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New Studies Demonstrate the Predictive Value of the Vectra Test in People Diagnosed with Rheumatoid Arthritis – GlobeNewswire

November 10th, 2019 5:44 am

Graph 1

Vectra Predicts Risk of Radiographic Progression in 1 Year

Myriad Genetics, Inc.

Graph 2

Vectra Predicts Risk of Cardiovascular Events in Patients with RA

Myriad Genetics, Inc.

SALT LAKE CITY, Nov. 09, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in precision medicine, announced that its Myriad Autoimmune business unit will present new data on the Vectra test at the 2019 ACR/ARP Annual Meeting being held Nov. 8-13, 2019 in Atlanta, GA. The key findings are that the Vectra test predicts the risk of radiographic progression (RP) within one year, and the Vectra score, in combination with other clinical measures, predicts the risk of a cardiovascular (CV) event in people with rheumatoid arthritis (RA).

A hallmark feature ofrheumatoid arthritisisinflammation, which increases the risk of joint damage, cardiovascular disease and other comorbidities, said Elena Hitraya, M.D., Ph.D., rheumatologist and chief medical officer at Myriad Autoimmune. The data being presented by our academic collaborators at ACR show that the Vectra test accurately measures inflammation and can help predict patients risk of adverse health outcomes, enabling clinicians to tailor precision treatment plans to achieve better outcomes.

Vectra Posters

Title:Predicting Risk of Radiographic Progression for Patients with Rheumatoid Arthritis.Presenter:Jeff Curtis, M.D., M.S., MPH, University of Alabama at Birmingham.Date:Sunday, Nov. 10, 2019. 9:00-11:00 a.m.Location:Poster 466.

This study evaluated the ability of the Vectra test to predict patients individual percentage risk of RP within one year. The analysis included combined data from 973 patients in four cohorts. The results demonstrate that the adjusted Vectra score was a superior predictor of RP within one year compared to DAS28-CRP, CRP, CDAI and swollen joint count. Additionally, the risk of permanent joint damage increased continuously with the adjusted Vectra score, meaning patients with a low adjusted Vectra score had a one to three percent risk of RP in one year, while patients with a moderate-to-high score had between seven and 47 percent risk (Graph 1). Based on these new data, the company is working to enhance the Vectra test report to provide patients with their individual risk of radiographic progression in one year.

To view Graph 1: Vectra Predicts Risk of Radiographic Progression in 1 Year,please visit the following link:https://www.globenewswire.com/NewsRoom/AttachmentNg/514919cd-81ca-4084-81df-682fedc1784b

Too often people with RA are over- or under-treated because it is difficult for clinicians to accurately measure inflammation and determine the long-term prognosis of RA patients. As a result, some people are at increased risk of rapid radiographic progression, said Jeff Curtis, M.D., M.S., MPH, lead investigator, rheumatologist and Professor of medicine in the Division of Clinical Immunology and Rheumatology at the University of Alabama at Birmingham. It is critical that clinicians have reliable information when making treatment decisions. Our study demonstrated that the Vectra score was the strongest predictor of radiographic progression, which may help inform treatment plans and prevent future joint damage.

Title:Derivation and Validation of a Biomarker-Based Cardiovascular Risk Prediction Score in Rheumatoid Arthritis.Presenter:Jeff Curtis, M.D., M.S., MPH; University of Alabama at Birmingham.Date:Tuesday, Nov. 12, 2019. 9:00-11:00 a.m.Location:Poster 2350.

This study evaluated 30,751 Medicare patients with RA to develop and validate the Vectra CVD score, which predicts risk for a first cardiovascular (CV) event by combining data from Vectra and clinical measures. The primary CV outcome was a composite of three types of CV events heart attack, stroke, and CV death occurring within 3 years from testing. When the performance of the Vectra CVD score was compared to four other CV prediction models, the Vectra CVD score was a significant predictor of CV risk and was superior to all four other models. Importantly, when risk scores were converted to 3-year percentage risk for having a CV event, approximately 80 percent of patients were found to have a moderate or high risk of a CV event over 3 years, based on risk categories analogous to those of the American College of Cardiology/American Heart Association 2018 guidelines (Graph 2).

To view Graph 2: Vectra Predicts Risk of Cardiovascular Events in Patients with RA, please visit the following link:https://www.globenewswire.com/NewsRoom/AttachmentNg/c902b4ec-a3c8-439f-9557-0a9b05631a1f

People with rheumatoid arthritis have almost double the risk of heart attack, stroke and atherosclerosis. Traditional CV risk factors alone do not fully explain the increased rates of CV events in RA, and inflammation is a missing component that is measured by the Vectra test, said Dr. Curtis. In this study, the Vectra CVD score effectively predicted CV risk in people with RA. We believe the Vectra CVD score may assist clinicians to more quickly identify patients at high risk for CV events and target interventions that can be potentially life-saving.

