Seattle Genetics Announces First Patient Dosed in Phase 2 innovaTV 207 Trial Evaluating Tisotumab Vedotin in Multiple Solid T...
July 12 2018 - 8:00AM
Business Wire
-Trial to Inform Broader Development Program
Strategy-
-Trial is Enrolling Patients with Colorectal,
Non-Small Cell Lung, Pancreatic or Head and Neck Cancers-
Seattle Genetics, Inc. (Nasdaq:SGEN) today announced dosing of
the first patient in the phase 2 innovaTV 207 clinical trial
evaluating the activity, safety and tolerability of tisotumab
vedotin as monotherapy in selected solid tumors with high Tissue
Factor expression. Tissue Factor is overexpressed in a broad range
of solid tumors that are associated with a poor prognosis.
Tisotumab vedotin is an investigational antibody-drug conjugate
(ADC) designed to target the Tissue Factor antigen on the surface
of cancer cells and deliver the cell-killing agent monomethyl
auristatin E (MMAE) directly inside cancer cells. Tisotumab vedotin
is being developed in collaboration with Genmab A/S. The
potentially pivotal phase 2 trial innovaTV 204 evaluating tisotumab
vedotin for patients with cervical cancer who have relapsed and/or
progressed after standard of care treatment was recently
initiated.
“The initiation of the phase 2 innovaTV 207 basket trial will
enable us to explore the safety and activity of tisotumab vedotin
in several tumor types where Tissue Factor is also expressed and is
intended to inform a potentially broad development program that
maximizes the opportunity for this ADC beyond cervical cancer,”
said Roger Dansey, M.D., Chief Medical Officer at Seattle
Genetics.
The phase 2 innovaTV 207 trial is a global, multicenter, open
label basket trial that will enroll up to 200 adult patients with
relapsed, locally-advanced or metastatic disease in one of four
cohorts: colorectal cancer, squamous non-small cell lung cancer
(NSCLC), pancreatic adenocarcinoma, and squamous cell cancer of the
head and neck (SCCHN). Patients will be treated with single-agent
tisotumab vedotin every three weeks. The primary endpoint of the
trial is confirmed objective response rate (ORR) defined as the
proportion of patients who achieve a confirmed complete or partial
response. Key secondary endpoints include confirmed and unconfirmed
ORR, disease control rate, duration of response, progression-free
survival, overall survival, safety and tolerability.
For more information about the phase 2 innovaTV 207 clinical
trial of tisotumab vedotin, please visit www.clinicaltrials.gov,
(Identifier: NCT03485209).
About Tisotumab Vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) composed
of Genmab’s human antibody that binds to Tissue Factor and Seattle
Genetics’ ADC technology that utilizes a cleavable linker and the
cytotoxic drug monomethyl auristatin E (MMAE). In cancer biology,
Tissue Factor is a protein involved in tumor cell signaling and
angiogenesis. Based on its high expression on many solid tumors and
its rapid internalization, Tissue Factor was selected as a target
for an ADC approach. In an earlier study, tisotumab vedotin
demonstrated an encouraging response rate and manageable safety
profile in patients with relapsed, recurrent and/or metastatic
cervical cancer.
Tisotumab vedotin is being co-developed by Seattle Genetics,
Inc. and Genmab A/S.
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 Statements
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, the referenced phase 2 clinical trial, trial design,
targeted patient population and enrollment numbers, and the
intention of using the data therefrom to inform a potentially broad
clinical development program for tisotumab vedotin in collaboration
with Genmab, including evaluation in multiple solid tumor types,
and the company’s intention to become a global multi-product
oncology company. 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, 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; the inherent uncertainty
associated with the regulatory approval process, including the
risks that submissions for approval may not be accepted for filing
by, or ultimately approved by, the FDA in a timely manner
or at all, and that the company may otherwise experience a more
lengthy and costly regulatory approval process than anticipated;
the potential for newly-emerging safety signals, failure of
clinical results to support continued development or regulatory
approvals; failure to properly conduct or manage the company’s
clinical trials; and 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 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 March
31, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20180712005242/en/
Seattle Genetics, Inc.Media:Monique Greer, (425)
527-4641mgreer@seagen.comorInvestors:Peggy Pinkston, (425)
527-4160ppinkston@seagen.com
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