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Press release from Business Wire

Seattle Genetics Highlights Data Presentations from Genentech ADC Collaborator Programs at ASH Annual Meeting

<p class='bwalignc'> <i>-Encouraging Phase I Data from Two ADC Programs Utilizing Seattle Genetics' Technology-</i> </p>

Tuesday, December 11, 2012

Seattle Genetics Highlights Data Presentations from Genentech ADC Collaborator Programs at ASH Annual Meeting07:00 EST Tuesday, December 11, 2012 ATLANTA (Business Wire) -- Seattle Genetics, Inc. (Nasdaq:SGEN) today highlighted clinical data from two antibody-drug conjugate (ADC) programs in development by Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) that utilize Seattle Genetics' technology. The data were presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. Phase I data from both ADCs, an anti-CD22 ADC (DCDT2980S, RG7593) and an anti-CD79b ADC (DCDS4501A, RG7596), demonstrated antitumor activity in relapsed or refractory B-cell non-Hodgkin lymphoma (NHL) patients at generally well-tolerated doses. These ADC programs are currently being evaluated in a phase II clinical trial for patients with relapsed or refractory B-cell NHL. “Genentech's phase I data and their advancement of these two ADCs into phase II clinical development, as well as their utilization of our technology in six other clinical-stage programs, illustrates their commitment to ADCs as an innovative, targeted approach to treat cancer,” said Eric Dobmeier, Chief Operating Officer of Seattle Genetics. “Across our ADC collaborations, there is broad potential for our industry-leading technology to address the significant need for more effective and better tolerated treatment options.” Anti-CD22-MMAE and anti-CD79b-MMAE are ADCs designed to deliver potent cytotoxic treatment to targeted cells with improved tolerability. With over a decade of experience and knowledge in ADC innovation, Seattle Genetics has developed proprietary technology employing synthetic cytotoxic agents, such as monomethyl auristatin E (MMAE), and stable linker systems that attach these cytotoxic agents to the antibody. Seattle Genetics' linker systems are designed to be stable in the bloodstream and release the potent cell-killing agent once inside targeted cancer cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity. ADCETRIS® (brentuximab vedotin) is the first drug approved utilizing Seattle Genetics' ADC technology. A Phase I Study of the Anti-CD79b Antibody-Drug Conjugate (ADC) DCDS4501A Targeting CD79b in Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (Abstract #56) A phase I clinical trial is being conducted to evaluate the safety and activity of DCDS4501A in patients with relapsed or refractory B-cell NHL. DCDS4501A is an ADC consisting of an anti-CD79b monoclonal antibody conjugated to the cytotoxic agent MMAE using Seattle Genetics' ADC technology. In this analysis, 47 patients were evaluable for safety and 32 were evaluable for efficacy. Key findings included: Patients enrolled in the study were diagnosed with a variety of types of B-cell NHL, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma. All patients had relapsed or refractory disease and were heavily pretreated, with a median of four prior systemic therapies. Ninety-six percent of patients had received prior rituximab and 29 percent had received a prior autologous stem cell transplant (ASCT). The median age of patients enrolled was 64. Patients received doses ranging from 0.1 milligrams per kilogram (mg/kg) to 2.4 mg/kg on an every three week basis, and 2.4 mg/kg was selected as the recommended phase II dose. Among all 32 patients evaluable for efficacy, ten patients (31 percent) had an objective response to single-agent DCDS4501A. Among the 17 patients treated at doses greater than or equal to 1.8 mg/kg, eight patients (47 percent) had an objective response. The most common adverse events were neutropenia, diarrhea, fever, nausea, fatigue, anemia, hyperglycemia and thrombocytopenia. Most adverse events were Grade 1 or 2. The most common Grade 3 or 4 adverse events were neutropenia, thrombocytopenia, anemia and leukopenia. A Phase I Study of DCDT2980S, an Antibody-Drug Conjugate (ADC) Targeting CD22, in Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (Abstract #59) A phase I clinical trial is being conducted to evaluate the safety and activity of DCDT2980S in patients with relapsed or refractory B-cell NHL. DCDT2980S is an ADC candidate consisting of an anti-CD22 monoclonal antibody conjugated to the cytotoxic agent MMAE using Seattle Genetics' ADC technology. In this analysis, 43 patients were evaluable for safety and 33 were evaluable for efficacy. Key findings included: Patients enrolled in the study were diagnosed with a variety of types of B-cell NHL, including DLBCL, follicular lymphoma, transformed follicular lymphoma and small lymphocytic lymphoma. All patients had relapsed or refractory disease and were heavily pretreated, with a median of four prior systemic therapies. All patients had received prior rituximab and 16 percent had received a prior autologous stem cell transplant. The median age of patients enrolled was 66. Patients received doses ranging from 0.1 mg/kg up to 3.2 mg/kg on an every three week basis, and 2.4 mg/kg was selected as the recommended phase II dose. Among all 33 patients evaluable for efficacy, nine patients (27 percent) had an objective response to single-agent DCDT2980S. Among the 17 patients treated at doses greater than or equal to 1.8 mg/kg, seven patients (41 percent) had an objective response, including one complete response and six partial responses. The most common adverse events were fatigue, diarrhea, nausea, neutropenia and decreased appetite. Most adverse events were Grade 1 or 2. The most common Grade 3 or 4 adverse events were neutropenia, anemia, diarrhea and peripheral neuropathy. A randomized phase II trial evaluating both DCDS4501A and DCDT2980S in combination with rituximab for relapsed or refractory B-cell NHL is currently enrolling. This trial is designed to enroll up to 120 patients at 40 clinical sites in North America and Europe. For more information about the trial, visit www.clinicaltrials.gov. About Seattle Genetics Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. The U.S. Food and Drug Administration granted accelerated approval of ADCETRIS in August 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Agensys (an affiliate of Astellas), Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys and Genmab. 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 therapeutic potential of our collaborators ADCs. 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 risk of adverse events as these ADCs advance in clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company's 10-Q for the quarter ended September 30, 2012 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. Seattle Genetics, Inc.Investors:Peggy Pinkston, +1-425-527-4160ppinkston@seagen.comorMedia:Tricia Larson, +1-425-527-4180tlarson@seagen.com