PAK4

Research results from 18 studies across six various solid tumor types demonstrate the impact of Caris' approach to molecular profiling across the continuum of cancer care IRVING, Texas, Jan. 17, 2023 /PRNewswire/ -- Caris Life Sciences®(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, today announced that the company and partners within the Caris Precision Oncology Alliance™ (POA) will collectively present 18 studies across more than six tumor types at the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, January 19-21, 2023 in San Francisco (Tabletop #70). "We are proud of the large number of collaborative abstracts accepted for presentation at ASCO GI, demonstrating the power of Caris' comprehensive molecular profiling and the large-scale collaboration between POA sites," said Chadi Nabhan, M.D., MBA, FACP, Chairman of the Caris Precision Oncology Alliance. "The findings represent important observations in a variety of tumors, including rare tumors and new tumor sub-types, which could lead to novel therapeutic approaches and improved outcomes for patients." "At Caris, our goal is to enable clinicians to make the best treatment choices for their patients, researchers to discover new targets, and the biopharmaceutical industry to develop the next breakthrough medicines," said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris. "These presentations show how our scientists and partners in the POA are leveraging real-world clinical evidence from over 430,000 lifetime cases in Caris' unique AI-driven platform to deepen our understanding of cancer. While these discoveries are foundational, they provide key insights into advanced cancer and support developing precision oncology approaches in hardest to treat tumor types to better serve cancer patients." Highlighted presentations include the following: An oral abstract focusing on differences between human epidermal growth factor receptor 2 (HER2) low and high-expressing gastroesophageal cancers: Comparative analysis of the molecular profile and tumor immune microenvironment (TIME) of human epidermal growth factor receptor 2 (HER2) low (L)- versus high (H)-expressing gastroesophageal cancers (GEC). January 20, 9:00 AM PST Other notable studies among the 18 accepted abstracts focus on key topics in GI oncology such as mismatch repair defect testing in colorectal cancer and identifying biomarkers in rare tumor types: Molecular characterization and clinical outcomes of pancreatic NeuroEndocrineTumors (pNENs) harboring PAK4-NAMPT alterations. (Poster Number: G18) January 20, 12:00 – 1:30 PM PST Genomic profiling of rare undifferentiated and sarcomatoid subtypes of pancreatic carcinomas for potential response to immunotherapy. (Poster Number: M8) January 20, 12:00 – 1:30 PM PST Prognostic indicators of KRAS G12X mutations in pancreatic cancer. (Poster Number: M2) January 20, 12:00 – 1:30 PM PST Analysis of concordance between microsatellite instability by next generation sequencing (NGS-MSI) and mismatch repair deficiency by immunohistochemistry (IHC-MMR) in >28,000 colorectal tumors. (Poster Number: B5) January 21, 6:30 - 7:55 AM PST Analysis of HLA gene expression in patients with dMMR/MSI-H colorectal carcinoma resistant to immune checkpoint inhibitors. (Poster Number: L4) January 21, 6:30 - 7:55 AM PST Survival of patients with colorectal cancer (CRC) with low expression of homologous recombination proficient (HRP) genes. (Poster Number: M7) January 21, 6:30 - 7:55 AM PST Poster and abstract summaries highlighting this research will be available onsite at Caris' Tabletop #70. The full abstracts will be available through the official ASCO website on January 17. The Caris Precision Oncology Alliance includes 75 cancer centers and academic institutions in the United States and beyond. These institutions have early access to the extensive database and artificial intelligence platform within Caris to establish evidence-based standards for cancer profiling and molecular testing in oncology. By leveraging the comprehensive genomic, transcriptomic and proteomic data available through Caris molecular profiling, Caris seeks to provide this network with the ability to prioritize therapeutic options and determine which clinical trial opportunities may benefit their patients. POA members are also able to integrate with a growing portfolio of biomarker directed trials sponsored by biopharma. Additionally, as a member of the POA, institutions have access to Caris CODEai™, the most comprehensive data solution in the industry with cancer treatment information and real-world clinical outcomes evidence for over 275,000 patients covering over 1 million data points per patient. 