On November 8, 2019 Biodesix, Inc. reported that it has been named Company of the Year by the Colorado BioScience Association (CBSA) (Press release, Biodesix, NOV 8, 2019, View Source [SID1234550828]). The company was honored at the 16th Annual CBSA Awards Dinner on November 7, 2019. The CBSA serves as the hub for Colorado’s life science industry with member organizations spanning biotechnology, pharmaceutical, medical device, diagnostic, ag bio, mobile digital health, research, academic, and service providers. Biodesix was selected as Company of the Year in recognition of the significant milestones the company reached in advancing patient access to novel diagnostic testing in the clinic, and in ongoing development of new tests that address areas of high unmet clinical needs across the continuum of care in lung cancer. Lung cancer is still the leading cause of cancer death among men and women. In 2018, approximately 234,000 patients were diagnosed and 154,000 died due to lung cancer, which represents over 25 percent of all cancer deaths in the United States.

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"CBSA’s Annual Awards Dinner highlighted how health innovations from Colorado make a global impact. We are proud to honor Biodesix for its innovation and bringing top minds together to strengthen the future of healthcare. As the first company to provide four best-in-class diagnostic tests for patients in lung cancer, Biodesix has demonstrated its commitment to helping physicians and their patients navigate lung cancer therapy decisions. The timing of this award is an additional honor, as it is lung cancer awareness month," said Jennifer Jones Paton, President and CEO of CBSA. "CBSA is proud to honor Biodesix for its breakthroughs for patients, leadership in Colorado’s life sciences community and track record of success."

Key milestones for Biodesix in 2019:

Acquisition of Oncimmune in the U.S. to expand minimally invasive diagnostics to patients in North America with the EarlyCDT Lung test for lung nodule management, adding a 4th blood-based test to the portfolio
Expanded reach of Nodify XL2 testing for lung nodule management
Partnership with Thermo Fisher Scientific to develop a next-generation sequencing blood assay
Patenting of the Biodesix Collection Device (BCD) to improve on ease of blood collection, reduce cost and environmental impact
"Our greatest reward is the positive impact we can have on the lives of patients and their loved ones as they navigate lung cancer treatment decisions," said Scott Hutton, COO and incoming CEO for Biodesix.

"There is no higher honor than knowing that we played a part in improving the quality of life for a person facing the dreadful disease of lung cancer," said David Brunel, CEO for Biodesix. "We are proud to be building a Colorado-based bioscience company with 150 employees. We began as a Colorado start-up and this year we celebrated several important milestones. We greatly appreciate the recognition of the Colorado BioScience Association."

In addition to being headquartered in Colorado, Biodesix operates facilities in Boulder and Steamboat Springs, Colorado.

On November 8, 2019 A new study of 443 patients by Exact Sciences Corp. and its collaborators reported demonstrated 80% sensitivity at 90% specificity with a novel combination of six blood-based biomarkers for the most common type of liver cancer, hepatocellular carcinoma (HCC)i (Press release, Exact Sciences, NOV 8, 2019, View Source [SID1234550741]). The study also showed 71% sensitivity for early stage HCC at 90% specificity. The study compared performance to the alpha-fetoprotein (AFP) test, which demonstrated 45% sensitivity at 90% specificity for early stage HCC. Lead author Naga Chalasani, M.D., Associate Dean for Clinical Research at Indiana University School of Medicine and Director, Division of Gastroenterology and Hepatology, will present the findings Sunday, November 10th at the 2019 annual meeting for the American Association for the Study of Liver Diseases (AASLD) in Boston.

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The data are included by AASLD’s Scientific Program Committee in The Best of The Liver Meeting, a distinction that recognizes abstracts for their rigorous scientific methodology and key insights for patient care and ongoing research. Exact Sciences’ HCC test has also been granted Breakthrough Device designation by the U.S. Food and Drug Administration. The agency’s Breakthrough Devices program expedites development, assessment, and review processes to provide patients and health care providers with timely access to new technologies.

Liver cancer is the number four cancer killer globally, and more than 42,000 Americansii and 780,000 people worldwide are diagnosed with the disease each yeariii. HCC alone accounts for approximately 90% of primary liver cancersiv. Clinicians and patients need more accurate, convenient testing options to help combat rising incidence rates, which have more than tripled since 1980i.

Current guidelines recommend at-risk patients undergo testing every six months using ultrasound (US) with or without the AFP blood testv. Combined, US and AFP have demonstrated 63% sensitivity for early stage cancersvi. Nearly half of Medicare patients tested for HCC receive only the AFP testvii, which in Exact Sciences’ Study was less sensitive for HCC detection than US and AFP combined. Three-year survival rates nearly double for patients who undergo regular testing compared to those who do not, yet fewer than one-third of patients adhere to current guidelinesv.

"A growing number of patients around the world are considered high risk for developing HCC," said Kevin Conroy, chairman and CEO of Exact Sciences. "A more sensitive and convenient blood-based test could help catch the disease earlier, which may lead to better outcomes. We are encouraged by the data presented at The Liver Meeting, as it shows an important advancement over the options currently available."

