TIDMGEN
Media Release
Copenhagen, Denmark, November 3, 2022
-- Nineteen abstracts accepted, including multiple presentations on the
safety and efficacy of investigational epcoritamab (DuoBody(R)-CD3xCD20)
in a variety of treatment settings and hematologic malignancies
-- Four oral presentations highlighting data evaluating epcoritamab for the
treatment of relapsed/refractory (R/R) large B-cell lymphoma (LBCL), R/R
follicular lymphoma (FL), previously untreated FL, and Richter's syndrome
-- New data evaluating investigational medicines in Genmab's early portfolio
of cancer immunotherapies will also be presented
-- Genmab to host 2022 R&D Update and ASH Data Review meeting December 12
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Genmab A/S (Nasdaq: GMAB) announced today that 19 abstracts
evaluating various investigational medicines in its pipeline have
been accepted for presentation at the 64(th) Annual Meeting and
Exposition of the American Society of Hematology (ASH), being held
at the Ernest N. Morial Convention Center in New Orleans,
Louisiana, and virtually, December 10-13. The presentations will
include four oral and six poster presentations highlighting data
from several clinical trials evaluating the safety and efficacy of
epcoritamab (DuoBody(R) -CD3xCD20), an investigational subcutaneous
IgG1-bispecific antibody created using Genmab's proprietary DuoBody
technology, alone or in combination for the treatment of patients
with relapsed or refractory (R/R) large B-cell lymphoma (LBCL),
including diffuse large B-cell lymphoma (DLBCL), R/R follicular
lymphoma (FL), previously untreated FL and Richter's syndrome.
Additionally, abstracts evaluating two investigational medicines
in Genmab's early pipeline have been accepted for presentation,
including the first-in-human data from the phase 1/2 trial
evaluating GEN3014 (HexaBody(R) -CD38), an investigational novel
human CD38 monoclonal antibody, in patients with R/R multiple
myeloma (MM). In addition, preclinical data from a novel drug
candidate GEN3017 (DuoBody(R) -CD3xCD30) will also be
presented.
All abstracts accepted for presentation have been published on
the ASH
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website
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.
Epcoritamab is being co-developed by Genmab and AbbVie as part
of the companies' oncology collaboration. The companies are
committed to evaluating epcoritamab as a monotherapy, and in
combination, across lines of therapy in a range of B-cell
malignancies, including an ongoing phase 3, open-label, randomized
clinical trial evaluating epcoritamab as a monotherapy in patients
with relapsed/refractory LBCL, including DLBCL (NCT: 04628494) and
a phase 3, open-label randomized clinical trial evaluating
epcoritamab in combination in patients with relapsed/refractory
follicular lymphoma (FL) (NCT: 05409066).
"As part of our commitment to the blood cancer community, we
continue to advance our research and innovative technologies in an
effort to develop differentiated therapies with the goal of
transforming the future of treatment for patients," said Dr. Judith
Klimovsky, Executive Vice President and Chief Development Officer
of Genmab. "The robust data being presented at this year's American
Society of Hematology meeting are encouraging and support the
potential of epcoritamab to become a core therapy for B-cell
malignancies."
2022 R&D Update and ASH Data Review
On Monday, December 12, at 8:00 PM EST (7:00 PM CST / 1:00 AM
GMT), Genmab will host its 2022 R&D Update and ASH Data Review.
The event will be conducted and webcast live. Details, including
the webcast link and registration can be found here
https://www.globenewswire.com/Tracker?data=xK0r4QlpcfwYqNpGTZqQkLAgnixqjEE2w6Bpe0aLVbClVWv72BU3dw52myFHbsZikXPCo5kQRwtcsbTHrjbwQLlrGAmZHdthg4XSruyEz2O-yCfJjPHN8PEIfddfymb6tvY2ICbdnvmPLka2r3RrMN9lBuVKNKGaxODRwQ8j-cE=
. This meeting is not an official program of the ASH Annual
Meeting.
Abstracts accepted at ASH:
Epcoritamab (DuoBody(R)-CD3xCD20)
Abstract Abstract Title Type of Date/Time of
Number Presentation Presentation
-------- ----------------------------------------------- ------------- --------------------
348 Subcutaneous Epcoritamab in Patients Oral Saturday, December
with Richter's Syndrome: Early Results 10, 4:00 PM - 5:30
from Phase 1b/2 Trial (EPCORE CLL-1). PM
Kater et. al.
