Mologen: New Positive Data On Lefitolimod In HIV

BERLIN--(BUSINESS WIRE)--The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today that its partner, the Danish Aarhus University Hospital, presented new data on the TEACH study at the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, USA. In this study MOLOGEN’s TLR9 agonist, the Immune Surveillance Reactivator (ISR) lefitolimod, is tested in HIV-positive patients. For the first time it was shown that lefitolimod can induce a local antiviral immune response in sigmoid colon biopsies of HIV-infected patients undergoing antiretroviral treatment (ART). Lefitolimod triggered a potent response of type I interferon - a group of proteins that help regulate the activity of the immune system and is also crucial for anti-tumor responses - in the intestine, known as one major site of HIV persistence. Notably, lefitolimod did not induce unwanted inflammation. Furthermore, higher baseline TLR9 expression was associated with fewer integrated HIV-1 DNA copies. These findings strongly support the continued development of lefitolimod as an immune surveillance reactivator and represent the potential to eradicate the latent HIV reservoir. In addition, the data suggest that a similar tumor microenvironment development can be expected in the IMPALA study, a pivotal study of lefitolimod in metastatic colorectal cancer.

The TEACH study started in June 2015 and has since been extended based on the broad immune system activation induced by lefitolimod. This effect was shown by the increased activation of antiviral immunity in the initial study phase. In conclusion, and consistent with the underlying hypothesis for the mode of action, lefitolimod (MGN1703) led to the activation of plasmacytoid dendritic cells (pDC), natural killer cells (NK) and T cells in HIV positive patients during antiretroviral therapy (ART). Thus, lefitolimod (MGN1703) could play a role in the “kick and kill” concept of HIV eradication. In the first phase of the trial, patients received one month of treatment. Now, in the extension phase, a group of patients receive a longer treatment of six months with lefitolimod (MGN1703). Final study results are expected to be available in mid-2017.

The aim of the TEACH study is to see whether the immunotherapy with lefitolimod can activate the innate and adaptive immune system in HIV (Human Immunodeficiency Virus) positive patients to enhance killing of HIV-infected cells.

About TEACH

TEACH (Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV infection) is a non-randomized interventional phase I/IIa trial to evaluate lefitolimod (MGN1703) in HIV positive patients. In the first phase of the study, 15 participants received four weeks of lefitolimod (MGN1703) therapy (60 mg s.c. twice weekly). The extension phase includes 15 patients, too, who are treated for six months with lefitolimod. During the treatment period, each participant is closely monitored for safety and therapeutic effects of the drug. Aarhus University Hospital, Denmark is conducting the trial in two hospital centers in Denmark, for which it received funding from the American Foundation for AIDS research (amfAR). MOLOGEN is providing the Immune Surveillance Reactivator (ISR) lefitolimod (MGN1703).

The primary endpoint of the first study treatment phase is the change in proportions of activated natural killer cells in patients. Secondary study endpoints include, among others, a collection of safety, virological, immunological and pharmacodynamic data. In the extension phase the change in HIV-DNA in circulating T cells will be assessed as primary endpoint. Main secondary endpoints are – besides safety evaluation – changes of functional immune parameters.

HIV infects the immune system and destroys or affects the proper function of immune cells. Without antiretroviral treatment, this eventually leads to immune deficiency and the immune system can no longer fend off a wide range of infections and diseases. HIV remains a serious worldwide health issue. According to estimates by WHO and UNAIDS (United Nations Programme on AIDS) 37 million people worldwide were living with HIV at the end of 2015. Some 2 million people became newly infected in that same year, and 1.1 million died as a result of HIV-related causes globally.

MOLOGEN AG

With new and unique technologies and active substances, the biotech company MOLOGEN is one of the pioneers in the field of immunotherapy. Alongside a focus on immuno-oncology, MOLOGEN also develops immunotherapies for the treatment of infectious diseases.

The cancer immunotherapy lefitolimod (MGN1703) is the company’s lead product and best-in-class TLR9 agonist. Treatment with lefitolimod (MGN1703) triggers a broad and strong activation of the immune system. Due to this mode of action, namely to reactivate the monitoring function of the immune system, lefitolimod (MGN1703) can be recognized as an Immune Surveillance Reactivator (ISR). It has the potential to be applied to various indications. ISR lefitolimod (MGN1703) is currently being developed for first-line maintenance treatment of colorectal cancer (pivotal study) and small cell lung cancer (randomized controlled trial). Furthermore, it is also being investigated in a phase I study in HIV and a phase I combination study with the checkpoint inhibitor Yervoy^® (ipilimumab), which is expected to start shortly. Next to checkpoint inhibitors, lefitolimod is one of the few product candidates that are in a phase III clinical trial (IMPALA) in the field of immuno-oncology and close to reaching the market.

MOLOGEN’s pipeline focus is on new, innovative immunotherapies to treat diseases for which there is a high medical need.

www.mologen.com

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Biotechnologieverbund Berlin-Brandenburg (bbb) e.V. | BIO Deutschland e.V. | DECHEMA - Society for chemical technology and biotechnology e.V. | German industrial association of biotechnology (DIB) | Association for the Promotion of Science and Humanities in Germany | Association of German biotechnology companies (VBU) | Association of researching manufacturers of pharmaceuticals e.V. (VFA) | Association of the chemical industry e.V. (VCI)

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