The company plans to publish these new data in peer reviewed medical journal and make the Vectra CVD score available to clinicians in fiscal year 2020. Please visit Myriad Autoimmune at booth #1419 to learn more about Vectra. Follow Myriad on Twitter via @myriadgenetics and follow meeting news by using the hashtag #ACR19.

About VectraVectra is a multi-biomarker molecular blood test that provides an objective and personalized measure of inflammatory disease activity in patients with rheumatoid arthritis. Vectra provides unsurpassed ability to predict radiographic progression and can help guide medical management decisions with the goal of improving patient outcomes. Vectra testing is performed at a state-of-the-art CLIA (Clinical Laboratory Improvement Amendments) facility. Test results are reported to the physician five to seven days from shipping of the specimen. Physicians can receive test results by fax or the private web portal, VectraView. For more information on Vectra, please visit: http://www.vectrascore.com.

About Myriad GeneticsMyriad Genetics Inc. is a leading precision medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on five critical success factors: building upon a solid hereditary cancer foundation, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore, Prolaris, Foresight and Prequel are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Company presenting new data on the Vectra test at the 2019 ACR Annual Meeting; the Vectra test enabling clinicians to tailor precision treatment plans to achieve better outcomes; the Vectra score helping inform treatment plans and prevent future joint damage; the Vectra CVD score assisting clinicians to more quickly identify patients at high risk for CV events and target interventions that can be potentially life-saving; publishing these new data in peer reviewed medical journal; making the Vectra CVD score available to clinicians in fiscal year 2020; and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

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New Studies Demonstrate the Predictive Value of the Vectra Test in People Diagnosed with Rheumatoid Arthritis - GlobeNewswire

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Cell Expansion Technologies Market with Report In Depth Industry Analysis on top manufacturers and forecasts 2019-2026 – Chronicle Voice

November 10th, 2019 5:43 am

The report analyzes the leading players of the global Cell Expansion Technologies market by inspecting their market share, recent developments, new product launches, partnerships, mergers, or acquisitions, and their target markets. This report also includes an exhaustive analysis of their product profiles to explore the products and applications their operations are concentrated on in the global Cell Expansion Technologies market. Additionally, the report gives two distinct market forecasts, one from the perspective of the producer and another from that of the consumer. It also offers valuable recommendations for new as well as established players of the global Cell Expansion Technologies market. It also provides beneficial insights for both new as well as established players of the global Cell Expansion Technologies market.

In a word, the report provides major statistics on the state of the industry and is a valuable source of guidance and direction for companies and individuals interested in the market.

Whats covered in the report?

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Leading vendors in the market are included based on profile, business performance etc. Vendors mentioned as follows:

CYTOMATRIXDANAHER CORP.CORNING INC.LIFE TECHNOLOGIES LTD.MERCK MILLIPOREPLURISTEM THERAPEUTICS INC.GE HEALTHCARECELLPROTHERAEarthrise Nutritionals LLCOthers

We provide detailed product mapping and investigation of various market scenarios. Our expert analysts provide a thorough analysis and breakdown of the market presence of key market leaders. We strive to stay updated with the recent developments and follow the latest company news related to the industry players operating in the global Cell Expansion Technologies market. This helps us to comprehensively analyze the individual standing of the companies as well as the competitive landscape. Our vendor landscape analysis offers a complete study to help you gain the upper hand in the competition.

Market Segment by Type, can be divided into

Type 1

Type 2

Others

Market Segment by Applications, can be divided into

CLINICAL DIAGNOSTICSDRUG DISCOVERY AND DEVELOPMENTREGENERATIVE MEDICINE AND STEM CELL RESEARCH

Market segment by Region/Country including:

North America (United States, Canada and Mexico)

Europe (Germany, UK, France, Italy, Russia and Spain etc.)

Asia-Pacific (China, Japan, Korea, India, Australia and Southeast Asia etc.)

South America Brazil, Argentina, Colombia and Chile etc.)

Middle East & Africa (South Africa, Egypt, Nigeria and Saudi Arabia etc.)

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Knowing the trends influencing the industry performance

Stakeholders, marketing executives and business owners planning to refer a market research report can use this study to design their offerings and understand how competitors attract their potential customers and manage their supply and distribution channels. When tracking the trends researchers have made a conscious effort to analyze and interpret the consumer behaviour. Besides, the research helps product owners to understand the changes in culture, target market as well as brands so they can draw the attention of the potential customers more effectively.

