Seattle Genetics has developed next generation ADCs that link the proven selectivity and activities of monoclonal antibodies with highly potent cytotoxic agents. Our proprietary technology employs synthetic, potent tumor cell-killing agents called auristatins (such as MMAE and MMAF) and stable linkers that attach the auristatin to the antibody. Our novel 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 potentially enhancing antitumor activity.
Collaborating with leading biopharmaceutical companies is a cornerstone of Seattle Genetics’ business strategy. Product-focused collaborations, such as our collaboration agreement with Millennium: The Takeda Oncology Company to globally develop and commercialize brentuximab vedotin, provide significant near- and mid-term funding while bringing in additional resources and expertise to support, advance and expand promising development programs. Collaboration and license agreements around our proprietary ADC technology also generate cash for the company - more than $155 million to date - while providing further clinical validation of the ADC platform and, in some cases, opening the door to new product development opportunities.
Seattle Genetics, Inc. (Nasdaq:SGEN) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of ADCETRISTM (brentuximab vedotin) for two indications: (1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS. ADCETRIS is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years, and provides a new therapeutic alternative for Hodgkin lymphoma and systemic ALCL in these settings. Seattle Genetics expects to make ADCETRIS available to patients next week. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30.
Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. Seattle Genetics’ first product, ADCETRIS™, was approved by the FDA on August 19, 2011 for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and for the treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen. In addition to ADCETRIS, Seattle Genetics has three other clinical-stage 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, 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.
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August 22nd, 2011 at 04:46 pm