On November 4, 2019 Sentinel oncology Limited reported an expansion of it’s collaboration with PhoreMost Limited to accelerate the development of SOL686, a novel allosteric Polo-like kinase 1 (Plk1) inhibitor (Press release, Sentinel Oncology, NOV 4, 2019, View Source [SID1234550397]). The programme adds to Sentinel Oncology’s NeuroOncology pipeline, has started formal preclinical studies and is positioned to enter clinical development as a glioma treatment by 2021.

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Mitotic PLKs are widely recognised as playing crucial roles in disease causing pathways, including K-Ras mutant cancers. Traditional approaches to drugging PLK enzymes have focused on targeting their active site; however this tactic has been hindered by toxicity-associated adverse events. Sentinel Oncology’s allosteric PLK1 inhibitor takes the novel approach of targeting the Polo-box domain (PBD) of the PLKs, thereby aiming to mitigate adverse events seen by active site inhibitors.

The programme has demonstrated a promising combination of specific drug-like properties, mode of action and target validation data obtained so far. The programme, which originated from the laboratory of Prof Ashok Venkitaraman at the University of Cambridge, has been optimised by both PhoreMost and Sentinel Oncology to the point where SOL686 was recently identified as a candidate drug for the treatment of glioma. Both PhoreMost and Sentinel Oncology received funding from Innovate UK for the drug discovery programme.

On November 4, 2019 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and precision medicine, reported financial results for its fiscal first-quarter 2020, provided an update on recent business highlights and provided revised fiscal year and second-quarter 2020 financial guidance (Press release, Myriad Genetics, NOV 4, 2019, View Source [SID1234550239]).

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"We had a challenging start to fiscal year 2020 as hereditary cancer revenue accrual from small payers was impacted by the deletion of the historical hereditary cancer CPT codes. We had assumed this administrative change would have a minor impact to cash collections, but unfortunately, that has not proven to be the case. While the hereditary cancer business has returned to strong double-digit volume growth, the revenue accrual impact from these changes have led us to lower our financial outlook for the year," said Mark C. Capone, president and CEO, Myriad Genetics. "Despite this setback, we expect earnings to be significantly higher in the second half of the fiscal year and believe that a number of important upsides will materialize during the fiscal year generating momentum as we transition into fiscal year 2021."

Recent Business Highlights

Hereditary Cancer

In the fiscal first-quarter, Myriad made approximately an $11 million reserve adjustment for hereditary cancer revenue due to lower cash collections from small payers as a result of the deletion of the current procedural terminology (CPT) codes 81211 and 81213. As a result, the company has revised its revenue accrual rate, and is forecasting lower hereditary cancer rates for fiscal year 2020. Myriad will provide a detailed summary of the changes on its fiscal first-quarter 2020 earnings call.

Hereditary cancer volumes grew at a double-digit growth rate on a year-over-year basis for both the company’s oncology and women’s health business units.

GeneSight

Announced coverage decision from UnitedHealthcare, the largest commercial payer in the United States, covering GeneSight for patients that have a diagnosis of major depressive disorder or anxiety and have failed at least one prior medication.

Signed master service agreement with a large pharmacy benefit manager in the United States to offer GeneSight to its commercial payer and self-funded employer customers. A Fortune 50 company has already opted into the master service agreement.

Published the precision medicine analysis of the GUIDED study in the Journal of Clinical Psychiatry. The study evaluated 787 patients at baseline who were on medications with known gene drug interactions. The analysis showed that patients who had their treatment guided by GeneSight saw a 70 percent improvement in remission, 42 percent improvement in response, and a 23 percent improvement in symptoms, all of which were statistically significant.

Prenatal

Received acceptance for publication for new data in Prenatal Diagnosis demonstrating that Prequel is the only non-invasive prenatal screening (NIPS) test that outperforms traditional measures of aneuploidy detection across all classes of obesity. Other NIPS testing methodologies can have failure rates up to 24 percent in obese patients leading the American College of Gynecology to recommend against using NIPS in patients with significant obesity.

Prolaris

blished a clinical outcomes study in Personalized Medicine that demonstrated the Prolaris test can identify men with low-risk prostate cancer who can safely select active surveillance (AS) and defer the need for costly treatments such as radiation therapy or surgery. In the study of 664 men with low risk prostate cancer, 82.4 percent selected AS for their initial treatment and only 0.4 percent experienced disease progression. Additionally, the AS decision was durable with 91.2 percent of men remaining on AS at year one and 65.2 percent at year four.

