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AB SCIEX Proteomics Scientist Wins HUPO 2013 Science and Technology Award

The Human Proteome Organization (HUPO) recently awarded Christie Hunter, Ph.D, director of proteomics applications at AB SCIEX, its 2013 Science and Technology Award at an award ceremony during last week’s HUPO 2013 conference in Japan. Dr. Hunter was recognized for her contributions to the development and commercialization of a breakthrough approach for targeted proteomics. The analytical strategy of targeted proteomics was recently named “Method of the Year” by Nature Methods.

Targeted proteomics is a standardized, biological research workflow that focuses on reproducibly quantifying a specific subset of proteins within a sample. It generates data that is vital for biologists to answer hypothesis-driven, biological questions.

A decade ago, proteomics research was dominated by discovery workflows, which provided valuable information on a single sample but lacked the reproducibility to generate robust quantitation across a larger sample set. New innovation was needed at the time to move the field beyond simply producing large lists of identified proteins and toward providing highly quantitative answers.

This led to the development of a multiple reaction monitoring (MRM)-triggered, tandem mass spectrometry (MS/MS) workflow at AB SCIEX to rapidly create high sensitivity MRM assays to target peptides that are unique to their associated proteins. This workflow was made possible by the combination of triple quadrupole and linear ion trap functionality in a single system called the AB SCIEX QTRAP® System.

Dr. Hunter ‒ in collaboration with researcher Dr. Leigh Anderson, the founder of the Plasma Proteome Institute and head of SISCAPA Assay Technologies ‒ pioneered a workflow that applied MRM to the targeted quantification of proteins and peptides in plasma by mass spectrometry. In their initial publication[1], Dr. Hunter and Dr. Anderson demonstrated that a targeted workflow could be applied to multiplexed quantitation of proteins in human plasma with high reproducibility and high confidence in the results.

The impact of the paper resulted in broad adoption of the MRM technique around the world to accelerate the verification and validation of putative protein biomarkers, generating more than 800 citations, according to Google Scholar. Less than a decade after this important work, most proteomics laboratories today use a triple quadrupole-based mass spectrometer to perform MRM analysis.

“We congratulate Dr. Christie Hunter on receiving such a prestigious award from HUPO in recognition of her significant contributions to the rise of targeted proteomics as a viable technique to advance biomarker research,” said Dave Hicks, Vice President and General Manager of the Pharmaceutical and Academic Business at AB SCIEX.

“Dr. Hunter and her AB SCIEX colleagues continue to participate in exciting collaborations with leading proteomics researchers around the world to drive new innovations in software, chemistries and instrumentation that further expand quantitative proteomics workflows for the growing community of mass spectrometry users at large,” added Hicks.

Currently, Dr. Hunter is playing a pivotal role in the development of higher specificity workflows for targeted protein quantitation to overcome situations where sensitivity is limited by interferences or background. She is involved in the investigation of the utility of differential mobility separations for added selectivity of quantitation of peptides in complex mixtures. She is also working to enhance data-independent acquisition strategies, such as SWATHTM Acquisition, for quantitative proteomics to increase the multiplexing and reproducibility that can be achieved in a single experiment.

Source: AB SCIEX

Key Assay Development at HUPO

Proteome Sciences presented novel data and key assay developments at the HUPO 12th Annual World Congress in Japan covering Tau in Alzheimer’s disease, SysQuant® in pancreatic cancer and a missing isoform in sugar structures of clusterin, a plasma protein biomarker for Alzheimer’s in brain atrophy.

pTau

The new Tau phosphorylation assay (pTau SRM) demonstrated powerful sensitivity and reproductivity measuring Tau phosphorylation on human and mouse models of Alzheimer’s disease from a much smaller sample amount.

In a different application the pTau SRM was successfully used to determine the effect of Tau kinase inhibitors PS110 and PS278-05 on CK1d on the Tau protein in a mouse model of Alzheimer’s. The results confirmed that Tau phosphorylation was reduced by the two compounds but not affected by the control substance.

SysQuant®

Over 5,000 different phosphorylation sites were quantified in tumour and healthy tissue in pancreas cancer with SysQuant®. In addition to major alterations in proteins related to cell morphology and motility, individual patterns of pathway activation were able to accurately predict the likelihood of tumour recurrence and to provide a truly personalised treatment regime.

