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Definiens and Advanced Cell Diagnostics Launch Software for Quantitative RNA In Situ Hybridization

Definiens AG, a healthcare company that advances personalized medicine through image analysis and digital pathology solutions, and Advanced Cell Diagnostics (ACD) of Hayward California, a leader in molecular pathology, announced recently the commercial launch of RNAscope® SpotStudio™, a custom-designed image analysis software application for ACD’s RNAscope®Assays to detect and quantify RNA biomarkers. By combining state-of-the-art image analysis and advanced in situ hybridization technologies, gene expression can be measured quantitatively at single cell resolution and interpreted by pathologists within context.

University of Maryland, Baltimore’s Licensing Deals Fuel Local Life Sciences Community

University of Maryland (UM) Ventures recently announced agreements between University of Maryland, Baltimore (UMB) and five different life sciences companies across the Baltimore/Washington metropolitan region. The companies include Montgomery County-based Rexahn Pharmaceuticals, Baltimore County-based Plasmonix, Prince Georges County-based IGI Technologies, Howard County-based A&G Pharmaceuticals, and Frederick County-based BioAssay Works. These deals are part of UM Ventures’ continual efforts to accelerate technology commercialization, advance industry collaboration, and support projects with commercial value at both the Baltimore and College Park campuses of the university.

“UMB is very excited to collaborate with these companies, each an innovator in its own right,” said Phil Robilotto, Assistant Vice President, Office of Technology Transfer, UMB. “These types of collaborations are at the core of our mission to channel the expertise of our industry partners and highlight our efforts to support the Maryland biotechnology community.”

UMB/Rexahn Exclusive License Agreement: In June 2013, UMB and Rexahn Pharmaceuticals, a clinical-stage biopharmaceutical company developing the next generation of cancer drugs, executed an exclusive license agreement for a novel drug delivery platform, Nano-Polymer-Drug Conjugate Systems (NPDCS), which was co-developed by researchers with the University of Maryland (UM) School of Pharmacy in the Department of Pharmaceutical Sciences, including Assistant Professor Anjan Nan, Ph.D. Rexahn’s platform uses existing chemotherapeutic agents, delivering them directly into cancer tumors. The UMB/Rexahn collaboration began after the company and a team of UMB researchers received a Maryland
Industrial Partnership (MIPS) award. The MIPS program is aimed at technology acceleration, providing funds that are matched by Maryland companies to support university-based research.

UMB/Plasmonix License Agreement: Also in June 2013, UMB entered into a license agreement with Plasmonix for a pathogen detection technology. Plasmonix focuses on the enhancement of luminescent signals through advanced use of metal nanoparticles, applying its technology in life science and diagnostic assays. Joseph Lakowicz, Ph.D., Professor of Biochemistry & Molecular Biology within the UM School of Medicine, invented the licensed UMB technology. His laboratory focuses on advancement of fluorescence compositions and methods for use in both research and commercial applications.

UMB Option Agreements with IGI Technologies/A&G Pharmaceuticals: UMB also executed option agreements (giving each company the exclusive right to evaluate a university technology for a short period of time prior to executing a full license agreement) during June 2013 with IGI Technologies and A&G Pharmaceuticals, both university start-ups, although at different stages of company development. Founded by Raj Shekhar, Ph.D., and William Plishker, Ph.D., former UM School of Medicine researchers from the Department of Diagnostic Radiology, IGI Technologies is an emerging start-up developing high-speed medical image registration technology through a Phase II Small Business Technology Transfer (STTR) award from the National Institutes of Health (NIH). A&G Pharmaceuticals, which was founded as a UMB startup in 2007, is discovering and developing theranostics (drug/test combinations) that improve screening, detection, and treatment of cancer. The company also offers custom antibody development through its service division – Precision AntibodyTM. UMB’s option agreement with A&G Pharmaceuticals is to explore the potential for the company’s development of a new cancer diagnostic test based on the tissue biomarker research of lead inventor Yun Qiu, Ph.D., Professor of Pharmacology, UM School of Medicine.

