TIDMGEN
Company Announcement
-- Based on the topline results from the EPCORE(TM) NHL-1 clinical trial,
Genmab and AbbVie will engage global regulatory authorities to discuss
next steps
-- Data from the clinical trial to be presented at a future medical meeting
-- Large B-cell lymphoma (LBCL) is a common form of non-Hodgkin's lymphoma
(NHL) and currently has limited treatment options
COPENHAGEN, Denmark and NORTH CHICAGO, Illinois; APRIL 13, 2022
-- Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) announced
today topline results from the first cohort of the EPCORE(TM) NHL-1
phase 1/2, clinical trial evaluating epcoritamab
(DuoBody(R)-CD3xCD20), an investigational subcutaneous bispecific
antibody. The study cohort includes 157 patients with
relapsed/refractory large B-cell lymphoma (LBCL) who received at
least two prior lines of systemic therapy, including 38.9 percent
who received prior treatment with chimeric antigen receptor (CAR)
T-cell therapy. Based on the topline results, the companies will
engage global regulatory authorities to determine next steps.
The topline results from this cohort demonstrated an overall
response rate (ORR) of 63.1 percent as confirmed by an independent
review committee (IRC), which exceeded the protocol prespecified
threshold for efficacy. The observed median duration of response
(DOR) was 12 months. The most common treatment-emergent adverse
event was cytokine release syndrome (CRS) with 49.7 percent,
including 2.5 percent grade 3. The data will be submitted for
presentation at a future medical meeting.
Epcoritamab is being co-developed by Genmab and AbbVie as part
of the companies' broad oncology collaboration. The companies
remain committed to evaluating epcoritamab as a monotherapy, and in
combination, across lines of therapy, for a variety of hematologic
malignancies, including an ongoing phase 3, open-label, randomized
trial evaluating epcoritamab as a monotherapy in patients with
relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (NCT:
04628494
https://www.globenewswire.com/Tracker?data=SacB_yYNXMKTZ_6sslqSfepZJ57dMbceiagFTMaUZADHNY6pIJGPYt3k8v1PvJKeL3gs-jMYJhAXjEzZ_WoIxoo8GpeY0WvprinjtAEsOYPMSrsNs2ncujyhJNvGsK_sbFvHSfUlJJsRlPK1gQB4SGpC1G-f3di2CazkTkyH3-I=
).
"Together with our partner, AbbVie, we will work with regulatory
authorities to determine next steps and continue to evaluate
epcoritamab in a variety of clinical trials as a potential
treatment option for patients with various hematological
malignancies," said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab. "We look forward to sharing the findings at a
future medical meeting."
LBCL is a fast-growing type of non-Hodgkin's lymphoma (NHL) -- a
cancer that develops in the lymphatic system -- that affects B-cell
lymphocytes, a type of white blood cell. There are an estimated
150,000 new LBCL cases each year globally. LBCL includes DLBCL,
which is the most common type of NHL worldwide and accounts for
approximately 31 percent of all NHL cases.(1) (,) (2) (,) (3) (,)
(4)
"We aim to leverage AbbVie's strong blood cancer expertise to
further develop epcoritamab, alongside Genmab, for certain blood
cancer patients who have limited treatment options," said Mohamed
Zaki, M.D., Ph.D., Vice President and Head, Global Oncology
Development, AbbVie.
About the EPCORE(TM) NHL-1 Trial
EPCORE(TM) NHL-1 an open-label, multi-center safety and
preliminary efficacy trial of epcoritamab that consists of two
parts: a phase 1 first-in-human, dose escalation part; and a phase
2 expansion part. The trial was designed to evaluate subcutaneous
epcoritamab in patients with relapsed, progressive or refractory
CD20+ mature B-NHL, including LBCL and DLBCL. The dose escalation
findings, which determined the recommended phase 2 dose RP2D, were
published in
https://www.globenewswire.com/Tracker?data=qJJY9t2SbUSKCMcPu69dHvUheShiP0K4u4thhRTrsNviZe91u85tu0eBqt3YZOMTqSg0gCbKbJxi4bMBCnlY0mwK9HpdYstWCp2DIyXFIJtat3K8erHbBa3owDS4SVb7M2xyjQPHKMWn1OCHhyHEgnSKIMGhodcpvmCi-pV7788=
The Lancet in 2021. In the phase 2 expansion part, additional
patients are being treated with epcoritamab to further explore the
safety and efficacy of epcoritamab in three cohorts of patients
with different types of relapsed/refractory B-NHLs who had limited
therapeutic options.
The primary endpoint of the expansion part was ORR as assessed
by an IRC. Secondary efficacy endpoints included DOR, complete
response rate, duration of complete response, progression-free
survival, and time to response as determined by the Lugano
criteria. Overall survival, time to next therapy, and rate of
minimal residual disease negativity were evaluated as secondary
efficacy endpoints.
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.(5) 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.(6) (,) (7)
Epcoritamab is being co-developed by Genmab and AbbVie as part of
the companies' broad oncology collaboration.
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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.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow @abbvie on Twitter
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Genmab Media Contact:
Marisol Peron, Senior Vice President, Global Investor Relations
& Communications
T: +1 609 524 0065; E: mmp@genmab.com
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Genmab Investor Relations:
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
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AbbVie Media Contact:
U.S. Media
Ilke Limoncu
E: ilke.limoncu@abbvie.com
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Global Media
Mabel Martinez
E: mabel.martinez@abbvie.com
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Liz Shea
E: liz.shea@abbvie.com
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Genmab Forward-Looking Statements
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 Company Announcement 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) .
AbbVie Forward-Looking Statements
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, failure to
realize the expected benefits from AbbVie's acquisition of Allergan
plc ("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2021 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
References
(1) (") Diffuse Large B-Cell Lymphoma." Lymphoma Research
Foundation, https://www.lymphoma.org/aboutlymphoma/nhl/dlbcl/; date
accessed: 11 February 2022.
(2) (") Non-Hodgkin Lymphoma." Lymphoma Research Foundation,
https://lymphoma.org/aboutlymphoma/nhl/; date accessed: 7 April
2022.
(3) Sehn, Salles. "Diffuse Large B-Cell Lymphoma." New England
Journal of Medicine. 2021;384:842-858. DOI:
10.1056/NEJMra2027612
(4) Martelli, Ferreri, Agostinelli, et al. "Diffuse large B-cell
lymphoma." Crit Rev Oncol Hematol. 2013;87(2):146-71. DOI:
10.1016/j.critrevonc.2012.12.009
(5) 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.
(6) 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/.
(7) 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/.
Company Announcement no. 15
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
-- 130422_CA15_Epcoritamab Topline Results
https://ml-eu.globenewswire.com/Resource/Download/b82fa9bd-e5c7-4480-ae6b-afb21682b5fe
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April 13, 2022 17:25 ET (21:25 GMT)
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