Glycopreotomics

Novel data was presented that showed diagnostic changes in sugar structures attached to clusterin, a plasma marker for Alzheimer’s in brain atrophy. This revealed a unique isoform that lacked a specific branching pattern in patients with high levels of brain atrophy.

Commenting from Yokohama, Dr. Ian Pike, Chief Operating Officer, said: 

“We were delighted to be invited to the 12th HUPO congress to show results from the powerful biomarker services platform that we have developed from our TMT® mass tags for customers where we are at the forefront in proteomics. New assays for pTau and clusterin glycoprotein provide important additions to the range of assays and services that we offer our customers in Alzheimer’s The added power delivered by SysQuant® identifies thousands of phosphorylation sites across key signalling pathways that give clinicians the ability for the first time to provide real time patient management, in this case in pancreas cancer. These are exciting developments from proteomics that are fundamentally changing how clinicians identify and manage disease.”

Source: Proteome Sciences

Kantar Health Launches CancerMPact Biomarker Analysis

Kantar Health, a leading global healthcare consulting firm, today announced the availability of CancerMPact® Biomarker Analysis, a global offer that examines biomarker segmentation in the current and evolving oncology landscape. The analysis is based on a thorough review of literature and recently published data covering the following biomarkers:

  • BRAF (melanoma)
  • EGFR (non-small lung cancer)
  • EML4-ALK (non-small cell lung cancer)
  • KRAS (colorectal cancer)
  • TNBC (breast cancer)

CancerMPact Biomarker Analysis helps clients identify the percentage of cancer patients with a specific biomarker; ascertain variations in biomarker prevalence by race, ethnicity or geography; determine which information to use to inform forecasting and market sizing; and pinpoint which patient segments are available for targeted therapies and clinical trials. Through this new offer, pharma companies are able to better understand which patient subpopulations are candidates for unique treatment options in this complex therapeutic area.

“The era of ‘personalized’ medicine has arrived, and while physicians and patients are ready to embrace it, many factors need to be considered by a manufacturer to accurately evaluate their market opportunities,” Kantar Health Vice President David Robinson said. “We estimate that 17 to 20 percent of oncology patients are currently eligible for personalized care due to either biomarkers or histology-based treatments. This number will grow in the near future as more biomarkers are validated and new patient subpopulations are identified as being appropriate for novel targeted therapeutics.”

CancerMPact Biomarker Analysis is produced by the same oncology experts as CancerMPact®, which has become an invaluable oncology decision support tool for market analysis, strategic planning and identification of commercial opportunities in the U.S., Western Europe, Japan and China. This tool, composed of web-based integrated modules, includes Treatment Practices and Evolution (Treatment Architecture and Future Trends and Insights), Patient Metrics, and Monthly Drugs and Regimens.

Crescendo Bioscience to Present New Data on Vectra DA Use to Assess Radiographic Progression Risk in Patients with Rheumatoid Arthritis Treated with Traditional and Biologic Therapies at the European League Against Rheumatism Annual Meeting (EULAR)

Crescendo Bioscience, a molecular diagnostics company dedicated to developing and commercializing quantitative blood tests for rheumatoid arthritis (RA) and other auto-immune diseases, announced today that it will present data from ten different studies that further support the important role Vectra® DA can play in managing Rheumatoid Arthritis (RA) at the European League Against Rheumatism (EULAR) Annual Meeting held in Madrid, Spain, on June 12-15. EULAR is the largest gathering of rheumatology healthcare professionals in Europe. Vectra DA is an objective, validated blood test that provides rheumatologists with a score of 1-100, giving biological insight into the level of disease activity of rheumatoid arthritis. Data presented at EULAR will demonstrate Vectra DA’s ability to assess risk of radiographic progression (joint damage over time) in patients with RA currently treated with traditional and biologic agents, including TNF inhibitors. In addition, data will show how Vectra DA can detect a high level of RA disease activity in patients with a low C-reactive protein (CRP) without being affected by fibromyalgia, a painful non-inflammatory condition that can co-exist with RA.

This week, researchers will present data from a study conducted by the University of Occupational and Environmental Health in Kitakyushu, Japan, A Multi-biomarker Disease Activity (Vectra DA Algorithm) Score is Associated with Radiographic Outcomes in RA Patients Treated with TNF inhibitors (#SAT0012) . This study found that patients who were being treated with adalimumab, etanercept or infliximab and had a low Vectra DA score (29 or less) in at least two of three visits over one year showed little or no radiographic progression. In contrast, patients with high scores (greater than 44) for at least two of three visits had a much higher risk of clinically relevant radiographic progression. In addition, researchers found that change in the Vectra DA score over the first six months of treatment correlated with radiographic outcomes in the first year. This is the first time risk of radiographic progression in patients treated with TNF inhibitors was assessed using Vectra DA over time.

