Medigene AG /
Medigene acquires Trianta Immunotherapies
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Press and analysts conference call with webcast today, 27 January 2014, 3 p.m.
* Transformative acquisition boosts Medigene's pipeline through three
complementary T cell-focussed immunotherapy platforms with clinical
development programs to treat cancer
* Medigene will leverage Trianta's key immunology know-how and integrate a
team of experts to be led by Prof. Dolores J. Schendel as Chief Scientific
* Milestone-based acquisition for approx. 1 m newly issued Medigene shares for
approx. EUR 4 m plus future milestone payments
* Unchanged cash reach at least until beginning of 2015
Martinsried/Munich, 27 January 2014. Medigene AG (MDG1, Frankfurt, Prime
Standard) has acquired the Munich-based company, Trianta Immunotherapies GmbH
(Trianta), a spin-off of the Helmholtz Zentrum MÃ¼nchen. Trianta is developing
three highly innovative and complementary immunotherapy platforms with programs
in clinical development to treat various tumour types. Trianta's proprietary
technologies will enhance Medigene's advanced pipeline with cutting-edge
therapies. Prof. Dolores J. Schendel, Managing Director of Trianta and Director
of the Institute for Molecular Immunology at the Helmholtz Zentrum MÃ¼nchen, is
intended to join the Executive Management Board of Medigene as Chief Scientific
Officer and will be accompanied by her team of 15 immunotherapy specialists from
the Helmholtz Zentrum.
Trianta is at the forefront of personalized T cell immunotherapy, focussing on
next generation antigen-tailored dendritic cell (DC) vaccines, T cell receptor
(TCR)-based adoptive cell therapy and T cell-targeted antibodies (TABs).
Trianta's DC vaccines are being evaluated in two ongoing, externally funded
investigator-initiated trials: a clinical phase I/II trial in acute myeloid
leukaemia (AML) at the Ludwig-Maximilians University Hospital GroÃŸhadern,
Munich, and a clinical phase II trial in prostate cancer at the Oslo University
Hospital. Previous clinical compassionate use studies with Trianta's DC-vaccines
have already provided encouraging data for safety and clinical benefits in
several tumour types.
Acquisition structure and financials: Medigene has acquired 100% of Trianta
shares. The previous Trianta shareholders will receive 1,017,811 newly issued
Medigene shares worth approximately EUR 4 million and potential incremental
payments in further Medigene shares or in cash of up to a maximum total of EUR
5.875 million upon the achievement of future milestones. Medigene will partly
utilize its authorized capital to issue 1,017,811 new shares which will be
subject to a lock-up period of 12 months. This capital measure will increase
Medigene's share capital from currently EUR 9,872,139.00 by EUR 1,017,811.00 to
EUR Â 10,889,950.00. Medigene's management continues to anticipate that funding
is secured until at least the beginning of 2015. Additional financial and
operational guidance will be provided with the annual financial and operations
report and conference call on 27 March 2014.
Frank Mathias, Chief Executive Officer of Medigene, comments: "This is a truly
transforming acquisition for Medigene. Immunotherapy is regarded as the future
of cancer therapy with exciting scientific breakthroughs and increasing interest
of the pharmaceutical industry. In this promising sector we have secured access
to world-class science and innovative therapy platforms with programs that are
being evaluated in patients. It strengthens our expertise in the fields of
oncology and immunology and paves the way for sustainable growth. Prof. Dolores
Schendel is a renowned expert in immunology with many years of management
experience. She and her highly qualified, well-established team will make a
significant contribution to Medigene's future."
Prof. Dolores J. Schendel, Managing Director of Trianta and designated Chief
Scientific Officer of Medigene, explains: "T cells activated by dendritic cells
are by nature the best weapons against cancer. The understanding of immune
mechanisms has increased enormously over the last decade, and now our vision of
activating T cells to effectively combat cancer is becoming a clinical reality.
Trianta will benefit from Medigene's experienced team and established
operational structures. The union of our two companies will unlock diverse
synergies to take our therapy platforms and innovative drug candidates through
clinical development with the goal to improve lives of seriously ill patients."
Peter Llewellyn-Davies, Chief Financial Officer of Medigene, states: "We will
now combine promising proprietary immunotherapy platforms with late stage drug
candidates and a marketed product. Medigene has developed drugs to market, is
currently leading two other drug candidates to advanced clinical development and
closed successful partnerships. With the acquisition of Trianta, we are now
achieving our next strategic goal of strengthening Medigene's drug pipeline
through high-quality clinical projects with innovative unique selling points.
The newly acquired therapy platforms will provide a competitive and sustainable
extension of our portfolio of drug candidates, opening up multiple partnering
and financing opportunities."