UMB/BioAssay Works Commercial Evaluation and Option Agreement: In September 2012, UMB entered into a commercial evaluation and option agreement with BioAssay Works to evaluate a Staph aureus diagnostic technology based on the work of lead inventor, Mark E. Shirtliff, Associate Professor, Department of Microbial Pathogenesis, with a dual appointment in UM Schools of Dentistry and Medicine. Dr. Shirtliff studies bacterial biofilms, a mode of growth where pathogens such as Staph aureus become resistant to conventional therapy. He was
awarded the 2013 BioMaryland LIFE Prize for his promising Staph vaccine work. BioAssay Works focuses on antibody-based and antigen-based detection technologies, and on their application in lateral-flow immunoassay. The partnership between BioAssay Works and UMB may lead to the development of a rapid and sensitive test for Staph, in particular the treatment-resistant type (“MRSA”).

Since UM Ventures launched in 2012, the University has helped faculty entrepreneurs manage and commercialize their discoveries, and has helped student entrepreneurs participate in and lead real-world early-stage business ventures. UMB and UMCP startups include a wide range of success stories. UM Ventures provides resources, funding, and expertise to help startups bring innovative technologies to the market.

Source: University of Maryland

MolecularMD Corp. Obtains License to Commercialize Predictive Diagnostic Based on Actionable Biomarker, DDR2, for Uses in Lung Cancer and Targeted Kinase Therapy

MolecularMD Corp. recently announced 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 DDR2 mutations for diagnostic, prognostic and predictive uses for humans in the area of lung cancer. Such patent rights are jointly-owned by The Broad Institute and Dana-Farber Cancer Institute. The inventors named on the patent are Drs. Matthew Meyerson, Peter Hammerman, and Alexis Ramos.

About DDR2 Mutations in Lung Cancer

Research into understanding the genetic basis of cancer has led to identification of novel biomarkers that have been successfully exploited with targeted therapies. In non-small cell lung cancer (NSCLC), several such targets have been discovered for adenocarcinoma including EGFR, ALK, and MET. Unfortunately, these therapeutic targets are not relevant for squamous cell carcinoma (SCC), which is the second most frequent histological subtype in NSCLC. Recent discoveries identified mutations in the discoidin domain receptor 2 (DDR2) of SCC patient tumors that are oncogenic and also responsive to existing drugs targeting kinase inhibition. DDR2 is a membrane receptor tyrosine kinase involved in cell adhesion, proliferation and migration. In xenograft models, DDR2-mutant tumors regressed under treatment with the tyrosine kinase inhibitor, dasatinib. Remarkably, an SCC patient with no detectable EGFR mutation had a long-term response to the combination of erlotinib plus dasatinib. This patient was found to harbor a DDR2 mutation further suggesting that DDR2 mutations may be clinically relevant. Given the availability of a variety of therapies targeting tyrosine kinases, these findings provide a rationale for designing clinical trials for patients with SCC using existing FDA-approved drugs such as dasatinib, imatinib, nilotinib and ponatinib as well as novel, selective tyrosine kinase inhibitors for DDR2.

MolecularMD is developing DDR2 diagnostic assays, including next-generation sequencing tests, for clinical trials exploring efficacy of targeted therapies and DDR2 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 commercialization of DDR2 technology through sublicensing to clinical reference laboratories and diagnostic assay developers and manufacturers.

According to Dr. Greg Cox, MolecularMD’s Director of Licensing, “DDR2 is potentially the first actionable biomarker available for SCC patients, whose treatment options are currently limited to chemotherapy. It’s exciting that these patients may benefit from existing FDA-approved targeted therapies, and we are eager to support clinical trials examining these novel treatment possibilities and enable widespread access to DDR2 diagnostics.”

ColoMarker: Convenient, Low-cost, Early Stage Colon Cancer Blood Test Reports Validation

EDP Biotech, the US-based developer of a blood test to detect the early stages of colon cancer called ColoMarker™, recently announced its plans to commercialize the product and bring the new technology to market. Unlike other diagnostic tests currently in development, the ColoMarker test detects a level of CA11-19 antigen, a specific protein molecule found in the bloodstream. While every human being produces this protein, elevated levels in the bloodstream suggest the presence of colon cancer.

