Agensys and Seattle Genetics Announce Interim Phase I Data from ASG-5ME Clinical Trial for Prostate Cancer
Dose-Escalation Completed and Preliminary Antitumor Activity Observed
SANTA MONICA, Calif. & BOTHELL, Wash.--(BUSINESS WIRE)--Jun 4, 2012 - Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., and Seattle Genetics, Inc. (Nasdaq: SGEN) today announced interim data from a phase I clinical trial evaluating ASG-5ME for the treatment of castration-resistant prostate cancer (CRPC). ASG-5ME is an antibody-drug conjugate (ADC) targeting the SLC44A4 antigen that is being co-developed by both companies for the treatment of solid tumors. The data are being presented at the American Society of Clinical Oncology (ASCO) annual meeting being held June 1-5, 2012 in Chicago, IL.
“SLC44A4 is an attractive target in prostate cancer and is present in the majority of patients with both localized and metastatic disease,” said Leonard Reyno, M.D., Senior Vice President and Chief Medical Officer of Agensys. “The current Phase I data demonstrates the tolerability of this antibody drug conjugate and further evaluation of safety and antitumor activity in patients with castration resistant prostate cancer is ongoing.”
“It is encouraging to observe these preliminary data with ASG-5ME in prostate cancer, a disease for which late-stage patients need additional therapeutic options,” said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine of Seattle Genetics. “In addition to prostate cancer, our two companies are continuing to evaluate the potential use of ASG-5ME in other solid tumor indications. In parallel, we are collaborating with Agensys to co-develop ASG-22ME, an ADC targeting Nectin-4 for solid tumors.”
Phase 1 trial of ASG-5ME in metastatic castration-resistant
prostate cancer (CRPC) (Abstract #4568)
ASG-5ME is being evaluated in a single-agent phase I clinical trial
to determine the maximum tolerated dose (MTD) and to assess the
safety, pharmacokinetic profile and antitumor activity of
escalating doses of ASG-5ME. At the time of data analysis, 26
patients were enrolled. The median age of the patients was 69.5
years and the median baseline prostate-specific antigen (PSA) level
was 82.25.
Key findings, presented by Dr. Michael Morris from Memorial Sloan Kettering Cancer Center in New York, NY, and clinical investigator on the study include:
- ASG-5ME was given to cohorts of patients with CRPC as a single IV infusion every three weeks at doses ranging from 0.3 milligrams per kilogram (mg/kg) to 3.0 mg/kg. The MTD was exceeded at 3.0 mg/kg.
- Across all dose cohorts, the most common Grade 1 and 2 adverse events occurring in more than 20 percent of patients included fatigue (50.0 percent), decreased appetite (42.3 percent), peripheral neuropathy (34.6 percent) and nausea (23.0 percent).
- PSA reductions were observed in several patients, providing preliminary evidence of antitumor effect with ASG-5ME treatment.
The phase I trial is ongoing, with enrollment to two expansion cohorts in chemotherapy naïve and chemotherapy exposed CRPC patients planned.
Seattle Genetics and Agensys recently completed enrollment in a phase I pancreatic cancer trial of ASG-5ME dosed weekly. The companies plan to evaluate ASG-5ME in patients with gastric cancer based on preclinical expression data.
About ASG-5ME
ASG-5ME is an ADC composed of a fully human antibody directed to
SLC44A4, a solute carrier antigen family member identified by
Agensys to be overexpressed in epithelial cancers, including more
than 80 percent of samples derived from patients with prostate,
pancreatic and gastric cancers. The antibody is attached to
monomethyl auristatin E (MMAE) via an enzyme-cleavable linker using
Seattle Genetics' proprietary technology. The ADC is designed to be
stable in the bloodstream, but to release MMAE upon internalization
into SLC44A4-expressing tumor cells, resulting in targeted
cell-killing.
Seattle Genetics and Agensys are co-developing and will globally co-commercialize and share profits on a 50:50 basis for ASG-5ME and ASG-22ME. Seattle Genetics also has an option for 50:50 cost and profit-sharing of a third ADC program at the time of investigational new drug submission.
About Agensys
Agensys, Inc., an affiliate of Astellas Pharma Inc., is developing
a pipeline of therapeutic fully human monoclonal antibodies (MAbs)
to treat cancer. The MAb product pipeline is being generated to
Agensys' diverse portfolio of proprietary, clinically relevant
cancer targets. Agensys' target portfolio and related products are
protected by a large patent estate. The company has full
capabilities to generate, develop and manufacture antibody
products. Agensys is progressing a pipeline of both naked and
antibody-drug conjugated (ADC) therapeutic antibodies, directed at
a variety of cancer indications, including those of the prostate,
kidney, pancreas, ovary, bladder, lung, colon, breast and skin. ADC
products are based on drug platform technologies developed by
Seattle Genetics. Agensys is developing a growing pipeline of
clinical stage functional MAbs and ADC products.
About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical
company dedicated to improving the health of people around the
world through the provision of innovative and reliable
pharmaceutical products. Astellas has approximately 17,000
employees worldwide. The organization is committed to becoming a
global category leader in urology, immunology & infectious
diseases, oncology, neuroscience, DM complications & metabolic
diseases. For more information on Astellas Pharma Inc., please
visit
www.astellas.com/en.
About Seattle Genetics
Seattle Genetics is a biotechnology company focused on the
development and commercialization of monoclonal antibody-based
therapies for the treatment of cancer. The U.S. Food and Drug
Administration granted accelerated approval of
ADCETRIS® (brentuximab vedotin) in August 2011 for
two indications. ADCETRIS is being developed in collaboration with
Millennium: The Takeda Oncology Company. In addition, Seattle
Genetics has three other clinical-stage ADC 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.
For Seattle Genetics:
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to further
evaluation of ASG-5ME and the initiation of future clinical trials.
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 risk of adverse events
as ASG-5ME advances in clinical trials. More information about the
risks and uncertainties faced by Seattle Genetics is contained in
the company's 10-Q for the quarter ended March 31, 2012 filed 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.
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50298288&lang=en
Contact: Astellas
Jenny Kite, 847-682-4530
jenny.kite@us.astellas.com
or
Seattle Genetics
Peggy Pinkston, 425-527-4160
ppinkston@seagen.com
Posted: June 2012
