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.

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]

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.

On December 4, 2019 The International Myeloma Foundation (IMF) reported that four important research studies supported by the organization’s Black Swan Research Initiative (BSRI) to find a cure for multiple myeloma will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in Orlando, Dec. 7 – 10 (Press release, Myeloma UK‎, DEC 4, 2019, View Source [SID1234551950]). Approximately 32,000 new cases of multiple myeloma—a cancer of the bone marrow plasma cells—are diagnosed annually in the U.S. The disease is currently incurable, but thanks to tremendous advances in treatment, is highly treatable.

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Find the IMF at Booth 2006 at the American Society Hematology annual conference from Dec. 7–9, 2019, in Orlando.
Find the IMF at Booth 2006 at the American Society Hematology annual conference from Dec. 7–9, 2019, in Orlando.
The IMF activities at ASH (Free ASH Whitepaper) 2019 highlight the strength of each of the organization’s four pillars: myeloma research, patient education, patient support and patient advocacy:

RESEARCH

"The four BSRI-supported studies presented at ASH (Free ASH Whitepaper) this year underscore the critical importance of early diagnosis to treat and possibly ultimately cure the disease," said IMF Chairman Brian G.M. Durie, MD.

New results from the IMF-supported CESAR trial: The goal of CESAR, which treats high-risk smoldering myeloma with carfilzomib + lenalidomide + dexamethasone + autologous stem-cell transplant, is to identify patients who will have sustained minimal residual disease (MRD) negativity five years and beyond (and are potentially cured) versus those who might relapse. The ASH (Free ASH Whitepaper) 2019 update of the overall results shows that 98% of patients are alive at more than 30 months, with 93% in remission and 56% MRD-negative at the 10-6 level. The other CESAR trial presentation reports the results of mass spectrometry (Qip) of serum samples. Here, 18 MRD-negative patients were found to be positive using Qip to detect low levels of myeloma protein.
Two IMF-supported studies from the University of Pamplona: One study is of the types of T cells found in the bone marrow and blood of myeloma patients. It shows that T cells that react against myeloma cells have a pattern that is negative for the antigen CD27. These T cells build up in patients responding to treatment. The other Pamplona study is the first to report that mutations found in early ("progenitor") cells in the bone marrow are CD34 positive. This study suggests that damaged B cells in the bone marrow could be a source of myeloma cells. This insight that will play a role in efforts to develop curative therapies.
Black Swan Research Investigators Meeting, Dec. 5: Investigators will report updates on more than a dozen IMF-supported research projects currently in progress around the world focused on a cure.
i2TEAMM Meeting, Dec. 5: Co-led by IMF Chairman Brian G.M. Durie, MD, this group of researchers is working to validate MRD testing as a surrogate endpoint superior to traditional endpoints, such as CR (complete remission) or even sCR (stringent complete response) in myeloma clinical trials.
International Myeloma Working Group (IMWG) Breakfast Meeting, Dec. 7: The 200-plus members of the IMWG, the IMF’s research division, collaborate on a broad range of myeloma research projects. At ASH (Free ASH Whitepaper), members will preview the top ASH (Free ASH Whitepaper) 2019 abstracts and review ongoing and new IMWG research projects.
Brian D. Novis Research Award Reception, Dec. 7: Funded through donations from private individuals, the IMF’s annual research grants—named for the organization’s co-founder—enable investigators to become established in the field of myeloma. IMF-funded research has led to many publications in peer-reviewed journals and to a greater understanding of myeloma. Grant awardees will be joined by myeloma patients, many of whom help raise research funding.
EDUCATION

"Approaches to Achieve the Best Possible Outcomes in Myeloma," Dec. 6: This popular IMF-sponsored satellite symposium at ASH (Free ASH Whitepaper) attracts an overflow crowd each year. Moderated by Dr. Brian G.M. Durie, it features panelists Shaji Kumar, MD; Philippe Moreau, MD; S. Vincent Rajkumar, MD; Jesús F. San Miguel, MD, PhD; and Thomas G. Martin, MD.
"Making Sense of Treatment," the International Myeloma Working Group (IMWG) Livestream Conference Series, Dec. 9, 8:30 – 9:30 pm ET: Leading myeloma experts Dr. Brian G.M. Durie, Dr. Joseph Mikhael (IMF Chief Medical Officer) and Dr. María-Victoria Mateos will tackle questions facing myeloma doctors and patients in light of study results presented at ASH (Free ASH Whitepaper). Available online, both live and archived.
IMF-TV: Top myeloma experts and investigators at ASH (Free ASH Whitepaper) will share their opinions and summarize the most significant research findings in a series of brief videos, posted daily from Orlando.
"Best of ASH (Free ASH Whitepaper) 2019: What Patients and Caregivers Need to Know," Jan. 9, 7:00 pm ET: This IMF teleconference summarizes research findings for myeloma patients and caregivers.
PATIENT SUPPORT

IMF@ASH Social Media Team: The IMF brings more than a dozen myeloma patient and caregiver representatives to ASH (Free ASH Whitepaper), where they report to the community from a patient’s perspective. The IMF’s dynamic social media team consistently ranks in the "Top 10 Most Influential" list of ASH (Free ASH Whitepaper) attendees on Twitter. Follow @IMFmyeloma reporting with the hashtags #ASH19 and #IMFASH19. Blogs posted at www.ash2019blogs.myeloma.org.
PATIENT ADVOCACY

Global Myeloma Action Network (GMAN) Breakfast, Dec. 6: GMAN is a patient advocacy umbrella group that convenes international members and partners to share best practices, address mutual areas of concern, and elevate myeloma awareness.

On December 4, 2019 BioHybrid Solutions, LLC (BHS), a Pittsburgh-based protein engineering company, reported that it was awarded a contract worth up to $30 million from the United States Department of Defense to develop a next-generation prophylactic medical countermeasure (Press release, Myris Therapeutics, DEC 4, 2019, View Source [SID1234650500]). The project was sponsored by the U.S. Government through the Medical CBRN Defense Consortium (MCDC).

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The U.S. Defense Threat Reduction Agency (DTRA) selected BHS through a request for prototype proposal under the MCDC to apply its proprietary NanoArmored protein engineering technology to improve pharmacokinetics of the prophylactic while reducing the potential for immunogenic side effects. Over the five-year program, BHS will develop NanoArmored drug candidates, conduct studies to demonstrate functionality, scale manufacturing, and complete regulatory activities towards approval of the countermeasure by the U.S. Food and Drug Administration (FDA). BHS is leading the program in collaboration with FLIR Systems, Battelle, Ology Bioservices, the Allegheny Health Network, BTG PLC (now part of Boston Scientific) and the US Army.

"We have developed a unique way to protect against the toxic effects of chemical warfare agents and are honored to have been selected by DTRA to lead this very important program," said Alan Russell, Co-Founder and CEO of BioHybrid Solutions.

In order to expedite development, BHS will utilize its specialized high-throughput discovery technology to rapidly select the NanoArmor needed and then manufacture that drug candidate. "Our technology allows us to rationally tune protein performance through precision modification of proteins with a wide variety of synthetic polymers," noted Krzysztof Matyjaszewski, BHS Co-Founder and CSO. "To date, we have created thousands of different NanoArmored proteins for a variety of industrial and therapeutic indications. We are well positioned to apply our technology to this important national security and public health application."