Palleon Pharmaceuticals to Present Preclinical Data on EAGLE and HYDRA Platforms at the Society for Immunotherapy of Cancer’s (SITC) 34th Annual Meeting

On November 7, 2019 Palleon Pharmaceuticals, a leading biotech company developing drugs that target the Siglec-Sialoglycan axis to treat cancer, reported two poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting in National Harbor, MD (Press release, Palleon Pharmaceuticals, NOV 7, 2019, View Source [SID1234550659]).

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The first poster will show recent preclinical data on the company’s EAGLE platform, a first-in-class modality that targets the Siglec-Sialoglycan axis for treating cancer. The Siglec-Sialoglycan axis is very difficult to target by conventional approaches because of the structural diversity of sialylated tumor glycans and the redundancy of the Siglec receptors. The EAGLE platform makes targeting possible by enzymatically removing the critical common immunosuppressive moiety, terminal sialic acids, from tumor glycans regardless of their individual structures or Siglec receptor preferences. New data generated confirm anti-tumor activity and identify predictive biomarkers using EAGLE with engineered human sialidase in both in vitro and in vivo studies. Human sialidase poses fewer immunogenic concerns than bacterial sialidase, which was used in previous EAGLE proof-of-concept studies.

The second poster presentation describes Palleon’s HYDRA platform, an immunohistochemistry-based translational research technology, which allows the identification of a patient’s specific tumor cell surface glycan pattern, or tumor glyco-code. By overcoming the challenge posed by the significant structural heterogeneity of tumor surface glycans, HYDRA has the potential to help select patients who are most likely to respond to treatment.

"The Siglec-Sialoglycan axis, which was a previously underappreciated mechanism of immunosuppression, has recently emerged as a major tumor immune escape pathway," said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. "The collective data thus far across our three distinct technology platforms – EAGLE, CONVERGENCE and HYDRA – continue to support that targeting this axis could play an important role in how we develop targeted treatments for cancer and identify the patients who are most likely to respond to treatment."

Full details of the presentations are below.

Poster title: Blockade of glyco-immune checkpoint using EAGLE to potentiate anticancer immunity
Abstract ID: P273
Date & time: Friday, Nov. 8, 12:30 pm – 2:00 pm ET and 6:30 pm – 8:00 pm ET
Location: Prince George’s Exhibition Halls AB

Poster title: HYDRA platform development to investigate Siglec-engaging tumor immunosuppressive glyco-codes
Abstract ID: P118
Date & time: Saturday, Nov. 9, 12:35 pm – 2:05 pm ET and 7:00 pm – 8:30 pm ET
Location: Prince George’s Exhibition Halls AB

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

nCounter

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

nCounter

P481

Obesity impairs immunotherapeutic efficacy in pre-clinical breast cancer

Justin T Gibson, BS

University of Alabama at Birmingham

nCounter

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

nCounter (IO360)

P557

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

Daniel DiRenzo, PhD

Arcus Biosciences

nCounter

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

nCounter (M-IO360)

P634

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

Simon P. Keam

Peter MacCallum Cancer Center

nCounter (PCIP)

P647

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

Praveen Bommareddy, MS, PhD

Rutgers University

nCounter

P654

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

Sreedevi Danturti, PhD

University of Pennsylvania

nCounter (IO360)

P666

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

Su Chul Jang, PhD

Codiak Biosciences

nCounter

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

nCounter

P723

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

Yared Hailemichael, PhD

MD Anderson Cancer Center

nCounter (PCIP)

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

nCounter

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

nCounter

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

nCounter (IO360)

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

nCounter

P521

MEK inhibition enhances oncolytic herpes virus immunotherapy

Praveen Bommareddy, MS, PhD

Rutgers University

nCounter

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

nCounter

Precision Optics Corporation Schedules First Quarter Fiscal Year 2020 Conference Call for Thursday, November 14, 2019

On November 7, 2019 Precision Optics Corporation, Inc. (OTCQB: PEYE) (the "Company") reported that it has scheduled a conference call to discuss first quarter of fiscal 2020 financial results on Thursday, November 14, 2019 at 5:00pm ET (Press release, Precision Optics, NOV 7, 2019, View Source [SID1234550692]).

