Seattle Genetics and Millennium: The Takeda Oncology Company announced that they have initiated a phase I clinical trial of brentuximab vedotin (SGN-35) in combination with chemotherapy for the treatment of newly diagnosed systemic anaplastic large cell lymphoma (ALCL) patients
BOTHELL, WA, USA | March 1, 2011 | Seattle Genetics, Inc. (Nasdaq:SGEN – News) and Millennium: The Takeda Oncology Company today announced that they have initiated a phase I clinical trial of brentuximab vedotin (SGN-35) in combination with chemotherapy for the treatment of newly diagnosed systemic anaplastic large cell lymphoma (ALCL) patients. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, which is highly expressed in ALCL.
“The objective and complete response rates observed with single-agent brentuximab vedotin in relapsed or refractory systemic ALCL, and the manageable side-effect profile, provide encouraging justification for its investigation in earlier lines of treatment for this aggressive type of non-Hodgkin lymphoma,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. “There have been no significant advances for the treatment of front-line systemic ALCL since the introduction of CHOP chemotherapy for aggressive lymphomas decades ago. New approaches to improve upon the outcomes achieved with standard multi-agent chemotherapy regimens in newly diagnosed ALCL patients are needed.”
“ALCL is an area of significant unmet need, and the initiation of this study is an important milestone in our investigation of brentuximab vedotin in earlier lines of CD30-positive hematologic malignancies,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium.
The phase I dose-escalation trial will evaluate the safety profile, pharmacokinetics and antitumor activity of brentuximab vedotin when administered sequentially or in combination with multi-agent front-line chemotherapy regimens. The study is expected to enroll up to approximately 60 patients at multiple centers in the United States and Europe.
About Brentuximab Vedotin
Brentuximab vedotin is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease cleavable linker to a potent, synthetic drug, monomethyl auristatin E (MMAE) utilizing Seattle Genetics’ proprietary technology. The ADC employs a novel linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.
Seattle Genetics and Millennium are jointly developing brentuximab vedotin. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to 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.
About Systemic ALCL
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. ALCL is an aggressive type of T-cell non-Hodgkin lymphoma that highly expresses CD30. Although front-line combination chemotherapy can result in durable remissions, approximately 50 percent of ALCL patients relapse or are refractory to front-line treatment and have few therapeutic options. In the United States, approximately 2,000 systemic ALCL patients are diagnosed annually.
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 submitted a Biologics License Application to the U.S. Food and Drug Administration for its lead product candidate, brentuximab vedotin, for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma in February 2011. Brentuximab vedotin is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has four other clinical-stage programs: SGN-75, ASG-5ME, dacetuzumab (SGN-40) and SGN-70. 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, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. 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 Company’s research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, www.millennium.com.
SOURCE: Seattle Genetics
Post Views: 35
Seattle Genetics and Millennium: The Takeda Oncology Company announced that they have initiated a phase I clinical trial of brentuximab vedotin (SGN-35) in combination with chemotherapy for the treatment of newly diagnosed systemic anaplastic large cell lymphoma (ALCL) patients
BOTHELL, WA, USA | March 1, 2011 | Seattle Genetics, Inc. (Nasdaq:SGEN – News) and Millennium: The Takeda Oncology Company today announced that they have initiated a phase I clinical trial of brentuximab vedotin (SGN-35) in combination with chemotherapy for the treatment of newly diagnosed systemic anaplastic large cell lymphoma (ALCL) patients. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, which is highly expressed in ALCL.
“The objective and complete response rates observed with single-agent brentuximab vedotin in relapsed or refractory systemic ALCL, and the manageable side-effect profile, provide encouraging justification for its investigation in earlier lines of treatment for this aggressive type of non-Hodgkin lymphoma,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. “There have been no significant advances for the treatment of front-line systemic ALCL since the introduction of CHOP chemotherapy for aggressive lymphomas decades ago. New approaches to improve upon the outcomes achieved with standard multi-agent chemotherapy regimens in newly diagnosed ALCL patients are needed.”
“ALCL is an area of significant unmet need, and the initiation of this study is an important milestone in our investigation of brentuximab vedotin in earlier lines of CD30-positive hematologic malignancies,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium.
The phase I dose-escalation trial will evaluate the safety profile, pharmacokinetics and antitumor activity of brentuximab vedotin when administered sequentially or in combination with multi-agent front-line chemotherapy regimens. The study is expected to enroll up to approximately 60 patients at multiple centers in the United States and Europe.
About Brentuximab Vedotin
Brentuximab vedotin is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease cleavable linker to a potent, synthetic drug, monomethyl auristatin E (MMAE) utilizing Seattle Genetics’ proprietary technology. The ADC employs a novel linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.
Seattle Genetics and Millennium are jointly developing brentuximab vedotin. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to 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.
About Systemic ALCL
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. ALCL is an aggressive type of T-cell non-Hodgkin lymphoma that highly expresses CD30. Although front-line combination chemotherapy can result in durable remissions, approximately 50 percent of ALCL patients relapse or are refractory to front-line treatment and have few therapeutic options. In the United States, approximately 2,000 systemic ALCL patients are diagnosed annually.
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 submitted a Biologics License Application to the U.S. Food and Drug Administration for its lead product candidate, brentuximab vedotin, for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma in February 2011. Brentuximab vedotin is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has four other clinical-stage programs: SGN-75, ASG-5ME, dacetuzumab (SGN-40) and SGN-70. 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, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. 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 Company’s research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, www.millennium.com.
SOURCE: Seattle Genetics
Post Views: 35
