Immuno Cure BioTech, a clinical stage biotechnology group based in the Hong Kong Science Park, which specializes in PD-1-enhanced DNA vaccines and immunotherapies, has started its phase I clinical trial of ICVAX, a therapeutic vaccine against HIV/AIDS. The trial is taking place at the National Clinical Research Center for Infectious Diseases at The Third People’s Hospital of Shenzhen.
HIV-1 is the causative agent of AIDS. To date, HIV-1 continues to spread, leading to more than 38 million people living with the virus and over 40 million deaths worldwide by 2021.
Life-long antiretroviral treatment (ART) neither cures HIV/AIDS nor fully restores immune function, so Immuno Cure says it is critical to discover an effective immunotherapy of potentiating host immunity to achieve a functional cure, a state of suppressed viremia below detection limit for a prolonged period in HIV-infected patients without receiving ART.
Scientists at HKU-AIDS Institute have created the PD-1-enhanced DNA vaccine platform, which has been exclusively licensed to Immuno Cure on a worldwide basis. The innovation of this platform is based on soluble PD-1-linked antigen targeting to dendritic cells for inducing enhanced host immune responses especially CD8+ T-cells, which is the major immune surveillance force for eliminating HIV-1 infected cells.
ICVAX is developed by Immuno Cure in collaboration with HKU-AIDS Institute, aiming to induce broadly reactive polyfunctional viral-specific T cells to achieve functional cure in HIV/AIDS.
The trial is designed as a randomized, double-blinded, placebo-controlled, dose-escalation study to evaluate the safety and immunogenicity of ICVAX in stable HIV/AIDS patients under antiretroviral therapy. By the end of the study, an optimal vaccine regimen that is both safe and immunogenic in stable HIV patients will be identified for subsequent clinical trials in the future.
Immuno Cure has been granted $1 million funding for this clinical trial under the Clinical Translational Catalyst Program of the Institute for Translational Research (“ITR”) of the Hong Kong Science Park.
In addition to ICVAX, Immuno Cure currently has another PD-1-enhanced DNA vaccine, ICCOV, in preparation for advancement to a phase 2 clinical trial for the fight against COVID-19.
Jin Xia, CEO of Immuno Cure said: “Initiation of this phase 1 clinical trial is supported by promising preclinical study results and safety evaluation that demonstrated the antiviral activity of this first-in-class therapeutic vaccine designed and developed specifically against HIV. We are extremely impressed by the professionalism of the National Clinical Research Center at The Third People’s Hospital of Shenzhen. I am optimistic in the outcome of this trial and eager to proceed to the next phase soon.”
Chen Zhiwei, director of AIDS Institute at the University of Hong Kong and the principal scientific advisor of Immuno Cure, said: “HIV has been a major public health challenge for more than four decades. With support from Theme-based Research Scheme, our vaccine platform has demonstrated safety and potent efficacy in non-human primates. I am excited to kick off this clinical trial, which will benefit patients immediately and help us assess whether the excellent preclinical data can be translated into humans, laying a solid foundation for vaccine development towards HIV-1 functional cure.”