Immuno Cure kick off Phase I Clinical Trial in Shenzhen

A significant step for developing our PD-1-Enhanced DNA Vaccine against HIV/AIDS

HONG KONG,Feb. 16,2023 -- Immuno Cure BioTech,a clinical stage biotechnologygroup based in the Hong Kong Science Park specialising in PD-1-Enhanced DNA vaccines and immunotherapies,announced the kicking off of the Phase I Clinical Trial of ICVAX,a therapeutic vaccine against HIV/AIDS,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 over 38 million people living with the virus and over40 million deaths worldwide by 2021. Since the life-long antiretroviral treatment ("ART") neither cures HIV/AIDS nor fully restores immune function,it is critical todiscover 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 invented the PD-1-Enhanced DNAvaccine 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 ΗΚ$8 million funding for this clinical trial under the Clinical Translational Catalyst Program ("CTC 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,called ICCOV,in preparation for advancement to Phase 2 clinical trial for the fight against COVID-19.

Dr JIN Xia,CEO of Immuno Curesaid,"Initiation of this phase 1 clinical trialis supported by promising preclinical study results and safety evaluationthat 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."

Professor CHEN Zhiwei,Director of AIDS Institute at the University of Hong Kong and the Principal Scientific Advisor of Immuno Curesaid,"HIV has been a majorpublic 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,whichwill benefit patients immediately and help us assess whether the excellent preclinical data can be translated into human,laying solid foundation for vaccine developmenttowards HIV-1 functional cure."

Dr Percy CHENG,Chairman of Immuno Cureconcludes,"We are privileged to be partnering with HKU-AIDS Institute and ITR of the Hong Kong Science Park and grateful for the CTC Program funding in support of this translational process. We also treasure the funding support from ITF since 2018 during the early stage of the development of ICVAX. We would also like to express our special thanks to our volunteers in advance for their selfless contributions,without whom we would not be able tocarry out this exciting clinical trial."

Immuno Cure kick off Phase I Clinical Trial in Shenzhen A significant step for developing our PD-1-Enhanced DNA Vaccine against HIV/AIDS

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Notes:

Immuno Cure BioTech

ImmunoCure BioTech is a clinical stage biotechnology group based in the Hong Kong Science Park,focusing on research and development of vaccines and immunotherapies for cancers,inflammatory and infectious diseases based on its patented PD-1-Enhanced DNA vaccine and Anti-Δ42-PD1 Blocking Antibody technology platforms inventedby HKU-AIDS Institute.

To learn more about Immuno Cure BioTech,please visithttp://www.immunocure.hk

AIDS Institute,HKUMed

The AIDS Institute of the University of Hong Kong was established in November 2007 to take HKU in a new strategic direction in fighting this global epidemic and help to make it a leader in the region in AIDS research,education and prevention. Scientists at the AIDS Institute are fully committed to conducting basic and applied research that facilitates the understanding of AIDS pathogenesis and the development of effective AIDS vaccines. Activities in the Institute include basic research to examine the virological and immunological mechanisms underlying HIV pathogenesis; new concept,design,preparation and laboratory testing of vaccine candidates for HIV and other infectious diseases; and monitoring the evolution of HIV epidemic in Hong Kong and in the region. Currently,the institute is leading the Hong Kong Theme-based Research Scheme entitled "Potentiating Host Immunity for HIV-1 Functional Cure".

To learn more about AIDS Institute of the University of Hong Kong,please visithttps://www.med.hku.hk/aidsinst/