Companion Diagnostics

Filed a supplementary Premarket Approval Application with the U.S. Food and Drug Administration (FDA) to authorize BRACAnalysis CDx as a companion diagnostic test for olaparib in metastatic, castrate-resistant, prostate cancer patients with germline BRCA mutations.

Received the first FDA approval for myChoice CDx as a companion diagnostic to identify women with ovarian cancer who are candidates for Zejula monotherapy in the late-line setting.

Submitted our myChoice CDx test for approval by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in ovarian cancer.

Fiscal Year 2020 and Fiscal Second-Quarter 2020 Financial Guidance

Below is a table summarizing Myriad’s fiscal year 2020 and fiscal second-quarter 2020 financial guidance:

Revenue

Myriad’s fiscal year 2020 and second-quarter 2020 adjusted earnings per share guidance excludes the impact of stock based compensation expense, non-cash amortization associated with acquisitions and certain non-recurring expenses. These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The company will provide further details on its business outlook during the conference call today and discuss the fiscal first-quarter financial results and fiscal year 2020 financial guidance.

Conference Call and Webcast

A conference call will be held today, Monday, November 4, 2019, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal first-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-945-0427. International callers may dial 1-212-231-2918. All callers will be asked to reference reservation number 21931991. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.

On November 4, 2019 Paragon Genomics, Inc., a leader in amplicon-based target enrichment solutions for next-generation sequencing (NGS), reported the upcoming introduction of two new products at the 2019 Association for Molecular Pathology (AMP) Annual Meeting & Expo—a CleanPlex CFTR Panel for cystic fibrosis and CleanPlex Fusion Detection Methods for the diagnostic and prognostic assessment of cancer tumor progression (Press release, Paragon Genomics, NOV 4, 2019, View Source [SID1234550256]).

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The CFTR Panel leverages Paragon Genomics’ CleanPlex technology in a multiplex PCR-based targeted resequencing assay designed to simplify the evaluation of somatic and germline variants across the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene. Mutations in this gene cause the devastating disease cystic fibrosis, and more than 1700 mutations have been identified to date. Different mutations affect functioning of the CFTR gene in different ways, so a comprehensive assessment is essential for determining optimal treatment. The CleanPlex CFTR Panel covers all exons of the CFTR gene and includes the important American College of Medical Genetics (ACMG)-recommended mutations, in a rapid and easy-to-use format.

Paragon Genomics also announced early access to its CleanPlex Fusion Detection Methods for known and novel gene fusions. At present, scientists have identified more than 21,000 gene fusions in almost all main subtypes of human cancers. Fusion genes, which often are oncogenes, contribute to tumor formation. The identification of fusion genes can serve as diagnostic and prognostic markers of tumor progression. The CleanPlex Fusion Detection Methods are built upon Paragon Genomics’ key ultra-high multiplex PCR and PCR background cleaning technologies, enabling the detection of fusion genes with or without known breakpoints in a rapid and easy-to-use format. Early access to the first panel, a Lung Cancer Fusion Panel, is now open, and the company will start to provide additional panel products along with a custom fusion assay design service towards the end of this year.

Paragon Genomics is sponsoring a Corporate Workshop at AMP 2019, Precision Medicine Powered by a Rapid, Flexible, and Scalable Target Enrichment Technology, on November 6 from 12:00-12:50 pm in Room 318-320 at the Baltimore Convention Center. Presentations by internal and external scientists will include discussions of the ultra-high multiplexed, rapid CleanPlex TMB panel; a CleanPlex custom 180-gene pharmacogenomics NGS panel; and CleanPlex-powered targeted sequencing of single circulating tumor cells for liquid biopsy applications retrieved using the RareCyte platform. Click here to register.

Paragon Genomics researchers are presenting a poster1 at AMP 2019 demonstrating the utility of its CleanPlex TMB Panel, an ultra-high multiplexed amplicon based NGS target enrichment approach for accurate, rapid and comprehensive TMB profiling, covering all the exons of 500 genes in a robust assay. Additionally, Paragon Genomics’ collaborator, RareCyte, is presenting a poster2 showing how the CleanPlex technology facilitates targeted sequencing of single circulating cancer cells retrieved using the RareCyte platform for liquid biopsy applications.