Apart from this, the valuable document weighs upon the performance of the industry on the basis of a product service, end-use, geography and end customer.

The industry experts have left no stone unturned to identify the major factors influencing the development rate of the Cell Expansion Technologies industry including various opportunities and gaps. A thorough analysis of the micro markets with regards to the growth trends in each category makes the overall study interesting. When studying the micro markets the researchers also dig deep into their future prospect and contribution to the Cell Expansion Technologies industry.

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The report on global Cell Expansion Technologies market is intended to offer business owners, stakeholders and field marketing executives a broad overview of the business they should be focussing on for the estimated period. The research further holds vital information on the size of market and data on the prominent leaders product owners have to compete with, in the coming years. Assessments of the broad strengths, as well as weaknesses too, add value to the overall research. Products details not only cover the popular applications and its performance, but it also unveils certain trends and value of specific products within specific regions.

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Should You Invest in the Invesco Dynamic Biotechnology & Genome ETF (PBE)? – Yahoo Finance

November 10th, 2019 5:42 am

Looking for broad exposure to the Healthcare - Biotech segment of the equity market? You should consider the Invesco Dynamic Biotechnology & Genome ETF (PBE), a passively managed exchange traded fund launched on 06/23/2005.

Passively managed ETFs are becoming increasingly popular with institutional as well as retail investors due to their low cost, transparency, flexibility and tax efficiency. They are excellent vehicles for long term investors.

Sector ETFs also provide investors access to a broad group of companies in particular sectors that offer low risk and diversified exposure. Healthcare - Biotech is one of the 16 broad Zacks sectors within the Zacks Industry classification. It is currently ranked 2, placing it in top 13%.

Index Details

The fund is sponsored by Invesco. It has amassed assets over $227.92 M, making it one of the average sized ETFs attempting to match the performance of the Healthcare - Biotech segment of the equity market. PBE seeks to match the performance of the Dynamic Biotechnology & Genome Intellidex Index before fees and expenses.

This is comprised of stocks of 30 U.S. biotechnology and genome companies. These are companies that are principally engaged in the research, development, manufacture and marketing and distribution of various biotechnological products, services and processes and companies that benefit significantly from scientific and technological advances in biotechnology and genetic engineering and research.

Costs

Expense ratios are an important factor in the return of an ETF and in the long term, cheaper funds can significantly outperform their more expensive counterparts, other things remaining the same.

Annual operating expenses for this ETF are 0.57%, making it on par with most peer products in the space.

Sector Exposure and Top Holdings

While ETFs offer diversified exposure, which minimizes single stock risk, a deep look into a fund's holdings is a valuable exercise. And, most ETFs are very transparent products that disclose their holdings on a daily basis.

This ETF has heaviest allocation in the Healthcare sector--about 100% of the portfolio.

Looking at individual holdings, Biogen Inc (BIIB) accounts for about 6.52% of total assets, followed by Vertex Pharmaceuticals Inc (VRTX) and Celgene Corp (CELG).

The top 10 holdings account for about 49.20% of total assets under management.

Performance and Risk

The ETF has added roughly 10.04% so far this year and is down about -3.11% in the last one year (as of 11/05/2019). In that past 52-week period, it has traded between $43.44 and $56.26.

The ETF has a beta of 1.43 and standard deviation of 23.63% for the trailing three-year period, making it a high risk choice in the space. With about 30 holdings, it has more concentrated exposure than peers.

Alternatives

Invesco Dynamic Biotechnology & Genome ETF carries a Zacks ETF Rank of 3 (Hold), which is based on expected asset class return, expense ratio, and momentum, among other factors. Thus, PBE is a reasonable option for those seeking exposure to the Health Care ETFs area of the market. Investors might also want to consider some other ETF options in the space.

SPDR S&P Biotech ETF (XBI) tracks S&P Biotechnology Select Industry Index and the iShares Nasdaq Biotechnology ETF (IBB) tracks Nasdaq Biotechnology Index. SPDR S&P Biotech ETF has $3.81 B in assets, iShares Nasdaq Biotechnology ETF has $7.02 B. XBI has an expense ratio of 0.35% and IBB charges 0.47%.

