MOLOGEN AG: Collaboration with licensing partner ONCOLOGIE gains momentum
April 20 2018 - 8:30AM
Business Wire
The biopharmaceutical company MOLOGEN AG announced today that
the collaboration with ONCOLOGIE, agreed on in February 2018, is
making good progress. The collaboration includes a license
agreement for the development, manufacturing and commercialization
for MOLOGEN’s lead compound lefitolimod in East Asian markets and a
global co-development leveraging novel biomarker know-how from
ONCOLOGIE. In this context lefitolimod is initially planned to be
developed in oncological indications with high unmet medical
need.
“We are excited about the forthcoming collaboration with
ONCOLOGIE: Under the partnership we will implement ONCOLOGIE’s
innovative biomarker-driven development strategy for our TLR9
agonist lefitolimod to unleash its full potential in different
oncological indications and support our development efforts in
China and also globally”, said Dr Mariola Soehngen, Chief Executive
Officer of MOLOGEN.
“ONCOLOGIE’s novel biomarker-driven approach allows us to
conduct targeted basket or umbrella trials with lefitolimod.
Therefore we will be able to unleash lefitolimod’s potential as
single agent and especially in combination with other
immunotherapeutics and develop tailor-made therapies against
different kinds of tumors”, said Dr Matthias Baumann, Chief Medical
Officer of MOLOGEN.
“With our operations now firmly established in the U.S. and
China, ONCOLOGIE is excited to collaborate globally with MOLOGEN
and leverage the unmet needs as well as the new opportunities
available for clinical development in China. We believe that we
have synergy with MOLOGEN that will help lefitolimod reach its full
potential as a best-in-class cancer therapeutic,” said Dr Laura
Benjamin, Chief Executive Officer of ONCOLOGIE.
Within the framework of the contract MOLOGEN has received an
initial payment of EUR 3 million and a EUR 2 million equity
investment by ONCOLOGIE is to follow within the next 12 months
after the signing of the contract. Besides the initial payment and
the equity investment, the parties agreed on further development
and commercialisation milestones. They are due upon reaching
predefined development steps as well as market approval. In
addition, commercial milestones are defined which are due upon
reaching certain sales thresholds. The total payments can amount to
above EUR 100 million and will be paid over several years.
Additionally, MOLOGEN will receive low double digit royalties on
sales. MOLOGEN and ONCOLOGIE will share the economic returns from
global joint development pursuant to both parties’
contributions.
All costs relating to development, registration, marketing and
commercialization of lefitolimod in the territory are to be covered
by ONCOLOGIE.
ONCOLOGIE Ltd.
ONCOLOGIE is an oncology therapeutics company committed to
delivering improved outcomes for cancer patients by leveraging
innovative compounds and biomarker-driven clinical development. The
current pipeline is focused on mid-stage clinical programs that
modify the tumor microenvironment. ONCOLOGIE has operations
established in Boston, Massachusetts, US, and Shanghai, China.
ONCOLOGIE is working with global partners to acquire and develop
innovative drugs for cancer patients around the world.
www.oncologie.international.
MOLOGEN AG
MOLOGEN AG is a 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 infectious
diseases.
The focus of the development work is on the product family of
DNA-based TLR9 agonists. This includes the lead product candidate
lefitolimod and the next-generation molecule family EnanDIM®.
The immunotherapeutic agent lefitolimod is the company’s lead
product candidate and is currently being investigated in a pivotal
trial. It is regarded as the best-in-class TLR9 agonist. Treatment
with lefitolimod triggers a broad and strong activation of the
immune system. On account of this mode of action, lefitolimod could
potentially be used in various indications. Lefitolimod is
currently being developed within the framework of a pivotal study
for first line maintenance therapy for colorectal cancer. Key data
of the phase II IMPULSE study in small cell lung cancer have been
announced in April 2017, and the final analysis in the first
quarter 2018 confirmed the data. Furthermore, data from the
extension phase of the TEACH study in HIV have also been published
in 2017. In addition, lefitolimod is currently being investigated
in a phase I combination study with the checkpoint inhibitor
ipilimumab (Yervoy®) in various cancer indications. Along with
various checkpoint inhibitors, lefitolimod, which is being
investigated as part of a phase III clinical trial currently, is
one of the few near-to-market product candidates in the field of
immuno-oncology.
MOLOGEN’s pipeline focus is on new innovative immunotherapies to
treat diseases for which there is a great medical demand in
particular.
MOLOGEN AG is a publicly listed company, headquartered in
Berlin. The shares (ISIN DE0006637200, SIN 663720) are listed in
the Prime Standard of the German Stock Exchange.
www.mologen.com
Note about risk for future predictions
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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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MOLOGEN AGClaudia NickolausHead of Investor Relations
& Corporate CommunicationsTel: +49 - 30 - 84 17 88 – 38Fax: +49
- 30 - 84 17 88 - 50investor@mologen.com