-SEA-BCMA is a Novel Empowered Antibody Targeting BCMA for Multiple
Myeloma-
-Adds to Seattle Genetics’ Robust Clinical-Stage Development Pipeline
across Multiple Hematologic and Solid Tumors-
BOTHELL, Wash.--(BUSINESS WIRE)--Nov. 14, 2018--
Seattle
Genetics, Inc. (Nasdaq:SGEN) announced today dosing of the first
patient in a phase 1 clinical trial evaluating the safety and
tolerability of SEA-BCMA for patients with relapsed or refractory
multiple myeloma (MM). SEA-BCMA is an investigational antibody empowered
using Seattle Genetics’ proprietary Sugar Engineered Antibody (SEA)
technology designed to enhance antibody dependent cellular cytotoxicity.
The target of SEA-BCMA, the cell surface protein B-cell maturation
antigen (BCMA), is broadly expressed on malignant plasma cells in
multiple myeloma. SEA-BCMA has demonstrated encouraging antitumor
activity in preclinical studies.
“Despite recent advances in the treatment of multiple myeloma, it
remains an incurable disease with a need for active and well-tolerated
agents,” said Roger D. Dansey, M.D., Chief Medical Officer of Seattle
Genetics. “BCMA is a validated therapeutic target for multiple myeloma.
SEA-BCMA represents a novel empowered antibody treatment approach that
has demonstrated antitumor activity and an acceptable safety profile in
preclinical evaluation to date. We look forward to evaluating SEA-BCMA
through our clinical development program and hope to meaningfully
improve outcomes for multiple myeloma patients.”
The phase 1 trial is an open-label, multi-center, dose-escalation and
expansion clinical study designed to enroll approximately 65 patients
with relapsed or refractory MM in the United States. The study is
expected to be conducted in two parts, with a dose escalation cohort to
evaluate safety and tolerability and to determine the maximum tolerated
dose of SEA-BCMA, followed by an expansion cohort to obtain further data
regarding safety and antitumor activity.
Data presented at the American Association for Cancer Research (AACR)
Annual Meeting 2018 demonstrate that SEA-BCMA exhibits encouraging
preclinical antitumor activity and has the potential to be an active,
tolerable and combinable agent.
For more information about the phase 1 study of SEA-BCMA for patients
with multiple myeloma and enrolling centers, please visit www.clinicaltrials.gov
(Identifier: NCT03582033).
About Multiple Myeloma
Multiple myeloma (MM) is an 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. MM is
the second most common blood cancer in the United States. According to
the American Cancer Society, more than 30,000 new cases of MM were
expected in the U.S. in 2018, with over 12,500 deaths. Despite recent
medical advances, MM still remains an incurable disease. It is managed
with sequential lines of treatment that typically yield shorter
durations of disease control with each subsequent relapse, and some
patients receive more than four lines of treatment over the course of
their disease.
About SEA-BCMA
SEA-BCMA is a novel investigational antibody empowered using Seattle
Genetics’ proprietary Sugar Engineered Antibody (SEA) technology that
leads to enhanced antibody dependent cellular cytotoxicity. SEA-BCMA is
a non-fucosylated BCMA-directed antibody that is designed to block
proliferative tumor cell signaling, mediate antibody dependent cellular
phagocytosis and induce enhanced cell lysis through antibody dependent
cellular cytotoxicity. The cell surface protein BCMA is expressed on
cells of several cancer types, including multiple myeloma and other
B-cell malignancies. BCMA is a validated therapeutic target for multiple
myeloma.
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 SEA-BCMA and its possible benefits and uses as monotherapy
and in combination with other agents, and anticipated clinical trial,
patient enrollment target and intended endpoints. 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 SEA-BCMA to show sufficient activity
in the clinical setting referenced above and the risk of adverse events
in connection with SEA-BCMA. 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, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181114005225/en/
Source: Seattle Genetics, Inc.
Media:
Monique Greer
(425) 527-4641
mgreer@seagen.com
Investors:
Peggy Pinkston
(425) 527-4160
ppinkston@seagen.com