bluebird bio and Medigene Establish Strategic T Cell Receptor Alliance in Cancer Immunotherapy

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™ 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^®
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.\