Gilead has teamed up with Aelix Therapeutics to trial a combination designed to free people with HIV from the need to take antiretroviral drugs. The planned clinical trial will test Gilead’s TLR7 agonist in combination with Aelix’s T-cell vaccine.
Gilead began testing the TLR7 agonist, vesatolimod, in HIV patients in 2016. In animal models, the combination of the drug and a broadly neutralizing antibody suppressed HIV for six months without additional treatment. The early-stage finding dialed up hopes that vesatolimod can boost immune responses and thereby contribute to the elimination of virus-infected cells.
Vesatolimod may need support to achieve HIV suppression, though. That's where Aelix comes in. The Spanish biotech is developing a T-cell vaccine designed to orchestrate immune attacks on vulnerable parts of HIV. Aelix’s interest in the approach grew out of research into people who are naturally more able to control HIV infections. Analysis of these people showed their T cells go after certain regions of HIV, suggesting this may be the key to controlling the virus.
If the drugs work as hoped, both individually and in combination, Aelix’s vaccine will direct immune attacks on vulnerable parts of HIV. Vesatolimod will complement this activity by activating expression of HIV and boosting the immune response.
Aelix and Gilead will test that idea in a placebo-controlled study of 90 patients who started treatment with antiretrovirals during early HIV infection. The participants will continue to take antiretrovirals until they receive the experimental combination. Then, under careful monitoring, investigators will stop the antiretroviral regimens temporarily and see what happens to HIV levels.
If HIV levels stay low in the absence of antiretroviral drugs, Aelix and Gilead will take an early step toward their ultimate goal.
“Maintenance of viral remission without antiretroviral therapy represents the next frontier in HIV treatment. We are excited to be collaborating with Gilead on this project, our first step to show the potential of our HTI immunogen as the backbone of combination regimens for maintenance of viral remission," Aelix Chief Medical Officer Lance Berman said in a statement.