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Metabolon Enters into Agreement with the Carlos Slim Institute, Patia and Clinica Ruiz for Quantose Prediabetes Test in Mexico

Metabolon, Inc., the world leading metabolomics company recently announced the signing of several exclusive multi-year, royalty-based Research Collaboration and Licensing agreements with Patia Biopharma, a Mexican biotech company working to make personalized preventive medicine a reality in Mexico and Latin America. The Research Collaboration provides Metabolon’s Quantose IR™ technology for use in several Diabetes Prevention Studies in Mexico. The License agreement provides exclusive access in Mexico to Metabolon’s prediabetes test technology for assessing insulin resistance in the general population of Mexico through Patia and Clinica Ruiz’s network of laboratories.

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.”

Matrix-Bio Options Metabolite Biomarker Technology from Purdue University to Evaluate Opportunities for New Cancer Diagnostic Tests

Matrix-Bio Inc., a diagnostics company that uses metabolite profiling to detect cancer and other diseases, has signed an exclusive agreement with the Purdue Research Foundation optioning metabolite biomarker technology and eight patent applications to evaluate the commercial potential of cancer diagnostics tests based on the technologies.

The optioned technologies include metabolite biomarkers for detecting esophageal, liver, pancreatic and colon cancer; for identifying liver cancer in patients with hepatitis C; and for predicting preoperative chemotherapy effectiveness for breast cancer treatment. Matrix-Bio’s agreement is for one year with an option to extend the agreement. No other terms of the agreement were released.

The new agreement builds on the existing master license agreement between Matrix-Bio and Purdue Research Foundation for breast cancer biomarkers and metabolite profiling technology developed by Dan Raftery, Matrix-Bio chief scientific officer and founder, while he was a member of the Purdue University research faculty. Raftery is now director of the Northwest Metabolomics Research Center at the University of Washington in Seattle, and is also a member of the Fred Hutchinson Cancer Research Center in Seattle, one of the world’s leading cancer research centers.

Matrix-Bio CEO Eric Beier said the agreement will enable the company to significantly expand its pipeline of cancer detection and monitoring tests, further advancing the company’s leadership in metabolomics-based cancer diagnostic technologies.

“Metabolite profiling is an emerging field of diagnostics that looks at the changes in small molecule biomarkers in cells. Patterns of these metabolite biomarkers in the blood are altered when cancer is present,” Beier said. “Dr. Raftery’s technology identifies metabolic changes with very high sensitivity and specificity, and can detect various cancers in early, more treatable stages more accurately than currently available tests. Studies have also demonstrated that metabolite profiling can assist in monitoring cancer treatment.”

The announcement comes on the heels of an exclusive global licensing and marketing agreement for metabolomic biomarkers Matrix-Bio signed with Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services. Under the agreement, Quest Diagnostics has the rights to use the Matrix-Bio biomarkers for the future, potential development of a clinical lab-developed test to aid in the detection of breast cancer recurrence. Quest Diagnostics also has the option to pursue an appropriate regulatory pathway for an in vitro diagnostic version of the test. Additional terms were not disclosed.

Source: Business Wire

Quest Diagnostics Launches Novel Rheumatoid Arthritis Tests

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, recently announced the availability of two new blood tests for aiding the early diagnosis of rheumatoid arthritis (RA), an autoimmune disorder that can cause debilitating joint damage.

The lab-developed tests are based on the proprietary 14-3-3eta protein biomarker through an exclusive license agreement for the U.S. market with Augurex Life Sciences. One test provides results of 14-3-3eta blood levels, while a comprehensive panel provides results of blood levels of the novel marker as well as the conventional RA markers cyclic citrullinated peptide (CCP) antibodies and rheumatoid factor (RF). Higher blood levels may suggest a greater likelihood of RA.

“These novel assays have significant potential to help physicians identify early stage RA, when treatment can often arrest further disease progression and disability,” said Stanley J. Naides, M.D., F.A.C.P., F.A.C.R., medical director, Immunology R&D, Quest Diagnostics. “We believe they are superb examples of the potential of diagnostic insights to promote better outcomes through earlier diagnosis and treatment.”

Diagnosis and initiation of treatment of RA within 12 weeks of symptom onset can help prevent joint damage, improve long-term function, and increase the likelihood of achieving disease remission. Yet, many patients are not diagnosed during this time frame, and conventional lab tests, which evaluate blood levels of CCP antibodies and RF, may fail to identify the disease in an early stage.

Physicians may consider results of RF and CCP antibody tests, along with a medical evaluation and X-rays, to diagnose RA. Elevated blood levels of the 14-3-3eta biomarker outperformed conventional RF or CCP antibody testing in a recent study of early RA, being positive in 60-82% of patients diagnosed with RA compared to RF alone (32-82%) or CCP antibody alone (44-82%). The combination of all three markers further increased sensitivity to 72-100%. In addition, co-morbid conditions, such as type 1 diabetes, osteoporosis and gout, do not abnormally raise blood levels of 14-3-3eta.

“The key to successful treatment of rheumatoid arthritis rests with early diagnosis so that appropriate treatment can be instituted before the appearance of joint damage. We still lack the ability to diagnose this disease early in a substantial proportion of patients who may not then receive timely care. The introduction of 14-3-3eta therefore fulfills an important unmet need for both rheumatologists and primary care physicians,” says Dr. Walter Maksymowych, the principal investigator of several 14-3-3eta studies as well as the International Chair of the Outcomes Measures in Rheumatology Clinical Trials Soluble Biomarker Subcommittee and Medical Research Professor of Medicine and Rheumatologist at the University of Alberta, Canada.

“There are multiple routes that biotechnology companies like Augurex can take to commercialize scientific discoveries for clinical use. We believe that Quest’s expertise in immunology and leading diagnostic services position is the best way for 14-3-3eta to reach US physicians and patients who can benefit most from it,” says Norma Biln, chief executive officer of Augurex, which announced the license agreement with Quest Diagnostics in October 2012.

Quest Diagnostics’ advanced clinical laboratory in San Juan Capistrano, Calif., developed, validated and now offers the new RA tests.

Quest Diagnostics offers a broad menu of immunology diagnostic-information services, including a full menu of diagnostic tests for immune function and autoimmunity.

Source: Quest Diagnostics