TEACH study (indication HIV)

TEACH (Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV infection) is an early exploratory phase Ib/IIa study of lefitolimod in HIV-infected patients under antiretroviral therapy (ART). The study is being conducted in collaboration with the Aarhus University Hospital in Denmark.

TEACH phase Ib/IIa started in 2015 and has continued in an expansion phase since the middle of 2016. Initially, patients received treatment for a period of one month; in the extension phase, the treatment time with lefitolimod was extended to six months based on the good results of the initial phase. 

In August 2017 the Company announced the key results of the extension phase of the TEACH study. In the extension phase lefitolimod alone on top of antiretroviral therapy (ART) did not show the desired effect on the viral reservoir. However, this study provides important positive findings with regard to the effects of the reactivation of the immune system, also in HIV. These data together with the favorable safety profile of lefitolimod now confirmed also in HIV form the basis for our future development strategy for lefitolimod in combination therapies. The Company is confident that lefitolimod can be an important component of therapeutic approaches aiming to cure HIV, e.g. monoclonal antibodies or vaccines.

A more extensive evaluation of the TEACH data is currently ongoing and detailed TEACH study results of the extension phase will be presented at an international scientific conference.

The recently financed combination study is a crucial element of this strategy:
In January 2017, the Danish Aarhus University received a grant of US$2.75 million from the biopharmaceutical company Gilead Sciences, Inc, Foster City, USA. The grant was to fund a planned clinical trial in HIV positive patients using ART in which MOLOGEN’s TLR9 agonist will be investigated in combination with innovative virus-neutralizing antibodies. The antibodies have been developed by the Rockefeller University in New York, USA. MOLOGEN would be providing lefitolimod for the study. Currently preparations are being made to start the study.