3rd EDITION - ICON plc

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Jun 5, 2017 - Patient 1: Advanced NSCLC, no genomic markers, PD- .... economics are key to making that hap- pen.” retr
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3rd EDITION

Monday June 5, 2017

Chicago • FREE

AboGen Announces Release of the GoPath Laboratories Positions S3® Saliva Collection System: The Itself as a Leader in NGS Holy Grail of Sample Collection Cancer Diagnostics

The Burden of Choice: ICON Oncology’s Opinion of How We Can Reach for the Stars With a Moonshot

AboGen developed and is now commercializing its disruptive S3® Saliva Collection System, which preserves all components of saliva including cells, white blood cells, serum proteins, extracellular material (cell free DNA and RNA, exosomes) and microbiota for several months at ambient shipping and storage

Contributing Authors: Dr. Martin Lachs — VP Project Management, Oncology & Haematology, ICON Dr. Reinhard Eisebitt — SVP, Innovation Centre, ICON Dr. Valerii Fedorov — VP, Innovation Centre, ICON

Article Courtesy of AboGen

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GPS Cancer™ Advanced Molecular Profiling: DNA + RNA + Protein — See it at NantWorks Booth #19135

Patient 1: Advanced NSCLC, no genomic markers, PDL1 negative — What do you do next? Patient 2: Metastatic breast cancer, HER2 positive, no response to anti-HER2 therapies — What do you do next?

GoPath Laboratories, a patient-centric molecular diagnostic and anatomic pathology laboratory, announces the development of two new NGS-based testing series designed to detect genetic changes in both solid tumors and hereditary cancers: OncoTargetTM and GeneticsNowTM. These comprehensive assays confirm GoPath as a leader in cutting-edge molecular cancer diagnostics and continues the company’s tradition of serving clients with a bet-

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Q&A with Dr. Maher Albitar, SVP, CMO and Director of R&D at NeoGenomics

Q: What have been the biggest advances in molecular diagnostics and medicine since ASCO 2016?

Know More Before — The Era of Complete Genomics and Proteomics is here When faced with a difficult treatment decision, GPS Can-

A: Some major advances are the fact that new biomarkers for predicting response to immunotherapy are evolving and more data is accumulating to support the value of these molecular biomarkers. Over the past year, tumor mutational burden has become a more promi-

Intermountain Precision Genomics Announces Translational Science Center

Rigel Announces Tavalisse™ as Proprietary Name for Fostamatinib in the United States

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SAINT GEORGE, Utah — Intermountain Precision Genomics announces the creation of a Translational Science Center (TSC) within the Intermountain Healthcare system. The center will house several of the latest highthroughput next-generation sequencing instruments for large-scale whole genome sequencing. This initiative comes as Intermountain’s next step to bring personalized medicine from the lab bench to clinical practice

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SOUTH SAN FRANCISCO, Calif. — Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name Tavalisse™ for the company's investigational product candidate, fostamatinib disodium, an oral spleen tyrosine kinase (SYK) inhibitor. In addition, Rigel has applied to the U.S. Patent and Trademark Office to obtain federal registration of the Tavalisse mark. The name Tavalisse was developed based on the FDA’s Guidance for Industry, Contents of a Complete

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Making the right choice of clinical trial is becoming

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Exciting Times for Cancer Researchers in The US Oncology Network

By C. Lance Cowey, MD, oncologist and cancer researcher with Texas Oncology, an affiliate of The US Oncology Network

As a physician researcher affiliated with The US Oncology Network and US Oncology Research, I have been privileged to play a role in some of the major recent advancements in cancer research, such as the emer-

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Proleukin® (Aldesleukin), IL-2, Provides a Stimulatory Immune Effect With Infrequent and Generally Manageable Immune-Related Events

Proleukin® is indicated for the treatment of adults with metastatic renal cell carcinoma or metastatic melanoma. Janice Dutcher, M.D., an authority in immunotherapy for cancer, answers questions about how the immune system is activated, autoimmune-related side effects and needed ongoing research. Opportunity

for

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3rd Edition • Monday, June 5, 2017

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Personalis Inc. Orders 10 Illumina NovaSeq™ 6000 Systems for Immuno-Oncology Genomics and Large-Scale Whole Genome Sequencing

alized cancer vaccines and is actively involved in numerous current and planned clinical trials, which leverage the company’s ACE ImmunoID Next Generation Sequencing Platform. Personalis ACE ImmunoID provides a comprehensive assessment of a tumor and its immune microenvironment, which includes the identification and characterization of neoantigens, Class I and Class II antigen presenting machinery, tumor escape mechanisms and tumor-infiltrating lymphocytes (TILs). This detailed characterization of individual tumors supports the synthesis of customized therapeutics for each patient. Additionally, Personalis also provides large-scale whole genome DNA sequencing services, including for the U.S. Department of Veterans Affairs’ pioneer-

ing Million Veterans Program. Personalis and Illumina have a long history of working together. Personalis CEO John West was previously the CEO of Solexa, Inc. (acquired by Illumina in 2007) and later the SVP of DNA Sequencing at Illumina. This long relationship helped Personalis immediately recognize the potential of NovaSeq systems in immuno-oncology (IO). “IO is the fastest growing segment in oncology therapeutics, but it is intensely competitive,” said West. “We believe that the comprehensive analysis of each patient’s tumor and its immune microenvironment will become ubiquitous in this field and that the NovaSeq Series’ combination of data quality and economics are key to making that happen.”

by pooling information. The relationship between homogeneity of constituent subtrials and variation of the whole cluster trial may lead to very significant time and financial savings. The key contribution of quantum computing in this model is to train various machine learning models to predict clinical trial outcomes from genomic and phenotypic information. In isolation, neither advanced statistical methods nor advanced computing techniques address the total oncology research challenge, however the combined approach generates scientific capabilities that catalyze the development of more successful, personalized cancer therapies.

