Genmab Achieves USD 40 Million Milestone in Collaboration with AbbVie
January 13 2021 - 9:20AM
Company Announcement
- Genmab to
receive USD 40 million milestone payment from AbbVie
- Milestone
triggered by progress in Phase 3 study of epcoritamab in diffuse
large B-cell lymphoma
Copenhagen, Denmark; January 13, 2021 –
Genmab A/S (Nasdaq: GMAB) announced today that it has
reached the first milestone in its collaboration with
AbbVie. A USD 40 million milestone payment was triggered
by the first patient dosed in the Phase 3 study of subcutaneous
epcoritamab versus investigator’s choice of chemotherapy in
patients with relapsed or refractory diffuse large B-cell lymphoma
(DLBCL).
“We are very pleased that the first Phase 3 study of epcoritamab
has been activated at multiple clinical sites and the first cancer
patient has been dosed. We look forward to continued rapid progress
in this exciting and rapidly broadening development program,” said
Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Epcoritamab is being co-developed by Genmab and AbbVie.
The milestone will be reflected in Genmab’s 2021 guidance, which
will be published on February 23, 2021.
About the StudyThe Phase 3, open-label,
randomized study (GCT3013-05, NCT04628494) will include
approximately 480 patients with relapsed or refractory DLBCL who
failed or are ineligible for autologous stem cell transplant
(ASCT). Patients will be randomized to receive either subcutaneous
epcoritamab or one of two chemotherapy regimens as per
investigator’s choice, either rituximab, gemcitabine and
oxaliplatin (R-GemOx) or bendamustine and rituximab (BR). The
primary endpoint of the study is overall survival.
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.1
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.2,3 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
patients with cancer. Founded in 1999, Genmab is the creator of
multiple approved antibody therapeutics that are marketed by its
partners. The company aims to create, develop and commercialize
differentiated therapies by leveraging next generation antibody
technologies, expertise in antibody biology, translational research
and data sciences and strategic partnerships. To create novel
therapies, Genmab utilizes its next generation antibody
technologies, which are the result of its collaborative company
culture and a deep passion for innovation. Genmab’s proprietary
pipeline consists of modified antibody candidates, including
bispecific T cell engagers and next generation immune checkpoint
modulators, effector function enhanced antibodies and antibody-drug
conjugates. The company 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.
Contact:
Marisol Peron, Corporate Vice President, Communications &
Investor Relations T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior
Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com
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 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 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®; 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®.
1Engelbert 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: PMC6992935.2Rafiq, 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/.3Singh, 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. 02CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 130121_CA02_Epcoritamab Ph 3 Milestone
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