DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: First patient recruited in combination study with lefitolimod
and Yervoy(R)
13.07.2016 / 08:57
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE N 12 / 2016 of 07/13/2016
MOLOGEN AG: First patient recruited in combination study with lefitolimod
and Yervoy(R)
- Collaboration with MD Anderson Cancer Center, US
- Phase I study to evaluate combination of ISR lefitolimod (MGN1703) and
checkpoint inhibitor Yervoy(R)
- Combination of immunotherapies could lead to a broader activation of
the immune system
Berlin, 13 July 2016 - The biotech company MOLOGEN AG (ISIN DE0006637200;
Frankfurt Stock Exchange Prime Standard: MGN) announced today that its
collaborator, the University of Texas MD Anderson Cancer Center (MD
Anderson), has enrolled the first patient in the combination study (FPI:
first patient in) with a checkpoint inhibitor. In the phase I study
MOLOGEN's TLR9 agonist, the Immune Surveillance Reactivator (ISR)
lefitolimod (MGN1703) is tested in combination with the immunotherapy
ipilimumab (Yervoy(R)) in patients with advanced solid malignancies. The
collaboration has been initiated in January 2016 based on the idea that the
combination of these two immunotherapies could have synergistic effects
leading to a broader activation of the immune system. MD Anderson is
conducting the trial and will recruit around 50-60 patients at its center
in Houston Texas, US. MOLOGEN is providing the ISR lefitolimod (MGN1703).
Patient recruitment is expected to be completed at the beginning of 2018.
This will be the first time ISR lefitolimod is evaluated in combination
with a checkpoint inhibitor. The aim of the combination study is to
initially find the highest tolerable dose of lefitolimod (MGN1703) that can
be given in combination with ipilimumab (Yervoy(R)) to patients with
advanced tumors. The safety of this drug combination will also be analyzed.
Furthermore, this trial aims to evaluate the efficacy of the combination of
these two therapies in an expansion phase. Lefitolimod (MGN1703) is a TLR9
agonist that by broadly activating immune surveillance can trigger the
body's own cancer-fighting mechanisms.
The commercially available ipilimumab (Yervoy(R)), manufactured by Bristol-
Myers Squibb Co., is a recombinant, human monoclonal antibody and immune
checkpoint inhibitor approved to treat patients with unresectable or
metastatic melanoma. This combination of an immune surveillance reactivator
with a checkpoint inhibitor is of particular interest to the field of
immunotherapy.
"We are very pleased by the start of this combination study. It will be
exciting to learn more about this combination therapy given the positive
findings in pre-clinical models", said Dr. David S. Hong, Deputy Chair and
Associate Professor, Department of Investigational Cancer Therapeutics, MD
Anderson Cancer Center, and principal investigator of the study.
"To treat the first patient is an important milestone. We hope to show that
the combination of Yervoy(R) with lefitolimod will demonstrate improved
therapeutic responses compared to the use of either monotherapy alone. We
also strongly believe that the combination of different immunotherapies
will be of benefit in a number of patients. If successful, we could
substantially broaden the potential applications of lefitolimod", said Dr.
Mariola Söhngen, CEO of MOLOGEN.
About the combination study lefitolimod (MGN1703) with the checkpoint
inhibitor Yervoy(R)
The study titled "A Phase I Trial of Ipilimumab (Immunotherapy) and MGN1703
(TLR Agonist) in Patients with Advanced Solid Malignancies" is conducted by
MD Anderson Cancer Center (MD Anderson). MOLOGEN provides the Immune
Surveillance Reactivator (ISR) lefitolimod (MGN1703) and funds the study.
Around 50-60 patients will participate in MD Anderson Cancer Center in
Houston, Texas, USA. Patient recruitment began in July 2016 and is expected
to be completed at the beginning of 2018.
The primary aim of the study is to ascertain the best tolerable dosage for
administering lefitolimod (MGN1703) in combination with Yervoy(R). The
safety of this combination therapy will also be investigated and an
expansion phase is planned to evaluate the efficacy of this combination
therapy.
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 an extended phase I study in HIV and a phase
I combination study with the checkpoint inhibitor ipilimumab (Yervoy(R)).
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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13.07.2016 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.
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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
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481691 13.07.2016
DGAP-News: MOLOGEN AG: First patient recruited in combination study with lefitolimod and Yervoy(R)
| Source: EQS Group AG