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Seattle Genetics and Millennium to Present Brentuximab Vedotin (SGN-35) Clinical Data at the American Society of Clinical Oncol

^{Published on 2010-05-21 04:10:24 - Market Wire}
 

BOTHELL, Wash.--([ BUSINESS WIRE ])--Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium: The Takeda Oncology Company today announced that data regarding retreatment experiences with brentuximab vedotin in phase I and phase II clinical trials will be presented during a poster session at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 4-8, 2010 in Chicago, Illinois. The presentation will highlight data from Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL) patients who have been retreated upon relapse after discontinuing previous brentuximab vedotin therapy.

"Objective responses with brentuximab vedotin (SGN-35) retreatment in CD30-positive hematologic malignancies: A case series"

Details of the ASCO presentation are below and the full abstract is available on the ASCO website at [ www.asco.org ].

aObjective responses with brentuximab vedotin (SGN-35) retreatment in CD30-positive hematologic malignancies: A case seriesa

• Saturday, June 5, 2010, 8:00 a.m. to 12:00 p.m. Central Time
• Abstract # 8062
• Poster session: Lymphoma and plasma cell disorders
• First author: Dr. Nancy L. Bartlett, Siteman Cancer Center, Washington University, St. Louis, Missouri

About Brentuximab Vedotin

Brentuximab vedotin is an antibody-drug conjugate (ADC) comprising an anti-CD30 antibody attached by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE), using Seattle Geneticsa™ proprietary technology. The ADC is designed to be stable in the bloodstream, but to release MMAE upon internalization into CD30-expressing tumor cells, resulting in targeted cell-killing.

Seattle Genetics is developing brentuximab vedotin in collaboration with Millennium, under which Seattle Genetics has U.S. and Canadian development and commercialization rights and the Takeda Group has rights to develop and commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

Under the collaboration, Seattle Genetics and Millennium are conducting a pivotal trial of brentuximab vedotin for relapsed and refractory Hodgkin lymphoma under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). The pivotal trial was also discussed with the European Medicines Agency during the process of obtaining EU Centralized Scientific Advice on the brentuximab vedotin development program. Top-line data from the pivotal trial are expected in the second half of 2010. In addition, the companies are conducting a phase III clinical trial (the AETHERA trial) for patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant, a phase II trial for relapsed and refractory systemic ALCL, a phase II retreatment trial for relapsed patients who previously responded to brentuximab vedotin, and a phase I combination trial for front-line treatment of Hodgkin lymphoma.

About Seattle Genetics

Seattle Genetics is a clinical stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease. The companya™s lead product candidate, brentuximab vedotin, is in a pivotal trial under an SPA with the FDA. Brentuximab vedotin is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has four other product candidates in ongoing clinical trials: lintuzumab (SGN-33), dacetuzumab (SGN-40), SGN-70 and SGN-75. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Bayer; Celldex Therapeutics; Daiichi Sankyo; Genentech; GlaxoSmithKline; MedImmune, a subsidiary of AstraZeneca; Millennium: The Takeda Oncology Company; and Progenics, as well as an ADC co-development agreement with Agensys, an affiliate of Astellas. More information can be found at [ www.seattlegenetics.com ].

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Companya™s research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, [ www.millennium.com ].

For Seattle Genetics: Certain of the statements made in this press release are forward looking, such as those, among others, relating to the regulatory pathway and timelines of brentuximab vedotin. 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, among others: that the company may experience delays in the completion of the clinical trials of brentuximab vedotin in Hodgkin lymphoma and systemic ALCL, whether caused by competition, adverse events, patient enrollment rates, regulatory issues or other factors; that the clinical trials, including the pivotal clinical trial for relapsed or refractory Hodgkin lymphoma, may not demonstrate that brentuximab vedotin is both safe and effective; that data from our phase I clinical trials of brentuximab vedotin may not necessarily be indicative of the subsequent clinical trial results, including our potential pivotal clinical trial results; and that the safety and/or efficacy results of these trials, including the brentuximab vedotin pivotal clinical trial for relapsed or refractory Hodgkin lymphoma, will not support an application for marketing approval in the United States or any other country. More information about the risks and uncertainties faced by Seattle Genetics is contained in the companya™s 10-Q for the quarter ended March 31, 2010 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.