Seattle Genetics and Agensys announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of metastatic pancreatic cancer
BOTHELL, WA, USA | July 20, 2010 | Seattle Genetics, Inc. (Nasdaq:SGEN – News) and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of metastatic pancreatic cancer. ASG-5ME is an antibody-drug conjugate (ADC) that is being co-developed by both companies for the treatment of solid tumors.
“There is significant need for new pancreatic cancer therapies, demonstrated by the fact that most patients with advanced disease die within one year from diagnosis,” said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine at Seattle Genetics. “We believe ASG-5ME, which is an ADC designed to deliver the potent cytotoxic agent MMAE directly to tumor cells, has the potential to provide a new therapeutic option for this aggressive disease.”
The single-agent, phase I, open-label, dose-escalation study will evaluate the safety and tolerability of ASG-5ME in patients with pancreatic cancer and identify the maximum tolerated dose. Secondary objectives include assessing the pharmacokinetics and antitumor activity of ASG-5ME and identifying a recommended dose and regimen for future clinical trials. The study is designed to enroll up to approximately 50 patients at multiple centers in the United States.
Dr. David Stover, Vice President and Head of Research at Agensys, noted that ASG-5ME is an ADC composed of a fully human monoclonal antibody directed to SLC44A4 (AGS-5), a novel cancer target identified by Agensys to be upregulated in a number of epithelial tumors.
The antibody is attached to a highly potent, synthetic agent, monomethyl auristatin E (MMAE), via an enzyme-cleavable linker using Seattle Genetics’ proprietary technology. The novel linker system is designed to be stable in the bloodstream and release the potent cell-killing agent once inside antigen-expressing cancer cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing the antitumor activity. Preclinical data demonstrate that SLC44A4 (AGS-5) is expressed on more than 80 percent of samples derived from patients with pancreatic, prostate and gastric cancers. In addition, ASG-5ME induced long-term regressions in preclinical models of established pancreatic, prostate and colon cancers.
About Pancreatic Cancer
Pancreatic cancer is a fast-growing and difficult to detect form of cancer that affects the pancreas. According to the American Cancer Society, the annual incidence of pancreatic cancer is estimated to be greater than 43,000 cases, and more than 36,000 people are expected to die from the disease in 2010. Pancreatic cancer is the fourth leading cause of cancer-related death for both men and women. The 1- and 5-year survival rates for people diagnosed with any stage of pancreatic cancer are 25 percent and 6 percent, respectively.
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, brentuximab vedotin (SGN-35), is in a pivotal trial under a Special Protocol Assessment with the U.S. Food and Drug Administration. Brentuximab vedotin is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has five other clinical-stage programs: lintuzumab (SGN-33), dacetuzumab (SGN-40), SGN-70, SGN-75 and ASG-5ME. Seattle Genetics has collaborations for its ADC technology with multiple 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 http://www.seattlegenetics.com.
About Agensys
Agensys, Inc., an affiliate of Astellas Pharma Inc., is developing a pipeline of therapeutic fully human monoclonal antibodies (MAbs) to treat solid tumor cancers. The MAb product pipeline is being generated to Agensys’ diverse portfolio of proprietary, clinically relevant cancer targets that encompass 14 types of solid tumors. Agensys’ target portfolio and related products are protected by a large patent estate. The Company has full capabilities to generate, develop and manufacture antibody products. Agensys is progressing a pipeline of both naked and antibody-drug conjugated (ADC) therapeutic antibodies, directed at a variety of cancer indications, including those of the prostate, kidney, pancreas, ovary, bladder, lung, colon, breast and skin. ADC products are based on drug platform technologies developed by Seattle Genetics. Agensys is developing a growing pipeline of clinical stage functional MAbs and ADC products.
About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Astellas has approximately 15,000 employees worldwide. The organization is committed to becoming a global category leader by rapidly establishing a business model in urology, immunology & infectious diseases, neuroscience, DM complications & metabolic diseases and oncology. Astellas has discovered a treatment for over-active bladder (OAB), Vesicare® (solifenacin succinate) and an immunosuppressant, Prograf® (tacrolimus), which have enabled Astellas to become an established leader in both Urology and Transplant. For more information on Astellas Pharma Inc., please visit Astellas’ website at http://www.astellas.com/en.
