- Collaboration expands to include development of monospecific
antibody candidates to address malignant solid tumors
- Expanded collaboration leverages Genmab’s proprietary HexaBody®
technology platform to develop novel immunotherapies
- First monospecific antibody candidate GEN1053/BNT313 planned to
enter clinical trials by the end of 2022
- BioNTech and Genmab will share costs and potential future
profits on a 50:50 basis
MAINZ, Germany, and COPENHAGEN, Denmark,
August 5, 2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and
Genmab A/S (“Genmab”) today announced an expansion of their global
strategic collaboration to develop and commercialize novel
immunotherapies for the treatment of cancer patients. Under this
expansion, BioNTech and Genmab will jointly work to research,
develop and commercialize novel monospecific antibody candidates
for various cancer indications. Since 2015, the companies have been
working on the joint development of bispecific cancer antibodies
aimed at improving immunotherapy options for cancer patients.
“The expansion of our collaboration with Genmab
extends our antibody portfolio and will further strengthen our
oncology pipeline in indications with high unmet medical needs,”
said Prof. Ugur Sahin, M.D., Chief Executive Officer and
Co-Founder of BioNTech. “We are committed to working together
with our colleagues at Genmab to develop new treatments for people
affected by cancer.”
“We are thrilled to expand our collaboration
with BioNTech to include additional novel antibody therapies with
the goal to deliver them to patients in need of innovative
therapeutic options,” said Jan van de Winkel, Ph.D., Chief
Executive Officer of Genmab. “Strategic partnerships, like our
collaboration with BioNTech, are critical to developing
differentiated antibody medicines with the aim of improving
the lives of cancer patients.”
Under the expanded collaboration, the companies
will jointly develop and commercialize, subject to regulatory
approval, monospecific antibodies leveraging Genmab’s proprietary
HexaBody technology platform. The first monospecific antibody
candidate, GEN1053/BNT313, is expected to enter clinical trials by
the end of 2022. GEN1053/BNT313 is a CD27 antibody based on the
HexaBody technology, specifically engineered to form an antibody
hexamer (a formation of six antibodies) upon binding its target on
the cell membrane of the T cells. Under the terms of the agreement,
the companies will equally share the development costs and
potential future profit deriving from GEN1053/BNT313.
The companies currently have two jointly
developed investigational medicines in clinical testing since 2019,
fusing BioNTech’s proprietary immunomodulatory antibodies and
Genmab’s DuoBody® technology platform: GEN1046/BNT311 is being
evaluated in Phase 1/2 clinical trials for the treatment of
advanced solid tumors (NCT04937153, NCT03917381), and in a Phase 2
study of patients with non-small cell lung cancer (NSCLC)
(NCT05117242). GEN1042/BNT312 is being evaluated for the treatment
of metastatic or locally advanced solid tumors in a Phase 1/2 study
(NCT04083599).
About BioNTechBiopharmaceutical New
Technologies is a next generation immunotherapy company pioneering
novel therapies for cancer and other serious diseases. The Company
exploits a wide array of computational discovery and therapeutic
drug platforms for the rapid development of novel
biopharmaceuticals. Its broad portfolio of oncology product
candidates includes individualized and off-the-shelf mRNA-based
therapies, innovative chimeric antigen receptor T cells,
bi-specific checkpoint immuno-modulators, targeted cancer
antibodies and small molecules. Based on its deep expertise in mRNA
vaccine development and in-house manufacturing capabilities,
BioNTech and its collaborators are developing multiple mRNA vaccine
candidates for a range of infectious diseases alongside its diverse
oncology pipeline. BioNTech has established a broad set of
relationships with multiple global pharmaceutical collaborators,
including Genmab, Sanofi, Genentech, a member of the Roche Group,
Regeneron, Genevant, Fosun Pharma, and Pfizer. For more
information, please visit www.BioNTech.de.
