MOLOGEN AG: Collaboration with licensing partner ONCOLOGIE gains momentum

20-Apr-2018 Intellasia | BusinessWire | 7:30 PM Print This Post

BERLIN–(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

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 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.


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.

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.


Claudia Nickolaus
Head of Investor Relations
& Corporate Communications
Tel: +49 – 30 – 84 17 88 – 38
+49 – 30 – 84 17 88 – 50
[email protected]


Category: BusinessWire, PRAsia

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