Bayer submits an IND for its MN-IC antibody-drug conjugate to the FDA

Sep 9 2009

Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Bayer Schering Pharma AG, Germany. The milestone was triggered by Bayer’s submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for MN-IC, an ADC for solid tumors.

“We are pleased with the continued progress by our collaborators in advancing ADCs spanning a range of oncology indications and settings. MN-IC will be the third new ADC program utilizing our technology to advance into clinical trials during the past 12 months,” said Eric L. Dobmeier, Chief Business Officer of Seattle Genetics. “In addition to generating revenue, these collaborator programs broaden the clinical experience with our ADC technology and build on our understanding of its potential in the treatment of serious diseases.”

Under the terms of the ADC collaboration agreement, Bayer has rights to use Seattle Genetics’ ADC technology with antibodies against MN. Bayer is responsible for research, product development, manufacturing and commercialization of all products under the collaboration. Seattle Genetics receives material supply and annual maintenance fees as well as research support payments for any assistance provided to Bayer in developing ADC products. The antibody component of the ADC targeted to MN is derived from HuCAL technology that Bayer licensed from MorphoSys AG.

Seattle Genetics is advancing a proprietary pipeline of ADC programs, including brentuximab vedotin (SGN-35), which is in an ongoing pivotal trial for relapsed or refractory Hodgkin lymphoma and a phase II trial for systemic anaplastic large cell lymphoma. Seattle Genetics is also developing a number of preclinical ADCs, including SGN-75, which the company is advancing towards a planned 2009 IND submission for CD70-positive hematologic malignancies and solid tumors. The company is also developing ASG-5ME in collaboration with Agensys, a subsidiary of Astellas Pharma. An IND submission of ASG-5ME for solid tumors is planned in the first half of 2010.

ADCs utilize the targeting ability of monoclonal antibodies to deliver potent, cell-killing payloads to specific cells. Seattle Genetics’ technology employs synthetic, highly potent drugs attached to antibodies through proprietary linker systems. The linkers are designed to be stable in the bloodstream but to release the drug payload under specific conditions once inside target cells, thereby sparing non-target cells many of the toxic effects of traditional chemotherapy.

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