- 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)
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.
This Smart News Release features multimedia.
View the full release here:
http://www.businesswire.com/news/home/20160928006578/en/
“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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160928006578/en/
Contact MedigeneJulia Hofmann, Dr. Robert Mayer, +49 - 89
- 20 00 33 - 33 01investor@medigene.comorContact bluebird
bioManisha Pai, +1-617-245-2107mpai@bluebirdbio.comorElizabeth
Pingpank, +1-617-914-8736epingpank@bluebirdbio.com
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