DGAP-News: MOLOGEN AG / Key word(s): Alliance/Study
MOLOGEN AG: First combination trial with MGN1703 and a checkpoint inhibitor
in collaboration with MD Anderson
19.01.2016 / 08:09
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE N 1 / 2016 of 01/19/2016
MOLOGEN AG: First combination trial with MGN1703 and a checkpoint inhibitor
in collaboration with MD Anderson
Berlin, 19 January 2016 - The biotech company MOLOGEN AG (ISIN
DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) today announced
that it has entered into a collaboration agreement with The University of
Texas MD Anderson Cancer Center (MD Anderson). The agreement relates to a
phase I trial with MOLOGEN's immunomodulator lefitolimod (MGN1703) in
combination with the immunotherapy Yervoy(R) (ipilimumab) in patients with
advanced solid malignancies. This is the first time that lefitolimod
(MGN1703) will be evaluated in combination with a checkpoint inhibitor.
Should MGN1703 succeed in augmenting the efficacy of immune checkpoint
blockade, the potential applications of the compound could be broadened.
This study has been initiated based on the idea that the combination of
these two immunotherapies could have synergistic effects by a broader
activation of the immune system.
The aim of the study titled "A Phase I Trial of Ipilimumab (Immunotherapy)
and MGN1703 (TLR Agonist) in Patients with Advanced Solid Malignancies" is
to initially find the highest tolerable dose of lefitolimod (MGN1703) that
can be given in combination with Yervoy(R) (ipilimumab) to patients with
advanced tumors. The safety of this drug combination will also be studied.
Furthermore, this trial aims to evaluate the efficacy of the combination of
these two therapies in an expansion phase. The combination of a TLR9
agonist and a checkpoint inhibitor is of particular interest: lefitolimod
(MGN1703) broadly activates the immune system and enables it to fight
cancer. 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.
"We are excited about the opportunity to study this combination. Our hope
is not only to define a safe dose but understand if the combination will
have activity and further understand the underlying biology of these
drugs", said Dr. David S. Hong, Deputy Chair and Associate Professor,
Department of Investigational Cancer Therapeutics, Division of Cancer
Medicine, MD Anderson Cancer Center, and principal investigator of the
study.
Dr. Alfredo Zurlo, Chief Medical Officer (CMO) of MOLOGEN AG commented:
"Our study program with lefitolimod as monotherapy in colorectal and lung
cancer is well on track. We are now moving to explore for the first time
the combination of MGN1703 with a checkpoint inhibitor. Yervoy(R)
monotherapy can dramatically improve the outcome of a minority of melanoma
patients; we hope to show that the combination with MGN1703 can expand both
the frequency and potency of these responses."
"We look forward to learning more about this combination as ipilimumab and
MGN1703 each target distinct, yet essential components of the immune system
necessary to reject tumors. Boosting both of these arms in concert has
shown improved therapeutic responses in pre-clinical models relative to
either monotherapy alone", said Dr. Michael Curran, Assistant Professor,
Department of Immunology, MD Anderson Cancer Center, and collaborator on
the study.
MD Anderson will conduct the trial with around 50-60 patients at its center
in Houston Texas, US. MOLOGEN will provide the immunomodulator lefitolimod
(MGN1703). The study will open for patient enrollment within the next few
weeks.
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 MGN1703 triggers a
broad and strong activation of the immune system. Due to this mechanism of
action, MGN1703 has the potential to be applied to various indications.
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.
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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19.01.2016 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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430523 19.01.2016
DGAP-News: MOLOGEN AG: First combination trial with MGN1703 and a checkpoint inhibitor in collaboration with MD Anderson
| Source: EQS Group AG