The facility aims for the development and application of key technologies for the clinical research and commercialization of Immuno Cure's ICVAX^®. ICVAX^® is developed by Immuno Cure with the aim of achieving antiretroviral therapy ("ART")-free functional cure for HIV infection. This project is carried out in collaboration with Prof. Zhiwei CHEN, the Founding Director of the AIDS Institute of Li Ka Shing Faculty of Medicine, the University of Hong Kong ("HKU AIDS Institute"), and Prof. Hongzhou LU, President of the Third People's Hospital of Shenzhen, in the capacity as advisors.

CIITS is a national-level achievement transformation platform co-built by Guangdong Province, Shenzhen Municipality, and Tsinghua University, and is located at the Hetao Shenzhen-Hong Kong Science and Technology Innovation Co-operation Zone ("Hetao Co-operation Zone"). It is committed to building a world's leading major technological innovation and industrialization platform with a global perspective. It focuses on key tracks including biomedicine, high-performance materials, and artificial intelligence (AI). It aims to aggregate global innovation resources, connect with leading enterprises, and conduct organized scientific research and achievement transformation to address national major strategic needs.

Since AIDS was first identified in 1981, 40.8 million people have died from HIV infection, with over 44.1 million people living with HIV globally. While antiretroviral therapy can effectively control HIV replication, it cannot cure the disease, highlighting the critical need for immunotherapies. Designed to enhance the host's immune response, immunotherapies aim to achieve sustained viral control without lifelong ART, ultimately leading to complete viral suppression and functional cure. Immuno Cure's proprietary innovative HIV therapeutic DNA vaccine, ICVAX^®, induces broad-spectrum, polyfunctional virus-specific T cells to achieve the ultimate goal of ART-free functional cure of HIV infection.

Immuno Cure completed the first-in-human Phase I clinical trial of ICVAX^® in November 2024, demonstrating excellent safety and promising immunogenicity. Two multi-center Phase II clinical trials—randomized, double-blind, and placebo-controlled—are scheduled to launch in Q2-2026 to evaluate the vaccine's mechanism of action and efficacy. The trials will be conducted at Prince of Wales Hospital in Hong Kong, as well as eight top-tier hospitals in China, including the Shenzhen Third People's Hospital, Beijing Ditan Hospital Affiliated to Capital Medical University, Beijing Youan Hospital affiliated to Capital Medical University, the Eighth People's Hospital of Guangzhou, the Second People's Hospital of Tianjin, the Sixth People's Hospital of Zhengzhou, Chengdu Public Health Clinical Medical Center, and Chongqing Public Health Medical Center.

Notably, standardized testing systems for evaluating immunological and virological indicators are crucial for HIV vaccine clinical trials. However, the lack of domestic standard operating procedures (SOPs) for infectious samples in clinical trials hinders the clinical development and regulatory approval of novel infectious disease therapies like ICVAX^®. The mission of this research facility at CIITS is to establish an internationally aligned standardized clinical testing system for T-cell immunogenicity and viral reservoirs, as well as identify core biomarkers associated with vaccine efficacy — filling a domestic technical gap. Immuno Cure will offer the ICVAX^® Phase II clinical trial to facilitate the development of this standardized precision testing method for clinical sample analysis.

Dr. Xia JIN, CEO of Immuno Cure, stated, "I am delighted to be appointed to lead this key project of CIITS. I would also like to thank CIITS for the fully fitted modern laboratory space and the RMB10.0m funding support for this 2-year initial phase. My whole scientific team is committed to contributing diligently to the success of this project. I have no doubt that the development of a standardised testing regime would not only enhance the quality of our clinical trials for ICVAX^® but would also eventually be adopted as industry and national standards for the clinical translation of medicine for HIV/AIDS and other infectious diseases.

Renchen LIU, Executive Deputy Dean of Research Institute of Tsinghua University in Shenzhen and Director of CIITS, stated, "Warmest congratulations on the inauguration of the research facility for ICVAX^® at the CIITS. In the future, CIITS will continue to leverage its platform resources to implement full-chain incubation services. Project managers will provide service support throughout the entire project period, ensuring the smooth progress of the project through resource integration, talent recruitment and development, clinical collaboration, and achievement transformation. These efforts will safeguard the steady progress of the project."

As the project advances, Immuno Cure's ICVAX^® is positioned to become the world's first therapeutic DNA vaccine to deliver an ART-free functional cure for HIV infection, bringing new hope to people currently living with HIV. In parallel, the standardized testing platform and collaborative innovation model developed through this effort will provide a scalable, replicable blueprint for R&D of novel therapies targeting other major infectious diseases. Together, these outcomes will strengthen the global competitiveness of biomedicine development in GBA and contribute to the development of national biosecurity capabilities and a more resilient public health system.


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https://immunocure.hk
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About the Center of International Innovation for Technology and Science ("CIITS")

Center of International Innovation for Technology and Science (CIITS), as the international headquarter of the Greater Bay Area National Center of Technology Innovation (GBA NCTI), is operated by Research Institute of Tsinghua University in Shenzhen (RITS). CIITS actively promotes the commercialization of technology and scientific advances with overseas and domestic innovation institutions and teams, as well as industry partners, focusing on areas such as biomedicine, advanced materials and artificial intelligence.

To learn more about CIITS, please follow the WeChat official account: gh_425f503135d5

About Immuno Cure

Immuno Cure is a clinical-stage biotechnology group headquartered at Hong Kong Science Park. Immuno Cure is committed to the R&D of innovative DNA vaccines and antibody immunotherapies for infectious diseases, inflammations, and cancers. Immuno Cure possesses two technologies: the "PD-1 Enhanced DNA Vaccine Platform" and the "Anti-Δ42PD1 Antibody".

To learn more about Immuno Cure, please visit: www.immunocure.hk

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