InterVenn Biosciences Advances Glycoproteomics to Propel Understanding and Find New Therapies in Complex Diseases

On January 13, 2020 InterVenn Biosciences reported multiple achievements in its development of AI-enabled glycoproteomics, as it looks to solving difficult challenges in various disease areas of unmet medical need (Press release, InterVenn Biosciences, JAN 13, 2020, View Source [SID1234553118]). Over the last 12 months, InterVenn has received positive interim results from its first clinical trial (V.O.C.A.L.) evaluating a new, simple blood test for the care of patients with ovarian tumors; secured partnerships with seven leading cancer research organizations, including the University of Iowa and the Parker Institute for Cancer Immunotherapy, to develop novel approaches in immuno-oncology; and made a freemium version of its proprietary, AI-powered mass spectrometry analysis software, OpenPIP, publicly available to the research community. In the coming weeks, InterVenn will complete a move to a new facility in South San Francisco, with research laboratories capable of high throughput sample processing to expand the company’s repertoire of interrogating additional indications, as well as a CLIA-CAP-accredited facility.

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"Until now, glycoproteomics has been considered simply too complex to lend itself to discovering and applying meaningful information to help patients, despite its huge promise that we have been aware of for a long time," said Aldo Carrascoso, Chief Executive Officer of InterVenn Biosciences. "We have made it our absolute priority to interface our technology with a number of key institutional and industry players to deploy and validate our array of AI- and deep machine learning-based tools to allow transitioning the powerful realm of glycoproteomics into an actionable armamentarium for patient care and drug discovery. This will enable us to massively accelerate all of our partners’, collaborators’, and alliances’ workflows."

Over the last 15 years, glycobiology has developed into an increasingly solid scientific discipline, based on the seminal work of Professors Carolyn Bertozzi (Stanford) and Carlito Lebrilla (UC Davis), both of whom helped co-found InterVenn and are serving as members of the company’s Scientific Advisory Board. InterVenn has demonstrated that combining proteomics with glycomics, along with relevant phenotypical annotations and a powerful bioinformatics approach, affords critical advances in biomarker and target discovery not realized with other technologies. InterVenn’s approach to glycoproteomics leverages the power of ultra-high-pressure- liquid-chromatography, coupled-mass-spectrometry for high-resolution, accurate-mass generation of post-translational protein modification data with the prowess of artificial intelligence and machine learning technology to streamline and expedite the processing and analysis of these data. At the same time, InterVenn’s algorithms ensure that the vagaries and variabilities inherent in any clinical study – from patient recruitment bias/variability, sample collection, sample processing, all the way to instrument measurements – are minimized, and the results are reproducible. OpenPIP, the company’s AI-enabled mass spec analysis software, dramatically reduces the time and cost of integrating and quantifying mass spectrometry data while increasing the quality of output and interpretation by eliminating observer-based bias.

InterVenn’s study investigating its leading product, a clinical decision-making tool for ovarian cancer aimed at distinguishing malignant pelvic tumors from benign ones, with neither compromising diagnostic accuracy nor subjecting women to undergoing potentially unnecessary and harmful surgery, is currently actively enrolling patients in a multicenter, international clinical trial (V.O.C.A.L.) in the U.S., Australia, and Southeast Asia, with interim results indicating that the InterVenn test performs significantly better than the currently most widely used ovarian cancer test, CA 125, in terms of both specificity and sensitivity. InterVenn expects to complete enrollment and receive preliminary data from the V.O.C.A.L. trial in late 2020.

In the fall of 2019, InterVenn added Klaus Lindpaintner, M.D., MPH, FACP, FACMG, to the team as Chief Scientific Officer and Chief Medical Officer, a role in which he will lead all of InterVenn’s global scientific operations and clinical affairs. Dr. Lindpaintner is spearheading collaborations with a number of institutional and industry partners with the promise of finding new, actionable diagnostic and therapeutic approaches for a broad spectrum of diseases. Klaus also oversees both InterVenn’s Scientific and Medical Advisory Boards, notable members of which include Giuila Kennedy, Ph.D., Chief Scientific Officer and Chief Medical Officer of Veracyte; and Tony Wyss-Coray, Ph.D., Professor of Neurology & Neurological Sciences at Stanford University School of Medicine, among other luminaries.

"We have known for some time that diseased cells exhibit different protein glycosylation patterns compared to healthy cells, but the scientific community has so far been unable to accurately, and on a real-time scale, quantify and monitor what these changes are, how they occur, and how they specifically relate to disease biology," said Dr. Lindpaintner. "With InterVenn’s technology’s powerful platform of wet- and dry-lab tools, we have reached the inflection point where technological advances meet biological complexity to reveal unprecedentedly powerful insights into pathobiology that have been elusive for so long."

To find out more about InterVenn Biosciences and how the company is leveraging artificial intelligence and mass spectrometry to the transformation of medical technology, visit View Source For all general and media inquiries about InterVenn Biosciences, please contact Andrea Vuturo at [email protected].

Geneoscopy’s Preventive Screening Test for Colorectal Cancer and Precancerous Adenomas Earns FDA Breakthrough Device Designation

On January 13, 2020 Geneoscopy, Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal (GI) health, reported that its preventive screening test for colorectal cancer and precancerous adenomas earned FDA Breakthrough Device Designation (Press release, Geneoscopy, JAN 13, 2020, View Source [SID1234553116]). The agency’s Breakthrough Devices program expedites the development and prioritizes the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions to provide patients and health care providers with timely access to these technologies.

