Entry into a Material Definitive Agreement.

On November 8, 2019, Humanigen, Inc. (the "Company") reported that it has entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement") with Lincoln Park Capital Fund, LLC ("LPC"), pursuant to which the Company has the right to sell to LPC up to $20,000,000 in shares of the Company’s common stock, $0.001 par value per share (the "Common Stock"), subject to certain limitations and conditions set forth in the Purchase Agreement (Filing, 8-K, Humanigen, NOV 8, 2019, View Source [SID1234551036]).

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Under the Purchase Agreement, the Company has the right, from time to time at its sole discretion and subject to certain conditions, to direct LPC to purchase up to 100,000 shares of Common Stock, with such amounts increasing based on certain threshold prices but not to exceed $750,000 in total proceeds on any purchase date. The purchase price of shares of Common Stock pursuant to the Purchase Agreement will be based on the market prices of the Common Stock at the time of such purchases as set forth in the Purchase Agreement. Such sales of Common Stock by the Company, if any, may occur from time to time, at the Company’s option, over the 36-month period commencing on the date that a registration statement, which the Company agreed to file with the Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus in connection therewith is filed and the other terms and conditions of the Purchase Agreement are satisfied.

In addition to regular purchases, as described above, the Company may also direct LPC to purchase additional amounts as accelerated purchases if the closing sale price of the Common Stock is not below certain threshold prices, as set forth in the Purchase Agreement. In all instances, the Company may not sell shares of its Common Stock to LPC under the Purchase Agreement if it would result in LPC beneficially owning more than 4.99% of the Common Stock then outstanding.

LPC represented to the Company, among other things, that it was an "accredited investor" (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended (the "Securities Act")), and the Company sold the securities to LPC pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of, and Regulation D under, the Securities Act.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. During any "event of default" under the Purchase Agreement, all of which are outside of LPC’s control, LPC does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or other sale of shares to LPC until such event of default is cured.

Actual sales of shares of Common Stock to LPC under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. In consideration for entering in the Purchase Agreement, the Company has agreed to pay to LPC a commitment fee in shares of Common Stock. The Company will not receive any cash proceeds from the issuance of these shares.

The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to LPC. The Company expects that any proceeds received by the Company from such sales to LPC will be used for working capital and general corporate purposes.

This current report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Common Stock, nor shall there be any sale of shares of Common Stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Pieris Pharmaceuticals to Host R&D Event

On November 7, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that the Company will host an R&D event in New York on Tuesday, November 19, 2019 from 12:00 – 3:30 PM EST (Press release, Pieris Pharmaceuticals, NOV 7, 2019, View Source [SID1234550597]).

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The R&D event will feature presentations from management and thought leaders in immuno-oncology and respiratory diseases, including:

Michael A. Curran, PhD, Associate Professor, Department of Immunology and Scientific Director, ORBIT Platform, The UT MD Anderson Cancer Center
Geoffrey Y. Ku, MD, Assistant Attending Physician and Head, Esophagogastric Section, Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering
Anuradha Ray, PhD, Professor of Medicine, Department of Immunology and UPMC Endowed Chair in Lung Immunology Medicine, University of Pittsburgh
Sally E. Wenzel, MD, Professor of Medicine, Department of Medicine; Chair, Department of Occupational & Environmental Health; Acting Director, Asthma Environmental Lung Health Institute and UPMC Endowed Chair of Translational Airway Biology, University of Pittsburgh
Presentations will include expert discussant perspectives on recently presented data for PRS-343 and PRS-060, emerging data from the ongoing PRS-343 combination trial with atezolizumab, and perspectives on how these drug candidates could best fit into the emerging landscapes of asthma and immuno-oncology.

The event will be accessible via a live webcast through this link beginning at 12:30 PM EST on November 19, 2019.

Syndax Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Clinical and Business Update

On November 7, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the third quarter ended September 30, 2019. In addition, the Company provided a clinical and business update (Press release, Syndax, NOV 7, 2019, View Source [SID1234550614]). As of September 30, 2019, Syndax had $72.2 million in cash, cash equivalents and short-term investments.

