Cell Signaling Technology Granted Patent for PCR Methods for Detection of a Subset of Treatable Non-Small Cell Lung Cancers

  Cell Signaling Technology Granted Patent for PCR Methods for Detection of a
  Subset of Treatable Non-Small Cell Lung Cancers

Business Wire

DANVERS, Mass. -- January 7, 2013

Cell Signaling Technology, Inc. (CST) of Danvers, MA, announced today the
issuance of US Patent No. 8,288,102, relating to PCR-based methods for the
detection of EML4-ALK (anaplastic lymphoma kinase) polynucleotides in patient
samples. The presence of the fusion kinase EML4-ALK has been reported in a
subset of patients with breast, colon, and non-small cell lung cancer (NSCLC).
Pfizer’s XALKORI^® (crizotinib) is approved in the US for the treatment of
patients with locally advanced or metastatic non-small cell lung cancer
(NSCLC) with ALK fusions as detected by an FDA-approved test.

Cell Signaling Technology Granted Patent for PCR Methods for Detection of a
Subset of Treatable Non- ...

Cell Signaling Technology Granted Patent for PCR Methods for Detection of a
Subset of Treatable Non-Small Cell Lung Cancers (Photo: Business Wire)

The methods disclosed in the patent, entitled “Gene defects and mutant ALK
kinase in human solid tumors”, include the amplification of DNA or RNA fusion
polynucleotides from patient blood, tissue, or cells and the determination of
a therapeutic regimen based on the presence of the fusion in the sample. Lung
cancer is the world's leading cause of cancer death with more than 1.6 million
new cases diagnosed each year. About 85 percent of lung cancer patients are of
the non-small cell type and are usually diagnosed with advanced disease with a
very low survival rate. Preliminary epidemiology suggests that approximately
3–5 percent of NSCLC patients have tumors positive for the ALK fusion gene.

Cell Signaling Technology, Inc., a leader in the development and manufacture
of high performance antibody products for the medical research market,
discovered the abnormal gene rearrangement EML4-ALK in NSCLC. The presence of
the ALK fusion gene in lung cancer was also reported by a Japanese researcher
in 2007. CST’s patent portfolio includes other methods of detecting the
EML4-ALK fusions, including detection by FISH (fluorescence in situ
hybridization) and antibody-based assays for the detection of polypeptides
(e.g., US Patent Nos. 7,700,339, 8,168,383, and 8,232,060). Additionally, CST
and Astellas Pharma, Inc. have pooled their respective worldwide intellectual
property estates relating to the fusion kinase EML4-ALK.

“Cell Signaling Technology’s growing patent portfolio and dominant
intellectual property directed to the detection of EML4-ALK translocations is
very important to our company mission,” said Michael J. Comb, Ph.D., President
and CEO of CST. “We are thrilled that the strategic R&D and intellectual
property investments we’ve made in the area of EML4-ALK translocation
detection are being applied to significant unmet needs in the diagnosis and
treatment of cancer patients, and are pursuing all avenues of
commercialization.”

Cell Signaling Technology, Inc. has also entered into a license agreement with
Ventana Medical Systems, Inc., a member of the Roche Group, who, in
collaboration with Pfizer Inc., is developing the first fully automated and
standardized immunohistochemistry (IHC) companion diagnostic test for ALK gene
rearrangements using CST’s D5F3 antibody.

About Cell Signaling Technology, Inc.

Cell Signaling Technology, Inc. is dedicated to delivering the world’s highest
quality research, diagnostic, and therapeutic products to accelerate
biological understanding and enable personalized medicine. Through its
proprietary monoclonal antibody technology, NG-XMT™, and PTMScan® proteomics
technology, CST continues to be at the forefront of applied systems biology
research, promoting greater understanding of biochemical aberrations that
underlie critical diseases, including cancer. CST has made significant
discoveries in cancer research through its internal research group, and from
this has built an intellectual property portfolio around biomarkers relevant
to non-small cell lung cancer.

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Contact:

Cell Signaling Technology, Inc.
Claudia Hofmann, 978-867-2314
Marketing Communications Manager
chofmann@cellsignal.com
www.cellsignal.com
 
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