Medigene AG / Medigene AG: bluebird bio and Medigene establish strategic
T cell receptor (TCR) alliance in cancer immunotherapy . Processed and
transmitted by Nasdaq Corporate Solutions. The issuer is solely
responsible for the content of this announcement.
-- T cell receptor (TCR) therapeutic candidates against four targets to be
generated using Medigene's proprietary TCR technology platform and
bluebird bio's lentiviral vector, genome editing, synthetic biology, and
manufacturing capabilities
-- Medigene responsible for the generation and delivery of the TCRs to
bluebird bio
-- Joint preclinical development of all product candidates
-- bluebird bio responsible for clinical development and commercialization
of resulting products
-- Medigene to receive an upfront payment of USD 15 million, R&D funding,
potential preclinical, clinical and commercial milestone payments, which
together could total over USD 1 billion, in addition to royalties on net
sales
-- bluebird bio will hold worldwide development and commercial rights and
exclusive license for IP covering the TCRs
-- Medigene conference call and webcast (in English) today, 29 September
2016, at 3:00 pm CEST (9:00 am EDT)
Martinsried/Munich and Cambridge, MA, 29 September 2016. Medigene AG
http://www.medigene.de/ (MDG1, Frankfurt, Prime Standard), Germany, and
bluebird bio, Inc. (Nasdaq: BLUE), USA, today announced the signing of a
strategic research and development collaboration and licensing agreement
encompassing T cell receptor (TCR) immunotherapies against four targets.
"We are delighted to collaborate with bluebird bio, a leader in the
field of cell and gene therapy, including cancer immunotherapy," said
Dolores J. Schendel, Chief Executive Officer and chief scientific
officer, Medigene. "With its T cell immunotherapy expertise and
outstanding gene delivery and genome editing capabilities, bluebird bio
is an ideal partner for us to jointly discover and develop a new
generation of T cell therapeutics to treat unmet oncology indications."
"Medigene's proprietary technology to generate highly active natural
TCRs makes them an ideal partner, enabling us to broaden our pipeline
with TCR-based product candidates against four new targets and continue
to build our leadership in immuno-oncology," said Rick Morgan, Ph.D.,
Vice President of Immunotherapy, bluebird bio. "This agreement exploits
our core expertise in lentiviral gene transfer, genome editing and
synthetic biology, and leverages our manufacturing and clinical
development capabilities to build a broad, fully integrated
immuno-oncology franchise."
"Our first commercial agreement based on Medigene's TCR technology is
testimony to our rapid progress as an immuno-oncology company," added
Dave Lemus, Chief Operating Officer, Medigene. "Furthermore, the
agreement provides Medigene with significant additional financial
resources for both the short term and potentially the long term as we
participate in the value creation of the cell therapeutics that we
jointly create."
Under the terms of the agreement, Medigene will be responsible for the
generation and delivery of the TCRs using its TCR isolation and
characterization platform. Following the collaborative preclinical
development, bluebird bio will assume sole responsibility for the
clinical development and commercialization of the TCR product candidates
and will receive an exclusive license for the intellectual property
covering the resulting TCRs.
Medigene will receive an upfront payment of USD 15 million as well as
potential preclinical, clinical, regulatory and commercial milestone
payments, which together could total over USD 1 billion in the aggregate
for the four potential TCR products across several indications.
Additionally, Medigene will receive R&D funding for all work performed
in the collaboration and is eligible for tiered royalty payments on net
sales up to a double-digit percentage.
Contractual parties to the agreement are Medigene Immunotherapies GmbH,
a wholly owned affiliate of Medigene AG, and bluebird bio, Inc.
Press and analysts' conference call: Medigene will hold a press and
analysts conference call (in English) today at 3:00 pm CEST / 9:00 am
EDT and will webcast the call live via Medigene's website,
www.medigene.com.
About Medigene's TCR technology: The TCR technology aims at arming the
patient's own T cells with tumor-specific T-cell receptors. The
receptor-modified T cells are then able to detect and efficiently kill
tumor cells. This immunotherapy approach attempts to overcome the
patient's tolerance towards cancer cells and tumor-induced
immunosuppression by activating and modifying the patient's T cells
outside the body (ex-vivo).
