Advaxis to Present at 12th Annual LD Micro Main Event Investor Conference

On December 4, 2019 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that Kenneth A. Berlin, President and Chief Executive Officer will present at the upcoming LD Micro Main Event Investor Conference being held from December 10-12, 2019 at the Luxe Sunset Boulevard Hotel in Los Angeles, California (Press release, Advaxis, DEC 4, 2019, View Source [SID1234551913]).

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Presentation Information:

Date: Tuesday, December 10, 2019

Time: 9:20 AM PT / 12:20 PM ET

Location: Luxe Sunset Boulevard Hotel (Los Angeles, CA)

Webcast: View Source

Foundation Medicine Expands Indication for FoundationOne®CDx as a Companion Diagnostic for Piqray® (alpelisib)

On December 4, 2019 Foundation Medicine, Inc. reported it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen (Press release, Foundation Medicine, DEC 4, 2019, View Source [SID1234551930]). FoundationOne CDx is the first and only FDA-approved broad comprehensive genomic profiling (CGP) test for all solid tumors, including breast cancer, that incorporates multiple companion diagnostics.

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"Foundation Medicine is proud to achieve another FDA approval for FoundationOne CDx as a companion diagnostic for Piqray for the treatment of metastatic breast cancer with a PIK3CA mutation," stated Brian Alexander, M.D., M.P.H. Foundation Medicine’s Chief Medical Officer. "The advancements we are seeing in the treatment of breast cancer underscore the importance of harnessing genomic insights to enable personalized medicine. Taking a comprehensive and validated approach to genomic testing is critical for patients with metastatic breast cancer to help physicians determine a treatment roadmap upfront that may include FDA-approved targeted therapies like Piqray."

In May of 2019, Novartis announced that the FDA approved Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2-, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen metastatic breast cancer with a PIK3CA mutation following progression on or after an endocrine-based regimen. PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer; approximately 40% of patients living with HR+/HER2- breast cancer have this mutation1. Professional guidelines were updated in September of 2019 to recommend assessment for PIK3CA mutations as part of the workup of HR+/HER2- advanced or metastatic breast cancer.

Piqray is the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer. Foundation Medicine and Novartis have an ongoing collaboration to support the development of companion diagnostics for the Novartis oncology portfolio.

Foundation Medicine will also be presenting new data at this year’s San Antonio Breast Cancer Symposium (SABCS) highlighting the utility of comprehensive genomic profiling in cancer care, including research on PIK3CA, as well as emerging biomarkers in breast cancer.

COTA Presents Posters at ASH Annual Meeting, Reviewing Complexities of Generating RWD and How it Complements Traditional Clinical Trial Data

On December 4, 2019 COTA, Inc., a healthcare technology company that uses real-world data (RWD) to bring clarity to cancer care, reported is presenting posters at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, ASH (Free ASH Whitepaper) 2019, in Orlando, FL from December 7-10, 2019 (Press release, COTA, DEC 4, 2019, https://www.prnewswire.com/news-releases/cota-presents-posters-at-ash-annual-meeting-reviewing-complexities-of-generating-rwd-and-how-it-complements-traditional-clinical-trial-data-300969065.html [SID1234551947]). Collectively, the posters review existing challenges for generating RWD and the promise of this data to support new research in cancer biology.

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"The genetic environment – whether of individual patients or cancer cells – is playing an increasing role in how patients are being treated. Examining sources of real-world data in depth allows us to quickly, inexpensively test hypotheses related to the treatment of patients with specific biomarkers and their outcomes," said Andrew Norden, MD, Chief Medical Officer at COTA.

The Unforeseen Medical and Business Challenges Found When Integrating Abstracted Data from Disparate EHR Systems While Building the Curecloud Direct-to-Patient Multiple Myeloma Registry

Researchers from COTA and Multiple Myeloma Research Foundation (MMRF) explore challenges associated with existing methods of patient data curation to build the MMRF Registry. Despite a significant investment in electronic health records in the United States, many institutions are unable to provide relevant, research-grade clinical data in a timely, cost-free, and coded manner. A comprehensive, research-focused data abstraction process for coded data exchange is being established to support future RWD projects.

