TIDMGEN
Media Release
Copenhagen, Denmark, October 1, 2021
-- Mini-oral presentation highlighting data from first-in-human trial
evaluating investigational bispecific antibody DuoBody(R)-CD40×4-1BB
(GEN1042)
-- Poster presentation of clinical results from study evaluating
investigational bispecific antibody DuoBody(R)- PD-L1×4-1BB
(GEN1046)
-- Additional poster presentations highlighting an investigational
early-stage therapy in Genmab's solid tumor product pipeline, new
research and technologies
Genmab A/S (Nasdaq: GMAB) announced today that multiple
abstracts evaluating several investigational therapies and
technologies in the company's solid tumor product pipeline will be
presented at the Society for Immunotherapy of Cancer's 36(th)
Annual Meeting (SITC 2021), being held in Washington, DC, and
virtually, November 10-14. The presentations will include a
mini-oral session featuring the results of the first-in-human (FIH)
phase 1/2 trial evaluating the safety and initial clinical activity
of the investigational bispecific antibody, DuoBody(R) -CD40×4-1BB
(GEN1042), in patients with advanced solid tumors. Data from
another FIH phase 1/2a trial, evaluating the investigational
bispecific antibody, DuoBody(R) -PD-L1×4-1BB (GEN1046) in patients
with advanced solid tumors, will be presented as a poster. In
addition, four posters will be presented, including one evaluating
DuoBody(R) -CD3xB7H4 (GEN1047), an investigational therapy in
Genmab's early-stage solid tumor product pipeline.
All the abstract titles have been published on the SITC website
and may be accessed online via the SITC Annual Meeting website
https://www.globenewswire.com/Tracker?data=Wn6vVphasCRQoGJam1CC3U08bRG9odtz6THXWbyDkMRkc6no76RsOAugzFLKx5HKOeY8ca6ufSeUHWphnflIvUu6cEPQBF6B3CFueURg99FUdTLyhZ7mMtMarWBXOm6Z
. Full abstracts will be posted on November 9, 2021, at 8:00 a.m.
ET.
GEN1046 and GEN1042 are being co-developed by Genmab and
BioNTech (NASDAQ: BNTX) under an agreement in which the companies
share all costs and future profits on a 50:50 basis.
"We are excited to present the results of these important
clinical and pre-clinical studies to show the progression of the
innovative technologies and investigational medicines in our
antibody product pipeline and to demonstrate our commitment to
delivering new therapeutic options to patients," said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab. "While most of
these studies have been conducted in the beginning stages of the
clinical evaluation process, we are encouraged by the early results
and look forward to seeing further results from ongoing clinical
trials."
Abstracts accepted for presentation at SITC 2021:
DuoBody(R) -CD40×4-1BB (GEN1042):
-- First-in-human phase 1/2 trial to evaluate the safety and initial
clinical activity of DuoBody(R)-CD40×4-1BB (GEN1042) in patients
with advanced solid tumors
DuoBody(R) -PD-L1×4-1BB (GEN1046):
-- Peripheral and tumoral immune activity in the expansion part of the
first-in human DuoBody(R)-PD-L1×4-1BB (GEN1046) trial
-- Dose selection for DuoBody(R)-PD-L1×4-1BB (GEN1046) using a
semi-mechanistic pharmacokinetics/pharmacodynamics model that leverages
preclinical and clinical data
DuoBody(R) -CD3xB7H4 (GEN1047):
-- In vitro and in vivo studies establish DuoBody(R)-CD3xB7H4 as a novel
drug candidate for the treatment of solid cancers
New Research and Technologies:
-- A scalable deep learning framework for rapid automated annotation of
histologic and morphologic features from large unlabeled pan-cancer H&E
datasets
-- A translational approach to catalog pancreatic cancer heterogeneity using
spatial genomics in large patient cohorts to empower target validation
and rational combination selection
-- Molecular characterization of AXL in solid tumor malignancies using
real-world data
About DuoBody(R) -PD-L1×4-1BB (GEN1046)
DuoBody-PD-L1x4-1BB (GEN1046) is a proprietary bispecific
antibody, jointly owned by Genmab and BioNTech, created using
Genmab's DuoBody technology. It targets PD-L1 and 4-1BB, selected
to block the inhibitory PD1/PD-L1 axis and simultaneously
conditionally activate essential co-stimulatory activity via 4-1BB
using an inert DuoBody antibody format. Two clinical studies
(NCT03917381
https://www.globenewswire.com/Tracker?data=h0g0Zmzjv0kBBo_RKCMWG9OTmIG6KaXBWsN5fDnsYCIk21H4VdYDLW1LqHUAct1KrVFiDPZwqk0o1P8Cdp0aYTE5cw0tuMwcKEct3px2N_f0dWPYNqwVO57-8QH3JNGSuI-9062J5sBo2g1UtO15e5k4T_6ubTNFhen3hhAqmOs=
, NCT04937153
https://www.globenewswire.com/Tracker?data=h0g0Zmzjv0kBBo_RKCMWG5kSsqE3ibEEfQY7Q3eEROqgiNtQ26pfSMreGkJR1DNmZwmb6dR2XUDpQS6JfDwLu9rgSl2HEzkMSDKtCVh-kWZme4WKDBkCmjCnj4RHUeErNKh1NsoLslZdCna0ifMO3pOIlGdqPqfS__XD4gMThQA=
) in solid tumors are ongoing. DuoBody-PD-L1x4-1BB is being
co-developed by Genmab and BioNTech under an agreement in which the
companies share all costs and profits for the product on a 50:50
basis.
About DuoBody(R) -CD40×4-1BB (GEN1042)
DuoBody-CD40x4-1BB (GEN1042) is a proprietary bispecific
antibody, jointly owned by Genmab and BioNTech, created using
Genmab's DuoBody technology. CD40 and 4-1BB were selected as
targets to enhance both dendritic cell (DC) and antigen-dependent
T-cell activation, using an inert DuoBody format. A Phase 1/2
clinical study (NCT04083599
https://www.globenewswire.com/Tracker?data=h0g0Zmzjv0kBBo_RKCMWG8PnBKsQt0QHFtpLPW8vquqPZunG2hrZvefsTFrb8e0GBng0rLFeJuJSRsOu_zoTZiel5dmrm2PRXhp5xr0BP1yYIgzXixt1q2Jb-ufMhcJxEspcS8zFbrUjuvbv9xKtOk3ghsY7KuCeIGAquuYG67M=
) of DuoBody-CD40x4-1BB in solid tumors is ongoing.
DuoBody-CD40x4-1BB is being co-developed by Genmab and BioNTech
under an agreement in which the companies share all costs and
profits for the product on a 50:50 basis.
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
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and follow us on Twitter.com/Genmab
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.
Contact:
Marisol Peron, Senior Vice President, Global Investor Relations
& Communications
T: +1 609 524 0065; E: mmp@genmab.com
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For Investor Relations:
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
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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) ;
HexElect(R) ; and UniBody(R) .
Media Release no. 11
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
-- 011021_i11_SITC Curtain Raiser
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October 01, 2021 08:00 ET (12:00 GMT)
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