Aelix Therapeutics –a clinical-stage biotechnology company based in the Barcelona Science Park and specialized in the discovery and development of immunotherapies for HIV infection– today announces positive topline results in the AELIX-002 trial. The study evaluated the safety, tolerability, immunogenicity and efficacy of Aelix’s HTI T-cell therapeutic HIV vaccine, within early-treated people living with HIV. The clinical trial results have been presented today at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI). 

The AELIX-002 trial was carried out in the Germans Trias i Pujol Hospital in Badalona (Catalonia, Spain), and is performed by investigators from the IrsiCaixa AIDS Research Institute and the Fight AIDS and Infectious Diseases Foundation. The study was a randomized, single-center, double-blind and placebo-controlled trial to evaluate the safety, tolerability, immunogenicity and antiviral effect of Aelix’s therapeutic HIV vaccine – after discontinuation of ART in 45 early-treated people living with HIV (PLWH). Among the 45 participants who started the study, 41 reached the interruption phase and, of these, 26 received the vaccine and 15 received placebo.

The study met its primary and secondary endpoints for safety, tolerability and immunogenicity. The trial also evaluated the efficacy of HTI vaccines to avoid, delay or contain viral rebound – compared to a placebo group. For this evaluation, participants underwent an analytical treatment interruption (ATI) in their antiretroviral therapy (ART) for up to 24 weeks. In particular, among the participants without favourable genetic background predisposing to spontaneous HIV control, 8 (40%) vaccinated participants were able to remain off ART treatment for over 22 weeks, compared to only 1 (8%) in the placebo group.

These encouraging efficacy data demonstrate that the HTI vaccine was able to modulate an individual’s HIV-specific immune response, in a way that can contribute to a better HIV control in the absence of ongoing antiretroviral therapy”, say Dr Beatriz Mothe, principal investigator of the study at  the Fight AIDS and Infectious Diseases Foundation and associate researcher at the IrsiCaixa AIDS Research Institute, located at the Hospital Germans Trias i Pujol, in Badalona, Spain.

“We wish to express our deep gratitude to all the participants for their altruism and commitment to this long clinical trial, as well as to our colleagues at FLS, IrsiCaixa and BCN-Checkpoint, especially for their courage in finalizing the study under the stressful conditions of the COVID-19 pandemic”, say Dr José Moltó, subinvestigator at FLS. “Their collective effort has been rewarded with this important milestone towards improving health care for people living with HIV”.

“The HTI vaccine is aimed at refocusing the immune response to especially vulnerable sites in HIV. The vaccine contains antigenic regions of HIV such as the ones that are more commonly targeted by individuals who naturally control the virus”, say Dr Christian Brander, chief scientific officer at Aelix. “Maintenance of viral remission without antiretroviral therapy represents the next frontier in HIV infection treatment.”

“With these promising data, Aelix’s first-in-class HTI lead candidate could be a game-changer in HIV cure strategies”, say Dr José Luis Cabero, CEO of Aelix “Developing a cure for HIV is a global priority. An intervention that can immunologically control the virus would be of great interest to individuals living with HIV and to the HIV research community. This supports our vision to position HTI as the backbone for future cure strategies, where it can be combined with other agents. In this sense, Aelix is a front-runner in the race to achieve a ‘functional cure’, or long-term viral suppression in the absence of ART, for people living with HIV. We are looking forward to moving ahead with the next financing round and working on larger combination trials.”

The AELIX-002 study was conducted in the context of a clinical collaboration agreement between AELIX and Gilead Sciences. HTI-based vaccines as a component of combination cure regimens are being evaluated in the ongoing AELIX-003 clinical trial testing HTI in combination with Gilead’s investigational TLR7 agonist vesatolimod (NCT04364035), in people living with HIV on ART.

The HTI immunogen was designed by Dr Christian Brander, chief scientific officer at Aelix Therapeutics and head of the IrsiCaixa Host Genetics and Cellular Immunity group, with Beatriz Mothe, and his colleagues. It is based on the observation that T-cell responses to certain parts of HIV are enriched in individuals with a non-progressor clinical phenotype. The HTI immunogen combines these regions in a vaccine immunogen.

» More information: Aelix Therapeutics website [+]