Luye Pharma Group (HKEX: 02186) is advancing its LY01620 mRNA therapeutic vaccine into Phase II development in China for HPV16-positive cervical high-grade squamous intraepithelial lesions (HSIL), after reporting an HPV clearance rate of approximately 90% in Phase I, according to an August 20 announcement.
The Phase II study will enroll patients with histologically confirmed HPV16-positive HSIL to further evaluate efficacy and safety. Luye did not disclose the planned enrollment, endpoints, or study design.
The Phase I study evaluated safety, tolerability, immunogenicity, and preliminary efficacy in the same population. Luye reported an HPV clearance rate of approximately 90% and said histopathological improvement "nearly reached" that achieved with surgical treatment. The vaccine also induced cellular and humoral immune responses. Adverse events were described as typical vaccine-related reactions, although detailed safety results were not disclosed.
LY01620 uses mRNA encoding the HPV16 E6 and E7 oncoproteins to induce antigen-specific immune responses against HPV-infected cells. Unlike prophylactic HPV vaccines, which prevent new infections, LY01620 is intended to treat established persistent HPV16 infection and associated precancerous cervical lesions. A successful therapeutic approach could potentially allow some patients to avoid surgical excision, which can affect cervical integrity and future pregnancy outcomes.
The cervical precancer field has begun to move beyond surgery. Asieris Pharmaceuticals' Cevira, a hexaminolevulinate-based photodynamic therapy, received NMPA approval in March 2026 for cervical high-grade squamous intraepithelial lesions, providing a non-surgical treatment option. Inovio Pharmaceuticals' VGX-3100, a DNA-based immunotherapy targeting HPV16/18 E6 and E7, previously reached Phase III development, although its US program was discontinued after FDA requested additional biomarker evidence.