Genmab and Seattle Genetics to Initiate New Study of Novel Antibody-Drug Conjugate Tisotumab Vedotin in Cervical Cancer
October 10 2017 - 6:44AM
Business Wire
- Phase II study of tisotumab vedotin
in patients with advanced cervical cancer
- Study provides opportunity for
accelerated approval and is expected to begin in the coming
months
Genmab A/S (Nasdaq Copenhagen: GEN) and Seattle Genetics,
Inc. (NASDAQ: SGEN) announced today a decision to start a Phase II
study of tisotumab vedotin in patients with recurrent and/or
metastatic cervical cancer. The study could provide the basis
for a regulatory application for approval. Tisotumab vedotin
consists of a tissue factor (TF)-targeted antibody linked to the
cell-killing agent monomethyl auristatin E (MMAE). TF is a protein
expressed on a broad range of solid tumors. The Phase II trial is
single arm and includes about 100 patients with recurrent or
metastatic cervical cancer who relapsed or progressed after
standard of care treatment. The companies plan to start enrolling
patients by the first half of 2018.
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“We are very pleased to see the clinical development of
tisotumab vedotin progress in patients with cervical cancer – an
area with a strong unmet medical need. The study provides an
opportunity for accelerated registration. We look forward to the
continuing development of this promising first-in-class
antibody-drug conjugate,” said Jan van de Winkel, Ph.D., Chief
Executive Officer of Genmab.
“Standard therapies for previously treated recurrent and/or
metastatic cervical cancer generally result in response rates of
less than 15 percent and a median overall survival of six to eight
months,” said Clay Siegall, Ph.D., President and Chief Executive
Officer of Seattle Genetics. “Based on promising data from the
phase 1/2 clinical trial of tisotumab vedotin in recurrent and/or
metastatic cervical cancer and feedback from the Food and Drug
Administration (FDA) on the planned trial, we and Genmab are
advancing the program into a potentially registrational study for
these patients with high unmet medical need.”
About the Phase II study
The single arm, multicenter Phase II study (GCT1015-04) of
tisotumab vedotin monotherapy is expected to enroll about 100
patients with recurrent or metastatic cervical cancer who have
experienced disease progression on or after platinum containing
chemotherapy and who have received or are ineligible for
bevacizumab. The primary endpoint of the study is overall response
rate (ORR) as assessed by independent review of RECIST v1.1
criteria. The main secondary endpoints are duration of response
(DoR) and safety.
About Cervical Cancer
Cervical cancer originates in the cells lining the cervix, which
connects the uterus to the birth canal. About 13,000 women are
expected to be diagnosed with cervical cancer in the US in 2017,
with an estimated 4000 deaths. Globally, it was estimated that
527,000 people would be diagnosed and 265,000 would die from the
disease in 2012, the vast majority of these patients being in the
developing world. Routine medical examinations and the human
papillomavirus (HPV) vaccine have had a positive impact on the
incidence of cervical cancer in the developed world. Despite these
advances, women are still diagnosed with cervical cancer, which can
have a devastating impact, particularly in the recurrent or
metastatic setting. Standard therapies for previously treated
recurrent/metastatic cervical cancer generally result in response
rates of less than 15 percent and a median overall survival of 6 to
8 months.
About Tisotumab Vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) composed
of Genmab’s human antibody that binds to tissue factor (TF) and
Seattle Genetics’ ADC technology that utilizes a cleavable linker
and the cytotoxic drug monomethyl auristatin E (MMAE). TF is a
protein involved in tumor signaling and angiogenesis. Based on its
high expression on many solid tumors and its rapid internalization,
TF was selected as a target for an ADC approach. Tisotumab vedotin
is being evaluated in ongoing Phase I/II clinical studies for solid
tumors and a Phase II trial in recurrent and/or metastatic cervical
cancer is planned to start by the first half of 2018. Tisotumab
vedotin is being co-developed by Genmab and Seattle Genetics, under
an agreement in which the companies share all future costs and
profits for the product on a 50:50 basis.
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 has two approved antibodies, DARZALEX® (daratumumab)
for the treatment of certain multiple myeloma indications, and
Arzerra® (ofatumumab) for the treatment of certain chronic
lymphocytic leukemia indications. Daratumumab is in clinical
development for additional multiple myeloma indications, other
blood cancers, and solid tumors. A subcutaneous formulation of
ofatumumab is in development for relapsing multiple sclerosis.
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, and the HexaBody® platform
which creates effector function enhanced antibodies. 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. For more
information visit www.genmab.com.
About Seattle Genetics
Seattle Genetics is an innovative biotechnology company
dedicated to improving the lives of people with cancer through
novel antibody-based therapies. The company’s industry-leading
antibody-drug conjugate (ADC) technology harnesses the targeting
ability of antibodies to deliver cell-killing agents directly to
cancer cells. Seattle Genetics commercializes ADCETRIS®
(brentuximab vedotin) for the treatment of several types of
CD30-expressing lymphomas. The company is also advancing a robust
pipeline of novel therapies for solid tumors and blood-related
cancers designed to address significant unmet medical needs and
improve treatment outcomes for patients. More information can be
found at www.seattlegenetics.com and follow @SeattleGenetics on
Twitter
Forward Looking Statement for Genmab
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 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. Genmab does not undertake any obligation to update
or revise forward looking statements in this Company Announcement
nor to confirm such statements in relation to actual results,
unless required by law.
Genmab A/S and its subsidiaries own the following trademarks:
Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the
Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™;
HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra® is
a trademark of Novartis AG or its affiliates. DARZALEX® is a
trademark of Janssen Biotech, Inc.
Forward Looking Statement for Seattle Genetics
Certain of the statements made in this press release are
forward-looking, such as those, among others, relating to the
therapeutic potential of tisotumab vedotin, its possible use in
treatment of cervical cancer, the timing, size or conduct of the
Phase II clinical trial, and the possibility that the trial and
resulting data could support registration or accelerated approval
of tisotumab vedotin. Actual results or developments may differ
materially from those projected or implied in these forward-looking
statements. Factors that may cause such a difference include the
inability of tisotumab vedotin to show sufficient activity in the
clinical setting referenced above and in future potential clinical
trials, the risk of adverse events associated with tisotumab
vedotin and regulatory actions which may affect the future
development of our drug candidates or those of our collaborators.
More information about the risks and uncertainties faced by Seattle
Genetics is contained under the caption “Risk Factors” included in
the company’s Quarterly Report on Form 10-Q for the quarter ended
August 1, 2017 filed with the Securities and Exchange Commission.
Seattle Genetics disclaims any intention or obligation to update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
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GenmabRachel Curtis Gravesen, +45 33 44 77 20Senior Vice
President, Investor Relations & CommunicationsM: +45 25 12 62
60r.gravesen@genmab.comorSeattle GeneticsInvestors:Peggy
Pinkston, 425-527-4160Vice President, Investor
Relationsppinkston@seagen.comorMedia:Kavita V. Shah,
425-527-4188Ph.D., Associate Director, Corporate
Communicationskshah@seagen.com
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