-------- ----------------------------------------------- ------------- --------------------
443 Subcutaneous Epcoritamab + R-DHAX/C Oral Sunday, December
in Patients with Relapsed or Refractory 11, 9:30 AM - 11:00
Diffuse Large B-Cell Lymphoma Eligible AM
for Autologous Stem Cell Transplant:
Updated Phase 1/2 Results. Abrisqueta
et. al.
-------- ----------------------------------------------- ------------- --------------------
609 Subcutaneous Epcoritamab with Rituximab Oral Sunday, December
+ Lenalidomide in Patients with Relapsed 11, 4:30 PM - 6:00
or Refractory Follicular Lymphoma: PM
Phase 1/2 Trial Update. Falchi et.
al.
-------- ----------------------------------------------- ------------- --------------------
611 Subcutaneous Epcoritamab in Combination Oral Sunday, December
with Rituximab + Lenalidomide (R2) 11, 4:30 PM - 6:00
for First-Line Treatment of Follicular PM
Lymphoma: Initial Results from Phase
1/2 Trial. Falchi et. al.
-------- ----------------------------------------------- ------------- --------------------
4251 Epcoritamab Monotherapy Provides Deep Poster Monday, December
and Durable Responses Including Minimal 12, 6:00 PM - 8:00
Residual Disease (MRD) Negativity: PM
Novel Subgroup Analyses in Patients
with Relapsed/Refractory (R/R) Large
B-Cell Lymphoma (LBCL). Phillips et.
al.
-------- ----------------------------------------------- ------------- --------------------
3580 Improvements in Lymphoma Symptoms and Poster Sunday, December
Health-related Quality of Life in Patients 11, 6:00 PM - 8:00
with Relapsed or Refractory Large B-cell PM
Lymphoma Treated with Epcoritamab.
Phillips et. al.
-------- ----------------------------------------------- ------------- --------------------
4912 Indirect Comparison of the Efficacy Poster Monday, December
of Subcutaneous Epcoritamab Dose Expansion 12, 6:00 PM - 8:00
(EPCORE NHL-1 Trial) in Patients With PM
Relapsed or Refractory Large B-cell
Lymphoma. Salles et. al.
-------- ----------------------------------------------- ------------- --------------------
2874 Deep peripheral T cell subset immune-profiling Poster Sunday, December
in relapse/refractory non-Hodgkins 11, 6:00 PM - 8:00
lymphoma (NHL): Evaluation of baseline PM
samples from the Epcoritamab 3013-01
trial. Blum et. al.
-------- ----------------------------------------------- ------------- --------------------
2859 Transcriptomic Comparison of Non-Hodgkin Poster Sunday, December
Lymphomas in Relapsed/Refractory versus 11, 6:00 PM - 8:00
Newly Diagnosed Patients with Single PM
Slides. Jabado et. al.
-------- ----------------------------------------------- ------------- --------------------
1663 Phase 1b Trial of Subcutaneous Epcoritamab Poster Saturday, December
Among Pediatric Patients With Relapsed 10, 5:30 PM - 7:30
or Refractory Aggressive Mature B-Cell PM
Neoplasms. Cairo et. al.
-------- ----------------------------------------------- ------------- --------------------
4182 Evaluation of Epcoritamab and Rituximab Poster Monday, December
Combination in Preclinical Models of 12, 6:00 PM - 8:00
B-cell non-Hodgkin's Lymphoma (NHL). PM
Epling-Burnette et. al.
-------- ----------------------------------------------- ------------- --------------------
4206 Phase 3 Trial of Subcutaneous Epcoritamab Poster Monday, December
in Combination With Rituximab and Lenalidomide 12, 6:00 PM - 8:00
(R2) vs R2 Without Epcoritamab Among PM
Patients With Relapsed or Refractory
Follicular Lymphoma (EPCORE FL-1).
Falchi et. al.
-------- ----------------------------------------------- ------------- --------------------
4271 Phase 2 Trial to Evaluate Safety of Poster Monday, December
Subcutaneous Epcoritamab Monotherapy 12, 6:00 PM - 8:00
in the Outpatient Setting Among Patients PM
With Relapsed or Refractory Diffuse
Grade 1--3a Large B-Cell and Follicular
Lymphoma. Sharman et. al.