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. With a primary focus on cancer, Caris' suite of market-leading molecular profiling offerings assesses DNA, RNA and proteins to reveal a molecular blueprint that helps patients, physicians and researchers better detect, diagnose and treat patients. Caris' latest advancement is a blood-based, circulating nucleic acids sequencing (cNAS) assay that combines comprehensive molecular analysis (Whole Exome and Whole Transcriptome Sequencing from blood) and serial monitoring – making it the most powerful liquid biopsy assay ever developed. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Denver, Tokyo, Japan and Basel, Switzerland. Caris provides services throughout the U.S., Europe, Asia and other international markets. To learn more, please visit CarisLifeSciences.com or follow us on LinkedIn. Caris Life Sciences Media Contact: Lisa Burgner [email protected] 214.294.5606 SOURCE Caris Life Sciences

Data Supports the Application of RaDaR™ MRD Assay Across Tumor Types Early Research on Potential Biomarker in Melanoma Patients Unresponsive to Immunotherapy FT. MYERS, FL / ACCESSWIRE / September 7, 2022 / NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of cancer-focused genetic testing services and global oncology contract research services, today announces that its liquid biopsy focused subsidiary Inivata Limited ("Inivata"), alongside collaborators, will present new data on its RaDaR™ assay for the detection of minimal residual disease (MRD) and recurrence at the European Society for Medical Oncology (ESMO) Congress, taking place September 9th-13th, 2022. NeoGenomics and Inivata will host a joint booth in the exhibition hall at the conference. Data will be presented from the single-center prospective cohort ‘LIONESS' study in head and neck squamous cell carcinoma (HNSCC) patients receiving primary surgery with curative intent. The study demonstrated that the RaDaR assay was able to detect ctDNA in 100% of cases with confirmed clinical recurrences, highlighting the significant potential of the assay to guide treatment decisions and improve disease outcome. Inivata and collaborators will also present updated follow-up data and biomarker analysis from a study investigating administration of pre-operative ipilimumab and nivolumab for the treatment of advanced urothelial cancer. In the updated study, the RaDaR assay was used to confirm the association of pre-operative plasma ctDNA detection with pathological response that was observed in the earlier analysis. Results from the complete cohort will be presented at the ESMO Congress. NeoGenomics will present early research data from a collaboration with Biognosys and University of Zurich showing PAK4 as a potential biomarker for poor response to immunotherapy in melanoma patients. Elevated levels of PAK 4 were found in tumor samples of non-responder patients suggesting that the immune mechanisms of PAK4 are different in melanoma patients responding to immunotherapy. Vishal Sikri, Presidentand Chief Commercial Officer of Inivata, and President, Pharma Services, NeoGenomics, said: "The data from these latest studies further highlight the potential role of RaDaR in guiding treatment decisions, with applicability across different tumor types. We believe that the assay has the potential to transform cancer care as we progress towards broad-scale commercialization." Alongside this we will present early data that may help us understand why some melanoma patients do not respond to immunotherapy. Research in identifying biomarkers is an important step in our development of diagnostics for cancer patients." Abstracts are now available on the ESMO website and accompanying posters will be available to view during the conference, via the ESMO e-poster site, together with audio description. Details of the abstracts are as follows: Title: PAK4 as a potential marker for poor response to immunotherapy in melanoma patients Abstract No: 869P Speaker: Anna Juncker-Jensen Date and Time: Saturday, 10 September 2022, Poster session 10, 12:00 PM-1:00PM CEST Title: Liquid biopsy for detection of molecular residual disease and recurrence in head and neck squamous cell carcinoma Abstract No: 684P Speaker: Susanne Flach Date and Time: Sunday, 11 September 2022, Poster session 10, 2:00 PM-3:00 PM CEST Title: Updated follow-up data and biomarker analysis of pre-operative ipilimumab and nivolumab in locoregional advanced urothelial cancer (NABUCCO) Abstract No: 1770P Speaker: Chantal F. Stockem Date and Time: Monday, 12 September 2022, Poster session 18, 3:00 PM-4:00 PM CEST About NeoGenomics, Inc. NeoGenomics, Inc. specializes in cancer genetics testing and information services, providing one of the most comprehensive oncology-focused testing menus in the world for physicians to help them diagnose and treat cancer. The