“We know that anti-TNF drugs have been shown to help minimize the overall amount of radiographic progression,” said Yoshiya Tanaka, MD, PhD, Professor and Chairman, University of Occupational and Environmental Health, Kitakyushu, Japan. “This study underscores the clinical utility of Vectra DA to objectively assess which patients remain at risk of radiographic progression despite anti-TNF therapy. This information could be important in helping rheumatologists confirm or potentially revise their treatment plan.”

“This study demonstrates the additional value Vectra DA can bring to the overall RA patient management experience,” said Oscar Segurado, MD, PhD, Chief Medical Officer at Crescendo Bioscience. “With a number of RA drugs available today, and more than 50 agents in development, a quantifiable disease activity measurement test like Vectra DA can be a true asset for physicians.”

Researchers will also present new data regarding use of Vectra DA in patients with both RA and fibromyalgia. In Application of a Multi-Biomarker Disease Activity (Vectra DA) Score for Assessing Rheumatoid Arthritis Patients with Low CRP or Fibromyalgia (#SAT0099), researchers from the Brigham and Women’s Hospital and Harvard Medical School showed that in patients with RA, traditional methods of disease assessment, including tender joint count, DAS28-CRP, and Patient Global Assessment were markedly increased by the presence of fibromyalgia, a painful non-inflammatory syndrome that can confound the assessment of patients with RA. In contrast, the Vectra DA test measured essentially the same level of disease activity in patients with RA independent of the presence of fibromyalgia, which highlights the value of the objective nature of the test.

“Vectra DA provides additional information about disease activity that is not provided by other assessment tools such as C-reactive protein (CRP),” said Segurado. “This study showed that in patients with low CRP, nearly half had Vectra DA scores in the moderate to high disease activity range, indicating that their RA was actually more active than originally found with CRP. This information will help physicians attain better insight to the underlying biology of the disease.”

Additional Poster Highlights

A study selected by EULAR will be part of the Poster Tour (FRI0098) Friday, June 14 between 11:45 am and 1:30 pm, Biomarker-Based Estimates of Risk of Radiographic Progression in the Leiden Early Arthritis Cohort, and researchers from the Leiden University Medical Center, Leiden, the Netherlands will discuss the use of Vectra DA as a tool to estimate the risk of radiographic progression in RA.

“Using the Vectra DA score, we were able to see a correlation between the score and risk of radiographic progression over 12 months,” said Tom W.J. Huizinga, M.D., Head of the Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands and primary investigator. “This tells us that Vectra DA can be helpful in identifying patients at high risk for radiographic progression and, thus, give rheumatologists more information to help prevent future progression.”

Another poster, A Multi-Biomarker Disease Activity Blood Test (Vectra DA) Correlates with Radiographic Progression in Early Rheumatoid Arthritis: Results from the SWEFOT Trial (#FRI0060), focused on use of Vectra DA in assessing risk of radiographic progression in early RA. The SWEFOT study is the Swedish Pharmacotherapy Trial out of the Karolinska Institutet in Stockholm.

In early RA patients starting methotrexate, the study found that Vectra DA’s score, when assessed at baseline, significantly correlated with radiographic progression in the first year. “A high MBDA score at baseline was associated with a higher risk of radiographic progression, even in patients who had moderate disease activity by DAS28 or low CRP at baseline,” said Ronald F. van Vollenhoven,M.D., Ph.D., Professor and Chief, Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), Chief, Clinical Trials Unit, Department of Rheumatology, the Karolinska Institute and primary investigator of the study.

Other Vectra DA Posters Presented at 2013 EULAR Annual meeting

Additional study results (presented in six posters listed below) further demonstrate and confirm the ability of Vectra DA to objectively assess disease activity and/or potentially identify risk for radiographic progression in early- and later-stage RA patients.

Poster #FRI0061

Multi-Biomarker Disease Activity (MBDA) Score and the 12 Individual Biomarkers in Early Rheumatoid Arthritis Patients Relate Differently to Clinical Response and Radiographic Progression: Results from SWEFOT Trial; K. Hambardzumyan, Karolinska Institutet, ClinTRID, Stockholm, Sweden, and other collaborators.