TCR therapy is developed to detect a greater number of potential tumor
antigens than other T cell-based immunotherapies, such as chimeric
antigen receptor T cell (CAR T) therapy. Medigene is preparing the
clinical development of its first TCR candidates and is establishing a
library of recombinant T cell receptors, and has established Good
Manufacturing Practice (GMP)-compliant processes for their combination
with patient-derived T cells. The start of a clinical Phase I TCR
investigator-initiated trial (IIT) with Medigene participation is
expected in 2017. Medigene plans to commence its own first clinical TCR
trial in 2017 and a second trial in 2018.
Medigene's TCR technology for adoptive T-cell therapy is one of the
company's three highly innovative and complementary immunotherapy
platforms in immuno-oncology.
About bluebird bio: With its lentiviral-based gene therapies, T cell
immunotherapy expertise and gene editing capabilities, bluebird bio has
built an integrated product platform with broad potential application to
severe genetic diseases and cancer. bluebird bio's gene therapy clinical
programs include its Lenti-D product candidate, currently in a Phase
2/3 study, called the Starbeam Study, for the treatment of cerebral
adrenoleukodystrophy, and its LentiGlobin BB305 product candidate,
currently in four clinical studies for the treatment of
transfusion-dependent ß-thalassemia, and severe sickle cell
disease. bluebird bio's oncology pipeline is built upon the company's
leadership in lentiviral gene delivery and T cell engineering, with a
focus on developing novel T cell-based immunotherapies, including
chimeric antigen receptor (CAR T) and T cell receptor (TCR) therapies.
bluebird bio's lead oncology program, bb2121, is an anti-BCMA CAR T
program partnered with Celgene. bb2121 is currently being studied in a
Phase 1 trial for the treatment of relapsed/refractory multiple myeloma.
bluebird bio also has discovery research programs utilizing
megaTALs/homing endonuclease gene editing technologies with the
potential for use across the company's pipeline.
Medigene AG is a publicly listed (Frankfurt: MDG1, prime standard)
biotechnology company headquartered in Martinsried near Munich, Germany.
The company is developing highly innovative complementary treatment
platforms to target various types and stages of cancer with candidates
in clinical and pre-clinical development. Medigene concentrates on the
development of personalized T cell-based immunotherapies. For more
information, please visit 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(R) is a registered trademark of
Medigene AG. This trademark may be owned or licensed in select locations
only.
bluebird bio Forward-Looking Statements This release contains
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements regarding
the research, development and advancement of bluebird bio's product
candidates and immuno-oncology research program, including its TCR
research program and those shared with Medigene. Any forward-looking
statements are based on management's current expectations of future
events and are subject to a number of risks and uncertainties that could
cause actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. These risks and
uncertainties include, but are not limited to, the risk that the
research programs for these targets will be unsuccessful and not
identify any viable product candidates, the risk that our collaboration
with Medigene will not continue or will not be successful, the risk of
cessation or delay of any planned clinical studies and/or our
development of our product candidates, and the risk that any one or more
of our product candidates will not be successfully developed and
commercialized. For a discussion of other risks and uncertainties, and
other important factors, any of which could cause our actual results to
differ from those contained in the forward-looking statements, see the
section entitled "Risk Factors" in our most recent quarterly report on
Form 10-Q, as well as discussions of potential risks, uncertainties, and
other important factors in our subsequent filings with the Securities
and Exchange Commission. All information in this press release is as of
the date of the release, and bluebird bio undertakes no duty to update
this information unless required by law.
Contact Medigene
Julia Hofmann, Dr. Robert Mayer
Tel.: +49 - 89 - 20 00 33 - 33 01
Email: investor@medigene.com
Contact bluebird bio
Manisha Pai
Tel.: +1 (617) 245-2107
Email: mpai@bluebirdbio.com
Should you no longer wish to receive any information about Medigene,
please inform us by e-mail (investor@medigene.com). We will then delete
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