On December 11, 2019 PierianDx, the leading clinical genomics informatics company, reported that Intermountain Healthcare has selected the PierianDx Clinical Genomics Workstation to advance their precision medicine program, Intermountain Precision Genomics (Press release, PierianDx, DEC 11, 2019, View Source [SID1234552270]). Intermountain Healthcare will leverage PierianDx for next-generation sequencing (NGS) variant analysis, classification, and reporting services to assist in the identification of targeted therapies and potential clinical trial opportunities for cancer patients.

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PierianDx provides a SaaS platform, Clinical Genomics Workspace (CGW), the industry-leading clinical software for informatics, interpretation, and reporting of NGS data. By joining the PierianDx customer network, Intermountain Healthcare can access the genomic data within CGW’s knowledgebase, the most clinically robust database comprised of millions of biomedical findings driven by public and highly curated sources. Intermountain Healthcare joins a long list of other leading diagnostic labs and health systems using PierianDx.

"We are thrilled that Intermountain Healthcare has joined our rapidly expanding partner network," says Michael L. Sanderson, CEO of PierianDx. "Intermountain Healthcare is widely known as a leader in precision medicine and we look forward to continued collaboration opportunities."

On December 11, 2019 NanoString Technologies, Inc. (NASDAQ:NSTG), reported a leading provider of life science tools for translational research, reported the formation of the GeoMx Breast Cancer Consortium (GBCC) (Press release, NanoString Technologies, DEC 11, 2019, View Source [SID1234552269]).
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The consortium is focused on using the GeoMx Digital Spatial Profiler to address some of the most challenging translational research questions in breast cancer by applying spatial analysis. Some of the initial projects that the GBCC is planning include studies that will explore the immune interactions in HER2+ breast cancer, responsiveness to immunotherapy in triple-negative breast cancer (TNBC), disease evolution in metastatic breast cancer, and role of the tumor microenvironment in molecular epidemiological studies.

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Through the work of the GBCC, NanoString intends to develop a GeoMx Atlas database combining spatial and clinical data to enable meta-analyses to identify and validate oncology biomarkers in the spatial domain.

"By evaluating breast cancer with a spatial approach, we hope to expand our ability to understand the impact of treatments on the tumor, immune infiltrate and microenvironment," said Sandra Swain, M.D., Associate Dean for Research Development and Professor of Medicine at Georgetown University Medical Center. "In forming this consortium, we are promoting the importance of engaging innovative approaches across multiple studies to ensure rapid progress in discovery of novel biomarkers which may lead to more effective means of treating breast cancer."

"While earlier diagnosis and new therapies have improved patient outcomes in breast cancer, there are subgroups of patients with aggressive disease where effective therapies remain elusive," said Brad Gray, president and CEO of NanoString. "We believe that by applying spatial analysis, the GeoMx Breast Cancer Consortium can help to address some of the most pressing needs in breast cancer research."

Founding member institutions and investigators of the GeoMx Breast Cancer Consortium include:

The Dana Farber Cancer Institute: Elizabeth Mittendorf, M.D., Ph.D.
The Mayo Clinic: Jodi Carter, M.D., Ph.D.; Aubrey Thompson, Ph.D.; Fergus Couch, Ph.D.
The Peter MacCallum Cancer Centre: Sherene Loi, Ph.D.
The University of North Carolina, Chapel Hill: Melissa Troester, M.P.H., Ph.D.
Georgetown University Medical Center: Sandra Swain, M.D.
The Institut d’Investigacions Biomèdiques: August Pi i Sunyer (IDIBAPS): Aleix Prat, M.D., Ph.D.
Researchers that are interested in joining the GeoMx Breast Cancer Consortium can find an application at: View Source

On December 11, 2019 Phoenix Biotechnology, Inc. ("Phoenix" or the "Company" www.phoenixbiotechnology.com) reported that it has completed the private placement of 1,373,400 shares of common stock for gross proceeds of $4,120,200 (Press release, Phoenix Biotechnology, DEC 11, 2019, View Source [SID1234552268]).

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The gross proceeds of the offering are expected to be used for general corporate purposes including funding Phoenix’s continuing research at The University of Texas M.D. Anderson Cancer Center, University of Nebraska and University of L’Aquila (Italy); filing and prosecuting the Company’s U.S. and international patent portfolio; and paying general and administrative expenses.

Robert A. Newman, Ph.D., President and Chief Science Officer, said, "We are grateful to have received significant new resources for our continued research efforts. The ongoing research of our lead drug against glioblastoma appears to be very promising. In addition, we are proud of the research recently published of our drug’s efficacy against HTLV-1, a virus that affects millions of people with devastating declines in their quality of life. All of our work is aimed at providing hope for those afflicted with serious diseases for which there are few, if any, meaningful therapeutic options. The funds recently raised will assist us in continuing this important work."

