Project leadersBonaventura Clotet, Christian Brander, Jordi Naval
Participating organizationsIrsiCaixa, Laboratoris Esteve, YSIOS Capital, J&J Innovation - JJDC, Caixa Capital Risc
To develop a therapeutic HIV vaccine to be used in cure/eradication strategies. This vaccine program is based on an innovative T-cell vaccine immunogen design that directs the body’s immune system to the most vulnerable parts of the virus. AELIX hopes to be instrumental in developing the first therapeutic vaccine regimen to cure HIV infection.
AELIX Therapeutics is a spin-off of IrsiCaixa and the HIVACAT program, a Catalan public-private consortium conducting cutting-edge research in the field of AIDS and related diseases. HIVACAT has received funds from the “la Caixa” Foundation and Laboratorios Esteve, as well as public research funding. The company was incorporated in November 2015 and shortly after completed a €11.5 million ($12.5 million) series-A round of funding led by Ysios Capital, Johnson & Johnson Innovation – JJDC, Inc., and Caixa Capital Risc.
Most significant challenges
Before setting up the company, the most significant challenge was to define a joint project that all involved could agree on. Plus, the associated intellectual property was being used at that time for other research projects, which made it necessary to ensure this was compatible with commercial development. Currently, management of the manufacturing process is complex, as the company works with CMOs in England, Germany and Italy, which is an operational challenge.
The design of the immunogen, called ‘HTI’, is driven by immune data from nearly 1,000 individuals living with HIV from four cohorts on three continents. Preclinical data shows that mice and macaques immunized with HTI have a strong, broadly directed T-cell response that has been associated with HIV-1 control in previous human studies.
Clinical trial products have already been manufactured. A first-in-human (FIH) phase I study with HIV-infected individuals began in August 2017, the primary focus of which is to assess the safety and immunogenicity of the vaccine. The trial is taking place at Germans Trias i Pujol Hospital (HUGTIP) in Badalona. Results are expected in 2018.
The series-A funding will also go towards a phase II proof-of-concept efficacy trial in HIV-infected individuals who will undergo a therapeutic, heterologous prime-boost vaccination regimen.