MolecularMD Corp. Obtains Exclusive License to LKB1 Uses in Non-Small Cell Lung Cancer

PORTLAND, OR--(Marketwire - Jan 28, 2013) - MolecularMD Corp. announced today that it has entered into a license agreement granting the company exclusive patent rights to cancer diagnosis technology. Specifically, MolecularMD has obtained rights to commercialize patent-pending intellectual property pertaining to use of LKB1 for diagnostic, prognostic and predictive uses in humans in the area of non-small cell lung cancer. Such patent rights are jointly-owned by the governing bodies of four institutions: the Dana-Farber Cancer Institute (DFCI), the Massachusetts General Hospital (MGH), the University of North Carolina at Chapel Hill (UNC), and The University of Texas Southwestern Medical Center (UTSW). The inventors named in these patent rights include Drs. Kwok-Kin Wong, Bruce Johnson, Hongbin Ji, and Pasi Janne of DFCI; Dr. Nabeel Bardeesy of MGH; Dr. Norman E. Sharpless of UNC; and Dr. Diego Castrillon of UTSW.

About LKB1 in Lung Cancer
Research has shown that the gene named LKB1 (liver kinase B1)/STK11 (serine-threonine kinase 11) is a tumor suppressor that encodes a serine/threonine kinase that negatively regulates the mTOR (mammalian target of rapamycin) signaling pathway. LKB1 is mutated in 20-30% of non-small cell lung cancers and ranks as the 3^rd most frequently mutated gene in lung adenocarcinoma, after p53 and Ras. LKB1 mutations occur preferentially in smokers and are found concomitantly with alterations in other cancer genes including TP53, PIK3CA, MYC, CDKN2A and KRAS, but not with EGFR mutations. Loss of LKB1 protein predicts aggressiveness of cancer especially in the context of KRAS mutation. Therefore LKB1 mutation is likely to be an important biomarker to predict responsiveness to both targeted agents and chemotherapy. In lung adenocarcinoma, LKB1 mutation is potentially a negative predictive marker of response to both MEK and PI3K pathway inhibitors. These findings provide a rationale for discerning LKB1 mutation status in the clinic.

MolecularMD is developing diagnostic assays for LKB1 status, including immunohistochemistry (IHC) and next generation sequencing (NGS) tests, in support of a variety of clinical trials exploring LKB1 clinical utility. MolecularMD provides comprehensive clinical trial support through its CLIA-certified and CAP-accredited Clinical Reference Laboratory. In addition, MolecularMD provides IVD development and manufacturing capability to support companion diagnostic device commercialization. MolecularMD will also support further commercialization of LKB1 technology through sublicensing to Clinical Reference Laboratories and diagnostic assay developers and manufacturers.

According to Dr. Sabita Sankar, MolecularMD's Scientific Affairs Liaison, "Tumor suppressors play a critical role in determining responsiveness to therapies targeting oncogenes. MolecularMD's offering of both LKB1 IHC and NGS assays will provide critical additional information to predict responsiveness to both targeted agents and chemotherapy especially in the context of MEK inhibitors in KRAS mutant lung adenocarcinoma."

For additional information, please contact MolecularMD at 1-877-459-4979 or visit its website at www.molecularmd.com

About MolecularMD
MolecularMD Corporation develops and commercializes specialty molecular diagnostics for oncology applications. Its tests are designed to allow appropriate selection, monitoring and management of patients treated with molecularly-targeted cancer therapies. MolecularMD incorporates gold-standard and innovative technologies in providing its partners with the highest quality results. Assays are designed to meet clinical trial needs, and MolecularMD has appropriate systems and standards in place to enable development of companion diagnostic tests in conjunction with partners' novel anticancer agents. A private company based in Portland, Oregon, MolecularMD was founded by Dr. Brian Druker, director of the Knight Cancer Institute at Oregon Health & Science University, and Sheridan G. Snyder, entrepreneur and founder of Genzyme Corporation.