Exact Sciences’ multi-center, case-control study analyzed 443 blood samples, including 135 HCC cases and 308 age- and liver disease etiology-matched controls. The accuracies of both Exact Sciences’ HCC test and the AFP blood test were analyzed for all Barcelona Clinic Liver Cancer (BCLC) stages and for early stage HCC (stages 0 and A). With specificity set at 90%, Exact Sciences’ four methylated DNA markers and two protein markers detected 80% of HCC cases across all stages. The test demonstrated 71% sensitivity for early stage HCC, outperforming the AFP test, which detected 45% of early stage cancers and 62% of cancers across all stages in Exact Sciences’ study.

"There is a significant, worldwide unmet need for a blood-based, early detection diagnostic test for liver cancer in persons with elevated risk for the disease," said Dr. Chalasani. "The DNA methylation based liquid biopsy developed by Exact Sciences is timely and very promising for addressing this unmet demand."

Exact Sciences is finalizing its HCC test development and plans to make the test available in the second half of 2020. This will help generate real-world evidence to support guideline inclusion, broad reimbursement, and adoption of the test over time.

Note to editors: The full abstract (#109) can be found in the October 2019 supplement of Hepatology.

Media Contact:
Cara Connelly, [email protected], 614-302-5622

Investor Contact:
Megan Jones, [email protected], 608-535-8815

On November 8, 2019, Replimune Group, Inc presented the corporate presentation (Presentation, Replimune, NOV 8, 2019, View Source [SID1234550758]).

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On November 8, 2019 BERG, a clinical stage biopharmaceutical company that uses artificial intelligence (AI) to discover the underlying biology of disease, reported results from a study of its investigational drug BPM31510 (ubidecarenone) characterizing its immunomodulatory properties ex vivo and in tumor bearing mice. The study, presented as a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, Md., demonstrates a novel immuno-supportive activity of BPM31510 associated with enhanced T-cell function and diminished T-cell exhaustion which may contribute to its anti-tumor activity and synergize with Immuno-Oncology therapies (Press release, Berg, NOV 8, 2019, View Source [SID1234550774]).

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"Compromised T-cell function has a major impact on the effective anti-cancer response and outcomes observed in I/O therapies," said Dr. Niven R. Narain, BERG Co-founder, President and Chief Executive Officer. "The ability of BPM31510 to influence specific phenotypic attributes in T-cells to improve its effectiveness in the cancer microenvironment by targeting mitochondrial function represents a novel approach to impact immune system to improve cancer outcomes."

Combination of immunotherapies is under active investigation to improve anti-cancer outcomes. Immunometabolism is recognized as an important component of the immune function repertoire, an area with high untapped potential. BPM31510 impact on mitochondrial function and metabolism represents a novel and unique mechanism through its ability to synergize anti-cancer activities of I/O therapies in preclinical models and is under active investigation at BERG.

"These data set the stage to further explore BPM31510 impact on anti-tumor immunity and how to best deploy BPM31510 as part of an immunotherapy cocktail," said Vikas P. Sukhatme MD ScD, Professor of Medicine at Emory University School of Medicine and a Scientific Advisory Board member of BERG.

Details of the presentations include:
Date: Friday, November 8, 2019
BPM31510, a Metabolic Modulating Anti-Cancer Agent, Demonstrates Immune Potentiating Properties by Promoting Cytotoxic T Cells and Reversing Indices of Exhaustion and Immunosuppression
Abstract ID: P633 (Immune-stimulants and immune modulators)
Location: Poster Hall, Prince George AB of the Gaylord National Hotel & Convention Center, National Harbor MD, USA
Time: 7:00 AM – 8:00 PM

BERG collaborates with leading institutions like MD Anderson Cancer Institute (solid tumor and pancreatic trials), Harvard/BIDMC (Project Survival) and Stanford University (GBM trial), among others, in its commitment to serve patients afflicted with cancer.

On November 8, 2019 prismCDX, a highly specialized contract research organization reported the selection and adoption of the UltiMapper platform to broaden its offering of translational biomedical research services (Press release, PrismCDX, NOV 8, 2019, View Source [SID1234550829]). The addition of Ultivue’s highly standardized multiplex tissue marker assays enables the identification of critical cellular phenotypes and tissue marker signatures in support of translational and clinical research programs.

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"The combination of Ultivue’s next generation tissue marker assays with our platforms for genomic and proteomic analysis provides novel biological insights into the characterization of individual tumor microenvironments," commented Dong-Jun Bae, CEO with prismCDX. "Such complete tumor profiling and characterization data support our mission at prismCDX to partner with biopharma organizations developing targeted, precision medicine therapies and associated companion diagnostic tests."

Prior to the launch of those expanded capabilities, prismCDX has received scientific personnel training and certification at both Ultivue’s lab in Cambridge, MA and at its company facilities in Seoul, South Korea.