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14.03.2016 08:30:01
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DGAP-News: MOLOGEN AG
DGAP-News: MOLOGEN AG: MOLOGEN AG: Extension of TEACH study based on supportive first study results
Berlin, 14 March 2016 - The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today that the TEACH study with its immunomodulatory lefitolimod (MGN1703) in HIV patients will be extended as a result of the broad immune system activation induced by the drug. This was shown by the increased activation of various immune markers. In conclusion and consistent with the underlying hypothesis, lefitolimod (MGN1703) dosing led to the activation of plasmacytoid dendritic cells (pDC), natural killer cells (NK) and T cells in HIV patients during the antiretroviral therapy (ART). Thus, lefitolimod (MGN1703) could serve as a robust immune stimulator or "kill" agent in "kick and kill" HIV eradication trials. Initially patients received one month of treatment and now the protocol has been amended to give a longer treatment of six months with lefitolimod (MGN1703) in some more patients. Recruitment of these patients is expected in the next few weeks and final study results will now be available in the first half of 2017.
"We are excitedly following the developments of lefitolimod in HIV. The strong enhancement of antiviral immune responses observed after a short course of treatment gives us the rationale to extend the study, also at the light of the very good safety profile of the drug," said Ole Schmeltz Søgaard, MD, PhD, Associate Professor at the Aarhus University Hospital, Dept. of Infectious Diseases, Aarhus, Denmark.
"We have always believed that the immunomodulator lefitolimod could also play a role in infective diseases. We look forward to the results in HIV patients treated for a longer period of time with great interest," said Dr. Alfredo Zurlo, Chief Medical Officer of MOLOGEN AG.
The aim of the TEACH study is to see if the immunotherapy with MGN1703 can activate the innate and adaptive immune system in HIV patients, to enhance killing of the HIV infected cells.
Initial results of the first patients treated in the trial will be presented at the Keystone HIV Symposia (Keystone Symposia on molecular and cellular biology conference) from 20 - 24 March 2016 in Olympic Valley, USA.
Abstract & Poster details: Abstract title: "Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV-1 infection (TEACH)"
Poster: Presentation: 24 March 2016, Poster session 4 Poster #: 4025 Poster Title: "Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV-1 infection (TEACH)"
For more information on the Keystone conference please visit: http://www.keystonesymposia.org/
Furthermore, a publication is now available in the prestigious Journal of Virology: http://jvi.asm.org/search?fulltext=doi%3A10.1128%2FJVI.00222-16&submit=yes &x=0&y=0
About TEACH TEACH (Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV infection) is a non-randomized interventional phase I/IIa trial of lefitolimod (MGN1703) in HIV-infected 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 will include 10-11 more patients who will be treated for six months with lefitolimod. During the treatment period, each participant will be closely monitored for the safety and therapeutic effects of the drug. Aarhus University Hospital, Aarhus, Denmark is conducting the trial in two hospital centers in Denmark and already received funding from the American Foundation for AIDS research (amfAR). MOLOGEN is providing the immunomodulator lefitolimod (MGN1703).
The primary endpoint of the study is the change in proportions of activated natural killer cells in the patients. Secondary study endpoints include, among others, a collection of safety, virological, immunological and pharmacodynamic data.
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 fight 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 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 mechanism of action, lefitolimod (MGN1703) has the potential to be applied to various indications. 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) is expected to start within the first half 2016.
MOLOGEN's pipeline focus is on new innovative immunotherapies to treat diseases for which there is a high medical need.
www.mologen.com
Memberships in associations: 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)
MIDGE(R), dSLIM(R), EnanDIM(R) and MOLOGEN(R) are registered trademarks of MOLOGEN AG. Contact Claudia Nickolaus Head of Investor Relations & Corporate Communications Tel: +49 - 30 - 84 17 88 - 38 Fax: +49 - 30 - 84 17 88 - 50 investor@mologen.com
Note about risk for future predictions Certain information in this report contains forward-looking statements or the corresponding statements with negation or versions deviating from this or comparable terminology. These are described as forward-looking statements. In addition, all of the information given here that refers to planned or future results of business areas, key financial figures, developments of the financial situation or other financial figures or statistical data, is to be understood as such forward-looking statements. The company points out to investors that they should not rely on these forward-looking statements as predictions about actual future events. The company is not obligated and refuses to accept any liability for the forward-looking statements and has no obligation to update such statements in order to accurately reflect the current situation.
