The collaboration will enable the conduct of a clinical study, entitled Aelix -003, to investigate the safety, tolerability, immunogenicity and efficacy of a regimen containing Aelix Therapeutics' HTI T-cell vaccine and Gilead´s Toll-Like Receptor 7 agonist vesatolimod in HIV-infected individuals on antiretroviral therapy.
Vesatolimod is an investigational potent and selective oral TLR7 agonist that directly activates plasmacytoid dendritic cells.
In this study, vesatolimod is expected to activate expression of HIV in the body, and to enhance the vaccine-induced immune response leading to the elimination of virus-infected cells. Currently, vesatolimod is under clinical evaluation by Gilead in virally suppressed HIV-infected individuals.
The vaccine's HTI immunogen contains specific HIV antigenic regions toward which there is an enriched T-cell immune response in those individuals who have "controller phenotypes," meaning they can control the HIV to a large extent without taking antiretroviral drugs. The HTI vaccine is aimed at refocusing the immune response to especially vulnerable sites in HIV, including viruses activated from reservoirs.
AELIX-003 is a double-blind, placebo-controlled study that will be conducted in approximately 90 participants who have started antiretroviral therapy during early HIV infection, enrolled at various clinical trial sites in Spain.
All participants will be on antiretroviral therapy upon starting the study, with their HIV viral loads controlled under the limits of detection.
Following exposure to the vaccine/vesatolimod, all participants, under careful monitoring, will temporarily stop their antiretroviral drugs to determine if the intervention is effective in keeping their HIV levels under control.
The initiation of AELIX-003 is targeted for early 2019.
Aelix Therapeutics is a clinical-stage biotechnology company based in Barcelona, Spain. It is focused on the development of a therapeutic HIV vaccine to be included in cure/eradication strategies.
The company is a spin-off of HIVACAT, the Catalan public-private consortium conducting cutting-edge research in this field. AELIX holds a worldwide, exclusive license for the development and commercialization of the HTI immunogen.
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need.
The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
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