Immuno Cure BioTech, a clinical-stage biotechnology company based in Hong Kong Science Park, has entered into a collaboration agreement with PharmaJet to evaluate the safety and immunogenicity of its HIV therapeutic DNA vaccine ICVAX using PharmaJet's innovative needle-free injection technology. The material transfer agreement was signed on June 16, 2025, during the BIO 2025 International Convention in Boston.
Addressing Critical Global Health Challenge
HIV/AIDS remains a critical global health challenge despite advances in treatment and prevention. As of 2023, over 39 million people were living with HIV, and more than 40 million deaths have occurred since the start of the epidemic in 1981. Current antiretroviral therapy (ART) is highly effective in suppressing the virus in HIV-1 infected individuals, but it does not provide a cure. This underscores the necessity for an effective immunotherapy that can enhance the host immune response to establish a state of ART-free virological control, or a functional cure.
ICVAX Technology and Previous Results
ICVAX employs Immuno Cure's patented PD-1-Enhanced DNA Vaccine technology, which aims to achieve sustained, immune-mediated HIV-1 virological control without the need of ART. The vaccine represents a significant step towards achieving virological control by ICVAX without antiretroviral therapy and ultimately becoming a functional cure of HIV/AIDS.
Following the successful first-in-human ICVAX Phase I clinical trial that showed exceptional safety and promising immunogenicity profiles, this new clinical study will explore the use of the WHO prequalified PharmaJet Tropis device for the administration of ICVAX.
Needle-Free Intradermal Delivery Advantages
The collaboration will utilize PharmaJet's Tropis needle-free injection system, which allows precise intradermal delivery through its advanced needle-free technology. Intradermal delivery leverages the rich network of dendritic cells, macrophages, and T cells in the dermal layer and can provide a more potent and broader immunogenic response compared with intramuscular delivery.
Tropis' global regulatory clearances and manufacturing scale reduce development risk and may improve the DNA vaccine performance and patient's clinical experience. The Tropis system is commercially scaled, has been used for over 12 million injections, and is the first and only needle-free intradermal delivery technology to achieve World Health Organization prequalification.
Clinical Study Details
This study will be conducted at Prince of Wales Hospital in Hong Kong SAR, led by Professor Grace LUI, Head of the Division of Infectious Diseases at the Faculty of Medicine, the Chinese University of Hong Kong. The study is a collaborative effort among Immuno Cure, CUHK, and the AIDS Institute of the University of Hong Kong, and is partially supported by funding from the Public Sector Trial Scheme of the Innovation and Technology Commission of the HKSAR Government. Professor Zhiwei CHEN, Director of the AIDS Institute of the University of Hong Kong, serves as the Project Coordinator for this funding.
Executive Perspectives
Dr. Xia Jin MD PhD, CEO of Immuno Cure, said, "At Immuno Cure, our mission is to advance transformative therapies for infectious diseases and cancer. We are excited to partner with PharmaJet and leverage their Tropis Needle-free Injection System on our HIV therapeutic DNA vaccine program. We value innovative approaches that could enhance patient experience and vaccine performance."
Dan Mallon, Senior Vice President Corporate Development at PharmaJet, commented, "This agreement adds to our portfolio of global development partnerships with innovative oncology and infectious disease developers. Our partners are joining our call to challenge antiquated IM administration methods in favor of ID delivery based on the growing body of evidence demonstrating improved immune responses and safety profiles. PharmaJet's needle-free technology is safe and well-tolerated and has shown to enable immune responses that are robust and durable."
