Encouraging findings with immunotherapy aiming at ART-free virological control A significant step towards functional cure of HIV infection

HONG KONG SAR - Media OutReach Newswire – 12 November 2024 - Immuno Cure BioTech ("Immuno Cure"), a clinical-stage biotechnology group based in Hong Kong Science Park, is pleased to announce the completion of a first-in-human novel therapeutic HIV vaccine, ICVAX, Phase I clinical trial with encouraging findings of exceptional safety and promising immunogenicity profiles. This represents a significant step of ICVAX towards achieving antiretroviral therapy ("ART") free virological control by ICVAX and ultimately accomplishing as a functional cure of HIV/AIDS. Globally, there are more than 39 million people living with HIV ("PLWH") and over 40 million deaths since HIV was discovered in 1981. The currently available ART, while highly efficacious, does not cure HIV/AIDS, highlighting the need for an effective immunotherapy to assist ART. Such immunotherapy can potentiate host immune response, aiming to achieve a state of ART-free virological control, and ultimately a complete suppression of virus to an undetectable level in blood for a prolonged period of time, and hence achieving functional cure. Immuno Cure's ICVAX aims to induce broadly reactive polyfunctional viral-specific T cells to achieve sustained HIV-1 virological control in the absence of ART. This Phase I clinical trial is a randomized, double-blinded, placebo-controlled, dose-escalation study, approved by the National Medical Products Administration ("NMPA") and carried out at The Shenzhen Third People's Hospital ("Shenzhen Third Hospital"), for the evaluation of the safety, maximal tolerating doses, and for the exploration of immunogenicity of ICVAX in clinically stable HIV-1-infected patients whose virus replication are well-suppressed by antiretroviral therapy (clinicaltrials.gov no. NCT06253533), ("Phase I Trial"). A total of 45 participants were recruited and randomly assigned into three dosing groups (1 mg, 2 mg, and 4 mg groups), with an ICVAX-to-placebo ratio of 12:3 in each cohort. ICVAX was delivered by electroporation using Immuno Cure's NMPA-approved Class II Teresa EP device ("Teresa EP"). All trial data were reviewed by the Data Safety Monitoring Board ("DSMB") and unblinded in late September 2024. ICVAX was well tolerated and had a favorable safety profile at all doses studied. All 45 participants completed the scheduled visits. All reported treatment-related adverse events were mild, and no treatment-related severe adverse events were reported. Overall, ICVAX vaccine recipients demonstrated promising T cell responses. In those receiving the optimal ICVAX dose, a large majority had more than 2-fold increase in T cell responses. Critically, ICVAX could enhance functional T cells previously found in Elite Controllers ("EC") for HIV-1 control. The primary and secondary endpoints of the Phase I trial have been met. Immuno Cure plans to share such promising findings from the Phase I Trial in scientific conferences and in a peer-reviewed scientific journal. The Phase I Trial data will be submitted to regulatory agencies for review for advancing the vaccine into a Phase II efficacy clinical trial. Dr. Hongzhou LU MD, PhD,President of Shenzhen Third Hospital and Co-Principal Investigator of the Phase I Trial, said "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. 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. We thank the volunteers for their selfless participation and commitment to finish the entire trial. I believe many patients are eager to join the next stage of clinical trials of the candidate HIV vaccine." HKU AIDS Institute has been leading a collaborative research initiative in association with Immuno Cure and other academic institutions on ICVAX, which was awarded significant grant funding twice under the Theme-based Research Scheme ("TRS") from the Research Grants Council ("RGC"), aggregating to some HK$ 113.8 million. In the first 5-year term of TRS 18/19 (8^th round), HK$47.1 million was granted for basic research of ICVAX, studying PD-1-Enhanced DNA vaccine-based combination immunotherapy in monkey models and human subjects. Recently, in the second 5-year term of TRS 24/25 (14^th round), HK$66.7 million was granted for carrying out of further translational research, including multicenter clinical trials in the coming five years. The collaborative research was also...