Supplement: Who Gets Immunotherapy for Cancer?

Managing Patient Expectations Requires Better Biomarkers and Companion Diagnostics

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Improving Cancer Immunotherapy Success Rates

A successful response to cancer immunotherapy is only partly a matter of immune cell dynamics within a tumor. If a tumor is to be reduced and cleared, cancer immunotherapy must also engage systemic immunity. For example, successful cancer immunotherapy can activate a population of peripheral memory immune cells. Cancer immunotherapy can also incorporate responses at the tumor site influenced by interactions between the gut microbiome and the immune system.
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TruCulture System Proves Superior Reproducibility Over PBMCs

Standardized whole blood stimulation system proves superior reproducibility over PBMCs

A new paper on improved methods for monitoring differential immune response activation was published in Volume 183 of the journal Clinical Immunology. Researchers report on a multi-center study in seven FOCIS Centers of Excellence to directly compare whole blood syringe-based system, TruCulture, to the current method of isolation of PBMCs for immunomonitoring. To compare intra and inter-center variability between PBMC and TruCulture stimulation, the blood of 152 healthy donors was both stimulated in whole blood assay and after isolation of PBMC, across multiple centers. Following exposure to LPS, anti-CD3/anti-CD28, or media alone, samples were analyzed using multi-analyte profiling (MAP) for 55 proteins at Myriad RBM’s CLIA-certified laboratory. Focusing on analytes that were induced in both TruCulture and PMBC stimulation, further analysis was based on the 35 commonly induced proteins.
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Inflammatory Cytokines as Potential Biomarker for Pain Intensity

Biomarkers for pain assessment are needed for more accurate pain therapy treatment in patients unable to reliably self-report their circumstances such as patients with dementia, intubated patients, and infants. The authors of a study recently published in Biomarkers in Medicine, Soluble intercellular adhesion molecule-1: a potential biomarker for pain intensity in chronic pain patients, hypothesized that pain intensity might be assessable using inflammatory molecules measurable in serum.
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Phase I Clinical Results from FR104, a mAb Specific to CD28

Researchers led by Bernard Vanove of OSE Immunotherapeutics report in the December 7, 2016 issue of the Journal of Immunology on the first-in-human study of FR1041. OSE and collaborators at the University of Nantes and Janssen conducted a detailed phase I evaluation of safety, pharmacokinetics, pharmacodynamics and potency of FR104 in healthy volunteers.

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Myriad RBM Announces an Agreement with Sanofi to Measure Predictive Cardiovascular Biomarkers in Patients with Diabetes

Media Contact: Ron Rogers (801) 584-3065 rrogers@myriad.com
Investor Contact: Scott Gleason (801) 584-1143 sgleason@myriad.com
 

Myriad RBM Announces an Agreement with Sanofi to Measure Predictive Cardiovascular Biomarkers in Patients with Diabetes

SALT LAKE CITY, Utah, Oct. 25, 2016 – Myriad RBM, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ: MYGN), today announced that it will work with Sanofi, a global and diversified healthcare leader, to perform a biomarker analysis of blood samples from the Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) trial (NCT01147250).
“We know that cardiovascular risk is higher in people with diabetes and that cardiovascular disease negatively affects treatment outcomes,” said Riccardo Perfetti, head of Global Diabetes Medical Team, Sanofi. “Sanofi is committed to further exploring cardiovascular disease in this patient population. The biomarker work with Myriad RBM will allow us to further develop a molecular understanding of the cardiovascular risks in people with type 2 diabetes. Biomarker profiling supports our goal of developing potentially innovative new treatments for patients.”
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Myriad RBM’s TruCulture® and Gene Expression Profiling Characterizes Immune Response in Landmark Study Led by Institut Pasteur

Media Contact: Ron Rogers (801) 584-3065 rrogers@myriad.com
Investor Contact: Scott Gleason (801) 584-1143 sgleason@myriad.com
 

Myriad RBM’s TruCulture® and Gene Expression Profiling Characterizes Immune Responses in Landmark Study Led by Institut Pasteur

SALT LAKE CITY, Utah, September 7, 2016 – Myriad RBM, Inc., a wholly owned subsidiary of Myriad Genetics, Inc. (NASDAQ: MYGN) a global leader in personalized medicine, announced today that researchers from the Institut Pasteur have published new landmark research from the Milieu Interieur Project relating to the ability to perform standardized transcriptome profiling based upon a variety of immune stimuli in the August issue of Cell Reports. The study looked at the expression levels of different genes in 25 subjects following TruCulture incubation with twenty clinically relevant immune system stimulants. The research demonstrated that expression levels from as few as 44 of the 572 genes tested could segregate responses from the various stimuli and reveal variations in immune response.
“We are excited by the results of this study which demonstrated that a relatively small subset of gene expression targets could explain the variability in immune response to different immune stimuli seen among patients,” said Matthew Albert, co-coordinator of Milieu Interieur and director of the Immunobiology of Dendritic Cells Unit at the Institut Pasteur. “The ability of TruCulture to perform this analysis in an ex-vivo environment is truly unique making it an invaluable tool for assessing potential biomarkers relevant to immune response in patients.”
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Myriad RBM DiscoveryMAP® Technology Identifies Novel Biomarkers that May Predict Increased Risk of Cardiovascular Events in Patients with Diabetes

Media Contact: Ron Rogers (801) 584-3065 rrogers@myriad.com
Investor Contact: Scott Gleason (801) 584-1143 sgleason@myriad.com
 

Myriad RBM DiscoveryMAP® Technology Identifies Novel Biomarkers that May Predict Increased Risk of Cardiovascular Events in Patients with Diabetes

Protein Biomarkers May Accelerate the Future of Personalized Medicine for CV Disease

SALT LAKE CITY, Utah, Nov. 16, 2015 – Myriad RBM, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ: MYGN), today announced that its DiscoveryMAP® platform successfully identified combinations of 15 protein biomarkers associated with cardiovascular (CV) events or death in people with pre-diabetes or early type 2 diabetes, according to a study published by the journal Circulation.
“Cardiovascular diseases are one of the leading causes of deaths globally,” said Riccardo Perfetti, M.D., Vice President Medical Affairs, Global Diabetes at Sanofi, which sponsored the study. “We are optimistic that as we move toward personalized medicine, cardiovascular biomarkers will help us predict future events and possibly develop tailored treatment plans for patients that will save more lives.”
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