Trial Initiation Triggers $12 Million Milestone Payment from Genentech
BOTHELL, WA, USA | December 7, 2007 | Seattle Genetics, Inc. (Nasdaq:SGEN) announced today that it has initiated a phase IIb clinical trial of SGN-40 in combination with Rituxan(R) (rituximab) plus chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Under the terms of the company’s collaboration agreement with Genentech, Inc., Seattle Genetics will receive a $12 million milestone payment for initiating the study.
"This phase IIb clinical trial will provide key data on the safety and potential efficacy of adding SGN-40 to standard second-line therapy for the treatment of patients with relapsed diffuse large B-cell lymphoma," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We are moving forward with this global trial based on the encouraging safety profile and clinical activity observed in our phase I single-agent trial in patients with DLBCL, together with preclinical data demonstrating enhanced efficacy of SGN-40 when combined with chemotherapy."
The American Cancer Society estimates that more than 63,000 people will be diagnosed with NHL in the United States in 2007 and approximately 19,000 will die from the disease.
The phase IIb, randomized, double-blind, placebo-controlled clinical trial, named SeaGen MARINER, is expected to enroll approximately 200 relapsed or refractory DLBCL patients at more than 60 medical centers worldwide. Patients will receive either Rituxan, ifosfamide, carboplatin and etoposide (R-ICE) plus SGN-40 or R-ICE plus placebo. The primary endpoint of the study is complete response rate. Additional endpoints include safety, tolerability, failure-free and overall survival.
SGN-40 Development Program
SGN-40 is a humanized monoclonal antibody that targets the CD40 antigen, which is expressed on most B lineage hematologic malignancies including non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphocytic leukemia. CD40 is also found on many types of solid tumors, including bladder, renal and ovarian cancer.
Under the terms of an exclusive worldwide collaboration agreement for the development and commercialization of SGN-40, Seattle Genetics and Genentech are executing on a development plan that includes initiating multiple clinical trials in non-Hodgkin’s lymphoma and multiple myeloma. In addition to the SeaGen MARINER trial, a phase II single-agent trial of SGN-40 in DLBCL and a phase Ib trial of SGN-40 in combination with lenalidomide (Revlimid(R)) are ongoing. The companies plan to initiate three additional phase Ib clinical trials in combination with standard regimens for multiple myeloma and non-Hodgkin’s lymphoma by early 2008.
Seattle Genetics received an upfront payment of $60 million in February 2007, and has the potential to receive milestone payments exceeding $800 million and escalating double-digit royalties starting in the mid-teens. In addition, Genentech funds research, development, manufacturing and commercialization costs, including reimbursing Seattle Genetics for its costs to conduct SGN-40 clinical trials and development activities.
About Diffuse Large B-Cell Lymphoma
Non-Hodgkin’s lymphoma (NHL) represents a diverse group of cancers that develop in the lymphatic system and are characterized by uncontrolled growth and accumulation of abnormal lymphocytes. Lymphocytes are a type of white blood cells that are responsible for defending the body against infection. The most common forms of NHL are follicular (slow growth) and diffuse large B-cell lymphoma (a faster growing sub-type).
About Seattle Genetics
Seattle Genetics is a biotechnology company developing monoclonal antibody-based therapies for the treatment of multiple types of cancer, including lymphoma, multiple myeloma, leukemia and solid tumors. The company has an exclusive worldwide license agreement with Genentech to develop and commercialize SGN-40. Seattle Genetics also has three other proprietary programs in ongoing clinical trials: SGN-33, SGN-35 and SGN-30. In addition, the company has developed proprietary antibody-drug conjugate (ADC) technology comprised of highly potent synthetic drugs and stable linkers for attaching the drugs to monoclonal antibodies. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Genentech, Bayer, CuraGen, Progenics and MedImmune, as well as an ADC co-development agreement with Agensys. 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 SGN-40. 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 to show sufficient safety or activity in this phase II clinical trial and the risk of adverse clinical results as SGN-40 advances in clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained in the Company’s filings 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.
SOURCE: Seattle Genetics, Inc.
