Seattle Genetics, Inc. (Nasdaq:SGEN) announced today that it has
initiated a phase I clinical trial of SGN-70, a humanized monoclonal
antibody targeting CD70 that is being developed as an investigational
therapy for autoimmune diseases. The trial will assess the safety,
tolerability and pharmacokinetics of SGN-70 in healthy volunteers.
“CD70 targeted therapies have shown promise in
multiple preclinical models by reducing autoimmune disease activity at
well-tolerated doses,” said Thomas C.
Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. “This
clinical trial is designed to evaluate the safety and pharmacokinetics
of SGN-70 in humans and to serve as a foundation for future clinical
trials in patients with autoimmune disease.”
The phase I study is a dose-escalation trial in which cohorts of healthy
volunteers will receive single doses of SGN-70. The clinical trial will
be conducted in Switzerland and is expected to accrue approximately 60
volunteers.
The CD70 antigen is highly expressed on activated T- and B-cells but not
resting lymphocytes, and has been associated with a variety of
autoimmune and inflammatory disorders. SGN-70 has been shown in
preclinical models to selectively deplete CD70-positive lymphocytes and
block the co-stimulation pathway between CD70 and its receptor, CD27. By
specifically targeting the activated cells, SGN-70 may reduce the
damaging effects of autoimmune disease without globally suppressing the
immune system.
CD70 is also expressed on several types of cancer, including multiple
myeloma, lymphoma, renal cell cancer, glioblastoma and several other
solid tumors. In addition to SGN-70, Seattle Genetics is advancing
SGN-75, an antibody-drug conjugate targeting CD70, for the treatment of
cancer and expects to file an investigational new drug (IND) application
in 2009.
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 for 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 comprising 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, Daiichi
Sankyo and MedImmune, a wholly-owned subsidiary of AstraZeneca, as well
as an ADC co-development agreement with Agensys, a wholly-owned
subsidiary of Astellas Pharma.
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the therapeutic
potential of SGN-70. Actual results or developments may differ
materially from those projected or implied in these forward-looking
statements. Factors that may cause such a difference include the
inability to show sufficient safety in this phase I clinical trial and
the risk of adverse clinical results as SGN-70 moves into and advances
in clinical trials. More information about the risks and uncertainties
faced by Seattle Genetics is contained in the Company’s
filings with the Securities and Exchange Commission. Seattle Genetics
disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Seattle Genetics
Peggy Pinkston, 425-527-4160
ppinkston@seagen.com