Bottom Line

To learn more about this product and other ETFs, screen for products that match your investment objectives and read articles on latest developments in the ETF investing universe, please visit Zacks ETF Center.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free reportInvesco Dynamic Biotechnology & Genome ETF (PBE): ETF Research ReportsiShares Nasdaq Biotechnology ETF (IBB): ETF Research ReportsSPDR S&P Biotech ETF (XBI): ETF Research ReportsCelgene Corporation (CELG) : Free Stock Analysis ReportVertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis ReportBiogen Inc. (BIIB) : Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment Research

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Goodwin Biotechnology Launches a Digitization Initiative by Investing in a Sophisticated Electronic Quality Solution – Yahoo Finance

November 10th, 2019 5:42 am

FORT LAUDERDALE, Fla., Nov. 6, 2019 /PRNewswire/ --Goodwin Biotechnology, Inc. announced that it has recently licensed an industry leading electronic content and document management solution to enhance the efficiency and effectiveness of its Quality systems and operations. This improvement continues to ensure that Goodwin Biotechnology remains uniquely positioned as aqualified and flexible biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that offers an integrated Single Source Solution from Cell Line Development, Process Development and cGMP manufacturing including Scale-Up, cGMP Contract Manufacturing, and Aseptic Fill / Finish of mammalian cell-culture derived monoclonal antibodies, recombinant proteins, vaccines, and Antibody Drug Conjugates (ADCs).

"Acquisition and implementation of this sophisticated electronic solution demonstrates Goodwin's commitment to providing top-tier development and manufacturing services for our clients," noted Karl Pinto, Chief Executive Officer at Goodwin Biotechnology. "Goodwin's past successes supporting our clients through their early- and late-stage clinical trials, and regulatory compliant commercial manufacturing, will be strengthened through this recent investment. These strategic steps demonstrate our commitment to effectively support our clients through all stages of product development and cGMP manufacturing to assure conformance to worldwide regulatory standards." added Mr. Pinto.

About Goodwin Biotechnology, Inc.Goodwin Biotechnologyis a uniquely qualified and flexible, US-based CDMO that offers a Single Source Solution to enhance the value of complex biopharmaceuticals for our clients. With over 26 years of experience as an independent integrated contract manufacturer, Goodwin Biotechnology has worked as a strategic partner with companies of all sizes from small university spin-offs to major research institutes, government agencies and large, established and multi-national biopharmaceutical companies. Based on the impressive track record, Goodwin Biotechnology has received numerous industry awards that span from Frost & Sullivan's Customer Value and Leadership Award for Best Practices in Mammalian Contract Manufacturing to the Biologics cGMP Manufacturer of the Year 2018 by Global Health & Pharma News. Click here to view the press releases! Additional information may be found at http://www.GoodwinBio.com.

For more information, please contact:

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The Week Ahead In Biotech: Smid-Cap Earnings Deluge, SITC Conference In The Spotlight – Benzinga

November 10th, 2019 5:42 am

Biotech stocks extended their gains last week amid earnings news flow and the broader market strength. Large-cap pharma stocks saw particular strength.

Here are the key catalytic event a biotech investor should keep a tab on in the unfolding week.

The FDA is set to rule on Lipocine Inc (NASDAQ: LPCN)'s NDA for Tlando, or LPCN 1021 to treat hypogonadism in adult males. The PDUFA date is set for Saturday, Nov. 9.

Alkermes Plc (NASDAQ: ALKS) Phase 1/2 data for ALKS 4230 in solid tumors and ALKS 4230 in combination with Merck & Co., Inc. (NYSE: MRK)'s Keytruda in solid tumors.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) Phase 1 data for CDX-1140 in solid tumors (Friday, Nov. 8).

Pieris Pharmaceuticals Inc (NASDAQ: PIRS) Phase 1/2 data for PRS-343 in HER2-positive solid tumors.

CELYAD SA/ADR (NASDAQ: CYAD) Phase 1 data for CYAD-01 and FOLFOX in colorectal cancer (Friday, Nov. 8) and Phase 1 data for CYAD-101 in colorectal cancer (Saturday, Nov. 9).

Heat Biologics Inc (NASDAQ: HTBX) Phase 2 data for HS-110 and Bristol-Myers Squibb Co (NYSE: BMY)'s Opdivo in non-small cell lung cancer (Friday).

Oncolytics Biotech, Inc. (NASDAQ: ONCY) - interim Phase 1b data for Pelareorep and Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY)'s Tecentriq in breast cancer (Friday).

Nektar Therapeutics (NASDAQ: NKTR) updated Phase 1/2 data for NKTR-214 + Opdivo in multiple cancers (urothelial carcinoma, melanoma, renal cell carcinoma, and non-small cell lung cancer) (Saturday).

Mirati Therapeutics Inc (NASDAQ: MRTX) initial Phase 2 data for sitravatinib in urothelial carcinoma (Saturday).

Allena Pharmaceuticals Inc (NASDAQ: ALNA) Phase 2 data for reloxaliase, or ALLN-177, in primary hyperoxaluria and Phase 3 data for reloxaliase in enteric hyperoxaluria (Friday).