Poster #FRI0062

Evaluation of a Multi-Biomarker Disease Activity (Vectra DA Algorithm) in Early Rheumatoid Arthritis and Unclassified Arthritis Patients; K. I. Maijer, Department of Clinical Immunology and Rheumatology, Academic Medical Center/University of Amsterdam, Amsterdam, the Netherlands and other collaborators.

Poster #FRI0066

Behavior of the Multi-Biomarker Disease Activity (Vectra DA Algorithm) Score and Components in Patients with Rheumatoid Arthritis Treated with Tocilizumab; K. Hanami, The First Department Of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, and other collaborators.

Poster # FRI0075

A Multi-Biomarker Disease Activity (Vectra DA Algorithm) Score and Components are Associated with Sustained Clinical Remission in Rheumatoid Arthritis: the REMIRA Study; M. H. Ma, Academic Department of Rheumatology, King’s College London, London, United Kingdom and other collaborators.

Poster #FRI0079

Response to MTX Plus Prednisone in CAMERA II Using a Multi-Biomarker Disease Activity Test (Vectra DA) and DAS28-ESR; M. S. Jurgens, Rheumatology & Clinical Immunology, UMC UTRECHT, Utrecht, Netherlands and other collaborators.

Poster #SAT0033

Characterization of the Multi-Biomarker Disease Activity (Vectra DA Algorithm) Score in a Subgroup of Patients from the Epidemiological Investigation of Rheumatoid Arthritis (EIRA) Cohort Receiving Methotrexate; W. Li, Crescendo Bioscience, Inc., South San Francisco and other collaborators.

Source: GlobeNewswire

Edison Pharmaceuticals, Inc. Signs Licensing Agreement with Dainippon Sumitomo Pharma Co., Ltd. for Development & Commercialization of Orphan Mitochondrial and Adult Central Nervous System Disease Drugs

Edison Pharmaceuticals recently announced that it has entered into a research/development and commercialization agreement with Dainippon Sumitomo Pharma Co., Ltd. (DSP) for the development of EPI-743 and EPI-589 in Japan. Under the terms of the agreement, DSP will gain development and commercialization rights in Japan in exchange for Edison receiving $35 million in upfront and $15 million in R&D support. In addition, Edison will be eligible to receive $10-35 million in development milestones per indication and up to $460M in commercial milestone payments as well as royalties on commercial sales.

The initial scope of the transaction includes both pediatric orphan inherited mitochondrial and adult central nervous system diseases. Under the terms of the agreement, DSP will undertake activities required for development, approval, and commercialization of EPI-743 in Japan. The work will initially focus on orphan pediatric mitochondrial disease. Edison will retain 100% ownership and direct all research, clinical, and commercial development of EPI-743 and EPI-589 outside of Japan.

In addition, the parties will collaborate on the research and development of EPI-589 with a focus on adult central nervous system disease. This collaboration is based upon the emerging body of data implicating redox and mitochondrial dysfunction as a root cause of neurologic disorders.
Edison’s translational platform is based on redox biochemistry. It bridges key learnings derived from genetically confirmed pediatric rare mitochondrial disease to adult central nervous system disorders where redox and mitochondrial dysfunction are likely to also play a critical role.

The Edison redox platform consists of proprietary laboratory and clinical tools that enable the discovery, optimization, and clinical validation of redox-directed drugs. Specifically, through employing both laboratory and clinically derived redox signatures of disease and drug action, Edison is able to develop drugs at a fraction of the time and cost of current drug development processes, thereby reducing risk and cost and increasing the likelihood of success.

Edison will use proceeds derived from the partnership to advance the late stage development and commercialization of EPI-743 for Leigh syndrome and Friedreich’s ataxia, as well as to advance EPI-743 in other exploratory phase 2 trials for rare pediatric diseases with shared mitochondrial mechanisms.

“Our partnership with Dainippon Sumitomo Pharma will allow Edison to accelerate the development and approval of the first drug for inherited respiratory chain diseases of the mitochondria,” stated Guy Miller , MD, PhD, Chairman and CEO of Edison. “Our shared vision of the role of redox control and the mitochondria in human disease will help us extend our learnings derived from rare pediatric diseases to poorly treated acute and chronic adult CNS diseases.”

Source: PR Newswire