MOLOGEN AG
MOLOGEN AG: First patients enrolled in extension phase of the HIV study TEACH
DGAP-News: MOLOGEN AG / Key word(s): Study PRESS RELEASE N 09 / 2016 of 06/28/2016 MOLOGEN AG: First patients enrolled in extension phase of the HIV study TEACH – Collaboration with Aarhus University Hospital, Denmark – Extension of phase I study to confirm supportive results of initial study phase – Evidence of significant enhancement of antiviral immunity Berlin, 28 June 2016 – The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today that its partner, the Danish Aarhus University Hospital, treated the first patients (FPI) in the extension phase of the TEACH study. In the trial with MOLOGEN’s TLR9 agonist, the Immune Surveillance Reactivator (ISR) lefitolimod (MGN1703), is tested in HIV positive patients. The initial study started in June 2015 and it was announced in March 2016 that the study will be extended based on the broad immune system activation induced by lefitolimod (MGN1703). 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 will receive a longer treatment of six months with lefitolimod (MGN1703). Final study results are expected to be available in the first half of 2017. 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 2014. Some 2 million people became newly infected in that same year, and 1.2 million died as a result of HIV-related causes globally. MOLOGEN AG 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(R) (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. Memberships in associations: MIDGE(R), dSLIM(R), EnanDIM(R) and MOLOGEN(R) are registered trademarks of MOLOGEN AG. Contact Note about risk for future predictions
2016-06-28 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |
Language: | English | |
Company: | MOLOGEN AG | |
Fabeckstraße 30 | ||
14195 Berlin | ||
Germany | ||
Phone: | 030 / 841788-0 | |
Fax: | 030 / 841788-50 | |
E-mail: | presse@mologen.com | |
Internet: | www.mologen.com | |
ISIN: | DE0006637200 | |
WKN: | 663720 | |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart | |
End of News | DGAP News Service |