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.

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.

On January 13, 2020 Illumina, Inc. (NASDAQ: ILMN), the global leader in DNA sequencing and array-based technologies, and Roche, a global pioneer in pharmaceuticals and diagnostics, reported a 15-year, non-exclusive collaboration agreement to broaden the adoption of distributable next-generation sequencing-based (NGS) testing in oncology (Press release, Illumina, JAN 13, 2020, View Source [SID1234553112]). As the understanding of genomic drivers of cancer evolves, NGS has the potential to transform cancer risk prediction, detection, diagnosis, treatment and monitoring.

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This agreement brings together complementary capabilities of each company to broaden global adoption of NGS in cancer care. As part of this agreement, Illumina will grant Roche rights to develop and distribute in-vitro diagnostic (IVD) tests on Illumina’s NextSeq 550Dx System, as well as on its future portfolio of diagnostic (Dx) sequencing systems, including the forthcoming NovaSeqDx. Roche will in turn collaborate with Illumina to complement Illumina’s comprehensive pan-cancer assay, TruSight Oncology 500 (TSO 500), with new companion diagnostic (CDx) claims. The financial terms of the deal were not disclosed.

Under the IVD terms of the agreement, Roche will develop, manufacture and commercialize AVENIO IVD tests for both tissue and blood for use on Illumina’s NextSeq 550Dx System. Illumina will continue to sell the NextSeq 550Dx Systems and core sequencing consumables. Under the CDx terms of the agreement, Illumina and Roche will develop tests and pursue CDx claims on TSO 500 for both existing and pipeline oncology targeted therapies on the NextSeq 550Dx System. Illumina will lead the development and regulatory approval process, and will continue to manufacture, supply and commercialize TSO 500. Roche will support the development of the claims and regulatory filings.

"We are excited Roche has selected Illumina’s sequencers as their platform of choice to accelerate the adoption and broaden the reach of oncology-based, distributable IVD tests into clinical care," said Francis deSouza, CEO of Illumina. "This partnership complements and strengthens our strategy to establish TSO 500 as a comprehensive NGS panel for cancer therapies by expanding the supported set of CDx claims on this universal panel. Building on the momentum of other recently established diagnostic and pharmaceutical partnerships, together we aim to advance critical access to NGS testing to improve patient outcomes."

Illumina’s TSO 500 is a comprehensive pan-cancer assay designed to identify known and emerging tumor biomarkers. TSO 500 utilizes both DNA and RNA from tumor samples to identify key somatic variants underlying tumor progression, such as small DNA variants, fusions and splice variants. When used to test for companion diagnostics claims, TSO 500 is poised to identify cancer patients globally who might benefit from targeted therapeutics. As the anchor tenant of Illumina’s oncology product portfolio, TSO 500 enables labs to adopt a comprehensive genomic profiling panel, in a decentralized testing model, leveraging the accurate and reproducible results of Illumina’s diagnostic sequencing systems.

On January 13, 2020 Median Technologies (Paris:ALMDT), The Imaging Phenomics Company reported its preliminary full year 2019 unaudited financial results (Press release, MEDIAN Technologies, JAN 13, 2020, View Source [SID1234553111]). These results fully validate the strategy adopted in 2018 .

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In 2019, Median strengthened its Research and Development efforts on the iBiopsy imaging phenomics platform. iBiopsy is based on the most advanced technologies in AI and data sciences. Using non-invasive imaging biomarkers, the platform enables the identification of certain chronic disease signatures including cancer signatures, to dramatically enhance early detection, severity quantification and monitoring of diseases. A prototype of the platform was presented during the Radiological Society of North America (RSNA) annual meeting in early December (Chicago), to showcase the potential of the iBiopsy technology. The prototype demo created a lot of traction and interest. The company’s objective is now to finalize ongoing discussions with partners regarding collaborations to conduct iBiopsy clinical validations on large patient cohorts.

On December 19th, 2019, the company signed a €35 million finance contract with the European Investment Bank (EIB). The financing is going to further accelerate the iBiopsy investment and recruitment program for the coming years. The disbursement of the first tranche of €15 million is expected during the first semester of 2020.