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Trial Initiation Triggers $12 Million Milestone Payment from Genentech
BOTHELL, WA, USA | December 7, 2007 | Seattle Genetics, Inc. (Nasdaq:SGEN) announced today that it has initiated a phase IIb clinical trial of SGN-40 in combination with Rituxan(R) (rituximab) plus chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Under the terms of the company’s collaboration agreement with Genentech, Inc., Seattle Genetics will receive a $12 million milestone payment for initiating the study.
"This phase IIb clinical trial will provide key data on the safety and potential efficacy of adding SGN-40 to standard second-line therapy for the treatment of patients with relapsed diffuse large B-cell lymphoma," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We are moving forward with this global trial based on the encouraging safety profile and clinical activity observed in our phase I single-agent trial in patients with DLBCL, together with preclinical data demonstrating enhanced efficacy of SGN-40 when combined with chemotherapy."
The American Cancer Society estimates that more than 63,000 people will be diagnosed with NHL in the United States in 2007 and approximately 19,000 will die from the disease.
The phase IIb, randomized, double-blind, placebo-controlled clinical trial, named SeaGen MARINER, is expected to enroll approximately 200 relapsed or refractory DLBCL patients at more than 60 medical centers worldwide. Patients will receive either Rituxan, ifosfamide, carboplatin and etoposide (R-ICE) plus SGN-40 or R-ICE plus placebo. The primary endpoint of the study is complete response rate. Additional endpoints include safety, tolerability, failure-free and overall survival.
SGN-40 Development Program
SGN-40 is a humanized monoclonal antibody that targets the CD40 antigen, which is expressed on most B lineage hematologic malignancies including non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphocytic leukemia. CD40 is also found on many types of solid tumors, including bladder, renal and ovarian cancer.
Under the terms of an exclusive worldwide collaboration agreement for the development and commercialization of SGN-40, Seattle Genetics and Genentech are executing on a development plan that includes initiating multiple clinical trials in non-Hodgkin’s lymphoma and multiple myeloma. In addition to the SeaGen MARINER trial, a phase II single-agent trial of SGN-40 in DLBCL and a phase Ib trial of SGN-40 in combination with lenalidomide (Revlimid(R)) are ongoing. The companies plan to initiate three additional phase Ib clinical trials in combination with standard regimens for multiple myeloma and non-Hodgkin’s lymphoma by early 2008.
Seattle Genetics received an upfront payment of $60 million in February 2007, and has the potential to receive milestone payments exceeding $800 million and escalating double-digit royalties starting in the mid-teens. In addition, Genentech funds research, development, manufacturing and commercialization costs, including reimbursing Seattle Genetics for its costs to conduct SGN-40 clinical trials and development activities.
About Diffuse Large B-Cell Lymphoma
Non-Hodgkin’s lymphoma (NHL) represents a diverse group of cancers that develop in the lymphatic system and are characterized by uncontrolled growth and accumulation of abnormal lymphocytes. Lymphocytes are a type of white blood cells that are responsible for defending the body against infection. The most common forms of NHL are follicular (slow growth) and diffuse large B-cell lymphoma (a faster growing sub-type).
About Seattle Genetics
Seattle Genetics is a biotechnology company developing monoclonal antibody-based therapies for the treatment of multiple types of cancer, including lymphoma, multiple myeloma, leukemia and solid tumors. The company has an exclusive worldwide license agreement with Genentech to develop and commercialize SGN-40. Seattle Genetics also has three other proprietary programs in ongoing clinical trials: SGN-33, SGN-35 and SGN-30. In addition, the company has developed proprietary antibody-drug conjugate (ADC) technology comprised of highly potent synthetic drugs and stable linkers for attaching the drugs to monoclonal antibodies. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Genentech, Bayer, CuraGen, Progenics and MedImmune, as well as an ADC co-development agreement with Agensys. 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 SGN-40. 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 to show sufficient safety or activity in this phase II clinical trial and the risk of adverse clinical results as SGN-40 advances in clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained in the Company’s filings 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.
SOURCE: Seattle Genetics, Inc.
Post Views: 131
