LUYE PHARMA (02186) is set to launch II phase clinical trials in China for its mRNA vaccine LY01620, intended for the treatment of cervical precancerous lesions and HPV-related tumors.

LUYE PHARMA (02186) announced that the groups self-developed messenger RNA (mRNA) vaccine LY01620 is about to commence Phase II clinical trials in China. The study intends to enroll patients with histologically confirmed high-grade squamous intraepithelial lesions (HSIL) positive for human papillomavirus type 16 (HPV16) to further evaluate the efficacy and safety of LY01620. LY01620 is a therapeutic mRNA vaccine registered as a Class 1 therapeutic biological product, targeting the HPV16 subtype E6 and E7 protein antigens. LY01620 expresses HPV-specific antigens E6/E7 using mRNA, inducing the body to generate specific T cell immunity to eliminate HPV-infected cervical epithelial cells, interrupt the carcinogenic process, and restore normal cervical epithelial cells. The Phase I clinical study of LY01620 in China has yielded positive results, supporting the initiation of Phase II research. The Phase I study aimed to assess the safety, tolerability, immune response, immunogenicity, and preliminary efficacy of LY01620 in patients who are HPV16 positive and histologically confirmed as HSIL. The study results show that LY01620 significantly activates cellular and humoral immunity, achieving an HPV virus clearance rate of nearly 90%. The proportion of patients with improved histopathology approaches the standard surgical treatment level, and the product is non-invasive, not affecting fertility. The overall safety and tolerability of the product are good, with adverse reactions being common vaccine-related side effects. Compared to traditional surgical treatments, therapeutic vaccines can be applied at different stages of the HPV-infected disease process to prevent progression to cervical cancer. The groups management believes that the development of a therapeutic HPV vaccine, as an efficient non-surgical immunotherapy option, has become an urgent clinical need. LY01620 is expected to fill the gap in therapeutic vaccines for HPV, providing new treatment options for HPV-related diseases. Additionally, the group is actively exploring the clinical application prospects of LY01620 in HPV-related solid tumors, further tapping into the therapeutic value and potential of the product. The groups self-developed mRNA technology platform has established a complete technological closed-loop process for antigen screening, mRNA sequence optimization, proprietary delivery carrier system development, and GMP-scale production. Relying on this technology platform, the group has the capability to continuously develop personalized and universal mRNA vaccine products based on novel tumor antigens.