2019 has been a record year for Median’s iCRO business unit, which provides imaging solutions and services for oncology trials. As of December 31st, 2019, the annual revenue was €9 million, a 41% increase compared to 2018 revenue (€6.3 million). The company experienced a steady increase in its quarterly revenues all along 2019.

Median’s iCRO activity was already operationally at its break-event point as of June 30th, 2019. Full year performance demonstrated its capacity for sustainable growth and profitability.

As of December 31st, 2019, the order backlog reached €38.3 million, representing a €7.6 million increase compared to the backlog as of June 30th, 2019 and a €14.6 million increase compared to the backlog as of December 31st, 2018 (+61.6%). At the end of 2019, Chinese business represented 56% of the total order backlog compared to 39.2% at the end of 2018. As far as Europe and the US are concerned, Median largely exceeded all expectations, thanks to a dedicated sales strategy based on recurrent business. Strategy success shows a great deal of trust in Median’s execution, competitiveness and quality. In 2019, Median’s service quality was successfully validated through 12 client audits and one Food and Drug Administration (FDA) audit on a major Phase III study, sponsored by one of the top 3 pharma companies.

Considering the company’s performance, as of December 31st, 2019, the company cash and cash equivalents was €7.6 million, compared to €7.9 million as of June 30th, 2019 and €12.7 million as of December 31st, 2018. The company cash burn rate was €0.4 million per month over the year, dropping from €0.8 million per month over the first semester down to €0.3 million per month during the second semester, excluding the Research Tax Credit positive impact.

"Our excellent iCRO performance validates the strategy adopted in 2018 and we are pleased to see that the activity is now sustainable and profitable. We anticipate keeping up this momentum in 2020. Additionally, the extent of our order backlog makes us confident about our revenues for 2020", said Fredrik Brag, Median’s co-founder and CEO. "With the finance contract signed with EIB, we are now going to accelerate our iBiopsy investment program. 2020 is going to bring us partnerships and clinical data which will enable iBiopsy validations on large cohorts of patients and for different therapeutic indications", he added.

The preliminary results set forth above are based on management’s initial review of the Company’s operations for the year ended December 31, 2019 and are subject to revision based upon the Company’s year-end closing procedures and upon the completion and external audit of the Company’s year-end financial statements. Actual results may differ materially from these preliminary results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that the Company’s financial results are finalized, and such changes could be material. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results for the fourth quarter or full year ended December 31, 2019, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period.

On January 13, 2020 Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, reported that 11 new partner programs entered clinical development in 2019 (Press release, Adimab, JAN 13, 2020, View Source [SID1234553110]). This brings the total number of Adimab partner programs that have entered the clinic to 32. Partners initiating clinical trials in 2019 include Alector, Dragonfly Therapeutics, Hanmi Pharmaceutical, IASO Therapeutics, Innovent Biologics, Inc., Roche, Surface Oncology, and others.

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"This is the second year in a row that we have seen 11 or more new programs enter the clinic and we don’t expect that trend to slow anytime soon. In particular, we have seen younger companies backed by leading venture capital firms show remarkable success in translating new biological insight into clinical programs. On average, these venture-backed partners have advanced two out of every three discovery programs towards the clinic – that’s an incredible success rate compared to the industry at large," said Tillman Gerngross, Chief Executive Officer and Co-Founder of Adimab. "People aren’t very good at pricing failure. We see many antibody discovery shops push their cheap alternatives, but too many of those programs fail for technical or developability reasons."

In 2019, Adimab partners exercised ten commercial licenses to advance programs into product development, bringing the total number of optioned programs to more than 60. Partners exercising commercial options in 2019 include Acceleron, Innovent Biologics, Inc., Scholar Rock, Surface Oncology, and others.

"While the majority of the programs in the clinic came from Adimab’s core antibody discovery platform, there are now several programs in the clinic that came from new applications of Adimab’s technology. Some programs are antibodies that originally came from other technologies that we subsequently engineered to enhance their properties, or simply ‘fixed’ to reduce developability liabilities. We are also seeing a growing number of bispecific and CAR programs entering the clinic, and we expect that trend to continue in the coming years," said Guy Van Meter, Chief Business Officer of Adimab.