Immuno Cure Biotech Presents Promising Results on Phase I Clinical Trial of a Therapeutic HIV DNA Vaccine

(Hong Kong and Shenzhen, November 12, 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$66.7 million was granted for carrying out of further translational research, including multicenter clinical trials in the coming five years. The collaborative research was also granted an aggregate amount of HK$ 5.99 million by the Innovation and Technology Commission (“ITC”) for early-stage pre-clinical studies under the University and Industry Collaboration Program (“UICP”).

Prof. Zhiwei CHEN PhD, Founding Director of HKU AIDS Institute, Tenured Professor and Chair of Immunology and Immunotherapy in the Department of Microbiology, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, the University of Hong Kong (HKU), and Suen Chi-Sun Professor in Clinical Science, inventor of the patented PD-1 Enhanced DNA vaccine technology and the Principal Scientific Advisor of Immuno Cure, said “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. Our team members are very grateful for the significant amount of funding from RGC and ITC, which have enabled us to accomplish our interim achievements at this stage and to further expand our translational research, including an upcoming Phase II clinical trial for the benefit of more and more PLWH.”

Immuno Cure was granted a maximum amount of ΗΚ$8 million funding for this Phase I Trial under the Clinical Translational Catalyst (“CTC”) programme of the Institute for Translational Research (“ITR”) of the Hong Kong Science and Technology Parks Corporation (“HKSTP”). The CTC program is a highly specialized platform to provide all-round support to biomedical companies in the pre-clinical and early clinical stages, aiming to transform Hong Kong and the Greater Bay Area to become the go-to destination for translational medicine in the region. Under this program, funding support will be provided to biomedical companies of HKSTP to bring innovative, life-changing therapies and technologies to patients.

Ms. Gracie Ng, Chief of Staff and Acting Chief Corporate Development Officer, HKSTP said, “The HKSTP team was thrilled to hear the news that Immuno Cure has completed Phase 1 clinical trial for ICVAX. This pioneering vaccine represents a major advancement in our fight against HIV/AIDS. The success highlights our role as one of the global leaders in translational development, producing innovative therapies to improve patients’ quality of life.”

The Hong Kong AIDS Foundation, established in 1991, is a non-governmental social service organization with a mission to limit the spread of HIV infection in the community. Throughout the years, the Foundation has been actively engaged in the promotion of AIDS education, the provision of services, and the nurturing of a harmonious and caring environment for those infected with or affected by HIV/AIDS.

Dr. Che Hung LEONG MD, PhD, GBM, GBS, JP, President of Hong Kong AIDS Foundation and the Chairman of the Advisory Board of Immuno Cure said: “It is exciting to see the positive results of ICVAX, Immuno Cure’s therapeutic HIV vaccine, from its Phase I clinical trial. The trial data shows that ICVAX might potentially provide an alternative to ART which would alleviate the burden of drug compliance of patients. These results suggest that we may be on the brink of a breakthrough with a therapy that could enhance the quality of life for many PLWH and provide them a hope for functional cure in the longer term.”

Immuno Cure is communicating with the NMPA for the upcoming multi-centre, double-blinded, placebo-controlled, dose-finding Phase II clinical trial. The trial will aim to evaluate the immunogenicity and efficacy in controlling HIV viral load. It is anticipated to commence in mid-2025.

Dr. Xia JIN MD PhD, CEO of Immuno Cure concludes, “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. The success of development of ICVAX will not only prove the novelty of our DNA vaccine technology platform, but also mark a giant step towards functional cure of HIV/AIDS, and to enable the relief of burden on PLWH and improvement of their quality of life. Lastly, we thank the volunteers for their participation and the doctors and nurses at the Shenzhen Third Hospital trial site, as well as other clinical trial collaborators, CRO, SMO, CMO and clinical laboratories, for their dedication and diligence, for they are the key elements of the smooth completion of this trial. Also, we would like to thank HKSTP, ITC, and RGC for their generous funding support. Next, we plan to launch a cross-border multi-centre Phase II clinical trial in mid-2025, including CUHK Phase 1 Clinical Trial Centre, Shenzhen Third People’s Hospital, Guangzhou Eighth People’s Hospital, etc. Through this trial, we look forward to cooperating with the Greater Bay Area International Clinical Trial Institute ("GBAICTI"), which will soon begin its service to promote advanced biomedical technology research, clinical trials, and applications in Hong Kong and the Greater Bay Area, aiming to jointly develop Hong Kong into an international medical innovation hub.”