FDA Lifts Clinical Hold on Seattle Genetics’ Phase 1 Trials of Vadastuximab Talirine
March 06 2017 - 6:45AM
Business Wire
Seattle Genetics, Inc. (Nasdaq:SGEN), a global biotechnology
company, today announced that the U.S. Food and Drug Administration
(FDA) has lifted the clinical hold announced on December 27, 2016
on phase 1 trials of vadastuximab talirine (SGN-CD33A; 33A) in
acute myeloid leukemia (AML).
“The clinical hold on our early-stage vadastuximab talirine
clinical trials has been resolved through a comprehensive analysis
of the clinical data from over 300 patients treated to date,
evaluation by an independent committee of clinical experts,
collaborative interactions with the FDA, and protocol amendments
designed to further enhance patient safety,” said Jonathan
Drachman, M.D., Chief Medical Officer and Executive Vice President,
Research and Development at Seattle Genetics. “We will resume two
phase 1 trials in AML and plan to initiate a randomized phase 2
trial during 2017 evaluating vadastuximab talirine in combination
with standard of care chemotherapy in frontline, younger AML
patients. In addition, we are continuing to enroll our ongoing
phase 3 randomized CASCADE trial in frontline older AML patients
and our phase 1/2 trial in frontline high-risk myelodysplastic
syndrome (MDS).”
Seattle Genetics will resume two phase 1 trials of vadastuximab
talirine. The first is combination treatment with standard of care,
or 7+3, chemotherapy in newly diagnosed younger AML patients and
the second is monotherapy and combination treatment with
hypomethylating agents in both newly diagnosed and relapsed AML
patients. Seattle Genetics will not resume the phase 1/2 trial of
vadastuximab talirine monotherapy in pre- and post-allogeneic
transplant AML patients given the challenges of developing
therapies in this specific setting. The company’s randomized global
phase 3 CASCADE trial in frontline older AML and phase 1/2 trial in
frontline MDS were not placed on clinical hold and have continued
to enroll patients. Planned studies include a randomized phase 2
trial of vadastuximab talirine in combination with 7+3 chemotherapy
in frontline younger AML patients. Going forward, additional risk
mitigation measures will be implemented in all vadastuximab
talirine studies, including revised eligibility criteria and
stopping rules for veno-occlusive disease (VOD).
About Vadastuximab Talirine
Vadastuximab talirine (SGN-CD33A; 33A) is a novel
investigational ADC targeted to CD33 utilizing Seattle Genetics’
proprietary ADC technology. CD33 is expressed on most AML and MDS
blast cells. The CD33 engineered cysteine antibody is stably linked
to a highly potent DNA binding agent called a pyrrolobenzodiazepine
(PBD) dimer via site-specific conjugation technology (EC-mAb). PBD
dimers are significantly more potent than systemic chemotherapeutic
drugs and the EC-mAb technology allows uniform drug-loading onto an
ADC. The ADC is designed to be stable in the bloodstream and to
release its potent cell-killing PBD agent upon internalization into
CD33-expressing cells.
Vadastuximab talirine was granted Orphan Drug Designation by
both the U.S. Food and Drug Administration (FDA) and the European
Commission for the treatment of AML. FDA orphan drug designation is
intended to encourage companies to develop therapies for the
treatment of diseases that affect fewer than 200,000 individuals in
the United States.
About Seattle Genetics
Seattle Genetics is an innovative biotechnology company that
develops and commercializes novel antibody-based therapies for the
treatment of cancer. 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.
ADCETRIS® (brentuximab vedotin), the company’s lead product, in
collaboration with Takeda Pharmaceutical Company Limited, is the
first in a new class of ADCs commercially available globally in 66
countries for relapsed classical Hodgkin lymphoma (HL) and relapsed
systemic anaplastic large cell lymphoma (sALCL). Seattle Genetics
is also advancing vadastuximab talirine (SGN-CD33A; 33A), an ADC in
a phase 3 trial for acute myeloid leukemia. Headquartered in
Bothell, Washington, Seattle Genetics has a robust pipeline of
innovative therapies for blood-related cancers and solid tumors
designed to address significant unmet medical needs and improve
treatment outcomes for patients. The company has collaborations for
its proprietary ADC technology with a number of companies including
AbbVie, Astellas, Bayer, Celldex, Genentech, GlaxoSmithKline and
Pfizer. More information can be found at
www.seattlegenetics.com.
Forward-Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to our resumption of
clinical studies, future clinical trials and development activities
relating to 33A including the planned initiation of a randomized
phase 2 trial of vadastuximab talirine in combination with standard
of care chemotherapy in frontline, younger AML patients during 2017
and the possibility that vadastuximab talirine may be approved for
treatment of AML. 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
potential for newly emerging safety signals, failure of clinical
results to support on-going development, adverse regulatory
actions, failure to properly conduct or manage the clinical
studies, 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 in
the world from time to time in which case these 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 Annual Report on
Form 10-K for the year ended December 31, 2016 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: http://www.businesswire.com/news/home/20170306005337/en/
Seattle Genetics, Inc.Investors:Peggy Pinkston,
425-527-4160ppinkston@seagen.comorMedia:Brandi Robinson,
425-527-2910brobinson@seagen.com
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