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28.06.2016 08:30:01
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DGAP-News: MOLOGEN AG
DGAP-News: 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 aim of the TEACH study is to see whether the immunotherapy with lefitolimod (MGN1703) can activate the innate and adaptive immune systems in HIV (Human Immunodeficiency Virus) positive patients to enhance killing of HIV infected cells. Initial results of the first patients treated in the trial were presented at the Keystone HIV Symposium (Keystone Symposia on Molecular and Cellular Biology Conference) in March 2016 in Olympic Valley, US. 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 is planned to include 15 patients, too, who will be 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 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 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.
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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28.06.2016 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. Archive at 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 ---------------------------------------------------------------------------
474899 28.06.2016
DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: First patients enrolled in extension phase of the HIV study
TEACH
28.06.2016 / 08:30
The issuer is solely responsible for the content of this announcement.
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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 aim of the TEACH study is to see whether the immunotherapy with lefitolimod (MGN1703) can activate the innate and adaptive immune systems in HIV (Human Immunodeficiency Virus) positive patients to enhance killing of HIV infected cells. Initial results of the first patients treated in the trial were presented at the Keystone HIV Symposium (Keystone Symposia on Molecular and Cellular Biology Conference) in March 2016 in Olympic Valley, US. 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 is planned to include 15 patients, too, who will be 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 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 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.
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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28.06.2016 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. Archive at 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 ---------------------------------------------------------------------------
474899 28.06.2016
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