The unique and proprietary HTI immunogen sequence was designed by AELIX Therapeutics’ founders and is being delivered to the body by multiple viral and non-viral vectors. GMP-grade clinical trial supplies have been manufactured.
AELIX-002, the first clinical trial run by the company, started in September 2017. It is a phase-I randomised, double-blind, placebo-controlled safety, tolerability, and immunogenicity study of the HTI vaccine in early diagnosed, early treated HIV-infected individuals. It evaluates a therapeutic, heterologous prime-boost vaccination regimen using DNA plasmids and an MVA (Modified-Virus-Ankara) vector in the prime phase and a Chimpanzee-Adenovirus (ChAd) and MVA vectors in the booster phase. In a first phase, 15 HIV-infected individuals were included in the trial. Starting in June 2018, 30 additional participants were added to the study, which is still ongoing. After vaccination, the participants are subjected to an analytical anti-retroviral treatment interruption (ATI) to assess their capacity to control viral replication in the absence of anti-retroviral medication. Data from this trial were recently communicated at the 2021 Conference on Retroviruses and Opportunistic Infections (more information can be found under News).
In October 2018, AELIX announced that it had established a clinical collaboration agreement with Gilead Sciences. Under the framework of that agreement, AELIX-003, our second clinical trial, has recently started. It is a randomised, double-blind, placebo-controlled safety, tolerability, and immunogenicity study of AELIX’s HTI vaccine and Gilead’s TLR-7 agonist vesatolimod (GS-9620) in early diagnosed, early treated HIV-infected individuals. It will recruit 57 participants and be conducted in 10 sites in Spain. After vaccination and TLR-7 agonist treatment, the participants will proceed to an ATI phase to assess their capacity to control viral replication in the absence of anti-retroviral drugs. Data from this trial is expected in late 2022.
The capacity to control the viral load in the absence of anti-retroviral medication will thus establish the clinical Proof-of-Concept.