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. A First-in-Human (FIH) phase I study in HIV-infected individuals was started in September 2017. Its primary focus will be to evaluate vaccine safety and immunogenicity. Currently, data from this phase I study is anticipated in 2018.
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.