- Data presented from updated analysis
of full innovaTV 201 expansion cohort in recurrent or metastatic
cervical cancer
Genmab A/S (Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc.
(Nasdaq: SGEN) announced today that updated clinical data from the
innovaTV 201 Phase II study evaluating tisotumab vedotin in
patients with recurrent and/or metastatic cervical cancer will be
presented as a poster at the European Society for Medical Oncology
(ESMO) 2018 Congress taking place in Munich, Germany from October
19 to 23, 2018. Tisotumab vedotin is an investigational
antibody-drug conjugate (ADC) designed to target the Tissue Factor
antigen, which is expressed on a broad range of solid tumors.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20181008005822/en/
“We look forward to presenting an update on the expanded
cervical cancer cohort data showing that tisotumab vedotin
continues to demonstrate tolerability and clinical activity in
heavily pretreated patients with cervical cancer. We anticipate
publishing the final data from this cohort in the future,” said Jan
van de Winkel, Ph.D., Chief Executive Officer of Genmab. “In the
past year, the development program of tisotumab vedotin has also
been expanded with additional trials and indications, and we are
excited about the continued growth of this program.”
“In the recurrent and metastatic cervical cancer setting, there
remains an unmet need for new treatment options,” said Roger
Dansey, M.D., Chief Medical Officer at Seattle Genetics. “We are
pleased to be collaborating with Genmab to advance tisotumab
vedotin in the potentially pivotal innovaTV 204 clinical trial in
cervical cancer and to evaluate its potential in a broad range of
other solid tumors.”
Details of Poster Presentation:
Title: A Phase IIa study of tisotumab vedotin in patients with
previously treated recurrent or metastatic cervical cancer: updated
analysis of full cervical expansion cohortPresenter: Nicole Concin,
M.D. Medical University of Innsbruck, AustriaAbstract #:
963PSession: Poster Display Session: Biomarkers, Gynaecological
cancers, Haematological malignancies, Immunotherapy of cancer, New
diagnostic tools, NSCLC - early stage, locally advanced &
metastatic, SCLC, Thoracic malignancies, Translational researchDate
and Time: October 20, 12:30-13:30 CESTLocation: Hall A3 Poster
Area
The abstract is available on the ESMO website at
www.esmo.org.
About the innovaTV 201 (GEN701) Study
The innovaTV 201 study is a 170 patient, two-part Phase I/II
study of tisotumab vedotin in eight types of solid tumors: ovarian,
cervical, endometrial, bladder, prostate, esophageal, lung, and
head and neck. Part 1 is a classical 3+3 dose escalation design
testing various doses of tisotumab vedotin once every three weeks
to establish the recommended Phase II (RP2D) and maximum tolerated
dose as well as the safety profile of tisotumab vedotin. Part 2 of
the study investigates all eight indications in parallel expansion
cohorts. The cervical cancer cohort includes 55 patients. Patients
receive 2.0 mg/kg (=RP2D) of tisotumab vedotin once every three
weeks. The primary objective of this part of the study is to
further investigate the safety profile of tisotumab vedotin and
preliminary efficacy.
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 cell 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 or planned Phase II
trials in recurrent and/or metastatic cervical cancer, ovarian
cancer and other solid tumors. Tisotumab vedotin is being
co-developed by Genmab and Seattle Genetics.
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 and other
blood cancers. 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, the HexaBody® platform, which
creates effector function enhanced antibodies and the HexElect™
platform, which combines two co-dependently acting HexaBody
molecules to introduce selectivity while maximizing therapeutic
potency. 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, Inc. is an emerging multi-product, global
biotechnology company that develops and commercializes
transformative therapies targeting cancer to make a meaningful
difference in people’s lives. ADCETRIS® (brentuximab vedotin)
utilizes the company’s industry-leading antibody-drug conjugate
(ADC) technology and is currently approved for the treatment of
multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company
has established a pipeline of novel targeted therapies at various
stages of clinical testing, including three in ongoing pivotal
trials for solid tumors. Enfortumab vedotin for metastatic
urothelial cancer and tisotumab vedotin for metastatic cervical
cancer utilize our proprietary ADC technology. Tucatinib, a small
molecule tyrosine kinase inhibitor, is in a pivotal trial for
HER2-positive metastatic breast cancer. In addition, we are
leveraging our expertise in empowered antibodies to build a
portfolio of proprietary immuno-oncology agents in clinical trials
targeting hematologic malignancies and solid tumors. The company is
headquartered in Bothell, Washington, and has a European office in
Switzerland. For more information on our robust pipeline, visit
www.seattlegenetics.com and follow @SeattleGenetics on Twitter.
Forward Looking Statement for Genmab
This 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 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 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®. Arzerra® is
a trademark of Novartis AG or its affiliates. DARZALEX® is a
trademark of Janssen Pharmaceutica NV.
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 benefits and uses as
monotherapy, and the referenced Phase I/II clinical trial. 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 the risk of adverse events of tisotumab vedotin,
including the potential for newly-emerging safety signals, delays
in planned clinical trial initiations, enrollment and conduct,
obtaining data from clinical trials, and anticipated regulatory
submissions and approvals in each case for a variety of reasons,
including the difficulty and uncertainty of pharmaceutical product
development, unexpected adverse events and/or adverse regulatory
action, possible required modifications to clinical trials and the
inability to provide information and institute safety mitigation
measures as required by the FDA or other regulatory
authorities from time to time, failure to properly conduct or
manage the company’s clinical trials and failure of clinical
results to support continued development or regulatory approvals,
in which case our clinical trials may be delayed or discontinued.
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
June 30, 2018 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,
except as required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181008005822/en/
Genmab A/SRachel Curtis
Gravesen, +45 33 44 77 20Senior Vice President, Investor Relations
& CommunicationM: +45 25 12 62 60rcg@genmab.comorSeattle GeneticsMedia:Monique Greer,
425-527-4641mgreer@seagen.comorInvestors:Peggy Pinkston,
425-527-4160ppinkston@seagen.com
Seagen (NASDAQ:SGEN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Seagen (NASDAQ:SGEN)
Historical Stock Chart
From Apr 2023 to Apr 2024