On December 4, 2017 Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported the appointment of Prof. Stéphane Depil, MD, PhD, to the role of Senior Vice President Research & Development and Chief Medical Officer (Press release, Cellectis, DEC 4, 2017, View Source [SID1234522366]). Prof. Depil’s responsibilities include bringing Cellectis’ product candidates to clinical-stage development, strategic and operational management of all therapeutic activities, and supervising research and development projects for the Company. Stéphane Depil will keep academic and research activities as adjunct Professor at Léon Bérard Cancer Center & University Claude Bernard Lyon 1, France.

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"Stéphane Depil’s deep medical, academic, and clinical regulatory oncology experience – specifically in R&D for all phases within the pharmaceutical, biotechnology, and clinical research spaces – will be invaluable as he leads Cellectis’ strategy and promotes awareness of the breakthrough work that we are doing as a leader and innovator in the gene-editing field," said Dr. André Choulika, Cellectis CEO. "His strategic alliance-building, collaboration skills, understanding of the global environment with oncological clinical research, and firsthand experience running a pharma company all add a great degree of ability and depth to our leadership team. This will be tremendously advantageous as Cellectis continues its efforts to cure cancer with our off-the-shelf gene-edited CAR T-cell product candidates."

Prof. Depil is a board-certified physician in hematology, with over 15 years of experience in oncology clinical development, both in hospital / university and pharmaceutical companies. Prior to joining the Léon Bérard Cancer Center & Cancer Research Center of Lyon, France as Medical Director of the Cancer Immunotherapy Program, he served as Chief Executive Officer at Netris Pharma, where he was responsible for the management of an oncology startup and preclinical development of a first-in-class monoclonal antibody in Phase I. Prior to Netris, Stéphane Depil worked at Servier for 8 years in a variety of roles, including Director of Oncology Research and Development, where he managed 20 programs: 5 in the clinic, 7 at late preclinical stages, and 8 at early preclinical stages. He also directly supervised over 100 licensing opportunities.

"As we are at a transformative moment in history with CAR T-cell therapy, Cellectis is harnessing the power of gene editing to improve patients’ lives through the allogeneic approach," added Prof. Depil. "As such, Cellectis is well-positioned to make its mark with the Company’s unique pioneering approach, and I look forward to joining the team at this pivotal time. This is an unprecedented era of biopharmaceutical innovation to develop next-generation therapeutics that will transform patient care as we know it today."

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.

On December 1, 2017 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported an upcoming presentation at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition Dec. 9, 2017, in Atlanta (Press release, Curis, DEC 1, 2017, View Source [SID1234522330]). This presentation will provide an analysis of results from the Phase 2 trial of CUDC-907.

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Date/Time: Saturday, Dec. 9, 5:30 p.m. — 7:30 p.m. EST
Abstract Number: 1555
Presentation Title: Objective Responses Achieved in Patients with MYC-Altered Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated with the Dual PI3K and HDAC Inhibitor CUDC-907
Location: Building A, Level 1, Hall A2, Georgia World Congress Center, Atlanta
Additional information on the poster presentation can be accessed at View Source

On December 1, 2017 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported that it will present data from its most recent breast cancer diagnostic study during a poster session at the 2017 San Antonio Breast Cancer Symposium (SABCS) on December 7, 2017 (Press release, BioTime, DEC 1, 2017, View Source;p=RssLanding&cat=news&id=2319585 [SID1234522329]). The SABCS will take place at the Henry B. Gonzalez Convention Center in San Antonio, Texas, from December 5-9, 2017.

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The data to be presented are from the Company’s NICE-BC (Non-Invasive Confirmatory dEtection (of) Breast Cancer follow-on study. The data confirm the findings from OncoCyte’s previous breast cancer study, which were presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2016. In the earlier study, the 15-marker model resulted in an area under the curve (AUC) of 0.92 with a sensitivity of 90% and specificity of 76%. Given this level of accuracy, and subject to successful completion of further R&D and clinical studies, OncoCyte’s novel panel of serum protein biomarkers may become the foundation of a highly accurate, non-invasive breast cancer diagnostic test.

The AUC of a test is a measure that combines sensitivity and specificity to express its total accuracy, with 1.0 being perfect accuracy and 0.50 being a random result. Sensitivity and specificity are statistical measures of test performance, with sensitivity measuring the percentage of malignant lumps or masses that are identified correctly by the test and specificity measuring the percentage of benign lumps or masses correctly identified.

"We look forward to reporting data from our breast cancer diagnostic development program at this prestigious conference," said William Annett, President and Chief Executive Officer. "The data from our breast cancer studies are compelling and we look forward to continuing to advance the development program in 2018. We believe our test would address a significant unmet need by reducing the number of unnecessary invasive breast biopsies and lowering the financial burden to the healthcare system."

The data from the NICE-BC study will be presented at SABCS 2017 by Philip McQuary, Ph.D., Director, Product Development, at OncoCyte.

Abstract Title: Assessment of an immune response panel of serum protein biomarkers for the non-invasive detection of breast cancer
Poster Session: 2 (P2-02-03)
Session Title: Detection/Diagnosis: Circulating Markers
Session Date: December 7, 2017
Session Time: 7:00 am CT – 9:00 am CT

The current standard of care for breast cancer diagnosis – annual or biannual mammogram screenings – does not meet the needs of large populations of women for whom mammography alone is not sufficient. These populations include women with dense breast tissue, genetic mutations (BRCA), a family history of breast cancer, or those who have suspicious mammogram screening results (BIRADs 3 or 4). The Company’s non-invasive liquid biopsy breast cancer diagnostic is intended to be a confirmatory, post-mammogram test that would address the needs of some of these populations, thereby reducing the number of patients subjected to invasive procedures.

According to published reports, there are about 39 million mammograms performed annually in the U.S., resulting in 1.6 million breast biopsies per year. Of these, only 260,000 (16%) result in a cancer diagnosis. The large number of suspicious findings in diagnostic mammograms leads to a significant amount of unnecessary invasive follow-up procedures. The financial burden to the healthcare system imposed by the follow-up testing of false-positive mammograms and breast cancer over-diagnosis is estimated to be $4 billion a year.

About Breast Cancer

Breast cancer is the second most common cancer among US women. Current screening guidelines set forth by the American Cancer Society recommend screening mammography for the early detection of breast cancer in women at average risk. Specifically, guidelines call for annual mammography for asymptomatic women age 45 to 54 and once every two years for women age 55 and older. Suspicious screening mammograms are generally followed up with a diagnostic mammogram and sometimes by an MRI (Magnetic Resonance Image) or an ultrasound. Ultimately, suspicious findings unresolved by imaging typically result in the recommendation of a breast biopsy.