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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

Precision Therapeutics Announces Unparalleled Results That Show Recurrent Ovarian Cancer Patients Live 65% Longer in Breakthrough Prospective Clinical Trial

Precision Therapeutics, Inc., a life science company dedicated to developing personalized medicine products for individualized cancer care, recently announced that compelling results have been accepted for publication in Gynecologic Oncology, a leading, peer-reviewed clinical oncology journal. The accepted study is currently located on the Gynecologic Oncology website.

The prospective study, conducted in conjunction with Yale University School of Medicine and over 30 additional cancer centers nationwide, showed that recurrent ovarian cancer patients treated with a chemotherapy identified as sensitive by the ChemoFx® drug response assay lived 14-months longer, a (65%) improvement in overall survival, as compared to patients treated by non-sensitive chemotherapies classified by ChemoFx.

Additionally, ChemoFx was able to identify at least one sensitive chemotherapy agent for more than half of the recurrent ovarian cancer patients studied, approximately doubling current statistics suggesting that only 20 to 30 percent of cancer patients with recurrent ovarian cancer benefit when treated with chemotherapy chosen empirically.

262 evaluable patients were treated with one of 15 study-designated standard chemotherapy treatments selected by the treating oncologist, who was not informed of the ChemoFx results. When blinded to the results of the assay, physicians treated 25% of patients with a sensitive chemotherapy, while more than half (52%) of the study participants showed at least one assay-sensitive chemotherapy from which they could have benefited had the physician been assay-informed. The data implies that if ChemoFx results were utilized by physicians prior to treatment, the number of patients receiving sensitive treatments, and thereby experiencing improved survival outcomes, could have more than doubled. The study clearly shows that patients treated with sensitive chemotherapies identified by ChemoFx outperformed patients treated with alternate chemotherapies.

Median progression free survival also improved by 50% for patients treated with sensitive chemotherapies as identified by ChemoFx vs. those treated with non-sensitive agents (hazard ratio [HR] = 0.67, p = 0.009). The association with assay response was consistent in both platinum-sensitive and platinum-resistant tumors (HR: 0.71 vs. 0.66) and was independent of other covariates in multivariate analysis (HR = 0.66, p = 0.020). A statistically significant 14-month improvement in median overall survival (37.5 months for patients treated with sensitive agents vs. 23.9 months for who were not, HR = 0.61, p = 0.010) was also reported.

“This clinical study is a landmark for the treatment of ovarian cancer because it is the first prospective data that definitively shows that a personalized diagnostic test can make a significant clinical impact by improving overall survival by 65% in women with this devastating cancer,” said Thomas J. Rutherford MD, PhD, Professor of ObGyn and Reproductive Sciences and Section Chief, Gynecologic Oncology at the Yale School of Medicine, and lead investigator in the study.

ChemoFx results show a dramatic difference when compared to recent recurrent ovarian cancer studies that produced limited improvements in progression free survival (2-3 months), and very few if any improvement in overall survival (2 months)2-14

This breakthrough study shows that through the use of the ChemoFx assay, treating physicians can treat with effective chemotherapy drugs which may help extend the life of patients afflicted with this disease. No recent test, therapy or innovation compares in terms of impact on patient’s lives and it is reason for new hope for the treatment of this disease.

“The clinical significance of this study is that ChemoFx may have predictive abilities, enabling a physician to choose the most effective pharmaceutical treatment from among the available options for ovarian cancer,” said Robert Holloway, MD, Medical Director of Florida Hospital Gynecologic Oncology.

Study: A prospective study evaluating the clinical relevance of a chemoresponse assay for treatment of patients with persistent or recurrent ovarian cancer [Gynecologic Oncology]

Source: Business Wire

Faster, Simpler Diagnosis for Fibromyalgia May be on the Horizon

Researchers have developed a reliable way to use a finger-stick blood sample to detect fibromyalgia syndrome, a complicated pain disorder that often is difficult to diagnose.

If it were someday made available to primary care physicians, the test could knock up to five years off of the wait for a diagnosis, researchers predict.

In a pilot study, the scientists used a high-powered and specialized microscope to detect the presence of small molecules in blood-spot samples from patients known to have fibromyalgia.

By “training” the equipment to recognize that molecular pattern, the researchers then showed that the microscope could tell the difference between fibromyalgia and two types of arthritis that share some of the same symptoms.

