On April 19, 2018 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that financial results for the first quarter ended March 31, 2018 (Press release, Quest Diagnostics, APR 19, 2018, View Source [SID1234525534]).

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"We delivered strong revenue and earnings growth in the first quarter," said Steve Rusckowski, Chairman, President and CEO. "We grew revenue 3.7 percent despite severe winter weather and the impact of lower Medicare reimbursement under PAMA. Earnings growth was driven by our continued strong execution as well as the benefits of tax reform. Our two-point strategy of accelerating growth and driving operational excellence continues to produce results."

As used in this press release the term "reported" refers to measures under the accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP measures as follows: (i) for the purpose of income measures the term "adjusted" refers to operating performance measures that exclude special items such as restructuring and integration charges, excess tax benefit ("ETB") associated with stock based compensation and other items; and (ii) the term "adjusted diluted EPS excluding amortization" represents the company’s diluted EPS before the impact of special items (described above) and amortization expense.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed in listen-only mode by dialing 773-756-0467, passcode 3214469. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 800-846-1910 for domestic callers or 402-280-9953 for international callers. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on April 19, 2018 until midnight Eastern Time on May 3, 2018. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On April 19, 2018 Personal Genome Diagnostics Inc. (PGDx) reported that its wholeexome analysis platform contributed to an important new study published in the New England Journal of Medicine (NEJM) showing promising efficacy for a leading checkpoint inhibitor in early stage lung cancer (Press release, Personal Genome Diagnostics, APR 19, 2018, View Source [SID1234525533]).1 The study also showed that patients who had higher tumor mutation burden (TMB) according to the PGDx analysis had better responses to the checkpoint inhibitor than those with lower tumor mutation loads. The study was conducted by cancer researchers from Johns Hopkins University, including PGDx co-founder Victor Velculescu, MD, PhD, and the Memorial Sloan Kettering Cancer Center (MSK). Earlier this year, PGDx announced an agreement with MSK for developing, registering and commercializing products and services that include tumor mutation burden biomarker status.

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The NEJM study reported that non-small cell lung cancer (NSCLC) patients who received the anti-PD-1 agent nivolumab before undergoing surgery for their cancer experienced fewer relapses than patients who did not.
The nivolumab-treated patients also showed signs of anti-tumor immunity stimulated by the immuno-oncology
therapy. Importantly, the study showed a direct correlation between TMB and checkpoint inhibitor response– patients with higher mutation burden scores as measured by the PGDx platform had a better response to
nivolumab—the more tumor mutations, the better the response. TMB scores were even better predictors of
response to nivolumab than measurements of PD-1 itself.

John Simmons, PhD, Director of Translational Science at PGDx, commented, "We are proud that our pioneering
work in whole exome analysis has made our platform a standard for many in the field of oncology. The analysis
generated using the PGDx exome platform (shown in Figure 3 in the NEJM study) shows a striking correlation
between tumor mutation load and response to immune checkpoint blockade. We believe that the high-quality
mutation detection approach developed at PGDx, including our proprietary VariantDxTM bioinformatics pipeline,
contributed to the strength of the results."

Dr. Simmons added, "This study also highlights the clinical relevance of TMB, even in early stage disease prior
to therapy. Whole exome analysis has been the ‘gold standard’ driving the field’s understanding of how mutation
load affects clinical response to checkpoint blockade, but it isn’t currently practical for routine clinical use. Our
ongoing initiative to translate our expertise and research applications into standardized IVD testing products for
measuring TMB and other cancer biomarkers is intended to ensure wide accessibility and use of these tools by
drug developers and physicians."

"This study is an excellent example of how the advanced scientific work of our distinguished founders gives us
the opportunity to contribute to groundbreaking cancer research while reinforcing our credibility with our industry
partners," said Doug Ward, CEO of Personal Genome Diagnostics. "Our leading VariantDx bioinformatics
analysis pipeline that informed this study and fuels our PGDx assays has allowed PGDx to be a leader in
immuno-oncology testing. We look forward to working with our growing network of partners to deliver accurate,
accessible diagnostic tests that indicate the most effective therapies for patients–an essential part of the
genomic revolution that is transforming cancer treatment."

