Seattle Genetics Announces Initiation of Phase Ib Clinical Trial of SGN-40 in Combination with Rituxan and Gemzar for Non-Hodgkin Lymphoma
Tuesday April 8, 9:00 am ET
BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN - News) announced today that it has initiated a phase Ib clinical trial of SGN-40 in combination with Rituxan® (rituximab) and Gemzar® (gemcitabine) for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma.
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“We are executing on a multi-pronged development plan with SGN-40 in DLBCL, an aggressive type of non-Hodgkin lymphoma, based on data from our phase I single-agent trial with SGN-40 that demonstrated multiple objective antitumor responses in this disease,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. “The SGN-40 plus Rituxan/Gemzar combination trial complements our other ongoing DLBCL trials, including a phase IIb trial evaluating SGN-40 in combination with Rituxan plus chemotherapy in the second-line setting and a single-agent phase II trial in relapsed or refractory patients. These trials are part of our joint development plan with Genentech, Inc. to broadly assess the potential of SGN-40 in non-Hodgkin lymphoma and multiple myeloma.”
The phase Ib, open-label single-arm study will enroll up to approximately 30 patients with relapsed or refractory DLBCL at multiple cancer centers in the United States. Patients will receive escalating doses of SGN-40 in combination with Rituxan and Gemzar. The study will assess safety, pharmacokinetics and preliminary antitumor activity of the combination regimen.
SGN-40 Development Program
SGN-40 is a humanized monoclonal antibody that is currently in phase I and phase II clinical trials for non-Hodgkin lymphoma and multiple myeloma under a worldwide collaboration agreement with Genentech. SGN-40 targets the CD40 antigen, which is expressed on most B-cell lineage hematologic malignancies, as well as solid tumors such as bladder, renal and ovarian cancer.
Seattle Genetics and Genentech are conducting a joint development plan for SGN-40 that includes six ongoing or planned clinical trials of SGN-40 both as a single agent and combined with standard therapies for non-Hodgkin lymphoma and multiple myeloma. The ongoing trials include a phase IIb of SGN-40 in combination with R-ICE (Rituxan, ifosfamide, carboplatin and etoposide) in DLBCL, a phase II single-agent study in DLBCL, a phase Ib of SGN-40 in combination with Rituxan for follicular and marginal zone non-Hodgkin lymphoma and a phase Ib of SGN-40 in combination with Revlimid® (lenalidomide) for multiple myeloma.
Under the terms of the collaboration agreement with Genentech, Seattle Genetics received an upfront payment of $60 million in February 2007, and is entitled to receive potential milestone payments exceeding $800 million and escalating double-digit royalties starting in the mid-teens on sales of SGN-40. Seattle Genetics also has an option to co-promote SGN-40 in the United States. Genentech funds research, development, manufacturing and commercialization expenses for SGN-40, including reimbursing Seattle Genetics for costs incurred in connection with activities it funds for the program. To date, Seattle Genetics has earned a total of $20 million in milestone payments from Genentech associated with SGN-40 clinical trial initiations.
About Diffuse Large B-Cell Lymphoma
Non-Hodgkin lymphoma (NHL) represents a diverse group of cancers that develop in the lymphatic system and are characterized by uncontrolled growth and accumulation of abnormal lymphocytes. Lymphocytes are a type of white blood cells that are responsible for defending the body against infection. The most common forms of NHL are follicular (slow growth) and diffuse large B-cell lymphoma (a faster growing sub-type).
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 has a worldwide collaboration with Genentech to develop and commercialize SGN-40. Seattle Genetics also has two other product candidates in ongoing clinical trials: SGN-33 and SGN-35. In addition, the company has developed proprietary antibody-drug conjugate (ADC) technology comprised of highly potent synthetic drugs and stable linkers for attaching the drugs to monoclonal antibodies. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Genentech, Bayer, CuraGen, Progenics and MedImmune, as well as an ADC co-development agreement with Agensys. |