SOURCE: Seattle Genetics
Post Views: 34
Seattle Genetics and Agensys announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of metastatic pancreatic cancer
BOTHELL, WA, USA | July 20, 2010 | Seattle Genetics, Inc. (Nasdaq:SGEN – News) and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of metastatic pancreatic cancer. ASG-5ME is an antibody-drug conjugate (ADC) that is being co-developed by both companies for the treatment of solid tumors.
“There is significant need for new pancreatic cancer therapies, demonstrated by the fact that most patients with advanced disease die within one year from diagnosis,” said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine at Seattle Genetics. “We believe ASG-5ME, which is an ADC designed to deliver the potent cytotoxic agent MMAE directly to tumor cells, has the potential to provide a new therapeutic option for this aggressive disease.”
The single-agent, phase I, open-label, dose-escalation study will evaluate the safety and tolerability of ASG-5ME in patients with pancreatic cancer and identify the maximum tolerated dose. Secondary objectives include assessing the pharmacokinetics and antitumor activity of ASG-5ME and identifying a recommended dose and regimen for future clinical trials. The study is designed to enroll up to approximately 50 patients at multiple centers in the United States.
Dr. David Stover, Vice President and Head of Research at Agensys, noted that ASG-5ME is an ADC composed of a fully human monoclonal antibody directed to SLC44A4 (AGS-5), a novel cancer target identified by Agensys to be upregulated in a number of epithelial tumors.
The antibody is attached to a highly potent, synthetic agent, monomethyl auristatin E (MMAE), via an enzyme-cleavable linker using Seattle Genetics’ proprietary technology. The novel linker system is designed to be stable in the bloodstream and release the potent cell-killing agent once inside antigen-expressing cancer cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing the antitumor activity. Preclinical data demonstrate that SLC44A4 (AGS-5) is expressed on more than 80 percent of samples derived from patients with pancreatic, prostate and gastric cancers. In addition, ASG-5ME induced long-term regressions in preclinical models of established pancreatic, prostate and colon cancers.
About Pancreatic Cancer
Pancreatic cancer is a fast-growing and difficult to detect form of cancer that affects the pancreas. According to the American Cancer Society, the annual incidence of pancreatic cancer is estimated to be greater than 43,000 cases, and more than 36,000 people are expected to die from the disease in 2010. Pancreatic cancer is the fourth leading cause of cancer-related death for both men and women. The 1- and 5-year survival rates for people diagnosed with any stage of pancreatic cancer are 25 percent and 6 percent, respectively.
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, brentuximab vedotin (SGN-35), is in a pivotal trial under a Special Protocol Assessment with the U.S. Food and Drug Administration. Brentuximab vedotin is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has five other clinical-stage programs: lintuzumab (SGN-33), dacetuzumab (SGN-40), SGN-70, SGN-75 and ASG-5ME. Seattle Genetics has collaborations for its ADC technology with multiple 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 http://www.seattlegenetics.com.
About Agensys
Agensys, Inc., an affiliate of Astellas Pharma Inc., is developing a pipeline of therapeutic fully human monoclonal antibodies (MAbs) to treat solid tumor cancers. The MAb product pipeline is being generated to Agensys’ diverse portfolio of proprietary, clinically relevant cancer targets that encompass 14 types of solid tumors. Agensys’ target portfolio and related products are protected by a large patent estate. The Company has full capabilities to generate, develop and manufacture antibody products. Agensys is progressing a pipeline of both naked and antibody-drug conjugated (ADC) therapeutic antibodies, directed at a variety of cancer indications, including those of the prostate, kidney, pancreas, ovary, bladder, lung, colon, breast and skin. ADC products are based on drug platform technologies developed by Seattle Genetics. Agensys is developing a growing pipeline of clinical stage functional MAbs and ADC products.
About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Astellas has approximately 15,000 employees worldwide. The organization is committed to becoming a global category leader by rapidly establishing a business model in urology, immunology & infectious diseases, neuroscience, DM complications & metabolic diseases and oncology. Astellas has discovered a treatment for over-active bladder (OAB), Vesicare® (solifenacin succinate) and an immunosuppressant, Prograf® (tacrolimus), which have enabled Astellas to become an established leader in both Urology and Transplant. For more information on Astellas Pharma Inc., please visit Astellas’ website at http://www.astellas.com/en.
SOURCE: Seattle Genetics
Post Views: 34
