AELIX Therapeutics S.L. (‘AELIX’), a clinical-stage biotechnology company, member of CataloniaBio & HealthTech, specialized in the discovery and development of immunotherapies for HIV infection, today announced positive topline results from the AELIX-003 trial.
The study evaluated the safety, tolerability, immunogenicity and efficacy of AELIX’s HTI T-cell therapeutic HIV vaccine in combination with Gilead’s investigational Toll-Like Receptor 7 (TLR7) agonist, vesatolimod (VES), in people with HIV on antiretroviral therapy. VES is an immune modulator being evaluated as part of an investigational combination regimen that could potentially lead to viral remission. The results of the trial were presented today at the 2023 Conference on Retroviruses and Opportunistic Infections (CROI).
For this evaluation, participants underwent an analytical treatment interruption (ATI) in their antiretroviral therapy (ART) for up to 24 weeks. During this time, plasma viral load was monitored weekly. The data show that a higher proportion of HTI+VES-treated participants remained off ART for the full 24 weeks. The combination of the HTI vaccine and VES as part of an HIV cure strategy in early treated people with HIV was safe and well tolerated.
“These encouraging efficacy data demonstrate that the HTI vaccine in combination with VES may be able to modulate an individual’s HIV-specific immune response in a way that can potentially contribute to a better HIV control in the absence of ongoing ART. The AELIX-003 data are exciting, and confirm what we have seen in the AELIX-002 study, where the HTI vaccine alone also extended the time off ART for the vaccinated participants,” said Dr. Christian Brander, Chief Scientific Officer of AELIX.
“The HTI vaccine is aimed at refocusing the immune response to especially vulnerable sites in HIV. The vaccine contains antigenic regions of HIV that are more commonly targeted by individuals who naturally control the virus. Maintenance of viral remission without ART represents the next frontier in HIV infection treatment and an important step towards HIV eradication”, he adds.
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