MedX Health Corp. Announces Private Placement Closing

On November 7, 2019 MedX Health Corp. ("MedX" or the "Company") (TSX-V:MDX) reported that, pursuant to a non-brokered Private Placement Offering (the "Placement Offering"), it has completed an initial Closing of 1,251,000 Units effective November 4, 2019, to raise $150,120 from accredited investors pursuant to a Private Placement Offering announced on November 1, 2019 (Press release, MedX Health, NOV 7, 2019, View Source [SID1234550679]). Each Unit, priced at $0.12, comprises one fully paid common share and one share purchase warrant; each warrant entitles the holder to purchase one additional share at a price of $0.20 during the period up to two years from the closing date of the placement. The securities issued as a result of the Placement Offering will be restricted from trading for four months following each Closing. The Placement Offering is still open to subscribers, and further subscriptions may be accepted for further Closings. This Closing, and any further Closing of the Placement Offering, is subject to all relevant regulatory and other consents and approvals, including acceptance by the TSX Venture Exchange. In connection with the first Closing, a cash commission of $5,136 was paid and 42,800 Agent’s Warrants were issued.

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Following this Closing, MedX has 143,169,762 common shares issued and outstanding.

NantKwest Announces Presentation of Positive Phase 2 Clinical Data of Natural Killer Cell Therapy in Metastatic Merkel Cell Carcinoma at SITC 2019

On November 7, 2019 NantKwest Inc. (Nasdaq: NK), a next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and other diseases, reported the presentation of results from their Phase 2 trial investigation using aNK, NantKwest’s off-the-shelf natural killer cell-based therapeutic, in combination with N-803, ImmunityBio’s IL-15 superagonist, in patients with advanced refractory metastatic Merkel cell carcinoma (MCC) (NCT03853317) at The 34th Annual Meeting of the Society for Immunotherapy for Cancer (SITC 2019) on November 8, 2019 in National Harbor, Maryland. ImmunityBio is an affiliate company of NantKwest (Press release, NantKwest, NOV 7, 2019, View Source [SID1234550678]).

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Dr. Shailender Bhatia, Associate Professor of Medical Oncology at the University of Washington/Fred Hutchinson Cancer Research Center, will make an oral presentation entitled "Final results from a phase 2 study using off-the-shelf activated natural killer (aNK) cells in combination with N-803, an IL-15 superagonist, in patients with metastatic Merkel cell carcinoma (MCC)." That study demonstrated long term, durable responses in 2 of 7 patients with advanced refractory MCC. One of these patients achieved a radiologic complete response, and the second a durable partial response with more than 75% tumor regression and no subsequent therapy (response ongoing to date). Both patients with responses in the trial remain alive to date, 29 and 44 months after the initiation of treatment.

Results from this study provide evidence that treatment with aNK cell therapy can stimulate immune responses to checkpoint inhibitors, even in patients that have previously failed treatments using these types of therapies. One heavily pretreated subject refractory to pembrolizumab was rechallenged with this checkpoint inhibitor subsequent to receiving aNK cell therapy resulting in a durable complete response (CR) that is ongoing at this time, 44 months after receipt of first aNK cell infusion.

"We believe the results of this Phase 2 study are testament to the potential of our natural killer cell-based therapeutics to change the cancer treatment paradigm," said Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest. "Long term responses in patients with refractory metastatic disease is a remarkable achievement and is supportive of our upcoming trial, which will evaluate NantKwest’s off-the-shelf CD16-targeted haNK cells in combination with N-803 and Pfizer’s avelumab in patients with advanced MCC who are refractory to immune checkpoint inhibitors. We are particularly enthusiastic about the potential of aNK and N-803 to induce sensitization to checkpoint inhibitors, and thus, are evaluating this in our upcoming trial. We remain deeply committed to harnessing the power of immunogenic cell death across a wide range of indications to provide innovative treatments to patients with serious unmet need."

