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."
Hashtag: #ImmunoCure
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About Immuno Cure
Immuno Cure is a clinical stage biotechnology group based in the Hong Kong Science Park, focusing on research and development of innovative DNA medicines and antibody immunotherapies to fight against cancers, inflammatory and infectious diseases based on its patented PD-1-enhanced DNA Vaccine Platform and Anti-Δ42PD1 Antibody Platform
To learn more about Immuno Cure, please visit http://www.immunocure.hk.
About CUHK Medicine
Established in 1981, CU Medicine has achieved international recognition in teaching, research, and clinical practice and is the youngest medical school ranked among the world's top 25 in many global rankings. In the "Best Global Universities Subject Rankings 2025-26" by U.S. News and World Report, its "Gastroenterology and Hepatology", "Endocrinology and Metabolism" and "Clinical Medicine" programmes rank 1st in Asia, while Gastroenterology and Hepatology claims 2nd globally.
The Faculty comprises 14 clinical departments and five schools, delivering a world-class environment for teaching and research with a strong emphasis on interdisciplinary, interprofessional, and international collaboration. To date, it has cultivated over 6,000 medical graduates who are making an impact across local and global healthcare systems. The Faculty is dedicated to driving innovation by translating groundbreaking research into real-world clinical applications. Its contributions have reshaped medicine — evidenced by the filing of 3,000 patents, strategic patent acquisitions, and the establishment of more than 20 start-ups. Its pioneering research has not only rewritten international clinical guidelines but also revolutionised the prevention, diagnosis, and treatment of numerous diseases.
To learn more about CU Medicine, please visit http://www.med.cuhk.edu.hk.
About HKU AIDS Institute
HKU AIDS Institute was established in November 2007 to take HKU in a new strategic direction in fighting this global epidemic and help to make it a leader in the region in AIDS research, education and prevention. Scientists at the AIDS Institute are fully committed to conducting basic and applied research that facilitates the understanding of AIDS pathogenesis and the development of effective AIDS vaccines. Currently, the Institute is leading the Hong Kong Theme-based Research Scheme entitled "Potentiating Host Immunity for HIV-1 Functional Cure".
To learn more about HKU and AIDS Institute of HKU, please visit https://www.hku.hk/ and https://www.med.hku.hk/aidsinst/.
About BAY TRIAL
BAY TRIAL is a key initiative in implementing the "Notice of the State Council on Issuing the Development Plan for the Shenzhen Park of the Hetao Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone" (State Council [2023] No. 12). It serves as strong support for Shenzhen's development as an international science and technology innovation centre and for promoting the high-quality development of the biopharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA). Located in the Hetao Shenzhen-Hong Kong Cooperation Zone, BAY TRIAL leverages the zone's unique geographical and policy advantages to integrate clinical trial innovation resources across the GBA, deepen Shenzhen-Hong Kong science and technology collaboration, and establish a one-stop clinical trial platform.
To learn more about BAY TRIAL, please visit: https://baytrial.smart.org.cn/about/index.html
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