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Seattle Genetics Initiates Phase 1 Clinical Trial of SEA-BCMA for Patients with Relapsed or Refractory Multiple Myeloma

November 14, 2018

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/

CONTACT: Media:

Monique Greer

(425) 527-4641

mgreer@seagen.com

Investors:

Peggy Pinkston

(425) 527-4160

ppinkston@seagen.com

KEYWORD: UNITED STATES NORTH AMERICA WASHINGTON

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS ONCOLOGY PHARMACEUTICAL RESEARCH SCIENCE

SOURCE: Seattle Genetics, Inc.

Copyright Business Wire 2018.

PUB: 11/14/2018 08:00 AM/DISC: 11/14/2018 08:01 AM

http://www.businesswire.com/news/home/20181114005225/en

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