On December 4, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN, also known as pelareorep, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn ‘cold’ tumors ‘hot’, reported that it will present at the Oncolytic Virotherapy Summit (Press release, Oncolytics Biotech, DEC 4, 2017, View Source [SID1234522351]). Dr. Matt Coffey, Oncolytics’ President and Chief Executive Officer, will present on Wednesday, December 6 at 11:00 a.m. ET as part of a panel presentation and then present specifically on pelareorep in a Clinical Case Study presentation at 2:30 p.m. ET on the same day. The conference takes place on December 5th, 6th and 7th in Miami, Florida.

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"The Oncolytic Virotherapy Summit offers us another opportunity to highlight our extensive experience with pelareorep in the clinic and to illustrate its ability to induce an inflamed tumor phenotype amongst our peers and for potential partners," said Dr. Coffey. "Our clinical experience with pelareorep has led us to favorable feedback from the FDA following our end-of-phase 2 meeting which helps us define a clear regulatory path in metastatic breast cancer and a single 400-patient phase 3 registration study. Our phase 3 protocol will be made available following evaluation and completion of discussions with clinical advisors, potential partners and the EMA."

The panel presentation: "How Can We Improve The Efficacy of Oncolytic Virotherapies?", also including management from PsiOxus Therapeutics, Vyriad and Replimune Group, will cover:

Viral modulation of the tumor microenvironment
Increasing the viral impact with activated immune responses
Combination drug therapies to stimulate the immune response and prevent immunosuppression
Viral delivery for largest impact
Dr. Coffey’s individual presentation: "Clinical Progress and Robust Safety Findings of Using Reovirus as an Immuno-Oncology Viral Agent to Treat Cancer", will highlight:

The role of REOLYSIN in the activation of the immune system and the induction of an inflamed tumor phenotype in the tumor microenvironment
Overall survival data from the Company’s randomized phase 2 metastatic breast cancer study
The largest pooled safety database of any oncolytic virus
About REOLYSIN/Pelareorep
REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

On December 4, 2017 NantKwest Inc. (Nasdaq:NK), a pioneering, 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 inflammatory diseases, reported an oral presentations will be given at the upcoming 59th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Atlanta, Georgia on Saturday, December 9, 2017 (Press release, NantKwest, DEC 4, 2017, http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=RssLanding&cat=news&id=2320823 [SID1234522350]).

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Presentation Title

CD19-Chimeric Antigen Receptor (CAR) Engineered Natural Killer (NK) Cell Therapy: Novel "Off the Shelf" Immunotherapy in CD20 Resistant B-Cell Non-Hodgkin Lymphoma (NHL) Cell Lines, Primary NHL Cells, and a Human Lymphoma Xenograft Model Target Activated Natural Killer (CD19.taNK) Cellular Therapy: A Novel Immunotherapeutic Approach to the Treatment of Non-Hodgkin Lymphoma (NHL)

Abstract #110: View Source

Presenter: Sneha Purvey, MD, Department of Hematology and Oncology, Tufts Medical Center, Boston, MA

Date: Saturday, December 9, 2017, 9:45AM, Building C, Level 1, C101 Auditorium (Georgia World Congress Center)

Presentation Summary

This oral presentation will present preclinical data on the company’s CD19.taNK program. CD19.taNK cell therapy is based on the use of engineered NK cells expressing a human anti-CD19 CAR that target CD19 expressing cells. The study was designed to more deeply understand the mechanism of action associated with NK-based therapy in B cell NHL and determine the potential for CD19.taNK cells as an "off the shelf" therapy.

The study author’s identified high levels of NK activating ligands indicative of a conserved mechanistic response to CD19-CAR NK cell therapy. In addition, the authors determined that CD19.taNK cell therapy induced significant single-agent cytolytic activity against a wide range NHL cells, including primary DLBCL cells, and cells resistant to standard anti-CD20 antibody.

"CD20 targeted antibody therapy represent one of the most effective and widely used therapeutic interventions in blood cancers. However, resistance is common, occurring in a large percentage of patients," said Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest. "For next generation therapies, such as our CD19.taNK cell therapy, circumventing resistance requires both a deeper understanding of the mechanisms of resistance and the mechanisms of action. We believe these study results provide encouraging data elucidating the significant, single-agent cytolytic activity of CD19.taNK cell therapy and takes us one step closer in our focus to transition this novel NK cell therapy to clinical cancer care."

