On December 4, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that it will hold a R&D Update on December 11, 2017 at 8:00 PM Eastern Time (2:00 AM CET / 1:00 AM GMT on December 12) (Press release, Genmab, DEC 4, 2017, View Source [SID1234522362]). The event will take place in Atlanta, Georgia and will also be webcast live and archived on the company’s website. The meeting will include updates on daratumumab, including presentations by key opinion leaders on data from daratumumab studies presented at the 59th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) as well as a review of tisotumab vedotin, including data previously presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in September. Genmab speakers will also discuss the company’s product pipeline, 2017 progress and key goals for 2018.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The following cancer experts and senior Genmab staff will be at the event:

Key Opinion Leaders:

Professor Maria Victoria Mateos, University Hospital of Salamanca
Professor Philippe Moreau, University Hospital of Nantes
Dr. Saad Usmani, University of North Carolina at Chapel Hill, Levine Cancer Institute
Professor Ignace Vergote, Catholic University of Leuven

Genmab:

Dr. Jan van de Winkel, President and CEO, Genmab
David Eatwell, Executive Vice President and CFO, Genmab
Dr. Judith Klimovsky, Executive Vice President and CDO, Genmab
Dr. Kate Sasser, Corporate Vice President, Clinical Biomarkers, Genmab

The R&D Update will take place at the Omni Atlanta Hotel at CNN Center, International Ballroom AB, North Tower M2. Those wishing to attend in person should email [email protected].

The event may also be attended via webcast. To view this webcast, visit: View Source Webcast viewers may submit questions during the Q&A portion of the live webcast via the webcast player. An archive of the webcast will be available on Genmab’s website. The webcast will be conducted in English.

This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.

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 [SID1234522363]). 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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a company focused on helping improve patient lives by providing high quality biologics manufacturing services to biotechnology and pharmaceutical companies, reported that it will report financial results for the second quarter of fiscal year 2018 ended October 31, 2017 on December 11, 2017 after market close and will host a conference call and webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time) (Press release, Peregrine Pharmaceuticals, DEC 4, 2017, View Source [SID1234522364]). Peregrine’s senior management will discuss financial results for the second quarter and review recent corporate developments.

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To listen to the live webcast, or access the archived webcast, please visit: View Source
To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Peregrine Pharmaceuticals call.

On December 4, 2017 Radius Health, Inc. (Nasdaq:RDUS), reported that it will present data from multiple clinical and pre-clinical studies of elacestrant, an oral selective estrogen degrader, in ER-positive breast cancer at the San Antonio Breast Cancer Symposium Meeting December 5-9, 2017 at the Henry B. Gonzalez Convention Center in San Antonio, Texas (Press release, Radius, DEC 4, 2017, View Source [SID1234522365]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details for the abstracts related to elacestrant are below:

Abstract Title: Elacestrant, a novel oral selective estrogen receptor degrader (SERD), decreases tumoral 18F-FES uptake in a phase 1 study of ER+, HER2 -, advanced breast cancer patients
Poster Session 1 (P1-10-04)
Session Title: Treatment: New Drugs and Treatment Strategies
Session Date: Wednesday, 12/6/2017
Session Time: 5:00 PM — 7:00 PM
Location: Hall 1

Abstract Title: Elacestrant, oral selective estrogen receptor degrader (SERD) in patients with ER positive (ER+)/HER2- advanced breast cancer: Updated phase 1 efficacy, safety and pharmacodynamic results
Spotlight Session 5 (PD5-08)
Session Title: Endocrine Therapy: SERDS for metastatic ER+ breast cancer
Session Date: Thursday, 12/7/2017
Session Time: 5:00 PM — 7:00 PM
Location: Ballroom 1&2 – 3rd Level

Abstract Title: New oral SERD elacestrant (RAD1901) shows efficacy in breast cancer models harbouring ESR1 mutations and enhances the antiproliferative activity of mTORC1 and CDK4/6 inhibitors
Poster Session 4 (P4-04-09)
Session Title: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance
Session Date: Friday, 12/8/2017
Session Time: 7:00 AM — 9:00 AM
Location: Hall 1

Abstract Title: Anti-tumor activity of elacestrant (RAD1901) in combination with alpelisib (BYL-719) in patient-derived xenograft models of ER+ breast cancer
Poster Session 4 (P4-04-14)
Session Title: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance
Session Date: 12/8/2017
Session Time: 7:00 AM — 9:00 AM
Location: Hall 1

Abstract Title: Elacestrant (RAD1901) demonstrates anti-tumor activity in a fulvestrant-resistant PDX model
Poster Session 4 (P4-04-17)
Session Title: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance
Session Date: 12/8/2017
Session Time: 7:00 AM — 9:00 AM
Location: Hall 1

Abstracts for the posters can be found on the SABCS website at View Source

Webcast Information

Radius will host an investor meeting and webcast on Thursday, December 7th to highlight the elacestrant data presented at SABCS and provide a company update at 8:00 p.m. CT / 9:00 p.m. ET.

The live webcast titled "Oncology Program Update from San Antonio Breast Cancer Symposium — 2017" will be available at View Source or by visiting the Investors section of Radius’ website at View Source

A replay of the webcast will be archived on Radius’ website for 30 days following the presentation.

About Elacestrant (RAD1901)
Elacestrant is a selective estrogen receptor degrader (SERD), which is being evaluated for potential use as a once daily oral treatment for hormone-receptor positive breast cancer. Elacestrant is currently being investigated for potential use in women with advanced estrogen receptor positive, HER2 negative, breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.

Additional information on the clinical trial program of elacestrant (RAD1901) is available on www.clinicaltrials.gov.

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.