently developed novel mRNA personalized tumor therapeutic vaccine EVM16 has successfully completed the first patient dosing at Peking University Cancer Hospital, marking a milestone in this clinical trial project. The clinical trial project EVM16CX01 is the first human trial conducted by EVM16, initiated by Peking University Cancer Hospital and Fudan University Affiliated Cancer Hospital, to evaluate the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 injection monotherapy and combination with PD-1 antibody therapy in late-stage or recurrent solid tumor subjects in a dose escalation and expansion study. EVM16 is a novel mRNA personalized tumor therapeutic vaccine developed by China New Shine, driven by AI algorithms to identify tumor neoantigens. Using the independently developed and self-iterative EVER-NEO-1 "Miao Suan" tumor neoantigen artificial intelligence AI algorithm system, which recognizes tumor neoantigens with high immunogenicity based on each patient's unique tumor cell mutations, and designs mRNA therapeutic vaccines encoding dozens of tumor neoantigens. EVM16 efficiently delivers antigens in vivo through lipid nanoparticle (LNP) delivery system, activating the patient's own neoantigen-specific T cell immunity, thereby achieving the goal of killing tumor cells and treating cancer. In preclinical studies, EVM16 has elicited strong neoantigen-specific T cell immune responses in various mouse models and achieved significant tumor growth inhibition in a mouse melanoma B16F10 model. China New Shine's EVER-NEO-1 "Miao Suan" tumor neoantigen artificial intelligence AI algorithm system not only identifies the majority of reported tumor neoantigens, but also identifies multiple previously unreported tumor neoantigens, demonstrating comparable or superior neoantigen prediction capabilities in multiple independent validation studies compared to industry-leading algorithms. Preclinical data also demonstrate that EVM16 has a synergistic anti-tumor effect when used in combination with PD-1 antibodies, supporting the combination of personalized tumor vaccines with immune checkpoint inhibitors in clinical practice. In preclinical safety evaluation trials, EVM16 also demonstrated good safety. These results collectively suggest that EVM16 injection immunogenicity is strong, safety is good, and the combination with immune checkpoint inhibitors is expected to bring more clinical benefits to cancer patients. Professor Shen Lin, Director of the Department of Digestive Tumors at Peking University Cancer Hospital and Chairman of the Gastric Cancer Expert Committee of the Chinese Society of Clinical Oncology, said, "Our team is very pleased to have completed the first patient dosing of the personalized tumor vaccine EVM16, which marks a new phase in the clinical research of EVM16. EVM16 uses mRNA technology to 'tailor' anti-cancer solutions for patients based on the specific mutations or epitopes of each patient's tumor, activating the patient's own tumor-specific immune response and then recognizing and attacking tumor cells. Particularly encouraging, in preclinical studies, the combination of EVM16 vaccine with PD-1 antibody showed a significant synergistic anti-tumor effect, demonstrating broader clinical application prospects, indicating that EVM16 is expected to provide a more diverse treatment strategy. We are confident in the following studies and look forward to providing new and accessible treatment options for cancer patients, bringing hope of life to patients worldwide." China New Shine CEO Luo Yongqing said, "In recent years, AI-empowered new drug development has become an important trend, especially in the mRNA vaccine field, where AI is gradually becoming a key force driving the improvement of R&D efficiency and accuracy, receiving high attention from the biopharmaceutical industry and strong support from governments around the world. Since 2021, China New Shine's mRNA platform has successfully passed clinical verification, and the company is committed to the independent development of tumor therapeutic vaccines, using AI algorithms to discover tumor neoantigens, continuously optimizing the algorithm platform for more precise identification and validation of tumor neoantigens, laying the foundation and leading advantages for the self-developed mRNA therapeutic tumor vaccines. As the first personalized mRNA therapeutic tumor vaccine independently developed by China New Shine, the successful dosing of the first patient with EVM16 marks a solid step from laboratory research to clinical application, demonstrating that China New Shine's proprietary tumor neoantigen AI algorithm system and mRNA technology platform with independent intellectual property rights have successfully entered the human trial stage. Currently, China New Shine has successfully localized its self-developed mRNA platform that has been clinically validated and has built an end-to-end full-industry chain platform covering antigen design, mRNA sequence optimization, LNP delivery technology to industrial production, having the potential to address significant unmet medical needs globally. We look forward to EVM16 demonstrating its therapeutic potential in clinical trials, bringing new treatment options to cancer patients worldwide, improving treatment outcomes, providing more choices for patients with life-threatening tumors, and exploring new blue oceans in tumor immunotherapy." Globocan The 2022 statistics show that there are 19.976 million new cancer cases worldwide, with 9.744 million cancer deaths. Immune therapy, mainly immune checkpoint inhibitors, has become a significant part of certain cancer treatments. Still, it is only effective for some patients, and the oncology field urgently needs to develop novel immune therapies based on this. Personalized mRNA tumor vaccines have become a highly promising next-generation immune therapy. China New Shine is developing tumor and other therapeutic mRNA drugs through its proprietary mRNA technology platform and has full intellectual property rights and global ownership of these products. The company is currently developing multiple mRNA tumor therapeutic vaccines, including Personalized Cancer Therapeutic Vaccine (PCV), Tumor-Associated Antigen (TAA) Tumor Therapeutic Vaccine, Immune Modulating Tumor Therapeutic Vaccine, and Autologous CAR-T Products, and is developing a new generation LNP delivery system to enhance cell-mediated immune responses. The new drug clinical trial of the Tumor-Associated Antigen (TAA) vaccine will be submitted for approval in both China and the United States by 2025.