Chromosome 1q Amplification Is Associated with a History of Prior Malignancies Among Patients Newly Diagnosed with Multiple Myeloma

Researchers from COTA and Hackensack University Medical Center studied patients with newly diagnosed multiple myeloma who also had a history of prior malignancy. Using COTA’s RWD, they were able to identify an association with a prior history of cancer, especially prostate cancer, and amp(1q) in multiple myeloma. This relationship is worth further exploration of whether there is a common pathway associated with these characteristics. These findings are significant because patients with prior malignancies are often excluded from enrollment in clinical trials and rarely studied. Overall, the results reported suggest that RWD is an efficient and comparatively inexpensive tool to support research in cancer biology.

Thanks to a growing understanding and acceptance of RWD by regulatory bodies, it has been increasingly incorporated into clinical research, helping to expedite studies compared with traditional clinical trial methods alone. Rather than replacing clinical trials, these two models can complement each other to improve clinical trial design and postmarket research, allowing for a more complete picture of the patient group being studied.

Members of COTA’s Life Sciences team will be at ASH (Free ASH Whitepaper) to discuss their work with the Multiple Myeloma Research Foundation (MMRF) and Hackensack University Medical Center (HUMC). Contact [email protected] to set up a meeting to learn more about how RWD can accelerate clinical research and ultimately reduce the cost of clinical trials.

The two posters will be exhibited in Hall B, Level 2 on Monday, December 9, 2019, 6:00 PM – 8:00 PM and Saturday, December 7, 2019, 5:30 PM-7:30 PM.

Alector to Host R&D Day on December 13, 2019

On December 4, 2019 Alector, Inc. (Nasdaq: ALEC), a clinical stage biotechnology company pioneering immuno-neurology, reported that it will host an R&D Day for analysts and investors on Friday, December 13, 2019 at 8:00 a.m. ET in New York City (Press release, Alector, DEC 4, 2019, View Source [SID1234551914]).

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The event agenda will include a discussion of the Company’s therapeutic approach to neurodegeneration and Alector’s pipeline of novel, genetically validated therapeutics including: Phase 1b data for AL001 for frontotemporal dementia; Phase 1 data for AL002 for Alzheimer’s disease; a Phase 1 study update on AL003 for Alzheimer’s disease; and, an introduction to a new product candidate from the Company’s discovery platform, AL014.

The program will also feature presentations from leading key opinion leaders focused on the human genetics of neurodegeneration, including:

Mario Masellis, MSc (Pharm), M.D., Ph.D., FRCPC
Assistant Professor, Department of Medicine, Institute of Medical Sciences
Co-director, Cognitive Neurology Research Unit, Sunnybrook Health Sciences Centre
Elizabeth M. Bradshaw, Ph.D.
Adler Assistant Professor of Neurology, the Taub Institute for Research on Alzheimer’s Disease and the Aging Brain and the Institute for Genomic Medicine, Colombia University
Carlos Cruchaga, Ph.D.
Professor of Psychiatry and Neurology, Director of NeuroGenomics and Informatics Washington University in St. Louis
A live webcast of the event will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 90 days following the event. For further information, please contact [email protected]

Personal Genome Diagnostics Receives Investigational Device Exemption Approval from the FDA to Support Merck’s Precision Oncology Trial

On December 4, 2019 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported that it received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for the use of the company’s elio tissue complete assay in a Merck trial of pembrolizumab-based combination therapy (Press release, Personal Genome Diagnostics, DEC 4, 2019, View Source [SID1234551931]). The PGDx elio assay will be used during the trial to analyze genomic markers to direct patient enrollment and stratification.

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"We’re pleased with the FDA’s decision to approve PGDx’s elio tissue complete assay for this trial, as it validates the robustness of the test and reinforces the role of diagnostic biomarkers in investigating treatment strategies for patients living with cancer," said Doug Ward, Chief Executive Officer at PGDx. "Further, Merck’s selection of this assay for use in their trials underscores its value and performance in ongoing oncology research."

The PGDx elio tissue complete panel is a 500+ gene test for somatic alterations that detects single nucleotide variants (SNVs), small insertion/deletions, amplifications, rearrangements, microsatellite instability (MSI) and tumor mutation burden. PGDx provides genomic solutions from biomarker discovery to companion diagnostic development through its CAP/CLIA certified laboratory and is developing a portfolio of regulated tissue-based and liquid biopsy genomic products to enable local next-generation sequencing (NGS) testing in laboratories worldwide.