See Also: BTIG: Crispr Could Be A Takeover Target For Vertex

The earnings list is not comprehensive

Monday

Tuesday

Wednesday

Thursday

Friday

Galera Therapeutics has filed to offer 5 million shares in an IPO, with an estimated price range of $14-$16. The company has applied for listing its shares on the Nasdaq under the ticker symbol "GRTX."

89bio, a biotech company focusing on therapies for NASH and other metabolic disorders, is planning a 4.375-million IPO at an estimated price range of $15-17. The company has applied for listing its shares on the Nasdaq under the ticker symbol "ETNB."

Gene testing company Centogene is proposing to offer 4 million shares in an IPO, which are to be priced between $14 and $16. The company has applied to list the shares on the Nasdaq under the ticker symbol "CNTG."

CNS Pharmaceuticals, which develops therapies for brain cancer and other CNS tumors, has filed for a 2.125-million share IPO. The shares, which are likely to be priced in the range of $4-$5, are to be listed on the Nasdaq under the ticker symbol "CNSP."

Tela Bio, which sells soft tissue implants used in hernia repair and reconstructive surgery, is set to offer 4 million shares in an IPO, with each share to be priced between $14 and $16. The company seeks to list the shares on the Nasdaq under the ticker symbol "TELA."

BioNTech SE ADR (NASDAQ: BNTX)Vir Biotechnology Inc (NASDAQ: VIR)

2019 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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The Week Ahead In Biotech: Smid-Cap Earnings Deluge, SITC Conference In The Spotlight - Benzinga

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Global Biotechnology Market 2019, Trend, CAGR Status, Growth, Analysis and Forecast to 2024 – BoundWatch

November 10th, 2019 5:42 am

The company provides a detailed analysis of the market and future aspects of the Biotechnology Market. It focuses on critical and critical data that makes it a very important tool for research, experts, analysts, and managers to achieve ready-to-access analysis. The report provides an inclusive analysis of the Biotechnology market size forecast from 2018-2025.

Sample report can be viewed in a PDF form by visiting @ researchunt.com/report/global-biotechnology-market-size-status-and-forecast-2019-2025/#Free-Sample-Report

The report embraces the complete information of the key players involved in the worldwide Biotechnology market. In addition, it provides its market share by various regions with the company and product introduction and their position in the Biotechnology market. In addition, the report takes into account recent marketing developments as well as their marketing strategies along with an overall business overview. In addition, the report covers market growth factors and restraints of this market.

Prominent players of Biotechnology market:

Product Type Coverage (Market Size & Forecast, Major Company of Product Type etc.):

Application Coverage (Market Size & Forecast, Different Demand Market by Region, Main Consumer Profile etc.):

Regional Segmentation for Biotechnology market:

There are 10 chapters to put on view for Biotechnology market:

Chapter 1: Consumption by Regions

Chapter 2: Production, By Types, Revenue and Market share by Types

Chapter 3: Consumption, By Applications, Market share (%) and Growth Rate by Applications

Chapter 4: Complete profiling and analysis of Manufacturers

Chapter 5: Manufacturing cost analysis, Raw materials analysis, Region-wise manufacturing expenses

Chapter 6: Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 7: Marketing Strategy Analysis, Distributors/Traders

Chapter8: Market Effect Factors Analysis

Chapter9: Market Forecast

Chapter 10: Biotechnology Research Findings and Conclusion, Appendix, methodology and data source

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Customization of the Report:This report can be customized to meet the clients requirements. Please connect with our sales team ([emailprotected]), who will ensure that you get a report that suits your needs.

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Brokerages Anticipate Unity Biotechnology Inc (NASDAQ:UBX) Will Announce Earnings of -$0.49 Per Share – Slater Sentinel

November 10th, 2019 5:42 am

Analysts expect that Unity Biotechnology Inc (NASDAQ:UBX) will report earnings of ($0.49) per share for the current fiscal quarter, according to Zacks. Zero analysts have provided estimates for Unity Biotechnologys earnings. Unity Biotechnology posted earnings of ($0.43) per share in the same quarter last year, which indicates a negative year over year growth rate of 14%. The firm is expected to announce its next earnings report after the market closes on Wednesday, November 6th.

On average, analysts expect that Unity Biotechnology will report full year earnings of ($2.02) per share for the current financial year, with EPS estimates ranging from ($2.07) to ($1.96). For the next year, analysts expect that the company will post earnings of ($2.09) per share, with EPS estimates ranging from ($2.25) to ($1.93). Zacks Investment Researchs earnings per share averages are an average based on a survey of research firms that follow Unity Biotechnology.

Unity Biotechnology (NASDAQ:UBX) last released its earnings results on Wednesday, August 7th. The company reported ($0.54) earnings per share (EPS) for the quarter, missing analysts consensus estimates of ($0.44) by ($0.10).

