Medigene AG: bluebird bio and Medigene establish strategic T cell receptor (TCR) alliance in cancer immunotherapy
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Medigene AG: bluebird bio and Medigene establish strategic T cell receptor (TCR)
alliance in cancer immunotherapy
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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 (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(TM) product candidate, currently in a Phase 2/3 study, called the
Starbeam Study, for the treatment of cerebral adrenoleukodystrophy, and its
LentiGlobin(TM) 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(®) 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(at)medigene.com
Contact bluebird bio
Manisha Pai
Tel.: +1 (617) 245-2107
Email: mpai(at)bluebirdbio.com
Should you no longer wish to receive any information about Medigene, please
inform us by e-mail (investor(at)medigene.com). We will then delete your address
from our distribution list.
Press release English PDF:
http://hugin.info/132073/R/2045416/764080.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medigene AG via GlobeNewswire
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