Seattle Genetics Initiates Phase 1 Trial of SGN-CD352A for Patients with Relapsed or Refractory Multiple Myeloma
January 05 2017 - 8:00AM
Business Wire
-SGN-CD352A, a Novel Antibody-Drug Conjugate
(ADC), Represents Seattle Genetics’ 9th Clinical Stage Program in a
Robust Pipeline of Empowered Antibody Therapies-
-Preclinical Data Showing Potent Antitumor
Activity of SGN-CD352A in B-cell Cancers Presented at the 2016
American Association of Cancer Research Annual Meeting-
Seattle Genetics, Inc. (NASDAQ: SGEN), a global biotechnology
company, today announced enrollment of the first patient in a
multicenter phase 1 clinical trial of SGN-CD352A for patients with
relapsed or refractory multiple myeloma (MM). SGN-CD352A is an
investigational CD352-targeted antibody-drug conjugate (ADC)
utilizing Seattle Genetics’ proprietary ADC technology, an
engineered cysteine antibody (EC-mAb) stably linked to a highly
potent cytotoxic agent called a pyrrolobenzodiazepine (PBD) dimer.
CD352 is broadly expressed on B-cell cancers including multiple
myeloma, chronic lymphocytic leukemia and non-Hodgkin lymphoma,
while exhibiting low expression on normal white blood cells. The
trial is designed to assess the safety and antitumor activity of
SGN-CD352A. This study represents Seattle Genetics’ first
clinical-stage ADC program in development for MM, demonstrating the
breadth of potential therapeutic applications for its
industry-leading ADC technology platform.
“More than 124,000 people worldwide are diagnosed annually with
multiple myeloma, most relapsing or becoming resistant to current
therapies,” said Robert Lechleider, M.D., Senior Vice President,
Clinical Development at Seattle Genetics. “SGN-CD352A is a novel
targeted investigational compound for multiple myeloma, and it is
our latest antibody-drug conjugate, or ADC, in an expanding and
robust pipeline of clinical stage empowered antibody therapies to
address blood cancers and solid tumors. As we begin clinical
development of our first compound for multiple myeloma, we continue
to explore the broad potential of our ADC technology platform for
people with cancer.”
The phase 1, open-label multicenter clinical study is designed
to evaluate the safety and preliminary antitumor activity of
SGN-CD352A as a single agent in adults with relapsed or refractory
MM. The trial will be conducted in two parts, with a dose
escalation part to identify the maximum tolerated dose of
SGN-CD352A followed by an expansion part to further define safety
and antitumor activity. SGN-CD352A will be administered every four
weeks, and the study will enroll approximately 75 relapsed or
refractory patients at multiple centers in the United States.
Preclinical SGN-CD352A data presented at the 2016 American
Association of Cancer Research (AACR) Annual Meeting demonstrated
that SGN-CD352A specifically binds to target cells and induces
potent antitumor activity in both MM and non-Hodgkin lymphoma
disease models. In addition to being a potential new monotherapy
for MM, the tolerability profile from preclinical results suggests
that SGN-CD352A may be combined with current standard of care
treatments for MM. ADCs are designed to selectively deliver
cell-killing agents to tumor cells, and thus may reduce many of the
toxic effects of traditional chemotherapy while enhancing antitumor
activity. With more than 15 years of experience and innovation,
Seattle Genetics is the leader in ADC development.
For more information about the trial, including enrolling
centers, please visit www.clinicaltrials.gov.
About Multiple Myeloma
Multiple myeloma (MM) is a rare and aggressive cancer that forms
in white blood cells called plasma cells. Cancerous plasma cells
can crowd out healthy blood cells, impair bone strength and weaken
the immune system. Despite recent medical advances, MM still
remains an incurable disease in which patients eventually progress
and die. Within one year of first-line therapy, 32 percent of
transplant patients and 44 percent of non-transplant patients
relapse. Remission periods are typically shorter for each
subsequent line of therapy, with some patients receiving more than
four lines of treatment over the course of their disease. After
lymphoma and leukemia, MM is the third most common blood cancer in
the US. According to the World Health Organization, in 2015 more
than 124,000 new cases of MM were diagnosed worldwide and more than
87,000 people died from the disease.
About SGN-CD352A
SGN-CD352A is a novel investigational ADC targeted to CD352
utilizing Seattle Genetics’ proprietary ADC technology. CD352 is
broadly expressed on B-cell cancers including multiple myeloma,
chronic lymphocytic leukemia, and non-Hodgkin lymphoma, while
exhibiting low expression on normal white blood cells. The CD352
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
CD352-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 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 the therapeutic
potential of SGN-CD352A and its possible benefits and uses, 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-CD352A
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
September 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/20170105005273/en/
Seattle Genetics, Inc.Investors:Peggy Pinkston,
425-527-4160ppinkston@seagen.comorMedia:Kavita V. Shah, Ph.D.,
425-527-4188kshah@seagen.com
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