The shares of common stock have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. This news release does not constitute an offer to sell or the solicitation of an offer to buy any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which it would be unlawful.

On December 11, 2019 Novigenix SA, a leading Immuno-Transcriptomics company that develops and commercializes solutions for early cancer detection and precision medicine, reported the development of a new immune cell type specific Immuno-Transcriptomic signature for the detection of colorectal cancer (CRC) in blood (Press release, Novigenix, DEC 11, 2019, View Source [SID1234552267]). The data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress (11-14 December, Geneva, Switzerland).

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Immune cells play a key role in cancer progression. Their response to the tumor can promote or prevent tumor growth and can be used to increase the diagnostic power of a cancer detection test. In this study, RNA signatures specific for different immune cell types (neutrophils, monocyte, T cells, CD4, CD8, B cells, NK cells) were compiled from published data and tested on the RNA-seq transcriptome profiles of 561 peripheral blood mononuclear cells (PBMC) samples from 218 healthy donors, 189 CRC, 115 advanced adenomas and 39 other cancers patients. The signature analysis was performed on Novigenix’s LITOseek sequencing platform.

Myeloid cell (monocyte and neutrophil) RNA signatures were strongly upregulated in CRC compared to control samples (p<0.01), whereas the T-cell signature was significantly downregulated (p<0.01). The specificity of the different RNA signatures was demonstrated by their correlation with the respective cell count, performed with traditional method.

"These are very encouraging data on the utility of immune cell type specific RNA signature as biomarkers for CRC detection in blood," said Prof. Dr. G. Dorta from the Department of Gastroenterology and Hepatology at CHUV in Lausanne, Switzerland. "The correlation of the cell type specific RNA signature with traditional cell counting as well as the CRC discriminant power could be very valuable for the development of an early CRC detection test."

"This newly developed cell type specific RNA signature demonstrated strong differentiation power between CRC and other cancers," said Dr. Jan Groen, CEO of Novigenix. "Therefore, we are evaluating how a combination of cell type specific RNA signatures with a CRC specific profile could be incorporated into a test for the early diagnosis of colon cancer."

About LITOseek

Novigenix’s Blood Immuno-Transcriptomic sequence platform, LITOseek, analyzes the gene expression modifications (mRNA signatures) induced by the host response to various triggers, such as the onset of cancer. Disease specific algorithms are developed combining the mRNA signature with clinical and medical parameters. The combination of mathematical models with machine learning and collection of new data enables the continuous improvement of the predictive and adaptive algorithms.

On December 11, 2019 Exicure, Inc. (NASDAQ:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported an update from its Phase 1b/2 trial with AST-008 in patients with solid tumors (Press release, Exicure, DEC 11, 2019, View Source [SID1234552266]). AST-008 is an investigational SNA consisting of toll-like receptor 9 (TLR9) agonists designed for immuno-oncology application, and is being evaluated in combination with pembrolizumab in patients with solid tumors.

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"We’re very pleased with the preliminary data generated so far in our ongoing Phase 1b/2 trial and we look forward to enrolling patients in the Phase 2 portion of the trial," said Dr. David Giljohann, CEO of Exicure. "Based on these results, we are considering adding additional cohorts to the trial in other cancers where AST-008 may have benefit," concluded Dr. Giljohann.

The primary objective of the dose escalation portion of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AST-008 alone and in combination with pembrolizumab, and to produce a recommended Phase 2 dose. Fourteen patients have been enrolled and dosed with AST-008. No treatment-related serious adverse events or dose-limiting toxicities have been observed. The fifth and final dose escalation cohort is now open and enrolling.

The study has enrolled five melanoma patients, four Merkel cell carcinoma (MCC) patients, two cutaneous squamous cell carcinoma patients, two head and neck squamous cell carcinoma patients, and one mucosal melanoma patient. Prior to enrolling, most patients had progressive disease on anti-PD-(L)1 antibodies.

Available data show:

AST-008 administration, alone or in combination with pembrolizumab, produced cytokine and chemokine expression and immune cell activation in patient blood indicative of desired immune activation.
Of the 4 MCC patients, one patient, which had previously progressed on anti-PD-1 antibody therapy, has confirmed stable disease with decreased target lesion diameters for a period in excess of twelve weeks, while a second MCC patient experienced a target lesion complete response and a confirmed overall partial response longer than 24 weeks.
Nine patients had progressive disease, two patients have not yet been evaluated and one is not evaluable.
"The initial results are highly encouraging and warrant expansion of the trial, and I’m looking forward to participating," stated Dr. Steven O’Day, Executive Director of the John Wayne Cancer Institute and Cancer Clinic, and a principal investigator on the study.

Detailed results are expected to be presented at major upcoming oncology meetings. Based on these early results, showing positive biomarker data and initial tumor responses, Exicure anticipates enrolling MCC patients, which have previously failed anti PD-1/PD-L1 therapy, in its Phase 2 study during the first quarter of 2020.