INTENT DATA IN THE AGE OF DATA REGULATION

DECK 7 | March 23, 2020

Since the implementation of Data Protection Act in 2018, the approach behind the use of data has changed dramatically. Our clients and customers don’t just want a great experience, they also want to make sure they can trust us.   Tweet This!  And it makes perfect sense in the present time and space. But as data is considered a key factor in positive customer experience, the U.S. brands and agencies have found it to be increasingly complicated to earn customer trust while remaining compliant. In an article by John Snyder, CEO at Grapeshot, for Adexchanger, he says that the GDPR will remove 75% of third-party data and what’s left will be more expensive. This has caused the power dynamic between brands and agencies to evolve over time.

Spotlight

Achieving effective sequence analysis across biologic drug development their highly targeted specificity and efficacy in treating disease, monoclonal antibody (mAB) drugs have grown faster than any other class of therapeutic drugs in recent years. Accompanying this, a large body of work has focused on the generation of smaller antibodyderived synthetic molecules and small non-antibody scaffolds, overcoming some of the size and stability limitations of monoclonal antibodies for human therapy.


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CELL AND GENE THERAPY

New Research from the Caris Precision Oncology Alliance Finds Prognostic and Predictive Drug-Induced Gene Signatures for Colorectal Cancer Patients

Caris Life Sciences | April 11, 2022

Caris Life Sciences®(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, to present findings that provide a deeper understanding that tumor expression of genes related to extent of drug exposure, stratified by p53 status, is associated with clinical outcomes on the common chemotherapeutic regimens used to treat metastatic colorectal cancer (CRC). These results will be presented at the 2022 American Association for Cancer Research (AACR) Annual Meeting being held April 8 - 13, 2022 in New Orleans, Louisiana. The research with poster titled, "Prognostic and predictive drug-induced gene signatures for colorectal cancer patients personalized based on p53 status and treatment with FOLFOX, 5-FU, oxaliplatin or irinotecan" (Abstract #1231), was led by Wafik El-Deiry, M.D., Ph.D., FACP, Director of Brown University's Legorreta Cancer Center, Associate Dean at the Warren Alpert Medical School, a member of Caris' Precision Oncology Alliance (POA). Caris' POA is a growing network of leading cancer centers across the globe that collaborate to advance precision oncology and biomarker-driven research. This work is being presented in New Orleans by Lindsey Carlsen, a Pathobiology graduate student in the EL-DEIRY Lab at Brown. The goal of this study was to identify predictive biomarkers for chemotherapies used in CRC. The study used CRC cell lines to identify differentially expressed genes following 5-fluorouracil, irinotecan, or oxaliplatin treatment and stratified the signatures based on p53 status. From these in vitro studies, the researchers then examined whether these genes and gene signatures could predict CRC patient outcomes following chemotherapy (FOLFOX, 5-fluorouracil, irinotecan or oxaliplatin). 2,983 wild-type and 6,229 loss-of-function p53 CRC patient samples were analyzed by DNA/RNA next-generation sequencing at Caris Life Sciences. Real-world survival outcomes were inferred from insurance claims data and Kaplan-Meier estimates. Both prognostic and non-prognostic gene expression had a significant effect on survival outcomes following specific drug treatments. This study helps us understand the importance that gene signatures have in demonstrating an enhanced predictive ability compared to individual transcripts, Bridging basic and clinical research, this research allows us to better understand which therapies are more likely to benefit CRC patients." El-Deiry. The study found that tumor expression of genes related to drug exposure can predict outcomes after chemotherapy treatment: High EGR1 and FOS mRNA independently predict response to FOLFOX in patients with wild-type p53 tumors. Low CCNB1 mRNA correlates with good prognosis of CRC patients with tumors harboring TP53 loss of function mutations. Low expression of BTG2 predicts better prognosis in patients with MSI-High TP53 mutated tumors. Gene signatures may demonstrate enhanced predictive ability as compared to individual transcript effects. Caris' comprehensive molecular profiling assesses whole exome (DNA), whole transcriptome (RNA) and protein expression, providing an unmatched resource and the ideal path forward to conduct the translational research to accelerate discovery for detection, diagnosis, monitoring, therapy selection and drug development to improve the human condition. About Caris Life Sciences Caris Life Sciences® (Caris) is the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare and improve patient outcomes. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced artificial intelligence (AI) and machine learning algorithms, Caris has created the large-scale clinico-genomic database and cognitive computing needed to analyze and unravel the molecular complexity of disease. This information provides an unmatched resource and the ideal path forward to conduct the basic, fundamental research to accelerate discovery for detection, diagnosis, monitoring, therapy selection and drug development to improve the human condition.