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Geneoscopy’s preliminary data indicate that its screening test could provide a more effective method for early detection of advanced adenomas, thereby facilitating the removal of precancerous lesions that have the highest propensity for malignant transformation. Geneoscopy’s device could significantly reduce morbidity associated with the second deadliest cancer in the United States by detecting advanced adenomas at a higher rate than existing screening tests and preventing the development of colorectal cancer.

"Reduction in morbidity is the best way to reduce mortality associated with colorectal cancer," said Erica Barnell, CSO of Geneoscopy. "We are excited that the FDA has recognized the potential for Geneoscopy’s test to improve the health of the more than 100 million Americans recommended for colorectal cancer screening."

Illumina to Announce Fourth Quarter and Fiscal Year 2019 Financial Results on Wednesday, January 29, 2020

On January 13, 2020 Illumina, Inc. (NASDAQ:ILMN) reported that it will issue results for fourth quarter and fiscal year 2019 following the close of market on Wednesday, January 29, 2020 (Press release, Illumina, JAN 13, 2020, View Source [SID1234553115]).

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On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time) Francis deSouza, President and Chief Executive Officer, and Sam Samad, Senior Vice President and Chief Financial Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Wednesday, January 29, 2020. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597, or 1 (647) 689-6853 outside North America, both with Conference ID 2966099.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

QIAGEN Builds on Global Collaboration With Amgen for Companion Diagnostic Development in Non-small Cell Lung Cancer

On January 13, 2020 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported a strategic collaboration to develop tissue-based companion diagnostics for Amgen’s investigational cancer treatment AMG 510 to identify patients with cancers that have the KRAS G12C mutation (Press release, Qiagen, JAN 13, 2020, View Source [SID1234553114]). The agreement focuses initially on companion diagnostics for non-small cell lung cancer (NSCLC) but allows for further development of the tests for Amgen’s other oncology clinical development programs.

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"We are pleased to support Amgen by building on the success of our therascreen platform to develop a tissue-based companion diagnostic to identify patients who would benefit from AMG510. QIAGEN’s Sample to Insight workflows and experience in developing diagnostic solutions for Precision Medicine are well-suited to help aid in evaluating patients with non-small cell lung cancer," said Thierry Bernard, Interim CEO of QIAGEN and Senior Vice President, Head of the Molecular Diagnostics Business Area. "The success of our long-standing collaboration with Amgen is a demonstration of QIAGEN’s capabilities as a preferred partner of pharmaceutical and biotech companies for the creation of companion diagnostics."

"Amgen is committed to driving broad accessibility to biomarker testing in order to select appropriate patients who will directly benefit from targeted treatments," said David M. Reese, M.D., Executive Vice President of Research and Development at Amgen. "With one in eight patients with NSCLC having KRAS G12C, there’s a critical need to improve access to high quality diagnostics and more routine screening."

The therascreen-based companion diagnostic will screen for KRAS G12C, a genetic mutation that is one of the most common causes of cancer. The RAS gene family, studied for almost 40 years, includes the most frequently mutated oncogenes in human cancers with KRAS being the most prevalent driver mutation in NSCLC.

McKesson to Present at the 38th Annual J.P. Morgan Healthcare Conference: Will Provide Company Overview and Review Updated Financial Outlook

On January 13, 2020 McKesson Corporation (NYSE:MCK) reported that it will present at the 38th Annual J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco tomorrow, January 14, 2020 at 9:00 AM PT (12:00 PM ET). Brian Tyler, chief executive officer of McKesson, will provide a company overview and review topics including (Press release, McKesson, JAN 13, 2020, View Source [SID1234553113]):

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McKesson’s strategic growth initiatives
McKesson’s differentiated specialty portfolio
Company innovation such as the recent launch of AMP: Access for More Patients
Overview of McKesson’s capital allocation approach
Updated Fiscal 2020 Adjusted Earnings per diluted share outlook: the company now anticipates Adjusted Earnings per diluted share of $14.60 to $14.80 for full-year fiscal 2020, an increase from the previous range of $14.00 to $14.60.
"The focus on executing against our strategic growth initiatives and disciplined capital allocation is reflected in our updated outlook for fiscal 2020. Our businesses are well positioned to continue to deliver growth," said Brian Tyler, chief executive officer. "Based on the continued momentum and trends in our business, we have narrowed and raised our Adjusted EPS guidance range for fiscal 2020."

The live audio webcasts for the J.P. Morgan Healthcare conference will be available on McKesson’s Investor Relations website at View Source McKesson will host a conference call at 8:00 AM ET on February 4, 2020 to discuss third quarter fiscal 2020 financial results. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website, along with the company’s earnings press release, financial tables and slide presentation. The conference call can also be accessed by dialing 786-815-8297. The password is ‘McKesson’.

Adjusted Earnings

McKesson separately reports financial results on the basis of Adjusted Earnings. Adjusted Earnings is a non-GAAP financial measure defined as GAAP income/loss from continuing operations, excluding amortization of acquisition-related intangible assets, transaction-related expenses and adjustments, LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring, impairment and related charges, and other adjustments as well as the related income tax effects for each of these items, as applicable.

The company does not provide forward-looking guidance on a GAAP basis prospectively as McKesson is unable to provide a quantitative reconciliation of this forward-looking non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.