Institutional investors and hedge funds have recently made changes to their positions in the company. Aperio Group LLC acquired a new position in shares of Unity Biotechnology during the 2nd quarter worth $50,000. Citadel Advisors LLC grew its stake in Unity Biotechnology by 449.0% in the 2nd quarter. Citadel Advisors LLC now owns 238,386 shares of the companys stock valued at $2,265,000 after buying an additional 194,965 shares during the last quarter. Ellington Management Group LLC acquired a new position in Unity Biotechnology in the 2nd quarter valued at $103,000. BlackRock Inc. grew its stake in Unity Biotechnology by 5.0% in the 2nd quarter. BlackRock Inc. now owns 1,992,613 shares of the companys stock valued at $18,929,000 after buying an additional 94,183 shares during the last quarter. Finally, Virtus ETF Advisers LLC grew its stake in Unity Biotechnology by 84.8% in the 2nd quarter. Virtus ETF Advisers LLC now owns 30,554 shares of the companys stock valued at $290,000 after buying an additional 14,021 shares during the last quarter. Institutional investors own 38.32% of the companys stock.

UBX stock opened at $6.88 on Friday. Unity Biotechnology has a 12-month low of $5.61 and a 12-month high of $17.46. The company has a market cap of $295.51 million, a price-to-earnings ratio of -2.71 and a beta of -0.19. The company has a 50 day moving average of $6.81 and a two-hundred day moving average of $7.63.

About Unity Biotechnology

Unity Biotechnology, Inc, a biotechnology company, engages in the research and development of therapeutics to extend human health span. The company's lead drug candidates include UBX0101 that is in Phase 1 clinical study for musculoskeletal disease; and UBX1967 for ophthalmologic diseases. It is also developing programs in pulmonary disorders.

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Puma Biotechnology to Present at the Credit Suisse Healthcare Conference – Yahoo Finance

November 10th, 2019 5:42 am

LOS ANGELES--(BUSINESS WIRE)--

Puma Biotechnology, Inc. (PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 10:55 a.m. MST (9:55 a.m. PST, 12:55 p.m. EST) on Tuesday, November 12, at the Credit Suisse 28th Annual Healthcare Conference. The conference will be held at The Phoenician Resort in Scottsdale, Arizona.

A live webcast of the presentation will be available on the Companys website at http://www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to three drug candidates PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. NERLYNX was granted marketing authorization by the European Commission in September 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology can be found at http://www.pumabiotechnology.com.

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Generex Biotechnology Provides Guidance: Form 10k Annual Report will be filed Tuesday Morning November 12th 2019 – Yahoo Finance

November 10th, 2019 5:42 am

MIRAMAR, Fla., Nov. 08, 2019 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (GNBT) is pleased to announce that its 10k annual report will be filed Tuesday morning within the time afforded to public companies under the standard filing extension. Generex has received many calls in regard to this very important filing, and the company wants to assure everyone that the report has been completed, and the filing is definitive for Tuesday, November 12, 2019.

Joe Moscato, CEO and President commented, I appreciate everyones concern in this important filing as we march towards our NASDAQ listing. This annual report filing was much more complicated than last years report due to the many acquisitions the company made over the last year, which required that the financial audit be reviewed by multiple audit firms. Further, this is the first full audit that our new auditors have had to complete, so understanding all of Generex 23-year history of business, and the complexities of the MSO and healthcare initiatives that the company has initiated was no small task. Now that this first 10K audit has been completed for the NuGenerex family of companies, our financial accounting and auditing work will get easier, having been streamlined for the future with standard operating procedures.

About Generex Biotechnology Corp.

Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

In addition to advancing a legacy portfolio of immune-oncology assets, medical devices, and diagnostics, the Company is focused on an acquisition strategy of strategic businesses that complement existing assets and provide immediate sources of revenue and working capital. Recent acquisitions include a management services organization, a network of pharmacies, clinical laboratory, and medical device companies with new and approved products.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:

Generex Biotechnology Corporation

Joseph Moscato 646-599-6222

Todd Falls 1-800-391-6755 Extension 222investor@generex.com

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Generex Biotechnology Provides Guidance: Form 10k Annual Report will be filed Tuesday Morning November 12th 2019 - Yahoo Finance

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Puma Biotechnology Licensing Partner CANbridge Pharmaceuticals Receives Registration Approval in Hong Kong for NERLYNX (neratinib) for Extended…

November 10th, 2019 5:42 am

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that its licensing partner in Greater China, CANbridge Pharmaceuticals Inc., has received registration approval from the Department of Health in Hong Kong to market NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who have completed adjuvant trastuzumab-based therapy less than one year ago.

