Company Announcement
COPENHAGEN,
Denmark; July
18, 2022 –
Genmab A/S (Nasdaq: GMAB) today
announced that AbbVie (NYSE:
ABBV) will submit a conditional marketing authorization
application (MAA) with the European Medicines Agency (EMA) for
subcutaneous epcoritamab (DuoBody®-CD3xCD20), an investigational
bispecific antibody, for the treatment of patients with
relapsed/refractory diffuse large B-cell lymphoma (DLBCL), in the
second half of 2022. Genmab recently announced that the company
will submit a biologics license application (BLA) for epcoritamab
with the U.S. Food and Drug Administration (FDA) for the treatment
of patients with relapsed/refractory large B-cell lymphoma (LBCL),
also in the second half of 2022.
The MAA submission is supported by results from the large b-cell
lymphoma (LBCL) cohort of the pivotal EPCORE™ NHL-1 open-label,
multi-center trial evaluating the safety and preliminary efficacy
of epcoritamab in patients with relapsed, progressive or refractory
CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL), including DLBCL.
In April 2022, Genmab and AbbVie announced
the topline results from the Phase II expansion part of
the EPCORE™ NHL-1 trial. In June 2022, primary results
were presented in a late-breaking oral presentation as part of the
Presidential Symposium at the 27th Annual Meeting of the
European Hematology Association (EHA2022) in Vienna, Austria.
“The MAA submission will mark the next step towards potentially
obtaining marketing approval in Europe and being able to deliver a
new therapeutic option to patients with relapsed or refractory
DLBCL,” said Jan van de Winkel, Ph.D., Chief Executive Officer of
Genmab. “While there are existing treatments for DLBCL patients
across Europe, we recognize the significant medical need for
alternative therapeutic options for patients unable to tolerate
current treatments or whose treatments have failed.”
Epcoritamab is being co-developed by Genmab and AbbVie as part
of the companies' oncology collaboration. The companies will share
commercial responsibilities in the U.S. and Japan, with AbbVie
responsible for further global commercialization. The companies are
committed to evaluating epcoritamab as a monotherapy, and in
combination, across lines of therapy in a range of hematologic
malignancies, including an ongoing phase 3, open-label, randomized
trial evaluating epcoritamab as a monotherapy in patients with
relapsed/refractory DLBCL (NCT: 04628494).
About Diffuse Large B-cell Lymphoma
(DLBCL)DLBCL is a fast-growing type of NHL that affects
B-cell lymphocytes, a type of white blood cell. DLBCL, the
most common type of NHL worldwide, accounts for about 25 percent of
diagnosed cases of B-cell NHL worldwide. DLBCL can arise in lymph
nodes as well as in organs outside of the lymphatic system. The
disease occurs more commonly in the elderly and is slightly more
prevalent in men.i,ii
About the EPCORE™ NHL-1 TrialEPCORE™ NHL-1 is
an open-label, multi-center safety and preliminary efficacy trial
of epcoritamab including a phase 1 first-in-human, dose escalation
part; a phase 2 expansion part; and an optimization part. The trial
was designed to evaluate subcutaneous epcoritamab in patients with
relapsed, progressive or refractory CD20+ mature B-NHL, including
LBCL and DLBCL. Data from the dose escalation part of the study,
which determined the recommended phase 2 dose, were published
in The Lancet in 2021. In the phase 2 expansion part,
additional patients are treated with epcoritamab to further explore
the safety and efficacy of epcoritamab in patients with different
types of relapsed/refractory B-NHLs who had limited therapeutic
options.
The primary endpoint of the phase 2 expansion part was overall
response rate (ORR) as assessed by an IRC. Secondary efficacy
endpoints included duration of response, complete response rate,
progression-free survival, overall survival, time to response, time
to next therapy, and rate of minimal residual disease
negativity.
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.iii 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.iv,v
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 Media
Contact: Marisol
Peron, Senior Vice President, Communications and Corporate
AffairsT: +1 609 524 0065; E: mmp@genmab.com
Genmab Investor Relations:
Andrew Carlsen, Vice President, Head of Investor RelationsT: +45
3377 9558; E: acn@genmab.com Genmab
Forward-Looking StatementsThis 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®; HexElect®;
and UniBody®.
i Diffuse Large B-Cell Lymphoma.” Lymphoma Research Foundation,
https://www.lymphoma.org/aboutlymphoma/nhl/dlbcl/. Accessed 11
February 2022.ii Sandeep A. Padala; Avyakta Kallam. “Diffuse
Large B-Cell Lymphoma.” National Institutes of Health, National
Library of Medicine,
https://www.ncbi.nlm.nih.gov/books/NBK557796/#article-24581.s4.
Accessed 22 June 2022. iii 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.2019.102625iv 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 v 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
Company Announcement no. 33CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 180722_CA33_Epco Decision to Submit_EMA
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