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"We are pleased to have passed the final interim futility analysis of overall survival for E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, and anticipate the final overall survival readout in the second quarter of 2020," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Supported by highly compelling survival data from the Phase 2b ENCORE 301 trial, leading to Breakthrough Therapy designation for entinostat in HR+ breast cancer, we believe the combination of entinostat and exemestane has the potential to improve outcomes for patients with this difficult to treat disease."

Pending a positive overall survival (OS) assessment in E2112, Syndax intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for entinostat plus exemestane for the treatment of HR+, HER2- breast cancer.

Dr. Morrison added, "Beyond entinostat, patient dosing is now underway in the Phase 1/2 open-label AUGMENT-101 trial of SNDX-5613, our potent, highly selective, oral Menin inhibitor, in adults with relapsed/refractory acute leukemias. We look forward to establishing a safe dose that provides the appropriate target coverage to advance into the Phase 2 portion of the trial. We are committed to bringing this promising therapeutic option to patients, and expect to report initial data from this trial in 2020."

Pipeline Updates

Entinostat

In October 2019, Syndax reported that the E2112 trial passed its fifth and final interim OS analysis. E2112 is Syndax’s NCI-sponsored, ECOG-ACRIN-led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer.

The Company continues to anticipate the trial will reach 410 death events in 2Q20, which will trigger the final E2112 OS analysis. A positive OS assessment at that time would enable the Company to file for full regulatory approval in the U.S. The E2112 trial design was informed by the Phase 2b ENCORE 301 trial, the results of which led to entinostat’s Breakthrough Therapy designation in HR+ breast cancer, in which patients receiving the entinostat/exemestane combination demonstrated a strong OS benefit.

SNDX-5613

Earlier this week, the Company announced that the first patient has been dosed in the Phase 1/2 open-label AUGMENT-101 trial of orally administered SNDX-5613. The Phase 1 dose escalation portion of AUGMENT-101 will enroll adults with relapsed/refractory acute leukemias, including patients with MLL-rearrangements and NPM1c mutations, and establish a recommended Phase 2 dose. The Phase 2 portion will evaluate efficacy, as defined by Complete Response rate (per International Working Group response criteria), across three expansion cohorts: MLL-rearranged (MLL-r) acute lymphoblastic leukemia (ALL), MLL-r AML and NPM1 mutant AML. The Company expects to report initial clinical data from the trial in 2020.

SNDX-6352

Syndax reported that the FDA has agreed to a recent request to amend enrollment criteria for its ongoing Phase 1 dose escalation trial of SNDX-6352, the Company’s anti-CSF-1R monoclonal antibody, in patients with chronic graft versus host disease (cGVHD). Consistent with the evolving treatment paradigm for this patient population, the majority of patients will no longer be required to have progressed on prior IMBRUVICA (ibrutinib) therapy in order to enroll in the study. In addition, the FDA has agreed to expand enrollment to include adolescents.

Enrollment in this trial is ongoing, and Syndax continues to anticipate results in the second half of 2020. The trial is designed to evaluate the safety and preliminary efficacy of SNDX-6352 in cGVHD and to identify a recommended Phase 2 dose and schedule.

Third Quarter 2019 Financial Results

As of September 30, 2019, Syndax had cash, cash equivalents and short-term investments of $72.2 million and 31.6 million shares of common stock and prefunded warrants issued and outstanding.

Third quarter 2019 research and development expenses decreased to $9.9 million from $14.1 million for the prior year period. The decrease was primarily due to decreased activity in the ENCORE and SNDX-6352 clinical programs, decreased CMC activities for SNDX-6352, and decreased professional expenses and stock compensation, partly offset by increased activity in the Menin clinical program.

General and administrative expenses for the third quarter 2019 decreased to $3.6 million from $4.1 million for the prior year period. The decrease was primarily due to decreased legal and professional fees and decreased compensation expenses.

For the three months ended September 30, 2019, Syndax reported a net loss attributable to common stockholders of $12.8 million or $0.41 per share compared to $17.3 million or $0.68 per share for the prior year period.

Financial Guidance

For the fourth quarter and full year 2019, research and development expenses are expected to be $11 to $12 million and $45 to $46 million, respectively, and total operating expenses are expected to be $15 to $16 million and $60 to $62 million, respectively.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, November 7, 2019.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 9065948
Domestic Dial-in Number: 855-251-6663
International Dial-in Number: 281-542-4259
Live Webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

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