Company's Pharma Services Division serves pharmaceutical clients in clinical trials and drug development. NeoGenomics is committed to connecting patients with life altering therapies and trials. We believe that, together, with our partners, we can help patients with cancer today and the next person diagnosed tomorrow. In carrying out these commitments, NeoGenomics seeks to adhere to all relevant data protection laws, to provide transparency and choice to patients regarding the handling and use of their data through our Notice of Privacy Practices, and invest in leading technologies to ensure the data we maintain is secured at all times. Headquartered in Fort Myers, FL, NeoGenomics operates CAP accredited and CLIA certified laboratories in Fort Myers and Tampa, Florida; Aliso Viejo and Carlsbad, California; Research Triangle Park, North Carolina; Houston, Texas; Atlanta, Georgia; Nashville, Tennessee; and CAP accredited laboratories in Rolle, Switzerland; Singapore and China. NeoGenomics serves the needs of pathologists, oncologists, academic centers, hospital systems, pharmaceutical firms, integrated service delivery networks, and managed care organizations throughout the United States, and pharmaceutical firms in Europe and Asia. We routinely post information that may be important to investors on our website at . About Inivata Inivata is the liquid biopsy focused subsidiary of NeoGenomics Laboratories (NASDAQ: NEO). Inivata's proven InVision™ liquid biopsy platform unlocks essential genomic information from a simple blood draw which may be used by clinicians to guide personalized cancer treatment, to monitor response to treatment and to detect relapse. The commercially available InVisionFirst™-Lung test offers highly sensitive testing and provides molecular insights that enable clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata's personalized RaDaR™ assay allows the highly sensitive detection of residual disease and recurrence in certain cancers and has been granted Breakthrough Device Designation by the US FDA. Inivata is partnering with pharmaceutical, biotechnology companies and commercial entities in early through late-stage cancer development programs across a range of cancer types. The InVisionFirst-Lung test and RaDaR are laboratory developed tests (LDTs) performed by Inivata's CLIA certified, CAP accredited laboratory in Research Triangle Park, North Carolina, USA. Inivata also has R&D laboratories in Cambridge, UK. Inivata's technology is based on pioneering research from the Cancer Research UK Cambridge Institute, University of Cambridge. About the RaDaRTM assay Inivata's RaDaR™ assay is a personalized, tumor-informed, highly sensitive technology that tracks a set of up to 48 tumor-specific variants in cell-free DNA (cfDNA) within a cancer patient's blood plasma. Built on Inivata's proven InVision™ platform, the personalized RaDaR assay has been designed to detect MRD following curative intent or definitive treatment, and early signs of relapse, and has been validated for clinical use in lung, head and neck, and breast cancers. The RaDaR assay is a laboratory developed test (LDT) which has been granted Breakthrough Device Designation by the US FDA for use in the detection of MRD in early-stage cancer patients and has received the CE mark for the detection of MRD and recurrence. Forward Looking Statements This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as "anticipate," expect," plan," "could," "would," "may," "will," "believe," "estimate," "forecast," "goal," "project, "guidance," "plan," "potential" and other words of similar meaning, although not all forward-looking statements include these words. These forward-looking statements address various matters, including statements regarding the future success of the Company. Each forward-looking statement contained in this press release is subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include risks identified under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 25, 2022 as well as other information previously filed with the SEC. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at , for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document (unless another date is indicated), and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Charlie Eidson Director, Investor Relations and Corporate Development T: 239.768.0600 x2726 M: 952.221.8816 charlie.eidson@neogenomics.com Karen Chandler-Smith SVP Marketing and Communications Inivata +44 (0)7900 430235 karen.chandler-smith@inivata.com Inivata Media Contacts: Consilium Strategic Communications Chris Gardner/Angela Gray/Genevieve Wilson Alix Floyd (US) inivata@consilium-comms.com +44 (0)20 3709 5700 SOURCE: NeoGenomics, Inc. View source version on accesswire.com: