TIDMGEN
COPENHAGEN, Denmark; August 5, 2022
-- Collaboration expands to include development of monospecific antibody
candidates to address malignant solid tumors
-- Expanded collaboration leverages Genmab's proprietary HexaBody(R)
technology platform to develop novel monospecific antibodies
-- First monospecific antibody candidate GEN1053/BNT313 planned to enter
clinical trials by the end of 2022
-- Genmab and BioNTech will continue to share costs and potential future
profits on a 50:50 basis
https://www.globenewswire.com/Tracker?data=7BPjIwvTkc6KLi3w_bj42A7sEXw_SVWHVH7rbe2l8JAiVP3XQPQP7bUx9zWws3YBXZ7lx6c3pbyoIJ__3b2tQA==
Genmab A/S (Nasdaq: GMAB) and BioNTech SE (Nasdaq: BNTX,
"BioNTech") today announced an expansion of their global strategic
collaboration to develop and commercialize novel immunotherapies
for the treatment of cancer patients. Under the expansion, Genmab
and BioNTech 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.
"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."
"The expansion of our collaboration with Genmab expands 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."
Under the expanded collaboration, the companies will jointly
develop and commercialize, subject to regulatory approval,
monospecific antibodies leveraging Genmab's proprietary HexaBody(R)
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(R)
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(R) technology platform: GEN1046/BNT311
(DuoBody-PD-L1x4-1BB) is being evaluated in phase 1/2 clinical
trials for the treatment of advanced solid tumors (
https://www.globenewswire.com/Tracker?data=G-QoKlThEkF54nY6sENT5DGAcEB01pEri0EYWwIHz2J2hVzVfYZQXiHXmrnkF7-BTwKTfH0aFOxp1AZUYxDUI_HuSZUiPS6XwwcdblvbFhH2_ycMY2hvwUtnFXrLK7n2dV68bjrwwimLhDP-QvQXYw==
NCT04937153,
https://www.globenewswire.com/Tracker?data=G-QoKlThEkF54nY6sENT5DLgJjFiw7sNPnK6_zp65U5iNfmuRrVA5l5vS69V-frhg_gYLB3bXFhE8XadmpJQ9DsqKbc-Z0E5QkOEv9B1d49pUEt1XjHbrHBW-fWZGeYV-neQp0RueGEYW5ABo55NdA==
NCT03917381), and in a phase 2 study of patients with non-small
cell lung cancer (NSCLC) (
https://www.globenewswire.com/Tracker?data=G-QoKlThEkF54nY6sENT5NDZFwKNmY3i5oIDGOX6KebX5JJixNsTLsiiwG4fE61VtDtOVNIgdpWraKzbkdmkxrRHAuPNnHtMsNuJlhSwkWtgFXUef7Qum9e9Xn_k3swCa7c0YeDcEj14YucBy9wzdw==
NCT05117242). GEN1042/BNT312 (DuoBody-CD40x4-1BB) is being
evaluated for the treatment of patients with metastatic or locally
advanced solid tumors in a phase 1/2 study (
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NCT04083599).
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
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Genmab.com and follow us on
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Twitter.com/Genmab.
About BioNTech
Biopharmaceutical 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
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www.BioNTech.de.
Genmab Media Contact:
David Freundel, Director, Product Communications
T: +1 609 613 0504; E:
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dafr@genmab.com
Genmab Investor Relations:
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E:
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acn@genmab.com
BioNTech Contacts:
Investor Relations
Sylke Maas, Ph.D.
VP Investor Relations & Strategy
+49 (0)6131 9084 1074
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Investors@biontech.de
Media Relations
Jasmina Alatovic
VP Corporate Communications
+49 (0)6131 9084 1513
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Media@biontech.de
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
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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
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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(R) ; the Y-shaped Genmab logo(R) ; Genmab in combination
with the Y-shaped Genmab logo(R) ; HuMax(R) ; DuoBody(R) ; DuoBody
in combination with the DuoBody logo(R) ; HexaBody(R) ; HexaBody in
combination with the HexaBody logo(R) ; DuoHexaBody(R) and
HexElect(R) .
BioNTech Forward-Looking Statements
This 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 we may initiate 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 ability of BioNTech's
mRNA technology to demonstrate clinical efficacy outside of
BioNTech's infectious disease platform; 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.
Media Release no. 12
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
-- 080522_i12_BNT Agreement Expansion Media Release_FINAL
https://ml-eu.globenewswire.com/Resource/Download/a0623b87-c64d-4dd1-ab23-5380681cc589
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