Seattle Genetics Initiates Phase 1 Trial of SGN-CD123A for Patients with Relapsed or Refractory Acute Myeloid Leukemia
September 19 2016 - 8:00AM
Business Wire
-SGN-CD123A, A Novel Antibody-Drug Conjugate
(ADC), Represents Seattle Genetics’ Second Clinical ADC Program
Focused on AML-
- Preclinical Data Showing Potent Anti-Leukemic
Activity of SGN-CD123A Presented at the 2015 American Society of
Hematology Annual Meeting-
Seattle Genetics, Inc. (NASDAQ: SGEN) today announced enrollment
of the first patient in a multicenter phase 1 clinical trial of
SGN-CD123A for patients with relapsed or refractory acute myeloid
leukemia (AML). SGN-CD123A is an investigational antibody-drug
conjugate (ADC) targeted to CD123 utilizing Seattle Genetics’
proprietary technology, an engineered cysteine antibody (EC-mAb)
stably linked to a highly potent DNA binding agent called a
pyrrolobenzodiazepine (PBD) dimer. CD123 is expressed across AML
subtypes, including leukemic stem cells, which are difficult to
kill and may be responsible for high relapse rates even following
intensive therapy. The trial is designed to assess the safety and
anti-leukemic activity of SGN-CD123A. SGN-CD123A represents Seattle
Genetics’ second clinical-stage program in development for AML,
reflecting the company’s commitment to addressing the significant
unmet need for these patients.
“AML is an aggressive, life-threatening disease with at least
33,000 newly diagnosed cases in the U.S. and Europe each year, and
those patients have few effective treatment options,” said Jonathan
Drachman, M.D., Chief Medical Officer and Executive Vice President,
Research and Development at Seattle Genetics. “ADCs are an
established treatment modality designed to specifically target
cancer cells and minimize toxic side effects. The significant unmet
need for AML and frequent expression of the validated target CD123
on leukemic stem cells support initiating this phase 1 clinical
trial. Through our SGN-CD123A program, alongside vadastuximab
talirine targeted to CD33 and currently in a phase 3 study, we are
making a substantial effort to develop novel treatment options for
AML patients.”
The study is a phase 1, open-label, multicenter, dose-escalation
clinical trial. It will initially evaluate the maximum tolerated
dose of SGN-CD123A, followed by an expansion cohort to further
define safety and estimate anti-leukemic activity. In addition, the
trial will assess pharmacokinetics, remission rate, duration of
complete remission and overall survival. The study is designed to
evaluate SGN-CD123A administered every three weeks and will enroll
up to approximately 100 relapsed or refractory patients at multiple
centers in the United States.
Preclinical SGN-CD123A data presented at the 2015 American
Society of Hematology (ASH) Annual Meeting demonstrated enhanced
anti-leukemic activity across multiple AML disease models,
including those typically resistant to chemotherapy. With more than
15 years of experience and innovation, Seattle Genetics is the
leader in ADC development. ADCs are designed to selectively deliver
cell-killing agents to tumor cells, and thus reduce many of the
toxic effects of traditional chemotherapy while enhancing antitumor
activity.
For more information about the trial, including enrolling
centers, please visit www.clinicaltrials.gov.
About Acute Myeloid Leukemia
Acute myeloid leukemia, also called acute myelocytic leukemia or
AML, is an aggressive type of cancer of the bone marrow and blood
that progresses rapidly without treatment. AML starts in the bone
marrow (the interior part of bones, where new blood cells are made)
and quickly moves into the blood. According to the SEER database
and Kantar Health Sciences, in 2016 approximately 33,000 new cases
of AML (mostly in adults) will be diagnosed in the U.S. and Europe.
In the U.S. alone, nearly 10,500 deaths will occur from AML this
year.
About SGN-CD123A
SGN-CD123A is a novel ADC targeted to CD123 utilizing Seattle
Genetics’ proprietary technology. CD123 is expressed across AML
subtypes, including on leukemic stem cells, which are difficult to
kill and may be responsible for high relapse rates even following
intensive therapy. The CD123 antibody is attached to a highly
potent DNA binding agent, a pyrrolobenzodiazepine (PBD) dimer, via
a proprietary site-specific conjugation technology to a monoclonal
antibody with engineered cysteines (EC-mAb). PBD dimers are
significantly more potent than systemic chemotherapeutic drugs and
the site-specific conjugation technology (EC-mAb) allows uniform
drug-loading of the cell-killing PBD agent to the anti-CD123
antibody. The ADC is designed to be stable in the bloodstream and
to release its potent DNA binding agent upon internalization into
CD123-expressing cells.
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 65
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 is also advancing 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, 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 the therapeutic
potential of SGN-CD123A and planned clinical trials including
potential patient and site enrollment. 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 to show sufficient activity in
this recently initiated clinical trial and the risk of adverse
events as SGN-CD123A advances in clinical trials and regulatory
actions. 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, 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/20160919005140/en/
Seattle GeneticsInvestors:Peggy Pinkston,
425-527-4160ppinkston@seagen.comorMedia:Kavita V. Shah,
425-527-4188kshah@seagen.com
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