Other presentation highlights include:

Overall response rate of 29% (2 of 7 patients)
Evidence that aNK cell treatment may induce sensitivity to immune checkpoint inhibitors with a patient previously refractory to pembrolizumab demonstrating an ongoing complete response to the checkpoint inhibitor after completing aNK cell therapy
aNK cell therapy resulted in increased levels of tumor-infiltrating lymphocytes and increased immune response-related gene expression within tumor tissue
aNK cells in combination with N-803 were well-tolerated, with no treatment-related serious adverse events or grade ≥3 adverse events
Infusions all safely administered in the outpatient setting without observed immune related adverse events
Dr. Bhatia said, "Merkel cell carcinoma (MCC) is an aggressive skin cancer that is estimated to be three times more deadly than melanoma. PD-1 blockade works well for around 50 percent of patients with metastatic disease, but a significant proportion do not respond or progress later. Innate immunotherapy approach using aNK cells can potentially overcome resistance mechanisms in PD-1 refractory tumors. I am particularly enthusiastic about the preliminary results of the MCC study, with two complete responses in patients with very advanced metastatic disease."

NantHealth Reports 2019 Third-Quarter Financial Results

On November 7, 2019 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its third quarter ended September 30, 2019 (Press release, NantHealth, NOV 7, 2019, View Source [SID1234550677]).

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"For the 2019 third quarter, the top line for our SaaS business grew significantly over the same quarter last year," said Bob Petrou, Chief Financial Officer, NantHealth. "This performance, largely driven by an expanding customer base and increasing number of covered lives, demonstrates the integral role NantHealth’s SaaS solutions play in providing a continuum of care for payers, providers and, most importantly, the patients we serve. At the companywide level, we have made great progress managing our financial performance and growing gross margin, all resulting in reduced cash burn and enhanced bottom line results."

Software and Services Q3 Highlights:

Clinical Decision Support (Eviti):
Renewed a partnership contract with a leading provider of clinical solutions. The contract has a three-year term and a minimum estimated total value of $38.4 million
Signed an agreement with Wexford Health Sources, one of the nation’s largest correctional healthcare companies, bringing evidence-based standards and value-based oncology care to patients
Renewed an agreement with a large national health plan for federal employees, retirees and their families. Plan members will continue to receive streamlined preauthorization of cancer care
Launched several enhancements designed to provide payers with additional information about care management, including the intended use of brand name drugs and visibility into settings where care is provided. Payers with multiple plans can now permit their users to view multiple dashboards, which saves time by reducing the need for multiple logins and passwords
Received full accreditation from URAC for the Eviti platform. Eviti continues to meet URAC Health Utilization Management standards, valid through September 1, 2022. The designation recognizes those companies abiding by evidence-based standards and value-based care
Payer Engagement (NaviNet):
Added NaviNet’s Authorization Attachment application to the NaviNet implementation for one of the nation’s largest health insurance organizations. This feature ensures providers receive the right supporting documentation to make more informed, timely decisions
Expanded NaviNet Open functionality to provide additional notifications within the Authorization application, enabling users to receive information timely and respond quickly to critical requests, eliminating potential delays in caring for patients
NaviNet’s AllPayer product completed the conversion of 3,602 provider offices, more than 80% of AllPayer customers, from a legacy pricing model which will result in more than $1.0 million of additional annual recurring revenue
Connected Care (VCX, DCX):
Introduced VCX 3.0 (formerly VitalsConX), designed to reduce patient overstays and facilitate faster decision making. VCX 3.0 accelerates automated vital sign capture and provides easy entry of other customized observations at the point of care. Updates include streamlined data validation and a touch-based user interface to document vital signs quickly and easily. VCX 3.0 now supports "smart" patient vital sign monitors, including GE VC150
Announced new Shuttle cable features to help improve data collection, efficiency and accuracy using a medical-grade serial-to-USB interface cable
Signed a contract with Baxter expanding DCX (formerly DeviceConX) medical device driver development, enabling Baxter to connect additional devices to electronic medical record (EMR) systems.
In Q4, at the HIMSS Asia Pacific 2019 meeting, NantHealth led the Interoperability Showcase along with GE Healthcare, AirStrip and iProcedures. Together, the companies showcased how clinicians can spend less time on documentation and more time analyzing data in near real-time to improve patient outcomes
Sequencing and Molecular Analysis – Highlights:

Presented a poster on GPS Cancer at the IASLC (World Lung) meeting in Barcelona. Dr. Hossein Borghaei, Fox Chase Cancer Center, and authors from NantHealth and NantOmics, presented a poster, "222 NSCLC’s Classified by PAM50: Luminal A NSCLC Is a Distinct Subtype with Low TMB and Immune Suppressive TME." The poster concludes NantHealth and NantOmics can use GPS Cancer to identify a unique subset of patients who are likely to be resistant to conventional immune checkpoint inhibitor therapy, using a method that has not previously been well characterized in this clinical setting
Presented a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting. NantHealth and NantOmics, together with investigators from Moffitt Cancer Center, presented a poster, "Differential expression of immunoregulatory molecules and highly-associated cancer genes may provide novel insights into strategic trial design for therapeutics." The poster describes novel associations of immune checkpoint gene expression with cancer related genomic mutations beyond Tumor Mutation Burden (TMB) as a biomarker for immunotherapy response
Business and Financial Highlights

For the 2019 third quarter, total net revenue was $22.4 million, compared with $22.3 million in the 2018 third quarter. On June 7, 2019, the Company completed the divestiture of its home health care services business. Accordingly, financial results for the 2019 third quarter do not include the results of operations from this business, which over the last year averaged approximately $1.5 million of revenue per quarter.
Gross profit increased to $14.0 million, or 63% of total net revenue, compared with $11.1 million, or 50% of total net revenue, for the prior year period. The increase was primarily driven by continued growth of the Company’s higher margin SaaS business and overall cost management.
Selling, general and administrative expenses declined to $15.1 million from $17.0 million in 2018 third quarter. The decrease was mainly driven by ongoing cost management efforts and efficiencies in overall processes.
Research and development expenses decreased to $4.6 million from $4.8 million.
Net loss from continuing operations, net of tax, was $16.4 million, or $0.15 per share, compared with $97.5 million, or $0.89 per share, for the 2018 third quarter.
On a non-GAAP basis, net loss from continuing operations was $7.4 million, or $0.07 per share, down from $10.8 million, or $0.10 per share, for the third quarter of last year. The improvement reflects the company’s ongoing efforts to manage costs, growth of its SaaS business and efficiencies and process improvements.
At September 30, 2019, cash and cash equivalents totaled $9.3 million, an increase of $2.3 million from June 30, 2019.
Conference Call Information and Forward-Looking Statements

Thursday, November 7, 2019, after market close, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the third quarter ended September 30, 2019. The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 3294717. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.

Oncternal Reports Third Quarter 2019 Financial Results and Provides Business Update

On November 7, 2019 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported financial results for the third quarter ended September 30, 2019, and provided a business update (Press release, Oncternal Therapeutics, NOV 7, 2019, View Source [SID1234550676]).

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"We are excited about the potential of cirmtuzumab and TK216 in treating multiple types of hematologic and solid tumors, and by the encouraging interim results from our ongoing clinical trials of these product candidates," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We have now rounded out an experienced leadership team with key new hires and are focused on advancing our programs for the benefit of patients with cancer. We look forward to presenting additional interim clinical data for cirmtuzumab in patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL) and breast cancer, and for TK216 in patients with Ewing sarcoma, in the fourth quarter of 2019."