Though more analysis is needed to identify exactly which molecules are related to development of the disorder itself, the researchers say their pilot data are promising.

“We’ve got really good evidence of a test that could be an important aid in the diagnosis of fibromyalgia patients,” said Tony Buffington, professor of veterinary clinical sciences at The Ohio State University and senior author of the study. “We would like this to lead to an objective test for primary care doctors to use, which could produce a diagnosis as much as five years before it usually occurs.”

Patients with fibromyalgia are often desperate by the time they receive treatment because of the lengthy process required to make a diagnosis. The main symptoms, persistent pain and fatigue, mimic many other conditions, so physicians tend to rule out other potential causes before diagnosing fibromyalgia. Additional symptoms include disrupted sleep and memory or thought problems. An estimated 5 million American adults have the disorder, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

“The importance of producing a faster diagnosis cannot be overstated, because patients experience tremendous stress during the diagnostic process. Just getting the diagnosis actually makes patients feel better and lowers costs because of reductions in anxiety,” said Kevin Hackshaw, associate professor of medicine, division of rheumatology and immunology, at Ohio State’s Wexner Medical Center and lead author of the study.

The study is published in the Aug. 21, 2013, issue of the journal Analyst.

The technology used in this work is infrared microspectroscopy, which identifies the biochemical content of a blood sample based on where peaks of molecules appear in the infrared spectrum. The technology offers hints at the molecules present in the samples based on how molecular bonds vibrate when they are struck by light.

The spectroscopy works on dried blood, so just a few drops from a finger stick produce enough blood to run this test.

Researchers first obtained blood samples from patients diagnosed with fibromyalgia (14), rheumatoid arthritis (15) and osteoarthritis (12). These other conditions were chosen for comparison because they produce similar symptoms as fibromyalgia, but are easier to diagnose.

The scientists analyzed each sample with the infrared microspectroscopy to identify the molecular patterns associated with each disease. This functioned as a “training” phase of the study.

When the researchers then entered blinded blood samples into the same machinery, each condition was accurately identified based on its molecular patterns.

“It separated them completely, with no misclassifications,” Buffington said. “That’s very important. It never mistook a patient with fibromyalgia for a patient with arthritis. Clearly we need more numbers, but this showed the technique is quite effective.”

The researchers also analyzed some of the potential chemicals that could someday function as biomarkers in the fibromyalgia blood samples, but further studies are needed to identify the molecules responsible for the spectral patterns, he said.

Though an infrared microscope can be expensive, Buffington said the testing could be affordable if a central lab existed to run the samples. That the method can use dried blood samples makes this concept feasible because dried blood can be legally sent via U.S. mail, he noted.

Why is a veterinarian pursuing this type of research? Buffington is a renowned expert on domestic cats, including a painful bladder disorder they suffer called interstitial cystitis (IC). This syndrome also occurs in humans.

It turns out that the origins of IC, like such human disorders as irritable bowel syndrome and fibromyalgia, cannot be traced to the specific area of the anatomy most affected by the syndrome. These disorders are categorized as medically unexplained or functional syndromes, and Buffington has explored the possibility that a common link exists among these types of diseases, and that they might have origins in the central nervous system.

Buffington has filed two invention disclosures with the university, and Ohio State has filed multiple patent applications for the testing method, in the United States and internationally. In November, Ohio State was issued U.S. Patent 8,309,931 on a rapid diagnostic method for functional syndromes in humans and cats.

Additional co-authors include Luis Rodriguez-Saona and Marçal Plans of the Department of Food Science and Technology at Ohio State, and Lauren Bell of Metabolon Inc., based in Durham, N.C.

Study: A bloodspot-based diagnostic test for fibromyalgia syndrome and related disorders [Analyst]

Source: Ohio State University Wexner Medical Center

Abcodia and Cellmid Collaborate on the Studying of Midkine for Early Diagnosis of Colorectal Cancer

Abcodia Ltd, the UK biomarker validation company with a focus on early detection of cancer, today announced that it has entered into a collaboration agreement with Cellmid Ltd (ASX: CDY), for the testing of midkine (MK) in a collection of longitudinal serum samples using Cellmid’s MK-ELISA.

The initial objective of the collaboration is to validate midkine as a useful marker for the screening and early diagnosis of colorectal cancer. Serum samples will be provided by Abcodia and testing will be carried out by Cellmid.