On December 4, 2017 Abbott (NYSE: ABT) reported that it will present at the 36th Annual J.P. Morgan Healthcare Conference on Monday, Jan. 8, 2018 (Press release, Abbott, DEC 4, 2017, View Source [SID1234522346]). Brian Yoor, executive vice president of finance and Chief Financial Officer, will present at the conference at 6 p.m. Central time.

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A live audio webcast of the presentation will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the presentation will be available the next day.

On December 3, 2017 Vernalis plc (LSE: VER) reported that it has entered into a drug discovery collaboration with Daiichi Sankyo Company, Limited utilizing Vernalis’ fragment and structure-based drug discovery platform against undisclosed oncology targets (Press release, Vernalis, DEC 3, 2017, http://www.vernalis-research.com/respubs/research-press-releases/729-vernalis-plc-enters-into-research-collaboration-with-daiichi-sankyo [SID1234531525]).

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The financial terms of this collaboration are not disclosed.

Ian Garland, CEO of Vernalis, commented: "We are delighted to be working with Daiichi Sankyo on this project. This is another excellent endorsement of our market leading fragment and structure-based drug discovery platform and we look forward to a successful collaboration with Daiichi Sankyo."

On December 3, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has approved FoundationOne CDx, Foundation Medicine’s comprehensive companion diagnostic assay for personalised oncology care1 (Press release, Hoffmann-La Roche, DEC 3, 2017, View Source [SID1234522343]). FoundationOne CDx supports physicians in clinical decision-making by providing a report that describes the unique genomic profile of the patient’s tumour as well as associated approved therapies and relevant clinical trial information. FDA approval of this assay, based on its clinical and analytical validation, now means the service can be used as a companion diagnostic for therapy selection when people have been diagnosed with solid tumours.

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"The approval of FoundationOne CDx represents a major advance in the personalisation of cancer care, facilitating access for patients in the US to a comprehensive pan-tumour companion diagnostic that will help identify approved treatment options based on the molecular footprint of each individual’s cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "Our belief is that profiling will increasingly become routine in clinical practice, so we have worked closely with Foundation Medicine to develop an extensive clinically and analytically validated platform that can support both existing and future companion diagnostic needs."

FoundationOne CDx is the first FDA-approved pan-tumour comprehensive companion diagnostic assay to:

assess all four classes of genomic alterations in 324 genes known to drive cancer growth, providing information to help guide the decisions of treating physicians;

identify patients with advanced cancer who are likely to respond to targeted therapies, based on their individual genomic profile; and,

report genomic signatures, including microsatellite instability (MSI) and tumour mutational burden (TMB), and report genomic alterations in other genes [relevant to other therapies] for use by physicians for patient management according to professional guidelines in oncology.

Of the 17 therapies currently approved for inclusion in the report, twelve are approved as first-line treatment options for their respective indications. The number of on-label targeted therapies in the report is expected to increase over time as Foundation Medicine and its partners gain FDA approval for additional biomarkers on the platform.
The approval of FoundationOne CDx also represents the first next generation sequencing (NGS)-based companion diagnostic for Alecensa (alectinib), an FDA-approved monotherapy for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)2. Alecensa is approved in both the front-line setting and for people who have progressed on or are intolerant to crizotinib. Including ALK-rearrangements in a larger comprehensive panel may ensure that more patients are identified and eligible for treatment based on their ALK-positive status.

Roche acquired a majority stake in Foundation Medicine in April 2015, and since then, has been actively commercialising Foundation Medicine’s portfolio of services in countries outside the US, with more than 20 countries on three continents already having launched FoundationOne.

About FoundationOne CDx
FoundationOne CDx is a comprehensive genomic profiling service for solid tumours that provides potentially actionable information with the molecular profiling of 324 genes known to drive cancer growth. FoundationOne CDx is intended to be used as a comprehensive companion diagnostic for patients with certain types of NSCLC, melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients that may benefit from treatment with one of 17 targeted therapies following the detection of alterations in the EGFR, ALK, BRAF, ERBB2, KRAS, NRAS, and BRCA1/2 genes.

FoundationOne CDx is an NGS-based in vitro diagnostic for detection of base substitutions, insertion and deletion alterations (indels), copy number alterations (CNAs) and select gene rearrangements in 324 genes, as well as genomic signatures including MSI and TMB, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumour tissue specimens. FoundationOne CDx is intended to be used by physicians as decision-making support in consideration of a patient’s genomic profile for therapy selection and patient management according to professional guidelines in oncology for cancer patients.