Genmab Announces Enapotamab Vedotin Update
November 24 2020 - 10:40AM
Company Announcement
- Genmab will
not advance the development of enapotamab vedotin
- Data from
expansion cohorts did not meet stringent criteria for
proof-of-concept
- Genmab to
prioritize development of other innovative product
candidates
Copenhagen, Denmark; November 24, 2020 –
Genmab A/S (Nasdaq: GMAB) announced today that it will not
advance the development of enapotamab vedotin. While
enapotamab vedotin has shown some evidence of clinical activity,
this was not optimized by different dose schedules and/or
predictive biomarkers. Accordingly, the data from the expansion
cohorts did not meet Genmab’s stringent criteria for
proof-of-concept.
“We are committed to developing innovative antibody products for
patients with cancer, however the data from the enapotamab vedotin
expansion cohorts unfortunately does not support moving this
product candidate forward. This decision will allow us to focus
more of our resources and energy on other programs in our robust
next-generation antibody therapeutics pipeline,” said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab.
About Enapotamab VedotinEnapotamab vedotin is
an AXL targeted Antibody-Drug Conjugate (ADC) in which the
monoclonal antibody is conjugated to the antimitotic drug
monomethyl auristatin E. AXL is a signaling molecule overexpressed
in several hematologic and solid malignancies. In the context of
malignancy, evidence suggests that AXL overexpression drives
wide-ranging processes, including epithelial to mesenchymal
transition, tumor angiogenesis, resistance to chemotherapeutic and
targeted agents, and decreased antitumor immune response.
Enapotamab vedotin is fully owned by Genmab and the drug linker
technology used for enapotamab vedotin was licensed from Seagen
Inc.
About Genmab Genmab is a publicly traded,
international biotechnology company specializing in the creation
and development of differentiated antibody therapeutics for the
treatment of cancer. Founded in 1999, the company is the creator of
the following approved antibodies: DARZALEX® (daratumumab, under
agreement with Janssen Biotech, Inc.) for the treatment of certain
multiple myeloma indications in territories including the U.S.,
Europe and Japan, Kesimpta® (subcutaneous ofatumumab, under
agreement with Novartis AG), for the treatment of adults with
relapsing forms of multiple sclerosis in the U.S. and TEPEZZA®
(teprotumumab, under agreement with Roche granting sublicense to
Horizon Therapeutics plc) for the treatment of thyroid eye disease
in the U.S. A subcutaneous formulation of daratumumab, known as
DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S.,
has been approved in the U.S. and Europe for the treatment of adult
patients with certain multiple myeloma indications. The first
approved Genmab created therapy, Arzerra® (ofatumumab, under
agreement with Novartis AG), approved for the treatment of certain
chronic lymphocytic leukemia indications, is available in Japan and
is also available in other territories via compassionate use or
oncology access programs. Daratumumab is in clinical development by
Janssen for the treatment of additional multiple myeloma
indications, other blood cancers and amyloidosis. Genmab also has a
broad clinical and pre-clinical product pipeline. Genmab's
technology base consists of validated and proprietary next
generation antibody technologies - the DuoBody® platform for
generation of bispecific antibodies, the HexaBody® platform, which
creates effector function enhanced antibodies, the HexElect®
platform, which combines two co-dependently acting HexaBody
molecules to introduce selectivity while maximizing therapeutic
potency and the DuoHexaBody® platform, which enhances the potential
potency of bispecific antibodies through hexamerization. The
company intends to leverage these technologies to create
opportunities for full or co-ownership of future products. Genmab
has alliances with top tier pharmaceutical and biotechnology
companies. Genmab is headquartered in Copenhagen, Denmark with
sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and
Tokyo, Japan.
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®. Arzerra® and Kesimpta® are
trademarks of Novartis AG or its affiliates. DARZALEX® and DARZALEX
FASPRO™ are trademarks of Janssen Pharmaceutica NV. TEPEZZA® is a
trademark of Horizon Therapeutics plc.
Company Announcement no. 49CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
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