The collaboration focuses on the assessment of midkine in pre-diagnosis serum samples. Abcodia has exclusive access to a unique biobank of 5,000,000 serum samples collected through the UK Collaborative Trial for Ovarian Cancer Screening.

The biobank was derived from 200,000 initially healthy volunteers. Since first recruitment, more than 27,000 individuals have been diagnosed with cancer. A subset of 50,000 individuals within the 200,000 cohort have provided samples annually, making this a unique longitudinal resource for testing midkine levels early, even before symptoms appear.

The collaboration agreement allows for the testing of multiple cancer indications, but initially targeting the early detection and screening of colorectal cancer. Colorectal cancer ranks third in incidence and second in cancer-related mortality in the United States.

Although the five year survival rate for stage 1 cancers is as high as 74%, for stage 4 cancers, when the cancer has metastasized, this reduces to just 6%. Early diagnosis of colorectal cancer, before the spread to the lymph nodes and distant sites, is vital to reduce death rates.

Midkine has been extensively validated as a biomarker in a range of other cancers. t has been shown to appear very early in some solid tumours with demonstrated utility in disease management and monitoring. Since 2012 midkine has been commercially used as one of the biomarkers in CxBladder®, a diagnostic test for the monitoring of bladder cancer patients.

Cellmid’s CEO, Maria Halasz, said: “We are excited to collaborate with the expert team at Abcodia to measure midkine levels in their extensive collection of pre-diagnosis serum samples. It is an exceptional opportunity for Cellmid to take part in the development of an important cancer diagnostic test.”

Abcodia’s CEO, Dr Julie Barnes, said: “I am delighted to be able to form this partnership with Cellmid. Midkine is an intriguing marker and I hope that we can reveal an interesting profile in the early pre-symptomatic phase of colorectal cancer. The uptake of current screening methods for colorectal cancer (colonoscopy and haemoccult testing) is low and a simple blood test could help significantly improve early diagnosis and therefore improve treatment outcomes.”

Source: Abcodia

Biodesix Secures Medicare Coverage for VeriStrat Test

Biodesix, Inc., a fully integrated molecular diagnostic company dedicated to personalizing medicine, recently announced that Novitas Solutions, the Medicare Administrative Contractor for the region that includes Colorado, has established coverage for the company’s VeriStrat test. VeriStrat, a clinically validated blood-based protein test, helps physicians guide second-line therapy for patients with advanced non-small cell lung cancer (NSCLC). The coverage decision means that more than 49 million eligible Medicare enrollees in the U.S. will now be able to benefit from VeriStrat being a covered diagnostic test, according to specific lung cancer indications outlined by Novitas.

Lung cancer is the most common cancer worldwide, and is the leading cancer killer in both men and women in the United States. The five-year survival rate for lung cancer is roughly 15 percent, illustrating the need for predictive biomarker tests that can identify which therapies are most appropriate for individual patients. VeriStrat fills that role; the test was recently evaluated in a phase III clinical trial, with data presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting. Results confirmed that VeriStrat is predictive of differential treatment outcomes for the two types of therapies used in second-line treatment of advanced NSCLC: chemotherapy or the targeted drug erlotinib (Tarceva®).

Erlotinib, an EGFR inhibitor, is the drug most commonly used in patients who harbor an EGFR mutation. However, only a small percentage of patients have this mutation. The VeriStrat test helps oncologists guide treatment decisions between erlotinib and single agent chemotherapy in advanced lung cancer patients who do not harbor an EGFR mutation or whose mutation status cannot be obtained. VeriStrat requires only a simple blood draw and test results are returned in less than 72 hours, allowing physicians to make quick treatment decisions.

“Medicare’s decision to offer VeriStrat as a covered benefit will allow those patients enrolled in Medicare to benefit from better-informed, personalized decision-making when it comes to the treatment of their disease,” said David Brunel, Chief Executive Officer of Biodesix. “This is a major milestone for both Biodesix and for patients with lung cancer. Using the information from VeriStrat test results, physicians can improve patient outcomes by identifying the best course of treatment.”

Medicare’s positive coverage decision for VeriStrat, published in Novitas’ “Biomarkers for Oncology” Local Coverage Decision (LCD), describes multiple predictive and prognostic biomarkers in multiple tumor types. VeriStrat is included in the non-small cell lung cancer (NSCLC) section.