Recent third party validation of ColoMarker™, demonstrating test accuracy of 95 percent, has positioned EDP Biotech to pursue market launch in the near future. To EDP’s knowledge, no other routine sandwich ELISA technology identifies 95 percent of early stage colorectal cancer in blood.

EDP Biotech has partnered with Corgenix Medical Corporation to manufacture ColoMarker™. Corgenix is a world leader in the development and manufacturing of specialized diagnostic kits for more than 20 years. EDP is also aggressively pursuing CE Mark and fully anticipates approval and subsequent commercialization in Europe by the end of this year, followed by a strategic path towards FDA approval.

“We developed ColoMarker because of the critical need to detect cancer at its earliest stages,” says Tom Boyd, CEO of EDP Biotech. “This validation confirms that our technology has strong potential to save thousands of lives each year through early stage detection, and it’s our goal to make it available to diagnostic oncology labs and accessible to medical professionals throughout the world.”

ColoMarker™ has proven to be effective in identifying elevated levels of a biomarker in the bloodstream in 95 percent of early stage colorectal cancers, when the disease is most treatable and survival rates are highest. To date, physicians have relied primarily on colonoscopies and fecal occult blood testing (FOBT) to identify potential cases of early stage colon cancer.

A critical part of EDP Biotech’s research and development of the ColoMarker technology has been the involvement and consultation of some of the world’s most recognized experts in this field:

  • Dr. Gene Overholt – inventor of the scope for colonoscopies and recognized worldwide as the “father of the colonoscopy”
  • Dr. Herbert Fritsche – one of the world’s leading experts on cancer biomarkers and former Chief of Clinical Chemistry at MD Anderson Cancer Center
  • Dr. John Costanzi – internationally-known and considered a leading expert in the treatment of cancer

Recently Dr. Donald Wheeler – author, professor, statistician and renowned quality control expert – also joined EDP Biotech’s scientific advisory board as the company approaches commercialization.

Source: Business Wire

Empire Genomics Licenses Novel DNA Biomarker for Use in Diagnosing and Creating a Companion Diagnostic Test for Neuroendocrine Prostate Cancer

Empire Genomics recently announced that it has acquired an exclusive license for a patent pending novel genomic biomarker from Cornell University for use in developing a molecular diagnostic test that could help in diagnosing and determining treatment for patients with neuroendocrine (NEPC) prostate cancer.

Neuroendocrine prostate cancer (NEPC) is a lethal variant of prostate adenocarcinoma (PCA) that can arise de novo, but more commonly arises after hormonal therapy for PCA. Little is known about the underlying molecular biology of NEPC or how and why some patients with PCA progress to a predominantly neuroendocrine phenotype. There is currently no effective therapy for NEPC, and most patients survive less than one year. The poor molecular characterization of NEPC accounts in part for the lack of disease specific therapeutics.

“Each year, approximately, 30,000 men will die of advanced prostate cancer, most of whom will be treated with androgen suppression therapy, however, it is impossible to know just how many of them developed NEPC because patients are not typically biopsied at that stage of their disease,” said Dr. Brian Kelly , Director of Technology Commercialization and Liaison at the Weill Cornell Medical College office of the Cornell Center for Technology Enterprise and Commercialization (CCTEC). “We are delighted that Empire Genomics is now going to make this important diagnostic test available to this patient population and we look forward to working with the company and its seasoned management team.”

“We are delighted to work with Empire Genomics to help develop a commercial grade assay to test for abnormalities one of the key driving genes of the most aggressive form of prostate cancer. This clinical tool will be important as we move forward with precision medicine clinical trials for aggressive castration resistant prostate cancer lead by Dr. Himisha Beltran,” said Mark Rubin , Homer T. Hirst Professor of Pathology in Oncology and the Director of the Institute for Precision Medicine.

Empire Genomics will launch a genetic test for NEPC that will diagnose NEPC Prostate Cancer later this year and seek to partner with pharmaceutical companies to use this assay for accelerating patient stratification in clinical trials.

“We are very pleased to work with Drs. Rubin and Beltran and Cornell to commercialize this technology,” said Anthony Johnson , CEO of Empire Genomics. “It is another exciting genomic tool that we have added to our exclusive precision medicine portfolio.”

Source: Empire Genomics