PGDx has expertise in cancer genome analysis ranging from sample preparation and sequencing to data
interpretation and analysis. The company uses next-generation sequencing (NGS) and its proprietary algorithms
to identify alterations in complex cancer genomics and has developed novel technologies for non-invasive
approaches to cancer diagnostics. PGDx is also developing and will commercialize a portfolio of clinically
validated, regulated tissue and liquid biopsy cancer tests, enabling worldwide access to standardized NGS
testing.
1 – Neoadjuvant PD-1 Blockade in Resectable Lung Cancer, P.M. Forde, J.E. Chaft, K.N. Smith, V. Anagnostou, T.R.
Cottrell, M.D. Hellmann, M. Zahurak, S.C. Yang, D.R. Jones, S. Broderick, R.J. Battafarano, M.J. Velez, N. Rekhtman, Z.
Olah, J. Naidoo, K.A. Marrone, F. Verde, H. Guo, J. Zhang, J.X. Caushi, H.Y. Chan, J.-W. Sidhom, R.B. Scharpf, J. White, E.
Gabrielson, H. Wang, G.L. Rosner, V. Rusch, J.D. Wolchok, T. Merghoub, J.M. Taube, V.E. Velculescu, S.L. Topalian, J.R.
Brahmer, and D.M. Pardoll, New England Journal of Medicine, April 16, 2018

On April 19, 2018 Emergent BioSolutions Inc. (NYSE:EBS) reported that it will host a conference call on Thursday, May 3, 2018 at 5:00 pm (Eastern Time) to discuss the financial results for the first quarter of 2018, recent business developments, revenue guidance for the second quarter of 2018, and revenue and net income guidance for full year 2018 (Press release, Emergent BioSolutions, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343377 [SID1234525532]).

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This conference call can be accessed live by telephone or by webcast:

Live Teleconference Information:
Dial in number: (855) 766-6521
International dial in: (262) 912-6157
Conference ID: 93329114

Live Webcast Information:
Visit View Source for the live webcast feed.

A replay of the call can be accessed on Emergent’s website emergentbiosolutions.com under "Investors."

On April 19, 2018 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported that John A. Orwin, formerly CEO of Relypsa, has been appointed President and Chief Executive Officer of Atreca (Press release, Atreca, APR 19, 2018, View Source [SID1234525531]). He will also serve on the Company’s Board of Directors. Mr. Orwin replaces Atreca co-founder Dr. Tito A. Serafini in this role. Dr. Serafini will assume the newly created position of Chief Strategy Officer, responsible directly for research, preclinical development, technology, and intellectual property. Dr. Serafini also will remain on Atreca’s Board of Directors.

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"John Orwin is a seasoned leader with a very strong track record in scaling up clinical-stage companies. He brings core capabilities that will complement Tito’s vision and his ability to drive Atreca’s innovative science and the development and application of its broadly enabling technology platform," stated Brian Atwood, Atreca’s Chairman, and Founder and former President and CEO of Cell Design Labs. "We believe their combined talents and expertise will be highly synergistic, further differentiating the Company from others in the space and accelerating Atreca’s progress."

Mr. Atwood continued, "During Tito’s tenure leading Atreca, the Company went from early concept through the buildout of its Immune Repertoire Capture (IRC) technology, the creation of a discovery engine generating multiple scientific discoveries and a large collection of preclinical assets, and the rapid advancement of a lead candidate, with an anticipated IND filing in mid-2019. We are proud of the corporate culture of excellence Tito established, attracting a fantastic team and leading life sciences institutional investors, and for the considerable accomplishments achieved under his leadership."

"I am enthusiastically committed to Atreca, a company that I believe can both continue to transform the way new therapies are discovered and ultimately deliver life-changing treatment options to patients in need," said Dr. Serafini. "John’s joining the Company as CEO will have a profoundly positive impact on Atreca, given his successful track record scaling R&D companies, building out their clinical development organizations, manufacturing capabilities, and commercial and G&A functions. This is a very exciting time for Atreca, and I am thrilled with the Company’s prospects for continued and accelerated growth."