The rapid and smooth advancement of NERLYNX through the Hong Kong regulatory process to market approval is a testament to the quality of our regulatory expertise, and the CANbridge commitment to bring new treatments to underserved patient populations in greater China, said James Xue, PhD, Founder, Chairman and CEO, CANbridge Pharmaceuticals. With this first targeted therapy approved in our oncology platform, CANbridge is able to provide women in Hong Kong, with HER2-positive breast cancer at risk of recurrence, a new and vital treatment option shortly after approval in the West.

Alan H. Auerbach, Puma Biotechnologys Chairman, Chief Executive Officer and President, added, This registration approval through our partnership with CANbridge represents an important market entry for us as we execute on our global commercial strategy. CANbridge has the commercial infrastructure and resources to provide NERLYNX to patients in the region.

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

About CANbridge Pharmaceuticals

CANbridge Pharmaceuticals Inc. is a China-based biopharmaceutical company accelerating development and commercialization of specialty healthcare products for orphan diseases and targeted cancers, focusing on products that are unavailable or address medical needs that are underserved in the region. CANbridge has been widely recognized as a leader in orphan diseases in China. It has a global partnership with WuXi Biologics to develop and commercialize proprietary therapeutics for the treatment of rare genetic diseases. In addition, it has an exclusive licensing agreement to commercialize Hunterase, an enzyme replacement therapy for the treatment of Hunter syndrome, developed by GC Pharma and marketed in more than ten countries worldwide. CANbridge also has an oncology portfolio, which includes exclusive rights to develop and commercialize Puma Biotechnologys NERLYNX (neratinib), approved in the United States, and rights to other novel candidates.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. NERLYNX was granted marketing authorization by the European Commission in August 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology may be found at http://www.pumabiotechnology.com.

Important Safety Information Regarding NERLYNX (neratinib) U.S. Indication

NERLYNX (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS: The most common adverse reactions ( 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight decreased and urinary tract infection.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and http://www.NERLYNX.com or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

Please see Full Prescribing Information for additional safety information.

The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first dose of NERLYNX and continued during the first 2 months (56 days) of treatment and as needed thereafter.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at http://www.NERLYNX.com or 1-855-816-5421.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the worldwide expansion of NERLYNX. All forward-looking statements involve risks and uncertainties that could cause Pumas actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Pumas Annual Report on Form 10-K for the year ended December 31, 2018. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law.

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PDS Biotechnology Accepted for Oral Presentation at the 34th Annual Society for Immunotherapy of Cancer Annual Meeting – Yahoo Finance

November 10th, 2019 5:42 am

Dr. Lauren V. Wood, M.D. to present data from the companys phase 1 PDS0101 human trial demonstrating potent antigen-specific CD8+ T-cell responses in-vivo

PRINCETON, N.J., Nov. 06, 2019 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on the companys proprietary Versamune T-cell activating technology , today announced that Lauren V. Wood, M.D., Chief Medical Officer of PDS Biotechnology, has been selected to make an oral presentation reporting on the study design and clinical data from its previously announced Phase 1 study of PDS0101 at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting, taking place on November 7-10, 2019 in National Harbor, Maryland.

In addition to the immunogenicity and safety data from the Phase 1 study of PDS0101, we are very pleased to highlight follow-up data, demonstrating the translation of our Versamune-induced immunological mechanisms from animal to human studies in an oral presentation at the 34th annual SITC meeting, commented Lauren V. Wood, M.D., PDS Biotechnologys Chief Medical Officer. Based on this encouraging data, we are now focused on initiating three Phase 2 studies in the first quarter of 2020. These include our previously announced combination study to evaluate PDS0101 in combination with KEYTRUDA in the treatment of HPV16 positive head and neck cancer, a study to evaluate PDS0101 in combination with two immunotherapies in advanced HPV-associated cancers with the National Cancer Institute and a study, the details of which are included in our supplemental corporate presentation filed on October 29, 2019, to evaluate the combination of PDS0101 and chemoradiotherapy in patients with locally advanced cervical cancer.

Details for the oral presentation are below:

Abstract 017: A Novel Enantio-Specific Cationic Lipid R-DOTAP + HPV16 E6 & E7 Antigens Induces Potent Antigen-Specific CD8+ T Cell Responses In-Vivo in Subjects with CIN and High-Risk Human Papilloma Virus InfectionPresenter: Dr. Lauren V. Wood, M.D., Chief Medical Officer, PDS BiotechnologySession Title: Session 209: Virus Driven CancersDate: Friday, November 8th, 2019Time: 6:00 6:10pm ET

Full data from the Phase 1 study can be found in the supplemental corporate presentation filed on October 29, 2019.

