Arcelis AGS-004 dendritic cell-based immunotherapy for HIV infection.

Antiretroviral therapy represents a major breakthrough for the management of HIV-infected patients; however, it is not without side effects and is a life-long commitment. Thus, the development of novel strategies to enhance immune response and control viral replication are needed in order to limit exposure to antiretroviral therapy. To date, immunotherapies consisting of monocyte-derived dendritic cells expressing HIV antigens have elicited only limited immunogenicity and/or viral control. Thus, taking into consideration the variability of HIV, an investigational immunotherapeutic product (AGS-004, Argos Therapeutics Inc., NC, USA) that consists of autologous dendritic cells co-electroporated with in vitro transcribed RNA encoding four of the patient's own HIV antigens was developed. Based on the encouraging immunogenicity and tolerance observed in a Phase I study, a Phase II study has been initiated with good tolerance and partial viral control. A second Phase II placebo-controlled study is about to initiate.