Mr. Orwin brings over 25 years of diverse experience in the biotechnology and pharmaceutical industries, having held senior positions at leading pharmaceutical and biotechnology companies, including Johnson & Johnson, Affymax, Rhône-Poulenc Rorer, Genentech, and most recently Relypsa. During Mr. Orwin’s tenure at Relypsa, the company launched and commercialized its lead candidate, Patiromer (US brand name Veltassa), and was acquired by Galenica (Vifor Pharma) in a transaction worth over $1.5 billion. Prior to Relypsa, he served as Chief Executive Officer and a member of the Board of Directors of Affymax. Previously, Mr. Orwin was Senior Vice President of the BioOncology Business Unit at Genentech (now a member of the Roche Group), where he was responsible for all marketing, sales, business unit operations and pipeline brand management for Genentech’s oncology portfolio in the United States. He has also held senior marketing and sales positions at Johnson & Johnson, Alza Pharmaceuticals, Sangstat Medical Corporation, Rhône-Poulenc Rorer Pharmaceuticals and Schering-Plough Corporation. Mr. Orwin received an M.B.A. from New York University and a B.A. from Rutgers University.

"Under the collective vision of Tito and his team, Atreca has become the first mover in discovering and advancing candidates based on its unique approach of understanding the active adaptive immune response at the single cell level in patients," commented Mr. Orwin. "The Company has differentiated itself through its foundational technology, its discovery engine, its strategy for advancing candidates, and in terms of productivity, having generated a library of nearly 1,000 antibodies targeting public tumor antigens. I look forward to contributing to the next chapters of the Company’s evolution, including preparations to bring the first candidates into clinical development in 2019 and 2020."

On April 19, 2018 Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has received Orphan Drug Designation from the U.S. FDA for Oraxol for the treatment of angiosarcoma (Press release, Athenex, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343439 [SID1234525530]). Oraxol, an innovative development in the treatment of cancer, is a novel oral formulation of paclitaxel, a very effective and commonly used chemotherapy treatment for many cancers, combined with HM30181A (a novel orally non-absorbable gastrointestinal tract P-glycoprotein pump inhibitor).

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Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "We are pleased to receive Orphan Drug Designation for Oraxol for the treatment of angiosarcoma, a form of malignant blood vessel cancer. This designation represents our commitment to expand the use of Oraxol, in which the active pharmaceutical ingredient is paclitaxel, to additional clinical indications based on the known efficacy of paclitaxel and the observed improved pharmacokinetic profile of Oraxol. This is a parallel development with our clinical studies in metastatic breast cancer and gastric cancer, in which Oraxol has already shown promising efficacy and safety profile. We will be initiating the angiosarcoma clinical study soon."

The FDA grants Orphan Drug status to support development of medicines for the treatment of diseases that that affect fewer than 200,000 people in the United States. Orphan Drug Designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

Athenex previously announced that it had met its enrollment target for the second interim analysis for the Oraxol Phase III clinical trial for metastatic breast cancer and is scheduled to conduct this interim analysis in the third quarter of 2018. Additionally, the Company announced the receipt of the Promising Innovative Medicine designation for Oraxol by the United Kingdom Medicines and Healthcare products Regulatory Agency on December 27, 2017, qualifying Athenex to apply for Step II of the Early Access to Medicines Scheme to provide patients early access to Oraxol prior to receiving marketing authorization. Athenex also recently announced that the Chinese FDA has allowed the Investigational New Drug application for Oraxol on January 8, 2018. Athenex also announced initial results of a clinical study in Taiwan in patients with metastatic breast cancer, as well as results of the first cohort of patients in a study in Taiwan on the combination with ramucirumab (Cyramza, Eli Lilly’s monoclonal antibody against VEGFR2) in patients with gastric cancer.

Oraxol was initially discovered by Hanmi Pharmaceuticals and licensed to Athenex, in territories including North and Latin Americas, Europe, Japan, greater China and Southeast Asia, Australia and New Zealand. Athenex is leading the registration effort from IND and clinical studies.