-------- ----------------------------------------------- ------------- --------------------
5524 Assessing Safety, Tolerability, and Publication NA
Efficacy of Subcutaneous Epcoritamab
in Novel Combinations with Anti-Neoplastic
Agents in Patients with Non-Hodgkin
Lymphoma in a Phase 1b/2, Open-Label
Study. Sehn et. al.
-------- ----------------------------------------------- ------------- --------------------
GEN3014 (HexaBody(R) -CD38)
Abstract Abstract Title Type of Date/Time of
Number Presentation Presentation
-------- ------------------------------------------ ------------ -----------------
3254 Preliminary Dose-Escalation Results Poster Sunday, December
From a First-in-Human Phase 1/2 Study 11, 6:00-8:00 PM
of GEN3014 (HexaBody(R)-CD38) in Patients
(pts) With Relapsed or Refractory
(R/R) Multiple Myeloma (MM). Spencer
et. al.
-------- ------------------------------------------ ------------ -----------------
GEN3017 (DuoBody(R) -CD3xCD30)
Abstract Abstract Title Type of Date/Time of
Number Presentation Presentation
-------- -------------------------------------------- ------------ -------------------
1366 DuoBody(R)-CD3xCD30 shows potent preclinical Poster Sunday, December
anti-tumor activity in vitro in CD30+ 11, 6:00 PM - 8:00
hematologic malignancies. Oostindie PM
et. al.
-------- -------------------------------------------- ------------ -------------------
Real-World Evidence
Abstract Abstract Title Type of Date/Time of
Number Presentation Presentation
-------- -------------------------------------------- ------------ -------------------
Real-World Outcomes in Patients with Poster Sunday, December
2978 Relapsed or Refractory Diffuse Large 11, 6:00 PM - 8:00
B-cell Lymphoma Treated with Standard PM
of Care: a COTA Database Analysis.
Ip et. al.
-------- -------------------------------------------- ------------ -------------------
2296 Treatment Patterns and Outcomes in Poster Saturday, December
Patients With Follicular Lymphoma 10, 5:30 PM - 7:30
Receiving at Least 3 Lines of Therapy: PM
a Real-World Evaluation in the United
States. Phillips et. al.
-------- -------------------------------------------- ------------ -------------------
2215 Health Care Resource Utilization and Poster Saturday, December
Costs of CAR T Therapy in Patients 10, 5:30 PM - 7:30
With Large B-Cell Lymphoma: A Retrospective PM
US Claims Database Analysis. Davies
et. al.
-------- -------------------------------------------- ------------ -------------------
About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody
created using Genmab's proprietary DuoBody technology. Genmab's
DuoBody-CD3 technology is designed to direct cytotoxic T cells
selectively to elicit an immune response towards target cell types.
Epcoritamab is designed to simultaneously bind to CD3 on T cells
and CD20 on B-cells and induces T cell mediated killing of CD20+
cells.(i) CD20 is expressed on B-cells and a clinically validated
therapeutic target in many B-cell malignancies, including diffuse
large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma
and chronic lymphocytic leukemia.(ii) (,) (iii)
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:
David Freundel, Director, Product Communications
T: +1 609 613 0504; E: dafr@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 Company Announcement 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) .
(i) Engelberts et al. "DuoBody-CD3xCD20 induces potent
T-cell-mediated killing of malignant B cells in preclinical models
and provides opportunities for subcutaneous dosing." EBioMedicine.
2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625
(ii) Rafiq, Butchar, Cheney, et al. "Comparative Assessment of
Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic
Leukemia Cells Reveals Divergent NK Cell, Monocyte, and Macrophage
Properties." J. Immunol. 2013;190(6):2702-2711. DOI:
10.4049/jimmunol.1202588
(iii) Singh, Gupta, Almasan. "Development of Novel Anti-Cd20
Monoclonal Antibodies and Modulation in Cd20 Levels on Cell
Surface: Looking to Improve Immunotherapy Response." J Cancer Sci
Ther. 2015;7(11):347-358. DOI: 10.4172/1948-5956.1000373
Media Release no. 15
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
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