Tao Chen, CEO of Paragon Genomics, commented, "It’s gratifying to participate in a major industry event like AMP 2019 with important new products for our growing customer base. Our CleanPlex technology has the potential to make NGS-based genomic analyses across a wide variety of applications faster, easier, more accurate, more economical and more feasible. We look forward to sharing our latest advances with customers and colleagues in the coming days."

Paragon Genomics’ CleanPlex is a proprietary, ultra-high multiplexed NGS target enrichment technology featuring an innovative PCR background cleaning chemistry that allows tens of thousands of amplicons to be multiplexed in a single reaction pool, allowing a large number of targets to be interrogated in a single assay. The CleanPlex technology is available as ready-to-use panels or as customized assays designed and optimized using the company’s advanced panel design algorithm. For more information, contact [email protected].

1 – AMP Poster Program #ST061: Assessment of Tumor Mutational Burden Using a Rapid, Amplicon-Based NGS Target Enrichment Strategy for Accurate and Comprehensive Tumor Profiling, Exhibit Hall, Nov. 9, 2019, Session: Solid Tumors, 9:45–10:45 am.

2 – AMP Poster Program #1009: Amplicon-based Targeted Sequencing of Single Circulating Tumor Cell, Exhibit Hall, Nov. 9, 2019, Session: Informatics, 9:45–10:45 am. Presented by RareCyte, Inc.

Paragon Genomics’ CleanPlex products are for Research Use Only.

On November 4, 2019 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that engineers next-generation human enzymes to provide solutions for diseases with unmet medical need, reported two additions to its senior management team (Press release, Aeglea BioTherapeutics, NOV 4, 2019, View Source [SID1234550273]). The Company welcomes Dr. Ravi M. Rao as chief medical officer and Michael C. Hanley as chief commercial officer.

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"These appointments add important drug-development and commercial expertise to our leadership team as we advance our lead investigational therapy of pegzilarginase for patients with Arginase 1 Deficiency through a pivotal Phase 3 trial, and move two rare-disease pipeline programs into clinical studies," said Anthony G. Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. "Ravi brings extensive experience from GlaxoSmithKline and Roche, and has led programs across specialties in all stages of development, registration and launch. Mike is an accomplished life sciences commercial executive with diverse rare disease experience, having a track record of balancing a strategic long-term view with short-term performance and execution."

Dr. Rao joins Aeglea from GlaxoSmithKline (GSK) where he served as Vice President, Global Medical Affairs Head, Immunology and Specialty Franchise, leading programs across a number of emerging disease areas, previously serving as the Head Unit Physician and a Medicine Development Leader in immune-inflammation R&D. Prior to GSK, he served as Group Medical Director, Product Development Immunology and Clinical Development Site Head at Roche, where he played an important role in leading activities for the global clinical development and subsequent approvals of a number of the company’s key late-phase programs. Ravi was an academic physician-scientist at Imperial College (London) and is a Member of the Royal College of Physicians, London. He received his MB. BChir from Cambridge University and his Ph.D. in vascular biology from Imperial College, completing a postdoctoral fellowship at Harvard Medical School.

Mr. Hanley was previously Vice President and U.S. Chief Commercial Officer for Esteve Pharmaceuticals. He also previously served as Group Vice President, Marketing, Americas and Asia Pacific, Orphan Business Unit for Horizon Therapeutics with P&L responsibility for the company’s rare disease portfolio. In all, Mr. Hanley has 20 years of commercial leadership experience in the life sciences industry. Mr. Hanley holds a B.B.A. in Marketing from the University of Notre Dame and an MBA in Management and Strategy, Marketing from Northwestern University Kellogg School of Management.

On November 4, 2019 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY), reported that the company is scheduled to attend and present at upcoming conferences in November (Press release, Vivoryon Therapeutics, NOV 4, 2019, View Source [SID1234550200]).

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(1) BIO Europe

November 11-13, 2019; Hamburg Messe, Hamburg, Germany

Dr. Ulrich Dauer, CEO, and Dr. Michael Schaeffer, CBO, to host meetings
Dr. Dauer to present on Monday, November 11, 2019; at 3:30pm CET, in Hall B1, Room 6 on Level 1

(2) Deutsches Eigenkapitalforum

November 25-27, 2019; Sheraton Frankfurt Airport Hotel & Conference Center, Frankfurt, Germany

Dr. Ulrich Dauer, CEO, to host meetings and present on Monday November 25, 2019; at 3:00pm CET in Room Oslo