Recent Highlights

Opened randomized, Phase 2 clinical trial of cirmtuzumab in patients with CLL – In August, Oncternal announced the opening of a randomized, Phase 2 study of cirmtuzumab, its investigational anti-ROR1 monoclonal antibody, combined with ibrutinib in patients with CLL. The decision to open the Phase 2 portion of this ongoing Phase 1/2 clinical trial was based on favorable outcomes from the dose-finding and dose-confirming cohorts of the trial that included an observed interim objective response rate (ORR) of 100% for the first nine CLL patients with evaluable data receiving the recommended dosing regimen who completed 12 weeks of cirmtuzumab plus ibrutinib treatment in the dose-confirming cohort, and a well-tolerated safety profile consistent with that seen with ibrutinib alone.
Opened Phase 1b expansion cohort of a clinical trial of cirmtuzumab in patients with MCL – In October, Oncternal announced the opening of a Phase 1b expansion cohort of its clinical trial of cirmtuzumab in combination with ibrutinib for the treatment of patients with MCL. The decision to open the expansion cohort in MCL was based on favorable interim results from the dose-finding cohort of the trial, which included complete responses observed in two patients who had failed multiple prior treatment regimens, and the observation that the combination was well-tolerated with a safety profile consistent with that seen with ibrutinib alone.
Reported first sustained objective response in a patient with Ewing sarcoma treated with TK216 in a Phase 1 clinical trial – In September, Oncternal announced the presentation of a case study of a patient with Ewing sarcoma who achieved a sustained response following treatment with TK216, Oncternal’s investigational, targeted ETS oncoprotein inhibitor, in the company’s ongoing Phase 1 clinical trial. The patient, who had metastatic, recurrent Ewing sarcoma, achieved a confirmed objective response following two cycles of TK216 therapy given as a single agent. The response was sustained and continued at six months of treatment, with the patient receiving TK216 and vincristine in subsequent treatment cycles. The final remaining residual tumor nodule was later surgically removed, leading to a surgical complete remission. Treatment with TK216 was well-tolerated by this patient.
Strengthened leadership team – In August and September, Oncternal announced appointments of Frank Hsu, M.D., as Chief Medical Officer, Rajesh Krishnan, Ph.D., as Senior VP, CMC and Manufacturing, Gunnar Kaufmann, Ph.D., as Chief Scientific Officer, and Igor Bilinsky, Ph.D., as Chief Business Officer.
Expected Upcoming Milestones

Cirmtuzumab program
Presentation of additional interim data from the ongoing Phase 1/2 clinical study of cirmtuzumab in combination with ibrutinib in patients with CLL or MCL at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 annual meeting in December 2019. The abstract for the presentation, which is entitled, "Cirmtuzumab, a ROR1 Targeted Mab, Reverses Cancer Stemness, and Its Combination with Ibrutinib is Safe and Effective: Planned Analysis of the CIRLL Phase 1/2 Trial for CLL and MCL," is available on the conference website
Presentation of interim data from the ongoing, investigator-sponsored Phase 1 clinical study of cirmtuzumab in combination with paclitaxel in patients with Her2 negative, metastatic or locally advanced unresectable breast cancer in the fourth quarter of 2019
TK216 program
Presentation of interim data from the ongoing Phase 1 clinical study of TK216 in patients with Ewing sarcoma at the Connective Tissue Oncology Society (CTOS) annual meeting in November 2019
ROR1 CAR-T program
Selection of a candidate CAR-T construct for hematologic malignancies in the first half of 2020
Financial Results for the Third Quarter 2019

Oncternal’s grant revenue was $0.5 million for the quarter ended September 30, 2019. The company’s grant revenue is derived from a subaward under a grant from the California Institute for Regenerative Medicine (CIRM) to the University of California San Diego, which was awarded to advance Oncternal’s Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with CLL or MCL.

The company’s total operating expenses for the third quarter ended September 30, 2019, were $5.5 million. Research and development expenses for the quarter totaled $3.1 million, and general and administrative expenses for the quarter totaled $2.4 million. Net loss for the third quarter was $4.9 million, or a loss of $0.32 per share, basic and diluted.

As of September 30, 2019, Oncternal had $23.1 million in cash and cash equivalents. The company believes these funds will be sufficient to fund its operations through the second quarter of 2020. As of September 30, 2019, Oncternal had approximately 15.4 million shares of common stock outstanding.