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Illumina Introduces New Pan-Cancer Companion Diagnostic to Match Patients with Rare Genetic Mutations to Targeted Therapy

Illumina | May 27, 2022

Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight™ Oncology (TSO) Comprehensive (EU) test. This single test kit, recently launched across Europe, assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. The CDx pan-cancer indication will allow identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions including NTRK1, NTRK2 or NTRK3, and may benefit from targeted therapy with Bayer's VITRAKVI® (larotrectinib), in accordance with the approved therapeutic labeling. TSO Comprehensive (EU) is a comprehensive genomic profiling (CGP) test which combines less prevalent biomarkers with more prevalent ones in the same test, using a single biopsy specimen. This helps maximize the chances of identifying an actionable alteration so that patients can be treated with a targeted therapy or enrolled into a clinical trial based on their unique tumor genomic profile. The addition of this first CDx claim specific to NTRK gene fusions, a rare but highly actionable biomarker, helps provide patients harboring this genetic alteration with an opportunity to benefit from larotrectinib, a genomically matched treatment. This CDx claim, developed in partnership with Bayer, is the first of a series under development, building upon Illumina's broad portfolio of oncology partnerships with industry leaders to advance cancer diagnostics and precision medicine, We continue to focus on unlocking the potential of new biomarkers to identify those most likely to benefit from precision medicines so that no patient is left behind—we don't want anyone to miss the opportunity to have their biomarker detected and gain access to a potentially life-saving therapy." Paula Dowdy, Senior Vice President and General Manager of Illumina for Europe, the Middle East, and Africa. Across most solid cancer tumor types, NTRK gene fusions can have a rare prevalence of 0.1-3% and can be challenging to detect as these genes fuse with many different partners, many of them previously unknown. Most CDx tests are specific to one type of cancer, but the NTRK claim is pan-cancer, enabling TSO Comprehensive (EU) to target multiple solid tumor types and a broad range of known and novel gene fusion partners across all three NTRK genes. This helps maximize the chances of finding actionable information from each patient's biopsy, to inform treatment with larotrectinib. Since it launched four years ago, VITRAKVI has demonstrated high response rates and highly durable responses in adults and children with TRK fusion cancer, The CE marking of Illumina's TSO Comprehensive (EU) assay inclusive of NTRK gene fusion detection for VITRAKVI is an important advance in enabling precision oncology for patients in Europe. Assays that enable precision oncology through comprehensive genomic testing are crucial for informing optimal treatment plans and help to ensure the best possible outcomes for cancer patients. We look forward to continuing to collaborate with Illumina to ensure that more patients are evaluated comprehensively inclusive of NTRK gene fusions." Christine Roth, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Bayer's Oncology Strategic Business Unit. The performance of TSO Comprehensive (EU) with NTRK fu­sions was assessed by analytical and clinical validation studies. Pooled data from three clinical trials, LOXO-TRK-14001 (NCT02122913), NAVIGATE (NCT02576431) and SCOUT (NCT02637687), were used to demonstrate the clinical effectiveness and safety of TSO Comprehensive (EU) in identifying NTRK1, NTRK2 and NTRK3 gene fusion positive patients who may be eligible for treatment with larotrectinib. The primary endpoint was the overall response rate (ORR), measured as the patient presenting either a complete response, a surgical complete response or partial response, to larotrectinib. We were delighted to be the clinical study partner for Illumina in this significant achievement of the first CDx claim for the TSO Comprehensive (EU) panel, TSO Comprehensive (EU) represents a powerful and versatile platform with a broad range of cancer-relevant content, and we recognize its value to our biopharma partners, for the development and delivery of companion diagnostics to further precision medicines." Professor Richard Kennedy, Global VP of Biomarker Development & Medical Director, Almac Diagnostic Services. Illumina has a growing pipeline of CDx claims under development through partnerships with pharmaceutical companies, which will be added to TSO Comprehensive (EU) following appropriate regulatory approvals. These CDx claims will help unlock groundbreaking targeted therapies and immunotherapies to make a difference in the lives of cancer patients. As Illumina continues to expand its broad portfolio of oncology partnerships with industry leaders, the company aims to advance cancer diagnostics and precision medicine. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. About Illumina Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments.

