Seattle Genetics to Present SGN-35 and Lintuzumab Clinical Data at the European Hematology Association Congress
“In our SGN-35 presentation at EHA, we will provide additional data on durability of response and progression-free survival of patients in our every three week dosing study,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. “In addition, we will report a strong concordance between investigator-assessed and independent review of responses in the trial.”
The SGN-35 abstract is titled “Robust antitumor activity of the antibody-drug conjugate SGN-35 when administered every three weeks to patients with relapsed or refractory CD30-positive hematologic malignancies in a phase I study,” (Abstract #503). Updated data will be presented in an oral presentation on June 6, 2009, during a clinical session on Hodgkin lymphoma.
Seattle Genetics is advancing SGN-35 in an ongoing pivotal trial for relapsed and refractory Hodgkin lymphoma and a planned phase II trial for systemic anaplastic large cell lymphoma. The pivotal trial is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). SGN-35 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 Genetics' 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.
The lintuzumab abstract, #833, is titled “Prolonged exposure to lintuzumab monotherapy in acute myeloid leukemia and myelodysplastic syndromes – results of a phase I trial.” The data will be presented in an acute myeloid leukemia (AML) poster session on June 6, 2009.
“The presentation on lintuzumab will provide complete data from our phase I single-agent clinical trial in more than 80 patients,” added Dr. Reynolds. “Findings will include data on the tolerability profile and objective responses with lintuzumab as monotherapy in AML and myelodysplastic syndromes, primarily in older patients who were not candidates for intensive therapies.”
Lintuzumab is a humanized monoclonal antibody targeting CD33. Seattle Genetics is conducting a phase IIb randomized, double-blind, placebo-controlled clinical trial evaluating whether the combination of lintuzumab and low-dose cytarabine chemotherapy extends overall survival compared to low-dose cytarabine plus placebo in previously untreated AML patients age 60 and older who decline intensive chemotherapy. Full accrual of 210 patients to the phase IIb trial is complete, and data are expected in the first half of 2010.
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 company's lead product candidate, SGN-35, is in a pivotal trial under an SPA with the FDA. SGN-35 is empowered by Seattle Genetics' proprietary ADC technology comprising highly potent synthetic drugs and stable linkers for attaching the drugs to monoclonal antibodies. In addition, Seattle Genetics has three other product candidates in ongoing clinical trials: dacetuzumab (SGN-40), lintuzumab (SGN-33) and SGN-70. Dacetuzumab is being developed under a worldwide collaboration with Genentech (a wholly-owned member of the Roche Group). Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Genentech, Bayer, CuraGen, Progenics, Daiichi Sankyo, MedImmune, a subsidiary of AstraZeneca, and Millennium: The Takeda Oncology Company, as well as an ADC co-development agreement with Agensys, a subsidiary of Astellas Pharma. More information can be found at www.seattlegenetics.com.
Certain of the statements made in this press release are forward looking, such as those, among others, relating to the updated SGN-35 and complete lintuzumab phase I data to be provided at the EHA Congress. 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 adverse events, regulatory issues or other factors prior to the provision of such data. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company's Form 10-K for the year ended December 31, 2008 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.
Contact: Seattle Genetics, Inc.
Peggy Pinkston, 425-527-4160
Posted: May 2009