About Trianta: Based on more than 15 years of extensive research in the field of
immunotherapy, Trianta Immunotherapies GmbH was founded late 2013 as a spin-off
of the Helmholtz Zentrum MÃ¼nchen, the German Research Centre for Environmental
Health. Trianta exploits the therapeutic and commercial potential of T cell-
focused therapies developed by the team of Prof. Dolores J. Schendel at the
Helmholtz Zentrum Munich, in collaboration with Prof. Thomas Blankenstein at the
Max DelbrÃ¼ck Centre for Molecular Medicine, Berlin. The team of Trianta pursues
three complementary immunotherapeutic strategies to target various tumour types
and stages. Each one is focused on T cells, a type of white blood cell that
plays a pivotal role in immunity.
Dendritic cell (DC) vaccines
Clinical stage, suited for treatment of minimal residual disease or use in
Trianta has established a dendritic cell product platform that allows the design
of next generation dendritic cell vaccines. Dendritic cells can take up antigens
efficiently, process them and present them on their surface in a form that can
induce T cells to divide and mature. Dendritic cells can also induce natural
killer cells to become active and attack tumour cells. Trianta has established
new, fast and efficient methods for preparation of autologous (patient-specific)
mature dendritic cells that have relevant characteristics to activate both T
cells and natural killer cells. They are developed to carry multiple tumour
antigens to treat various types of cancer.
T cell receptor- (TCR) modified T cells
Late preclinical stage, suited for the treatment of advanced cancer:
The second therapy approach of Trianta aims to utilize the body's own machinery
- the T cell - to target and destroy cancer by arming normal patient-derived T
cells with new T cell receptors that enable them to detect and efficiently kill
tumour cells. This form of immunotherapy is supposed to overcome a patient's
tolerance to cancer since the T cells of the patient are activated and modified
outside the body, away from generalized immune suppression in the patient.
Compared to small molecule or antibody based therapies this approach can be used
for new targets to fight tumours. A large army of specific T cells is made
available to patients within just 10 days. Trianta is currently establishing a
comprehensive library of recombinant T-cell receptors and a GMP-compliant
process for their combination with patient-derived T cells.
Anti-TCR monoclonal antibodies (TABs)
Proof of technology, intended for the treatment of T cell-mediated diseases or
in preparation of transplantations
The third product platform of Trianta is based on the generation of monoclonal
antibodies that recognize T cells on the basis of their unique T cell receptors
(T cell antibodies - TABs). TABs are intended for taking out unwanted T cells to
treat T cell-mediated diseases, including T cell leukemia and different types of
autoimmune diseases. Trianta has established proof of technology in preclinical
studies with the isolation and characterization of monoclonal antibodies with
various specificities that distinguish different T cell receptors.
Trianta team members have attracted public grants to fund early developmental
work, including an m(4) award of the Bavarian Ministry of Economic Affairs and a
grant under the EXIST programme of the Federal Ministry of Economics and
Technology (BMWi). Trianta's shareholders are DJSMontana Holding GmbH (Munich),
BioM AG (Planegg/Martinsried), Prof. Dr. Thomas Blankenstein (Berlin) and
Ascenion GmbH (Munich).
About Prof. Dolores J. Schendel: Prof. Dolores J. Schendel, Managing Director of
Trianta Immunotherapies GmbH, has been Director of the Institute of Molecular
Immunology of the German Research Center for Environmental Health since 1998 and
has held a professorship in immunology at the Ludwig Maximilian University of
Munich since 1986. Her research focuses on human immunology and immunotherapy.
She has led preclinical groups for GMP process development and immune monitoring
for clinical studies. Prof. Schendel has experience in building and guiding
diverse teams required to initiate clinical studies of new immunotherapy
strategies based on DC vaccines and adoptive T cell therapy. She has served as a
Member of the German Cancer Aid Grants Review Panel and as Chair of a Life
Science Study Panel of the European Research Council.
Kempen & Co., Amsterdam, acted as advisor to Medigene in the acquisition of
Press and analysts' conference call: A press and analysts conference call (in
English) will be held today at 3 p.m. CET and will be webcast live. The
synchronized presentation slides and a recording can be accessed via Medigene's
Medigene AG is a publicly listed (Frankfurt: MDG1, prime standard) biotechnology
company headquartered in Martinsried near Munich, Germany. Medigene focuses on
clinical research and development of novel drugs against cancer and autoimmune
diseases. Medigene is the first German biotech company to have revenues from a
marketed product, Veregen(Â®), which is distributed by commercial partners
companies. Medigene has two drug candidates in clinical trials, EndoTAG(Â®)-1 and
RhuDex(Â®), and is developing an innovative vaccine technology. Further
information at www.medigene.com.
This press release contains forward-looking statements representing the opinion
of Medigene as of the date of this release. The actual results achieved by
Medigene may differ significantly from the forward-looking statements made
herein. Medigene is not bound to update any of these forward-looking statements.
Medigene(Â®), Veregen(Â®), EndoTAG(Â®) and RhuDex(Â®) are registered trademarks of
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