Management Webcast

Oncternal will host a webcast conference today, November 7, 2019, at 2:00 p.m. PST (5:00 p.m. EST) to review quarterly results and provide an update on the company’s development programs. The live webcast will be available online and may be accessed from the "Investors" page of the company website at View Source A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

NanoString Highlights the Results of Research Presented at the 2019 Annual Meeting of the Society of Immunotherapy for Cancer (SITC)

On November 7, 2019 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for translational research and molecular diagnostic products, reported the highlights of numerous abstracts demonstrating advances in understanding of immune response and cancer immunotherapy using the nCounter and GeoMx Digital Spatial Profiler (DSP) platforms that will be presented at the 34th Annual Meeting of the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) (Press release, NanoString Technologies, NOV 7, 2019, View Source [SID1234550675]).

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"Immunotherapy represents one of the most exciting fields for developing breakthrough treatments for cancer," said Brad Gray, president and CEO of NanoString. "We are honored to see the continuing contribution that our nCounter and GeoMx DSP technologies are making toward understanding the mechanism of cancers and the critical role that the immune system plays in predicting patient response."

More than 30 abstracts using NanoString’s nCounter and GeoMx DSP platforms will be presented at the SITC (Free SITC Whitepaper) Annual Meeting, being held Nov. 7–10, 2019, at the Gaylord National Hotel & Convention Center in National Harbor, Md. The research being presented spans a wide breadth of applications, including biomarker development, the study of immune responsiveness and resistance, and digital pathology.

Five studies include the use of NanoString’s GeoMx DSP platform in immuno-oncology research. These abstracts include numbers P3, P24, P30, P126 and P305 that are described below. GeoMx DSP allows for digital quantification of protein and gene expression from discrete regions of FFPE tissue in an automated and multiplex format.

NanoString is currently accepting applications for its Technology Access Program (TAP). To inquire, please e-mail [email protected].

nCounter-based Abstracts

Poster #: P361

Title: Molecular and Immunologic Profiling of CD8+ T Cell Responses in Patients Receiving a Multiple Antigen-Engineered Dendritic Cell Vaccine

Authors: Juraj Adamik, PhD; Patricia M. Santos, PhD; Samuel Du, BS; Lazar Vujanovic, PhD; Timothy Howes; Sarah Warren, PhD; Andrea Gambotto, MD; John M. Kirkwood, MD; Lisa H. Butterfield, PhD

Summary: This study utilized the new CAR-T panel and the PanCancer Immune Profiling panel to understand T cell biology in patients receiving a dendritic cell vaccine

View Source;ABSID=12232&CONF=SITC19&ssoOverride=OFF&CKEY=

Poster #: P123

Title: Identification of mRNA signatures that predict response to immunotherapy in melanoma patients

Authors: Ioannis A. Vathiotis, MD; Amy Sullivan; Sarah Warren, PhD; Nicole Gianino; Sandra Martinez-Morilla, PhD; Pok Fai Wong, MD, MPhil; Harriet Kluger, MD; Konstantinos N. Syrigos; David L. Rimm, MD, PhD

Summary: This study highlights the utility of the nCounter IO360 Gene Expression Panel and Data Analysis Service for biomarker discovery.

View Source;ABSID=12506&CONF=SITC19&ssoOverride=OFF&CKEY=

Poster #: P125

Title: Adenosine and AMP gene expression profiles predict response to adenosine pathway therapies and indicate a need for dual blockade of CD73 and A2AR with CD73 inhibitors

Authors: Stephen Willingham, PhD; Drew Hotson, PhD; Jessica Hsieh; Brian Munneke; Long Kwei, PhD; Joseph J. Buggy; Richard A. Miller, MD

Summary: This study investigates potential biomarkers of response for novel IO agents.

