Protea makes moves in biomarker realm

MORGANTOWN, W.Va.—Protea Biosciences Group Inc. made a pair of significant announcements this month within the oncology realm, most recently on April 25 with the announcement that it had entered into an exclusive license agreement with Yale University for new technology to improve the differential diagnosis of malignant melanoma. The other announcement being identification of potential lung cancer biomarkers, which we’ll get to shortly.

The licensing news involves a test in development that makes use of a new technology known as proteomic mass spectrometry imaging. The technology was developed jointly by the laboratory of Dr. Rossitza Lazova, an associate professor of dermatology and pathology at Yale School of Medicine and the laboratory of Dr. Erin Seeley, clinical imaging principal investigator at Protea Biosciences.

In October 2015, scientists at Yale and Protea presented the results of their first clinical study at the 52^nd Annual Meeting of the American Society of Dermatopathology, held in San Francisco, reporting that the sensitivity and specificity of the new method were both shown to be 99 percent and the test correctly classified all cases of malignant melanoma and benign melanocytic nevi.

“We are pleased to be working with Dr. Lazova at Yale, to develop this test that employs unique protein expression profiles that discriminate between benign melanocytic nevi and malignant melanomas,” stated Steve Turner, Protea’s CEO, adding: “We believe our technology will lead to the discovery of other clinically useful protein biomarker panels that can aid in the differential diagnosis of other cancer types.”

“Mass spectrometry imaging is an objective and reliable method that may be helpful in difficult cases, in which rendering a definitive diagnosis of either benign nevus or malignant melanoma may be very difficult,” noted Lazova. “The identification of protein expression profiles, which discriminate between benign melanocytic nevi and malignant melanomas, has led to the discovery of a set of clinically useful tumor biomarkers that can be incorporated into standard diagnostic and treatment strategies.”

Proteomic mass spectrometry imaging enables the direct molecular profiling of cells and tissues, Protea notes—the specific proteins can be identified, localized in tissue, then displayed, both as 2D or 3D molecular images. Hundreds of molecules can reportedly be identified in a single analysis, and results are rapidly available.

Getting back to the lung cancer news, announced roughly a week earlier, Protea Biosciences had made note of the use of its proprietary bioanalytical technology to achieve the molecular profiling of live tumor cells while they are under treatment.

Scientists from Protea and The West Virginia University Cancer Institute presented their results at the American Association for Cancer Research Annual Meeting 2016 recently in New Orleans. The presentation, titled “Mass Spectrometry Imaging Determines Biomarkers of Early Adaptive Precision Drug Resistance in Lung Cancer,” identified molecular changes occurring within drug-resistant lung cancer cells. The research used Protea’s proprietary mass spectrometry imaging (MSI) workflows to rapidly identify molecular changes occurring within residual tumor cells.

“Drug resistance emergence is a common problem that limits long term outcome benefits in the era of precision cancer therapy,” said Seeley. “Today we present the use of our mass spectrometry imaging technology to interrogate the biomolecular changes occurring within residual tumor cells under precision treatment with ALK-specific kinase inhibitor treatments.”

“Using Protea’s MSI technology, our team discovered several metabolites that were changing over a time course of treatment,” Seeley added. “Peptides were detected that showed differentiation with over 98-percent accuracy between treated and untreated xenograft tumors (FFPE); also, MSI analysis of frozen tumors allowed for detection of the precision therapy drug, as well as lipids that were changing in expression as a result of treatment.”

Further studies are planned to validate the use of the biomarkers to identify drug resistance in lung cancer.

That’s not all Protea’s been doing lately, and cancer isn’t the sum total of its experience, either. Back in mid-February, the company also announced that it is collaborating with Protein Metrics Inc., a provider of software solutions for the comprehensive characterization of proteins, to advance new analytical capabilities for use in the development of protein biotherapeutics.

“We are positioning Protea to be a leader in the next generation of bioanalytics, focused on the needs of the biotherapeutics industry,” stated Dr. Greg Kilby, Protea’s vice president and chief operating officer. “Our Protein Metrics collaboration will provide Protea access to advanced software for comprehensive protein characterization, PTM analysis and sequence variant analysis. We will combine our technologies, including our proprietary LAESI mass spec imaging platform, with Protein Metrics software to provide novel, ‘Big Data’ services to identify, characterize and quantify biologically important molecules. Biopharma is in need of these new bioanalytical capabilities.”

“The rapid adoption of our suite of software is entirely thanks to the input from our customers who have helped us design tools that are directly applicable and tailored to their needs,” added Chris Becker, president and CEO of Protein Metrics. “We are delighted to partner with Protea Biosciences and are looking forward to seeing our software advance the results they provide their clients.”