Seattle Genetics Announces First Patient Dosed in Phase 2 innovaTV 207 Trial Evaluating Tisotumab Vedotin in Multiple Solid Tumors

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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