HONG KONG SAR - Media OutReach Newswire - 26 January 2026 - Immuno Cure BioTech ("Immuno Cure") is pleased to announce today the initiation of a Phase I clinical study of ICVAX, a therapeutic DNA vaccine for HIV, in collaboration with the Faculty of Medicine of The Chinese University of Hong Kong ("CUMedicine"), the AIDS Institute of The University of Hong Kong ("HKU AIDS Institute"), and Greater Bay Area International Clinical Trials Center ("BAY TRIAL").

As a lead candidate under Immuno Cure's patented "PD-1-Enhanced DNA Vaccine Technology Platform", ICVAX aims to achieve sustained, immune-mediated HIV-1 virological control without the need of antiretroviral therapy. Following the successful first-in-human ICVAX Phase I clinical trial in Shenzhen that showed exceptional safety and immunogenicity profiles, this clinical study will explore the safety and immunogenicity of ICVAX in HIV-infected volunteers in Hong Kong, to be administered by three distinct delivery systems. This comparative approach will provide essential data on the optimal delivery method for ICVAX, and hence potentially identifying the most effective, patient-friendly and scalable option for enhancing immunotherapeutic responses in people living with HIV.

The clinical study will be conducted at Prince of Wales Hospital and will be led by Dr Grace LUI, Head of the Division of Infectious Diseases at CUHK Medicine's Department of Medicine and Therapeutics, as the Principal Investigator. This is a randomized clinical study to evaluate the immunogenicity and safety of ICVAX in a total of 22 HIV-infected volunteers using three delivery systems: Teresa-EPT-1 electroporation device, PharmaJet's Tropis, a WHO pre-qualified needle-free injection system, and PapiVax's TriGrid EP device.

This study has been granted ΗΚ$4.2 million funding under the Public Sector Trial Scheme of the Innovation and Technology Fund of the HKSAR Government (project reference number: UTT/002/23GM). Professor Zhiwei CHEN, Director of the HKU AIDS Institute and Principal Scientific Advisor of Immuno Cure, serves as the Project Coordinator for this funding. This study is also partially supported by Theme-based Research Scheme (TRS) of the Research Grants Council under the University Grants Committee of the Education Bureau (project reference number: T11-702/24-N).

"This Phase I clinical study is an important landmark, being the first evaluation of ICVAX in Hong Kong volunteers and incorporating multiple innovative delivery technologies," said Dr Grace LUI. "By testing these devices, we aim to optimize safety, immunogenicity, and patient experience for this promising HIV therapeutic DNA vaccine candidate."

"ICVAX is built on the innovative PD-1-Enhanced DNA vaccine technology invented and developed locally at the HKU," said Professor Zhiwei CHEN. "This study will help optimize delivery of ICVAX, paving the way for broader international deployment."

"The launch of this clinical study is a major milestone of vaccine development for Immuno Cure," said Dr Xia JIN, CEO of Immuno Cure. "By testing ICVAX for the first time in Hong Kong and comparing three innovative delivery devices this study not only advances our understanding of the performance of our DNA medicines, but also significantly supports the global commercialization of ICVAX and our other DNA medicines. Immuno Cure is committed to leading innovation in immunotherapy to combat infectious diseases and cancers."