View Source;ABSID=12270&CONF=SITC19&ssoOverride=OFF&CKEY=

GeoMx DSP Abstracts

Poster #: P03

Title: Immune infiltration correlates with TP53 mutational status in a multi-cohort acute myeloid leukemia study

Authors: Sergio Rutella, MD, PhD, FRCPath, Nottingham Trent University, John van Geest Cancer Research Centre and Centre for Health, Ageing and Understanding Disease (CHAUD), Sergio Rutella, MD, PhD, FRCPath, Jayakumar Vadakekolathu, PhD, Stephen Reeder, BS, Jenny Ashforth, Melissa Courtney, Amanda Coutts, PhD, Tressa Hood, MS, Sarah E. Church, PhD, Clare Coveney, PhD, Jan Davidson-Moncada, MD, PhD, Jorn Meinel, MD, Marc Schmitz, MD, Francesco M. Marincola, MD, Martin Bornhauser, MD, Sergio Rutella, MD, PhD, FRCPath

Summary: This study found that P53 mutational status was associated with increase inflammatory gene expression in AML. Additionally, immune infiltrate was evaluated spatially in a subset of samples using GeoMx.

View Source;ABSID=11562&CONF=SITC19&ssoOverride=OFF&CKEY=

Poster #: P24

Title: Molecularly guided digital spatial profiling for highly multiplexed analysis of gene expression with spatial and single cell resolution

Authors: Anushka Dikshit, PhD; Chris Merritt, PhD; Jamie Rose Kuhar, PhD; Karen Nguyen; Kristina Sorg; Bingqing Zhang; Courtney M. Anderson, PhD; Xiao-Jun Ma

Summary: Abstract highlights the combination of RNAscope reagents and GeoMx DSP workflow. Demonstrates that the chemistries perform well when the workflow is combined on a single slide and that data concordance between both technologies is robust.

View Source;ABSID=12091&CONF=SITC19&ssoOverride=OFF&CKEY=

Poster #: P30

Title: Deep Spatial Profiling of the Immune Landscape of MSI and MSS Colorectal Tumors

Authors: Sarah E. Church, PhD; Jason W. Reeves; Daniel R. Zollinger; Jill McKay-Fleisch; Andrew M. White, BSc; Michael D. Bailey; Arya Bahrami, PhD; Chris Merritt, PhD; Margaret Hoang; Sarah Warren, PhD; Joseph M. Beechem, PhD

Summary: Colorectal tumors that were characterized as Microsatellite Stable (MSS) or Microsatellite Instable (MSI) were profiled using IO360 and GeoMx DSP. 60 samples were run on IO360 for bulk gene expression profiling and then profiled using the tumor inflammation signature (TIS) scores, along with MSI status to identify immune hot and cold tumors for further profiling with GeoMx DSP using the new Cancer Transcriptome Atlas assay.

View Source;ABSID=12628&CONF=SITC19&ssoOverride=OFF&CKEY=

Poster #: P126

Title: Discovery of biomarkers associated with benefit from PD-1 checkpoint blockade in non-small-cell lung cancer (NSCLC) using high-plex digital spatial profiling

Authors: Jon Zugazagoitia, MD, PhD, Yale University School of Medicine, Pathology, Jon Zugazagoitia, MD, Swati Gupta, PhD, Kit Fuhrman, MS PhD, Scott N. Gettinger, MD, Roy S. Herbst, MD, PhD, Kurt A. Schalper, MD, PhD, David L. Rimm, MD, PhD

Summary: Digital Spatial Profiling (DSP) technology identifies spatially-resolved protein markers associated with outcome from single-agent PD-1 checkpoint blockade in NSCLC. High levels of CD56 (top tertile) and CD4 (median) measured in the CD45 compartment were the only markers that were predictive for all clinical outcomes, including longer PFS.

