AlphaNa Advances Clinical Development of a Next-Generation HPV mRNA Therapeutic Vaccine

AlphaNa Bioscience announced the initiation of a multicenter Phase IIb clinical trial of AFN0328 injection, a therapeutic mRNA vaccine targeting human papillomavirus (HPV)-associated diseases. The trial was launched at Peking University People's Hospital, the lead clinical site, with participation from more than 30 clinical centers across China.

The Phase IIb study represents an important milestone in the clinical development of AFN0328 and further advances AlphaNa’s efforts to develop innovative RNA-based immunotherapies for patients with unmet medical needs.

Photo 1. Professor Jianliu Wang, Principal Investigator of the AFN0328 Phase IIb clinical trial, 

and Professor Yucai Wang, Founder and Chief Scientist of AlphaNa Bioscience, at the trial initiation ceremony.

Addressing the Clinical Need in HPV-Associated Disease

Persistent infection with high-risk HPV is a major driver of cervical cancer development. High-grade squamous intraepithelial lesions (HSIL) represent a critical intervention window before malignant progression.

Current treatment options for HSIL primarily rely on local surgical procedures, which can effectively remove lesions but may cause tissue damage and potentially affect fertility. New non-invasive therapeutic approaches that can achieve immune-mediated disease control remain an important clinical need.

A Programmable mRNA Therapeutic Vaccine Platform

AFN0328 was developed through AlphaNa’s proprietary TALENT mRNA technology platform, integrating antigen engineering, immune activation components, advanced delivery technologies, and sequence optimization approaches.

The platform is designed to enhance antigen presentation, stimulate HPV-specific T-cell responses, and enable the development of next-generation therapeutic vaccines. AFN0328 has entered clinical development as a Class I innovative therapeutic biological product in China.

Clinical Development and Translational Progress

The Phase IIb trial is led by Professor Jianliu Wang from Peking University People's Hospital, with extensive expertise in gynecologic oncology, cervical disease, and clinical research.

As AFN0328 advances into Phase IIb clinical evaluation, the study will further assess its clinical potential and support the continued development of mRNA-based therapeutic approaches for HPV-associated diseases.

Executive Comment

“The initiation of the AFN0328 Phase IIb trial represents an important step in translating our mRNA and immune engineering technologies into clinical solutions,” said Yucai Wang, Founder and Chief Scientist of AlphaNa Bioscience. “We aim to develop innovative therapeutic vaccines that harness the power of the immune system to address significant unmet medical needs.”