MOLOGEN Signs License Deal for China and Global Co-Development Agreement with ONCOLOGIE for Lead Compound lefitolimod

The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200;
Frankfurt Stock Exchange Prime Standard: MGN) announced today the
signing of a license deal for the Chinese territory and a global
co-development agreement between MOLOGEN and ONCOLOGIE Inc. for its lead
compound lefitolimod. The signed agreement is conditional upon an
initial payment of EUR 3 million received by MOLOGEN. ONCOLOGIE is an
oncology-focused drug development company with headquarters in Boston
and operations in Shanghai. The company is backed by top-tier
international investors and has the objective to develop novel
personalized medicines in the field of immuno-oncology. The signed
agreement with ONCOLOGIE includes the development, manufacture and
commercialization of lefitolimod in China and a planned global
co-development program.

“We are delighted to partner our lead compound lefitolimod with
ONCOLOGIE. Their approach of an innovative biomarker-driven development
strategy for novel cancer immunotherapies has convinced us that
partnering with them will expand the opportunities for success of
lefitolimod. With the combined licencing and co-development deal for our
flagship compound lefitolimod we have achieved one of the main
milestones in implementing our strategy. In ONCOLOGIE we have found a
partner with a highly dedicated and experienced international team who
will not only drive lefitolimod development in China to achieve market
approval but will also strongly support our global development efforts.
Together we will strive to unleash lefitolimod’s full market potential
in China and on a global level”, said Dr Mariola Soehngen, Chief
Executive Officer of MOLOGEN.

“We are happy to partner with MOLOGEN on lefitolimod, a best-in-class
TLR9 agonist with exciting potential. This program complements
ONCOLOGIE’s strategy for biomarker-driven global development and has
multiple opportunities for treating indications prevalent in the Asian
market”, said Dr Laura Benjamin, Chief Executive Officer of ONCOLOGIE.

As previously announced, MOLOGEN had started negotiations on such a deal
with the Chinese iPharma. After a certain exclusivity period had
expired, MOLOGEN opened the licencing process also for additional
parties. Discussions and negotiations with ONCOLOGIE have now been
successfully completed and the deal could be signed. The terms of the
signed agreement with ONCOLOGIE describe development, manufacture and
commercialization of lefitolimod in China and a planned global
co-development program.

The contract comprises two parts: First, a license agreement including
sublicense rights under which MOLOGEN grants ONCOLOGIE an exclusive
license for the development, manufacturing and commercialization for
MOLOGEN’s lead compound lefitolimod in the following territory: China,
Hong Kong and Macao, Taiwan and Singapore. Second, a commitment for
global co-development leveraging novel biomarker plans from ONCOLOGIE.
MOLOGEN is to receive an initial payment of EUR 3 million as well as a
EUR 2 million equity investment by ONCOLOGIE within the next 12 months.
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 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. Headquartered in Boston, Massachusetts, US, with
operations also in Shanghai, China, ONCOLOGIE is working with global
partners to acquire and develop innovative drugs for cancer patients
around the world.


MOLOGEN AG is a biopharmaceutical company and considered 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 immunotherapy lefitolimod (MGN1703) is the company’s lead product
and 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 action mechanism, lefitolimod is an immune
surveillance reactivator (ISR) and could potentially be used in various
indications. The ISR 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. Detailed analyses of
IMPULSE data and data from the extension phase of the TEACH study in
HIV, published in August, are currently being conducted. 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.


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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