Seattle Genetics, Inc. (NASDAQ:SGEN) Files An 8-K Other EventsItem 8.01
Following Seattle Genetics, Inc.’s discontinuation of its phase 3 CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in frontline older acute myeloid leukemia patients and suspension of patient enrollment and treatment in all clinical trials of vadastuximab talirine announced on June 19, 2017, the Food and Drug Administration (the “FDA”) notified Seattle Genetics on June 21, 2017 that the Investigational New Drug application (the “IND”) for vadastuximab talirine has been placed on hold, and that no clinical trials may resume under the IND until the FDA lifts the clinical hold.
About Seattle Genetics, Inc. (NASDAQ:SGEN)
Seattle Genetics, Inc. is a biotechnology company focused on the development and commercialization of therapies for the treatment of cancer. The Company’s product ADCETRIS, or brentuximab vedotin, is an antibody-drug conjugate (ADC), comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE). The Company’s pipeline includes other clinical-stage ADC programs, which are SGN-CD33A, SGN-CD19A, SGN-LIV1A, SGN-CD70A, ASG-22ME, and ASG-15ME, and SEA-CD40, which is based on its sugar-engineered antibody (SEA) technology. SGN-CD33A is an ADC composed of an anti-CD33 monoclonal antibody indicated for the treatment of acute myeloid leukemia (AML). SGN-CD19A is an ADC composed of an anti-CD19 monoclonal antibody indicated for the treatment of hematologic malignancies. SGN-LIV1A is an ADC composed of an anti-LIV-1 monoclonal antibody indicated for the treatment of LIV-1-positive metastatic breast cancer.
