Immuno Cure Biotech has announced encouraging results from its Phase I clinical trial of ICVAX, a novel therapeutic HIV vaccine. The trial, a randomized, double-blinded, placebo-controlled, dose-escalation study, demonstrated that ICVAX was well-tolerated with a favorable safety profile and showed promising immunogenicity in clinically stable HIV-1-infected patients whose virus replication was well-suppressed by antiretroviral therapy (ART). The results mark a significant step toward achieving ART-free virological control and a potential functional cure for HIV/AIDS.
The Phase I trial (NCT06253533) enrolled 45 participants at The Shenzhen Third People’s Hospital, who were randomly assigned to three dosing groups (1 mg, 2 mg, and 4 mg) with an ICVAX-to-placebo ratio of 12:3 in each cohort. ICVAX was delivered via electroporation using Immuno Cure’s Teresa EP device. The primary endpoints of the trial focused on safety and tolerability, while secondary endpoints assessed immunogenicity.
Key Findings from the Phase I Trial
Data from the trial, reviewed by the Data Safety Monitoring Board (DSMB) and unblinded in late September 2024, indicated that ICVAX was well-tolerated across all doses. All 45 participants completed the scheduled visits, and all reported treatment-related adverse events were mild, with no treatment-related severe adverse events reported. Importantly, ICVAX vaccine recipients demonstrated promising T cell responses. In those receiving the optimal ICVAX dose, a large majority had more than a 2-fold increase in T cell responses. Critically, ICVAX could enhance functional T cells previously found in Elite Controllers (EC) for HIV-1 control.
Expert Commentary
"We are incredibly excited with these unprecedented results of the Phase I clinical trial of ICVAX upon unblinding after thorough review and clearance by the DSMB," said Dr. Hongzhou Lu, President of Shenzhen Third Hospital and Co-Principal Investigator of the Phase I Trial. "These promising trial data laid a solid foundation for the upcoming Phase II clinical trial, and for ICVAX to ultimately achieve ART-free virological control in HIV-1 patients and potentially the long-awaited functional cure of HIV/AIDS for PLWH."
Prof. Zhiwei Chen, Founding Director of HKU AIDS Institute and Principal Scientific Advisor of Immuno Cure, added, "The Phase I Trial preliminary data demonstrated satisfying safety and immunogenicity profiles of ICVAX in PLWH. It is encouraging to discover that ICVAX enhances functional T cells previously found in EC for HIV-1 suppression."
Future Directions
Immuno Cure is communicating with the National Medical Products Administration (NMPA) for an upcoming multi-center, double-blinded, placebo-controlled, dose-finding Phase II clinical trial, anticipated to commence in mid-2025. This trial will evaluate the immunogenicity and efficacy of ICVAX in controlling HIV viral load.
Dr. Xia Jin, CEO of Immuno Cure, stated, "The encouraging outcomes of the Phase I Trial are attributed by fruitful collaboration for over 8 years between Immuno Cure and Prof. Chen of HKU-AIDS Institute, representing a significant milestone of the development of ICVAX. Looking ahead, we shall move on with our BLA application under NMPA’s breakthrough drug regulatory regime after meeting the expected end points of the Phase II clinical trial."
About HIV and Current Treatments
Globally, over 39 million people are living with HIV, and over 40 million deaths have occurred since its discovery in 1981. While current ART is highly efficacious, it does not cure HIV/AIDS, underscoring the need for effective immunotherapies. ICVAX aims to induce broadly reactive polyfunctional viral-specific T cells to achieve sustained HIV-1 virological control in the absence of ART, potentially leading to a functional cure.