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MEDICAL

HistoSonics Announces Agreement with GE Healthcare

HistoSonics | May 24, 2022

HistoSonics Inc., developer of a completely non-invasive platform using the science of histotripsy, today announced an agreement formalizing ongoing efforts to use GE Healthcare's LOGIQ E10 Series ultrasound imaging platform to power the real time visualization features of HistoSonics' novel sonic beam therapy. As part of the agreement and upon market authorization, HistoSonics will distribute GE Healthcare's LOGIQ E10 Series on a one-to-one basis with its breakthrough liver therapy system. HistoSonics' Edison™ system, currently in development, uses the novel science of histotripsy to non-invasively destroy targeted liver tissue. HistoSonics intends to utilize GE Healthcare's LOGIQ E10 Series, currently the most technologically advanced ultrasound platform for guiding radiology interventions, to provide treating physicians with continuous visualization for key and unique elements of the histotripsy therapy procedure, including planning, monitoring, and immediate post-treatment verification. This agreement is aimed to support HistoSonics' efforts to launch their EdisonTM system leveraging their deep domain expertise along with GE Healthcare's world-class ultrasound imaging technologies, digital infrastructure, data analytics and clinical decision support capabilities. We are very excited to formalize our imaging partnership with GE Healthcare, which is a key part of bringing our transformative therapy platform, and an entirely new treatment option, to the clinic and to patients, We've developed a very collaborative relationship with GE Healthcare and look forward to expanding our efforts to realize the full potential of histotripsy across clinical applications, specialties, and care settings." Josh Stopek, HistoSonics Vice President of R&D. HistoSonics' non-invasive platform combines advanced imaging and proprietary software to deliver patient specific treatments using histotripsy to mechanically destroy and liquify targeted tissues at a sub-cellular level. The company believes the novel mechanism of action of their proprietary technology may offer significant advantages to patients, including precise and predictable treatment zones with equivalent treatment effect throughout the entire treated volume. Early clinical and pre-clinical results also suggest that histotripsy largely preserves critical structures such as the liver capsule, and larger vessels and bile ducts within or adjacent to the treated volume of tissue. Additionally, histotripsy enables the treating physicians to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today. The agreement between GE Healthcare and HistoSonics comes as HistoSonics continues enrollment in their U.S. and European #HOPE4LIVER Trials, evaluating the safety and efficacy of histotripsy for the destruction of targeted primary or metastatic liver tumors. Additionally, the company recently was awarded "Breakthrough Device Designation" by the FDA for histotripsy of liver tissue, validating the company's vision that histotripsy has the potential to provide advantages over existing therapies such as surgery, radiation therapy and thermal ablation. About HistoSonics HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on the continued development of its EdisonTM Platform, global clinical studies, and new strategic projects including future clinical applications and platforms. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.

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CELL AND GENE THERAPY

New Study Highlights Cell Avidity's Power to Provide Insights into the Robustness of T Cell Activation

LUMICKS | March 24, 2022

LUMICKS, a next generation life science tools company, today announced that a research study published in Cellular and Molecular Life Sciences from the Radboud University Medical Center, led by researchers in the team of Professor G. J. Adema, detailed a novel method to study lead compound effects on immune cell interactions by employing LUMICKS' z-Movi® Cell Avidity Analyzer. The interaction between dendritic cells (DCs) and T cells is a critical step in the activation of T cells and initiation of the immune response. The strength and duration of the bond formed between DCs and T cells plays an important role in the robustness of the immune response mounted by T cells. Therefore, modulating the functionality of DCs to increase their avidity to T cells could be a key factor in improving cancer immunotherapies. The z-Movi Cell Avidity Analyzer provides an exciting new method to assess the avidity between immune cells, such as DCs and T cells, in response to the addition of lead compounds that can alter DC functionality and potentially further the development of novel cellular immunotherapies. In this study, the authors examined the effect of a sialic acid-blocking mimetic on DCs and DC-T-cell interactions. The z-Movi platform was a great help to quantify dendritic cell – T-cell interactions and allowed us to demonstrate the important role sialic acids play in both antigen-dependent and the antigen-independent interactions between these immune cells." Prof. Adema, professor of Molecular Immunology at the Radiotherapy & OncoImmunology lab in the department of Radiation Oncology at RIMLS/Radboud. We are very pleased by this paper's findings about the important role measuring cell avidity can play in improving our understanding of the immune system. We take great pride in collaborating with and supporting leading scientific researchers around the world who find that the power of our revolutionary technology can help them discover underlying insights that advance our ability to treat human health issues." Andrea Candelli, Chief Scientific Officer of LUMICKS. The z-Movi measures the avidity between immune cells and their targets, enabling researchers to identify the most potent immunotherapeutic effector cells. This new technology provides predictive, reproducible, and fast results at a single-cell resolution without compromising cell viability, and ensures sterile and safe sample handling. LUMICKS' cell avidity solutions use acoustics to measure forces and interactions between cells, with the goal of shortening the drug development cycle for adoptive cell therapies and other immunotherapies and reducing failure rates in clinical trials. First introduced in 2020, the z-Movi has found wide appeal in academic and biopharma laboratories around the world, with a rapid uptake in sales in 2021. About LUMICKS LUMICKS is a leading life science tools company that develops equipment for Dynamic Single-Molecule and Cell Avidity analysis, two rapidly emerging areas in biology research and immuno-oncology. LUMICKS' tools allow researchers to build the crucial and as yet unfinished bridge between structure and function at both a molecular and a cellular level. This is achieved by applying and measuring forces around biological interactions, enabling the detailed real-time analysis of underlying biological mechanisms. LUMICKS' C-Trap® Optical Tweezers – Fluorescence & Label-free Microscopy, allows scientists to analyze complex biological processes in real-time. Similarly, the z-Movi® Cell Avidity Analyzer enables the measurement and selection of immune cells based on their real-time interactions with target cells.

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Spotlight

Achieving effective sequence analysis across biologic drug development their highly targeted specificity and efficacy in treating disease, monoclonal antibody (mAB) drugs have grown faster than any other class of therapeutic drugs in recent years. Accompanying this, a large body of work has focused on the generation of smaller antibodyderived synthetic molecules and small non-antibody scaffolds, overcoming some of the size and stability limitations of monoclonal antibodies for human therapy.

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