The unique and proprietary immunogen sequence “HTI” was designed by AELIX Therapeutics’ founders and is being delivered to the body in multiple viral and non-viral vectors. Initially, it will be evaluated in a therapeutic, heterologous prime-boost vaccination regimen using DNA plasmids and MVA (Modified-Virus-Ankara) vectors. DNA plasmids and MVA are well-known vectors whose efficacy and safety have been demonstrated in many vaccines for various diseases. Subsequently, the HTI immunogen incorporated into a Chimpanzee-Adenovirus (ChAd) vector will be added in the boost phase.
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 randomized, double-blind, placebo-controlled safety, tolerability, and immunogenicity study of the HTI vaccine in early diagnosed, early treated HIV-infected individuals. 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, that is ongoing. Data from this trial are expected during 2H-2020.
In October 2018, AELIX announced that it has established a clinical collaboration agreement with Gilead Sciences. Under the framework of that agreement, AELIX is preparing to start a phase II trial, AELIX-003, during 1H-2019. It will also be a randomized, double-blind, placebo-controlled safety, tolerability, and immunogenicity study of AELIX's HTI vaccine and Gilead's TLR-7 agonist vesatolimod in early diagnosed, early treated HIV-infected individuals.
The Series A financing will also support a Phase II Proof-of-Concept efficacy trial in HIV-infected individuals who will undergo a therapeutic, heterologous prime-boost vaccination regimen and subsequently stop their anti-retroviral therapy. The main efficacy endpoint will be duration of viral suppression in the absence of anti-retroviral medication.