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The Company intends to release its financial results and to file its 10-Q after the close of the market on November 14, 2019 followed by the conference call.

Conference Call Details

Date and Time: Thursday, November 14, 2019 at 5:00pm ET

Call-in Information: Interested parties can access the conference call by dialing (877) 317-6789 or (412) 317-6789.

Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available at View Source

Replay: A teleconference replay of the call will be available until November 21, 2019 at (877) 344-7529 or (412) 317-0088, confirmation #10136579. A webcast replay will be available at View Source

Aduro Biotech Provides Business Update and Reports Third Quarter 2019 Financial Results

On November 7, 2019 Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, reported financial results for the third quarter ended September 30, 2019 (Press release, Aduro Biotech, NOV 7, 2019, View Source [SID1234550708]).

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Cash, cash equivalents and short term and long term marketable securities totaled $235.4 million at September 30, 2019, compared to $277.9 million at December 31, 2018.

"We remain highly focused on the development of our STING and APRIL programs, with the initiation of our Phase 2 study of ADU-S100 in combination with pembrolizumab in head and neck squamous cell carcinoma and continued progress of our Phase 1 study of BION-1301 in IgA nephropathy," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "Our strong cash position of $235.4 million at the end of the third quarter enables us to continue investing in our STING and APRIL programs with the ultimate goal of providing therapeutic benefit to patients."

Recent Highlights

Cleared four healthy volunteer dose cohorts in the single ascending dose portion and one healthy volunteer dose cohort in the multiple ascending dose portion of the Phase 1 clinical trial of BION-1301 for the treatment of IgA nephropathy.

First patient dosed in Phase 2 clinical trial of ADU-S100 (MIW815) in combination with Keytruda (pembrolizumab), an approved anti-PD-1 antibody, as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma.

Financial Results

Revenue – Revenue was $4.8 million for the third quarter of 2019 and $13.6 million for the nine months ended September 30, 2019, compared to $3.1 million and $12.3 million, respectively, for the same periods in 2018. The increase in revenue for the quarter and the year to date was primarily due to ratable recognition of the upfront payment received from Eli Lilly in the first quarter of 2019.

Expenses –

Research and development expenses were $15.5 million for the third quarter of 2019 and $51.9 million for the nine months ended September 30, 2019, compared to $18.7 million and $58.2 million, respectively, for the same periods in 2018. The quarter and year to date costs decreased primarily due our strategic reset in January 2019, which resulted in reduced headcount and stock-based compensation expense. The reset also resulted in reduced spending towards deprioritized programs partially offset by higher spending towards our STING and APRIL programs.

General and administrative expenses were $8.7 million for the third quarter of 2019 and $25.8 million for the nine months ended September 30, 2019, compared to $9.1 million and $27.0 million, respectively, for the same periods in 2018. The quarter and year to date costs decreased primarily due to our strategic reset in January 2019, which resulted in reduced headcount and stock-based compensation expense.

Loss on impairment of intangible assets was $5.0 million for the third quarter of 2019. This expense was recorded due to the discontinuation of one of our acquired early research programs.

Net Loss – Net loss for the third quarter of 2019 was $21.0 million or $0.26 per share and $63.0 million or $0.79 per share for the nine months ended September 30, 2019, compared to net loss of $23.1 million or $0.29 per share and $69.0 million or $0.88 per share, respectively, for the same periods in 2018.

Agios Announces Pricing of $256 Million Public Offering of Common Stock

On November 7, 2019 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO) reported that it has priced an underwritten public offering of 8,250,000 shares of common stock at a price to the public of $31.00 per share, before underwriting discounts, which would result in aggregate gross proceeds of approximately $256 million (Press release, Agios Pharmaceuticals, NOV 7, 2019, View Source [SID1234550724]). All of the shares in the offering are to be sold by Agios. Agios has also granted the underwriters a 30-day option to purchase up to 1,237,500 shares of common stock sold in the public offering on the same terms and conditions. Closing of the offering is expected to occur on or November 12, 2019, subject to customary closing conditions.

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J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering.

The shares are being offered by Agios pursuant to an automatically effective shelf registration statement that has been filed with the Securities and Exchange Commission ("SEC"). The offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov.

The final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 866-803-9204; Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.