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14.03.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de
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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 ---------------------------------------------------------------------------
444677 14.03.2016
DGAP-News: MOLOGEN AG / Key word(s): Study/Conference
MOLOGEN AG: MOLOGEN AG: Extension of TEACH study based on supportive first
study results
14.03.2016 / 08:30
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE N 4/ 2016 of 03/14/2016
MOLOGEN AG: Extension of TEACH study based on supportive first study
results
Berlin, 14 March 2016 - The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today that the TEACH study with its immunomodulatory lefitolimod (MGN1703) in HIV patients will be extended as a result of the broad immune system activation induced by the drug. This was shown by the increased activation of various immune markers. In conclusion and consistent with the underlying hypothesis, lefitolimod (MGN1703) dosing led to the activation of plasmacytoid dendritic cells (pDC), natural killer cells (NK) and T cells in HIV patients during the antiretroviral therapy (ART). Thus, lefitolimod (MGN1703) could serve as a robust immune stimulator or "kill" agent in "kick and kill" HIV eradication trials. Initially patients received one month of treatment and now the protocol has been amended to give a longer treatment of six months with lefitolimod (MGN1703) in some more patients. Recruitment of these patients is expected in the next few weeks and final study results will now be available in the first half of 2017.
"We are excitedly following the developments of lefitolimod in HIV. The strong enhancement of antiviral immune responses observed after a short course of treatment gives us the rationale to extend the study, also at the light of the very good safety profile of the drug," said Ole Schmeltz Søgaard, MD, PhD, Associate Professor at the Aarhus University Hospital, Dept. of Infectious Diseases, Aarhus, Denmark.
"We have always believed that the immunomodulator lefitolimod could also play a role in infective diseases. We look forward to the results in HIV patients treated for a longer period of time with great interest," said Dr. Alfredo Zurlo, Chief Medical Officer of MOLOGEN AG.
The aim of the TEACH study is to see if the immunotherapy with MGN1703 can activate the innate and adaptive immune system in HIV patients, to enhance killing of the HIV infected cells.
Initial results of the first patients treated in the trial will be presented at the Keystone HIV Symposia (Keystone Symposia on molecular and cellular biology conference) from 20 - 24 March 2016 in Olympic Valley, USA.
Abstract & Poster details: Abstract title: "Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV-1 infection (TEACH)"
Poster: Presentation: 24 March 2016, Poster session 4 Poster #: 4025 Poster Title: "Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV-1 infection (TEACH)"
For more information on the Keystone conference please visit: http://www.keystonesymposia.org/
Furthermore, a publication is now available in the prestigious Journal of Virology: http://jvi.asm.org/search?fulltext=doi%3A10.1128%2FJVI.00222-16&submit=yes &x=0&y=0
About TEACH TEACH (Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV infection) is a non-randomized interventional phase I/IIa trial of lefitolimod (MGN1703) in HIV-infected 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 will include 10-11 more patients who will be treated for six months with lefitolimod. During the treatment period, each participant will be closely monitored for the safety and therapeutic effects of the drug. Aarhus University Hospital, Aarhus, Denmark is conducting the trial in two hospital centers in Denmark and already received funding from the American Foundation for AIDS research (amfAR). MOLOGEN is providing the immunomodulator lefitolimod (MGN1703).
The primary endpoint of the study is the change in proportions of activated natural killer cells in the patients. Secondary study endpoints include, among others, a collection of safety, virological, immunological and pharmacodynamic data.
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 fight 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 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 mechanism of action, lefitolimod (MGN1703) has the potential to be applied to various indications. 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) is expected to start within the first half 2016.
MOLOGEN's pipeline focus is on new innovative immunotherapies to treat diseases for which there is a high medical need.
www.mologen.com
Memberships in associations: 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)
MIDGE(R), dSLIM(R), EnanDIM(R) and MOLOGEN(R) are registered trademarks of MOLOGEN AG. Contact Claudia Nickolaus Head of Investor Relations & Corporate Communications Tel: +49 - 30 - 84 17 88 - 38 Fax: +49 - 30 - 84 17 88 - 50 investor@mologen.com
Note about risk for future predictions Certain information in this report contains forward-looking statements or the corresponding statements with negation or versions deviating from this or comparable terminology. These are described as forward-looking statements. In addition, all of the information given here that refers to planned or future results of business areas, key financial figures, developments of the financial situation or other financial figures or statistical data, is to be understood as such forward-looking statements. The company points out to investors that they should not rely on these forward-looking statements as predictions about actual future events. The company is not obligated and refuses to accept any liability for the forward-looking statements and has no obligation to update such statements in order to accurately reflect the current situation.
---------------------------------------------------------------------------
14.03.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
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 ---------------------------------------------------------------------------
444677 14.03.2016
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