ICON employs approximately 12,300 employees from 87 locations in 38 countries. Over the past five years, ICON has successfully completed almost 350 oncology studies worldwide. Our oncology services expedite every aspect of a cancer drug trial: • Early Phase and Consulting • Adaptive Trial Design • Site Performance Management — FIRECREST® • Patient Recruitment Solutions • Medical Imaging • Extensive Laboratory Testing Capabilities • Resourcing and FSP • Commercialization and Outcomes • Research Trials for U.S. Government Agencies • Biosimilar Trials

MENLO PARK, Calif. — Personalis, Inc., a precision medicine company focused on genomics solutions for immuno-oncology, cancer and genetic disease, announced the order of ten Illumina NovaSeq 6000 systems to continue to scale its operations in 2017. The first two instruments have now been de-

livered. Personalis is partnering with leading biopharmaceutical companies to accelerate cancer immunotherapy development with advanced next-generation sequencing (NGS) services for clinical trials and translational research. In particular, Personalis is a pioneer in the field of person-

ICON

and cost-effective studies. The approach is underpinned by mathematical models constructed to address computationally “hard” problems, and require computational power that is close to or beyond the current limits of contemporary computing. ICON and Lockheed Martin have teamed up to combine novel trial designs with the power afforded by the advent of quantum computing, thus facilitating increasingly sophisticated analysis of massive clinical trial data. The advance of quantum computing gives ICON’s statisticians and operational experts the opportunity to combine advanced statistical methods and the plethora of clinical/genomic information and merge the concepts of umbrella, basket and platform trials into a “cluster clinical trial” concept. Cluster trials comprise sub-trials involving common aspects such as histological classification of cancer, phenotype or genomic profile, to direct us to the homogeneity of sup-populations and at the same time to gain greater insights

About ICON ICON is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. These solutions span the clinical development lifecycle from compound selection to Phase I-III clinical studies, post-approval outcome research and market access solutions.

out contamination. Doubling time for the MCF-7 cells was calculated to be 33.81 hours, approximating the 29-hour cell doubling time referenced on the ATCC website. The objective of the second study was to compare the number of live human melanoma cells retrieved from the Celsee PREP100 system to those obtained using Ficoll density centrifugation media. Using a mouse PDX model, cells were collected into acid citrate dextrose (ACD) tubes via cardiac

puncture. Cells were then enriched using the Celsee PREP100 Enrichment and Purification Kit or Ficoll density gradients. After enrichment, cells from both methods were analyzed on a flow cytometer using the same gating strategy to identify live dsRed+/HLA+ melanoma CTCs. On average, the Celsee PREP100 platform isolated 4 to 5 times the number of live melanoma CTCs as compared to the Ficoll method. The results demonstrated that the Celsee platform was more

Celsee is a registered trademark of Denovo Sciences, Inc. LymphoPrep is a registered trademark of Nyegaard & Co. A.S. STEMCELL is a registered trademark of Stemcell Technologies Inc.

immunoassays. This study demonstrated that both DSP and AQUA are quantitative methods for profiling protein expression, eliminating the subjectivity and variability associated with conventional immunohistochemistry techniques. However, benchmarking against AQUA revealed several key advantages of DSP technology, including the high multiplex capability and wide dynamic range. These capabilities are of particular significance when profiling tumor cell specific

protein expression from the complex tumor microenvironment. Digital Spatial Profiling will be featured in two additional posters and a spotlight presentation during the AACR meeting. Merritt et al., will present recent technical advances of the platform including single cell selection and RNA profiling. Balko et al., applied the technology to characterizing checkpoint inhibitor therapy-induced autoimmune toxicities. The spotlight presentation will

feature the inventors of the technology, Dr. Gordon Mills and Dr. Joseph Beechem who will speak about the potential of the platform to enable deep molecular characterization of complex biological phenomenon and provide greater insight into tumor immune cell interactions. NanoString is accelerating the development of the Digital Spatial Profiling technology with customers via its Technology Access Program.

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ever more taxing for the pharmaceutical industry. There is an exponentially increasing menu for drug combinations and targets. This is underpinned by a volume of already available and to-be-tapped genomic challenging the old paradigm of targeting cancer histology alone. To address this burden of choice, ICON is investing in a Cancer Moonshot project capitalizing on the computational power and algorithmic of quantum computing. We need to combine genomic, clinical trial and healthcare record data to better inform the design and execution of oncology development programs. The key components to support the process are search engines, machine learning and predictive analytics, which together provide the capability to enhance the exploration and identification of non-trivial patterns within these very large and often poorly structured data sets. The output is critical to the design of targeted, ethical

CELSEE

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retrieved using 1 mL, 2 mL or 4 mL of media. Regardless of the amount of media used to retrieve the cells, approximately 100 percent viable cells resulted. To demonstrate the suitability of retrieved cells for long-term culture, MCF7 and SKBR3 cells were spiked into normal peripheral blood, then purified, enriched and retrieved. Cells were shown to grow in culture for up to 21 days with-

NANOSTRING TECHNOLOGIES (continued from page 32)

ment we do with the AQUA technology in our lab. We designed AQUA to measure at the molecular level rather than the cellular level and the same is true of NanoString’s DSP.” AQUA technology, which was developed by Dr. Rimm, has been demonstrated to be both reproducible and quantitative when applied to tissue-based

Learn more online at www.iconplc.com/oncology. Be sure to stop by Booth #23109 for more information. efficient in isolating live primary human melanoma CTCs from mouse blood after xenograft than Ficoll density gradients. For more information, visit Celsee Diagnostics at Booth #3020 or online at www.celsee.com.

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