BioNTech Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements may include, but may not be
limited to, statements concerning: the collaboration between
BioNTech and Genmab to jointly clinical develop the program
candidate GEN1053/BNT313; timing for commencement of a Phase 1
clinical trial as well as any subsequent data readouts; the
registrational potential of any trial for GEN1053/BNT313; the
nature and characterization of and timing for release of clinical
data across BioNTech’s platforms, which is subject to peer review,
regulatory review and market interpretation; the planned next steps
in BioNTech’s pipeline programs and specifically including, but not
limited to, statements regarding timing or plans for initiation of
clinical trials, enrolment or submission for and receipt of product
approvals with respect to BioNTech’s product candidates; the
potential safety and efficacy of our other product candidates;
BioNTech’s anticipated market opportunity and size for its product
candidates. Any forward-looking statements in this press release
are based on BioNTech’s current expectations and beliefs 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
discussions with regulatory agencies regarding timing and
requirements for additional clinical trials; and the ability to
produce comparable clinical results in future clinical trials.
For a discussion of these and other risks and
uncertainties, see BioNTech’s Annual Report as Form 20-F for the
Year Ended December 31, 2021, filed with the SEC on March 30, 2022,
which is available on the SEC’s website at www.sec.gov. All
information in this press release is as of the date of the release,
and BioNTech undertakes no duty to update this information unless
required by law.
About Genmab
Genmab is an international biotechnology company
with a core purpose to improve the lives of people with cancer. For
more than 20 years, Genmab’s vision to transform cancer treatment
has driven its passionate, innovative and collaborative teams to
invent next-generation antibody technology platforms and leverage
translational research and data sciences, fueling multiple
differentiated cancer treatments that make an impact on people’s
lives. To develop and deliver novel therapies to patients, Genmab
has formed 20+ strategic partnerships with biotechnology and
pharmaceutical companies. Genmab’s proprietary pipeline includes
bispecific T-cell engagers, next-generation immune checkpoint
modulators, effector function enhanced antibodies and antibody-drug
conjugates.
Genmab is headquartered in Copenhagen,
Denmark with locations in Utrecht, the Netherlands, Princeton, New
Jersey, U.S. and Tokyo, Japan. For more information, please visit
Genmab.com and follow us on Twitter.com/Genmab.
Genmab Forward-Looking Statements
This Media Release contains forward looking
statements. The words “believe”, “expect”, “anticipate”, “intend”
and “plan” and similar expressions identify forward looking
statements. Actual results or performance may differ materially
from any future results or performance expressed or implied by such
statements. The important factors that could cause our actual
results or performance to differ materially include, among others,
risks associated with pre-clinical and clinical development of
products, uncertainties related to the outcome and conduct of
clinical trials including unforeseen safety issues, uncertainties
related to product manufacturing, the lack of market acceptance of
our products, our inability to manage growth, the competitive
environment in relation to our business area and markets, our
inability to attract and retain suitably qualified personnel, the
unenforceability or lack of protection of our patents and
proprietary rights, our relationships with affiliated entities,
changes and developments in technology which may render our
products or technologies obsolete, and other factors. For a further
discussion of these risks, please refer to the risk management
sections in Genmab’s most recent financial reports, which are
available on www.genmab.com and the risk factors included in
Genmab’s most recent Annual Report on Form 20-F and other filings
with the U.S. Securities and Exchange Commission (SEC), which are
available at www.sec.gov. Genmab does not undertake any obligation
to update or revise forward looking statements in this Media
Release nor to confirm such statements to reflect subsequent events
or circumstances after the date made or in relation to actual
results, unless required by law. Genmab A/S and/or its subsidiaries
own the following trademarks: Genmab®; the Y-shaped Genmab logo®;
Genmab in combination with the Y-shaped Genmab
logo®; HuMax®; DuoBody®; DuoBody in combination
with
the DuoBody logo®; HexaBody®; HexaBody in
combination
with the HexaBody logo®; DuoHexaBody®
and HexElect®.
CONTACTS
BioNTechInvestor RelationsSylke Maas,
Ph.D.VP Investor Relations & Strategy+49 (0)6131 9084
1074Investors@biontech.de
Media RelationsJasmina AlatovicVP Corporate
Communications+49 (0)6131 9084 1513Media@biontech.de
GenmabGenmab Media Contact David
Freundel, Director, Product Communications+1 609 613
0504dafr@genmab.com
Genmab Investor Relations Andrew Carlsen, Vice President, Head
of Investor Relations+45 3377 9558acn@genmab.com
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