TIDMGEN
Media Release
Copenhagen, Denmark, November 4, 2021
-- Poster presentations highlighting safety and preliminary efficacy data of
epcoritamab (DuoBody(R)-CD3xCD20) in combination with other treatments in
patients with B-cell non-Hodgkin lymphoma (NHL)
-- Poster presentation highlighting preliminary data from clinical trial
evaluating epcoritamab in patients with chronic lymphocytic leukemia
(CLL)
-- More than 20 abstracts evaluating Genmab owned and partnered programs
accepted for presentation at ASH
-- Genmab to host virtual 2021 R&D Update and ASH Data Review meeting
December 14
Genmab A/S (Nasdaq: GMAB) announced today that multiple
abstracts evaluating several investigational medicines in the
company's pipeline, or created using Genmab's innovative drug
development platforms, will be presented at the 63(rd) Annual
Meeting and Exposition of the American Society of Hematology (ASH),
being held at the Georgia World Congress Center, in Atlanta, GA,
and virtually, December 11-14. The presentations will include data
from the phase 1b/2 EPCORE(TM) NHL-2 clinical trial evaluating the
safety and preliminary efficacy of epcoritamab
(DuoBody(R)-CD3xCD20) in various combinations for the treatment of
patients with B-cell non-Hodgkin lymphoma (NHL). In addition,
preliminary data from the phase 1b/2 EPCORE(TM) CLL-1 clinical
trial, evaluating epcoritamab in patients with relapsed, refractory
chronic lymphocytic leukemia (CLL), will be presented. Results from
more than 20 clinical trials evaluating Janssen Biotech, Inc.
(Janssen)'s daratumumab, the subcutaneous formulation of
daratumumab, and Janssen's bispecific programs leveraging Genmab's
DuoBody technology platform, will 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 (NYSE:
ABBV). Daratumumab is being developed by Janssen under an exclusive
worldwide license to develop, manufacture and commercialize
daratumumab from Genmab, and the companies have a research and
license agreement to create and develop bispecific antibodies using
Genmab's DuoBody technology platform.
"The data being presented at this year's ASH represent our focus
on harnessing the power of antibodies to develop differentiated
cancer treatments and our commitment to delivering new therapeutic
options to patients through our own research and development and
through industry partnerships," said Jan van de Winkel, Ph.D.,
Chief Executive Officer of Genmab. "We are especially encouraged by
the data from the early-stage epcoritamab clinical trials and look
forward to seeing results from additional studies."
On Tuesday, December 14, at 2:00 PM EST (8:00 PM CET / 7:00 PM
GMT), Genmab will host its 2021 Virtual R&D Update and ASH Data
Review. The event will be webcast live. Details, including the
webcast link, will be available on Genmab's website,
www.genmab.com. This meeting is not an official program of the ASH
Annual Meeting.
Abstracts accepted for presentation at ASH include:
Epcoritamab (DuoBody-CD3xCD20):
-- Subcutaneous Epcoritamab in Combination with R-CHOP in Patients with
Previously Untreated High-Risk Diffuse Large B-cell Lymphoma: Preliminary
Results from a Phase 1/2 Trial
-- Subcutaneous Epcoritamab in Combination with R2 (Rituximab and
Lenalidomide) in Patients with Relapsed or Refractory Follicular
Lymphoma: Preliminary Results from a Phase 1/2 Trial
-- Subcutaneous Epcoritamab in Patients with Relapsed/Refractory Chronic
Lymphocytic Leukemia: Preliminary Results from the EPCORE CLL-1 Trial
-- Phase 3 Trial (EPCORE DLBCL-1) of Epcoritamab versus Standard of Care in
Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
(DLBCL)
Daratumumab:
-- Daratumumab (DARA) with Bortezomib, Thalidomide, and Dexamethasone (VTd)
in Transplant-Eligible Patients (Pts) with Newly Diagnosed Multiple
Myeloma (NDMM): Analysis of Minimal Residual Disease (MRD) Negativity in
CASSIOPEIA Part 1 and Part 2
-- Efficacy of Daratumumab, Lenalidomide, and Dexamethasone Based on
