MOLOGEN AG Announces Top Line Data of Pivotal IMPALA Study in Metastatic Colorectal Cancer
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MOLOGEN AG Announces Top Line Data of Pivotal IMPALA Study in Metastatic
Colorectal Cancer
* Primary endpoint not met: median overall survival of 22 months in lefitolimod
group compared to 21.9 months in control group; p=0.2765; hazard ratio HR:
1.12 (95% CI: 0.91 - 1.38)
* No new safety signals detected
* Future focus on combination approaches for both lefitolimod and the first
clinical candidate from the EnanDIM(®) family
The biopharmaceutical company MOLOGEN AG (ISIN DE000A2LQ900, SIN A2L Q90)
announced today the top line data of its pivotal phase III IMPALA study. The
study compares the TLR9 agonist lefitolimod (MGN1703) with local standard of
care as a maintenance therapy in patients with metastatic colorectal cancer
presenting with an objective tumor response following first-line induction
therapy. The primary endpoint – overall survival (OS) – was not met
showing a median OS of 22.0 and 21.9 months in the lefitolimod and control
group respectively (p=0.2765; HR=1.12; 95% CI 0.91 - 1.38). Timepoint related
OS and predefined sub-group analyses did also not indicate a benefit, while
regarding Progression Free Survival (PFS) standard of care was superior to
lefitolimod treatment. No new safety signals were detected; hence the
favorable safety and tolerability profile was confirmed.
MOLOGEN is a pioneer in the field of immunotherapy, especially in the TLR9
field with the product family of DNA-based TLR9 agonists including its lead
compound lefitolimod, as well as its follow-up molecules EnanDIM(®). Given
its mode of action and confirmed favorable safety profile, lefitolimod is
being used as combination partner in anti-cancer and anti-HIV immunotherapies.
Dr med Stefan M. Manth, CEO of MOLOGEN, noted: “We are disappointed with
these top-line results and will now analyze the bountiful data coming out of
IMPALA in depth. We will then build on these analyses from IMPALA to further
inform the development of lefitolimod and its successor molecules from the
EnanDIM(®) platform for cancer and HIV patients. We are grateful to the
patients and investigators for their participation in this important study.”
Dr med Matthias Baumann, CMO of MOLOGEN, stated: “Unfortunately the positive
results in our single agent lefitolimod phase II IMPACT study did not
translate into a successful outcome of our phase III IMPALA trial despite the
fact that all learnings have been incorporated into the trial design. In
contrast to the time when the IMPALA design was conceived, it now appears that
for successful anti-cancer immunotherapies a combination approach is of
paramount importance. Due to the large body of evidence indicating the
potential of TLR9 agonism in this context we remain committed to the further
development of our candidates.”
The detailed data from this first top line analysis of the IMPALA trial will
be submitted for presentation at an upcoming international scientific
congress.
Strategic focus on combination therapies in indications with high medical need
and significant market potential
In light of these results the strategy of MOLOGEN going forward will focus on
combination approaches for both lefitolimod and the first clinical candidate
from the EnanDIM® family in ongoing and planned clinical trials. This
strategy serves as cornerstone for ongoing licensing and funding efforts.
Further to the IMPALA single-agent approach, lefitolimod is currently being
evaluated in a phase I/II clinical study in combination with the checkpoint
inhibitor Yervoy(®) (ipilimumab) in a broader variety of solid tumors. The
study is being conducted at the renowned MD Anderson Cancer Center, Texas,
USA. In addition to studies in the field of oncology, lefitolimod has also
been tested in HIV patients in a phase Ib/IIa study, the TEACH trial. Based on
the encouraging study results, lefitolimod will be investigated in a phase IIa
combination study, the TITAN trial, in HIV-infected patients in combination
with innovative virus-neutralizing antibodies developed by the Rockefeller
University in New York, USA. The trial will be conducted in cooperation with
the Aarhus University Hospital in Denmark, which was also the academic partner
of MOLOGEN in the TEACH trial. TITAN is funded by the US biotech company
Gilead Inc. Furthermore, plans for another clinical combination study in HIV
with a prominent US center are at an advanced stage.
The next generation TLR9 agonistic molecules of the EnanDIM(®)-family coming
out of the research labs of MOLOGEN offer additional potential for development
in various cancer indications and HIV. A first clinical candidate from the
EnanDIM(®) platform is presently in late pre-clinical testing and expected to
launch into clinical development in oncology at the end of 2019.
Checkpoint inhibitors alone are expected to generate sales of approximately
US$ 25 billion by 2022 (acc. to Research and Markets) in a growing variety of
indications. However, the greatest potential of checkpoint inhibitors is still
to be realized, i.e. with adequate combination partners to target indications
non-amenable to checkpoint inhibitor monotherapy. Estimates from the market
research organization Research and Markets project that the market for cancer
immunotherapies could rise to more than US$100 billion by 2024.
Background to the IMPALA study
IMPALA (Immunomodulatory MGN1703 in Patients with Advanced Colorectal
Carcinoma with tumor reduction during induction treatment) is a pivotal,
randomized, international, multicenter, open-label phase III trial. The study
involves more than 540 patients from eight European countries, including the
five major European pharmaceutical markets. Recruitment was completed in May
2017. The study includes patients with metastatic colorectal cancer who have
responded to standard first-line treatment. Lefitolimod is subsequently
administered subcutaneously 60 mg twice weekly as maintenance therapy. The
primary endpoint is overall survival and secondary study endpoints include
progression-free survival, safety and tolerability, as well as Quality of Life
(QoL).
The study is conducted in collaboration with three highly profiled national
collaborative study groups: Arbeitsgemeinschaft Internistische Onkologie (AIO)
in Germany, Grupo Español de Tratamiento de Tumores Digestivos (TTD) in Spain
and Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR) in France.
For more information on IMPALA please visit www.clinicaltrials.gov
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.
MOLOGEN AG
MOLOGEN AG is a German biopharmaceutical Company and a pioneer in the field of
immunotherapy on account of its unique active agents and technologies.
Alongside a focus on immuno-oncology, MOLOGEN develops immunotherapies for the
treatment of HIV and infectious diseases.
The focus of MOLOGEN’s development is on DNA-based TLR9 agonists, where it
has consistently been ahead of the course. This includes the lead compound,
the immunotherapy lefitolimod, and its next generation molecules EnanDIM(®),
building the foundation for a next generation immunotherapy platform in areas
of unmet need.
Forthcoming milestones include: the start of the TITAN study in HIV, the start
of the clinical development of EnanDIM(®) and additional combination studies
in cancer, including one with our strategic partner Oncologie Inc., which are
in an advanced planning stage.
MOLOGEN AG is a publicly listed Company, headquartered in Berlin. The shares
(ISIN, DE000A2LQ900/SIN: A2L Q90) are listed in the Prime Standard of the
German Stock Exchange.
www.mologen.com
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Disclaimer
Certain statements in this communication contain formulations or terms
referring to the future or future developments, as well as negations of such
formulations or terms, or similar terminology. These are described as
forward-looking statements. In addition, all information in this communication
regarding planned or future results of business segments, financial
indicators, developments of the financial situation or other financial or
statistical data contains such forward-looking statements. The company
cautions prospective investors not to rely on such forward-looking statements
as certain prognoses of actual future events and developments. The company is
neither responsible nor liable for these forward-looking statements. It is not
responsible for updating such information, which only represents the state of
affairs on the day of publication.
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Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 37
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com (mailto:investor@mologen.com)
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