View Source;ABSID=12617&CONF=SITC19&ssoOverride=OFF&CKEY=

Poster #: P305

Title: Response to Pembrolizumab and tumor microenvironment composition is associated with IL8 expression in a head and neck squamous-cell carcinoma cohort

Authors: Arun Khattri, PhD; Jason W. Reeves; SuFey Ong; Riyue Bao, PhD; Arya Bahrami, PhD; Yi-Hung Carol Tan, PhD; Andrew M. White, BSc; Michael P. Bailey; Heather A. Brauer, PhD; Sarah Warren, PhD; Joseph M. Beechem, PhD; Tanguy Seiwert, MD

Summary: More than 100 head and neck cancer samples were profiled using IO360. There was a modest association between tumor inflammation signature (TIS) and response. There was also a modest association between IL8 expression and progressive disease (PD) status. Follow-up analysis with GeoMx DSP used ISH staining to guide the selection of IL8+ and IL8- ROIs.

At the 2019 SITC (Free SITC Whitepaper) Annual Meeting, NanoString will showcase its nCounter platform, IO360 and Data Analysis and GeoMx Digital Spatial Profiler at booth #511.

ID

Abstract Title

First Author

Institution

NanoString
Platform

O2

Combining transcriptomic and tissue-based immune biomarkers to improve recurrence prediction in stage II-III melanoma

Robyn Gartrell, MD

Columbia University

nCounter

O3

Immune infiltration correlates with TP53 mutational status in a multi-cohort acute myeloid leukemia study

Sergio Rutella, MD, PhD

Nottingham Trent University

GeoMx DSP

O74

Fibroblast activation protein is expressed by human and murine leukocytes and nonspecific inhibition of FAP enhances anti-PD-1 therapy in murine models of PDAC

Louis Weiner, MD

Georgetown

nCounter

O75

Selective induction of S100a8/a9 heterodimer protein in pancreatic cancer in response to immune selection pressure

Louis Weiner, MD

Georgetown

nCounter

O82

A Phase 1 Dose Escalation Study of PRS-343, a HER2/4-1BB Bispecific Molecule, in Patients with HER2-positive Malignancies

Sarina A. Piha-Paul, MD

MD Anderson Cancer Center

nCounter (IO360)

P123

Identification of mRNA signatures that predict response to immunotherapy in melanoma patients

Ioannis A. Vathiotis, MD

Yale University

nCounter (IO360)

P125

Adenosine and AMP gene expression profiles predict response to adenosine pathway therapies and indicate a need for dual blockade of CD73 and A2AR inhibitors

Stephen Willingham, PhD

Corvus Pharmaceuticals

nCounter

P126

Discovery of biomarkers associated with benefit from PD-1 checkpoint blockade in non-small-cell lung cancer (NSCLC) using high-plex digital spatial profiling

Jon Zugazagoitia, MD, PhD

Yale University

GeoMx DSP

P22

Transcriptomic Characterization of Immune Response within Diverse Tumor Environments using the NanoString nCounter PanCancer IO 360 Assay

Jessica Perez, PhD

NanoString

nCounter (IO360)

P24

Molecularly guided digital spatial profiling for highly multiplexed analysis of gene expression with spatial and single cell resolution

Anushka Dikshit, PhD

Advanced Cell Diagnostics

GeoMx DSP

P260

Characterization of AB154, a Humanized, Non-depleting α-TIGIT Antibody Undergoing Clinical Evaluation in Subjects with Advanced Solid Tumors

Joanne BL. Tan, PhD

Arcus Biosciences

nCounter

P289

Macrophages modulate patient response to immune checkpoint inhibition in a novel lung tumour explant model

Lauren Evans, BSc, MSc

Cardiff University

nCounter IO360

P30

Deep Spatial Profiling of the Immune Landscape of MSI and MSS Colorectal Tumors

Sarah Church, PhD

NanoString

GeoMx DSP, IO360

P305

Response to Pembrolizumab and tumor microenvironment composition is associated with IL8 expression in a head and neck squamous-cell carcinoma cohort

Arun Khattri, PhD

Johns Hopkins Medical Center

GeoMx DSP, IO360

P361

Molecular and Immunologic Profiling of CD8+ T Cell Responses in Patients Receiving a Multiple Antigen-Engineered Dendritic Cell Vaccine"

Juraj Adamik, PhD

Lisa Butterfield, Pitt/PICI

nCounter

P42

An Integrated Multiplexing Approach for the Immunoprofiling of the Tumor Microenvironment of Ovarian Granulosa Cell Tumors