Lenalidomide Starting Dose in Transplant-ineligible Patients With Newly
Diagnosed Multiple Myeloma and Impaired Renal Function From the Phase 3
MAIA Study
-- Subcutaneous Daratumumab With Bortezomib, Cyclophosphamide, and
Dexamethasone (VCd) in Patients With Newly Diagnosed Light Chain (AL)
Amyloidosis: 18-month Landmark Analysis of the Phase 3 ANDROMEDA Study
-- Pomalidomide and Dexamethasone With or Without Subcutaneous Daratumumab
in Patients With Relapsed or Refractory Multiple Myeloma: Updated
Analysis of the Phase 3 APOLLO Study
-- Subcutaneous Daratumumab with Rapid Corticosteroid Tapering in Relapsed
or Refractory Multiple Myeloma Patients: Part 3 Update of the Open-label,
Multicenter, Phase 1b PAVO Study
-- Progression-free Survival Outcomes by Response Status for Bortezomib,
Melphalan, and Prednisone With or Without Daratumumab in Newly Diagnosed
Multiple Myeloma: Pooled Subgroup Analysis of OCTANS and ALCYONE
-- Daratumumab, Bortezomib, Melphalan, and Prednisone Versus Bortezomib,
Melphalan, and Prednisone in Transplant-Ineligible Patients with Newly
Diagnosed Multiple Myeloma: Pooled Analysis of OCTANS and ALCYONE
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 tumors to elicit an immune response towards
malignant cells. Epcoritamab is designed to simultaneously bind to
CD3 on T cells and CD20 on B cells and induces T cell mediated
killing of lymphoma B cells.(i) CD20 is a clinically validated
therapeutic target, and is expressed on many B-cell malignancies,
including diffuse large B-cell lymphoma, follicular lymphoma,
mantle cell lymphoma and chronic lymphocytic leukemia.(ii) (,)
(iii) Epcoritamab is being co-developed by Genmab and AbbVie as
part of the companies' broad oncology collaboration.
About DARZALEX(R) (daratumumab)
DARZALEX(R) (daratumumab) is the first monoclonal antibody (mAb)
to receive U.S. Food and Drug Administration approval to treat
certain multiple myeloma indications. Daratumumab is being
developed by Janssen Biotech, Inc. under an exclusive worldwide
license to develop, manufacture and commercialize daratumumab from
Genmab. The subcutaneous formulation of daratumumab (daratumumab
and hyaluronidase-fihj) is the first subcutaneous CD38 antibody
approved for the treatment of certain multiple myeloma indications
and the first and only approved treatment for certain patients with
light-chain (AL) amyloidosis.(iv) (,) (v) (,) (vi)
Please see local country prescribing information for all labeled
indication and safety information.
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) .
(i) Engelbert 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 Feb;52: 102625. doi: 10.1016/j.ebiom.2019.102625. Epub 2020
Jan 23. PMID: 31981978; PMCID: PMC6992935.
(ii) Rafiq, Sarwish, et al. "Comparative Assessment of
Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic
Leukemia Cells Reveals Divergent NK Cell, Monocyte, and Macrophage
Properties." Journal of Immunology (Baltimore, Md. 1950), U.S.
National Library of Medicine, 15 Mar. 2013,
www.ncbi.nlm.nih.gov/pmc/articles/PMC3631574/.
(iii) Singh, Vijay, et al. "Development of Novel Anti-Cd20
Monoclonal Antibodies and Modulation in Cd20 Levels on Cell
Surface: Looking to Improve Immunotherapy Response." Journal of
Cancer Science & Therapy, U.S. National Library of Medicine,
Nov. 2015, www.ncbi.nlm.nih.gov/pmc/articles/PMC4939752/.
(iv) DARZALEX Prescribing information, available at
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761036
Last accessed July 2021.
(v) DARZALEX Summary of Product Characteristics, available at
https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last
accessed June 2021.
(vi) DARZALEX FASPRO Prescribing information, available at:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761145
Last accessed June 2021.
Media Release no. 14
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
-- 041121_i14_ASH 2021
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