Juncker-Jensen, PhD

NeoGenomics

nCounter (PCIP

P433

Initial results of the phase 1 portion of an ongoing phase 1/2 study of RP1 as a single agent and in combination with nivolumab in patients with solid tumors

Mark R. Middleton, MD, PhD

University of Oxford

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P454

Induction of serum CXCL10 by tebentafusp, a gp100-CD3 bispecific fusion protein, was associated with survival in uveal melanoma in a Phase I/II Study

Marcus O. Butler, MD

Princess Margaret Cancer Centre

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P481

Obesity impairs immunotherapeutic efficacy in pre-clinical breast cancer

Justin T Gibson, BS

University of Alabama at Birmingham

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P485

Synergistic efficacy of anti-PD-L1/IL-15 fusion protein in combination with anti-CTLA-4 antibody in a murine orthotopic 4T1 breast carcinoma model

Stella Martomo, PhD

Kadmon Corporation

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P557

A2bR contributes to adenosine-mediated immunosuppression, which is relieved by the dual A2aR/A2bR antagonist AB928

Daniel DiRenzo, PhD

Arcus Biosciences

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P583

Building a translational pathway using pharmacodynamic and syngeneic tumour models in conjunction with gene expression to enable the development of cancer immune therapies

Louise Brackenbury, PhD

Charles River Portishead

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P634

Predicting radiation-induced immune trafficking and activation in localized prostate cancer

Simon P. Keam

Peter MacCallum Cancer Center

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P647

Is intracellular STING expression a biomarker for oncolytic herpes virus immunotherapy?

Praveen Bommareddy, MS, PhD

Rutgers University

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P654

CD137 agonists as an adjunct to immune checkpoint inhibitors to overcome resistance in melanoma

Sreedevi Danturti, PhD

University of Pennsylvania

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P666

Selective activation of antigen presenting cells by exoSTING enhances tumor antigen-specific immune response

Su Chul Jang, PhD

Codiak Biosciences

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P706

A TCR-CD3 bispecific fusion protein mediates increased presentation of peptide-HLA which associates with improved T cell activation and tumour cell killing

Duncan M Gascoyne, PhD

Immunocore

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P723

Interleukin-6 blockade to de-couple CTLA-4 blockade colitis from anti-tumor efficacy

Yared Hailemichael, PhD

MD Anderson Cancer Center

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P740

Leveraging Artificial Intelligence to Advance Immuno-oncology Drug Development using Functional Ex-Vivo 3D-Tumor Organoid Platforms of Fresh Patient Tissue Samples

Jenny Kreahling, PhD

Nilogen Oncosystems

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P816

DRP-104 Induces Durable Responses In Vivo by Inhibiting Tumor Glutamine Addiction, Remodeling the Tumor Microenvironment and Stimulating Both the Innate & Adaptive Immune Systems

Yumi Yokoyama, PhD

Dracen Pharmaceutical

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Session 305 Oral

Session 305: SITC (Free SITC Whitepaper) Sparkathon 2018 (SITCure): When is it Safe to Stop Immunotherapy? A Randomized Trial of Early Cessation of Immunotherapy in Patients with Melanoma after 6 Months or More of Stable Disease on Nivolumab Maintenance

Thomas Marron

SITC Sparkathon

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P509

Myeloid Cell-Selective STAT3 Inhibition Sensitizes Head and Neck Cancers to Radiation Therapy and Stimulates T-cell-Dependent Tumor Regression

Marcin Kortylewski, PhD

Beckman Research Institute

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P521

MEK inhibition enhances oncolytic herpes virus immunotherapy

Praveen Bommareddy, MS, PhD

Rutgers University

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P532

Increased adiposity reduces the response rate to a combinatorial CTLA-4 based therapy in diet-matched, renal tumor-bearing mice without substantially altering intra-tumoral T cell profiles

William J. Turbitt Jr., PhD

University of Alabama at Birmingham

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