About PDS Biotechnology

PDS Biotechnology is a clinical-stage immuno-oncology company developing multiple therapies based on the companys proprietary Versamune T-cell activating technology platform. The Versamune platform effectively delivers tumor-specific antigens for in-vivo uptake and processing, while also activating a critical immunological pathway, the type 1 interferon pathway, thus resulting in the production of potent tumor-specific killer T-cells. Using Versamune, PDS Biotechnology is engineering therapies designed to better recognize cancer cells and break down their defense systems to effectively attack and destroy tumors. PDS Biotechnologys pipeline combines the Versamune technology with tumor-specific antigens across several cancer types. To learn more, please visit http://www.pdsbiotech.com.

About PDS0101

PDS Biotechnologys lead candidate, PDS0101, combines the utility of the Versamune platform with targeted antigens in HPV-expressing cancers. In partnership with Merck and the National Cancer Institute (NCI), PDS Biotechnology is advancing PD0101 to Phase 2 studies in head and neck cancer and in HPV-related advanced cancer.

Forward Looking StatementsThis communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the Company) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Companys management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as may, will, should, would, expect, anticipate, plan, likely,believe,estimate,project,intend,and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the ability of the Company to integrate Edge and PDS Biotechnology following the merger; the Companys ability to protect its intellectual property rights; competitive responses to the completion of the merger; potential adverse reactions or changes to business relationships resulting from the completion of the merger;the Companys anticipated capital requirements, including the Companys anticipated cash runway and the Companys current expectations regarding its plans for future equity financings; the timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101 and PDS0102; the Companys interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or the future success of such trials;the successful implementation of the Companys research and development programs and collaborations; the acceptance by the market of the Companys product candidates, if approved;the timing of and the Companys ability to obtain and maintainU.S. Food and Drug Administrationor other regulatory authority approval of, or other action with respect to, the Companys product candidates;and other factors, including legislative, regulatory, political and economic developmentsnot within the Companys control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Companys annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

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Rakuten Medical Investigational Anti-cancer Therapy Candidate Seen to Activate Immune System Response and Synergize with PD1 Checkpoint Blockade in…

November 10th, 2019 5:41 am

NATIONAL HARBOR, Md., Nov. 9, 2019 /PRNewswire/ --Rakuten Medical, Inc. (RMI) a clinical-stage, global biotechnology company developing precision-targeted cancer therapies based on Rakuten Medical's Illuminox, its proprietary, anti-cancer treatment platform, introduced new preclinical data suggesting CD25 photoimmunotherapy (PIT) treatment, combined with an anti-PD1 therapy, may stimulate the immune system, and lead to a synergistic, anti-cancer activity in targeted tumors.

"These exciting data suggests that anti-CD25 photoimmunotherapy may alter the immune tumor environment and unlock the potential of combination immunotherapies for patients living with certain types of cancers for which there are few treatment options," said Miguel Garcia-Guzman, Ph.D., Vice Chairman and Chief Scientific Officer at Rakuten Medical. "We are committed to harnessing the full potential of the immune system through modulation of the cancer tumor environment, and these results support our clinical development program based on our anti-cancer treatment platform, Rakuten Medical's Illuminox."

The preclinical data were showcased during a poster presentation during the Society for Immunotherapy of Cancer (SITC) 34th annual meeting:

"Intratumoral depletion of regulatory T-cells using CD25 targeted photoimmunotherapy elicits anti-cancer immune activity and synergizes with PD1 checkpoint blockade in immunocompetent mouse models." (Abstract P774), presented by Jerry J. Fong, Cancer Biology and Pharmacology, Rakuten Medical.

The poster discusses intratumoral depletion of regulatory T-cells (Tregs), a significant source of immune suppression, with an anti-CD25-IR700 conjugate therapy using PIT. Anti-cancer activity and subsequent immune responses following anti-CD25-IR700 PIT treatment, administered alone or in combination with anti-PD1 treatment, were evaluated in immunocompetent mouse models. Key highlights from the studies include:

About Rakuten Medical Rakuten Medical, Inc. (RMI) is a privately funded, clinical-stage biotechnology company with offices in the U.S., Japan, Taiwan, Germany and the Netherlands. Rakuten Medical aims to become a leader in precision-targeted medicines through Rakuten Medical'sIlluminox, its proprietary, anti-cancer treatment platform. The Company's lead product, ASP-1929, the first investigational product based on RMI's Illuminox, has achieved Fast Track designation from both the FDA and the Japanese Ministry of Health, Labour, and Welfare. ASP-1929 is currently the subject of a global, Phase 3 clinical trial for recurrent head and neck squamous cell carcinoma. Additional Phase 2 studies for ASP-1929 are also underway to evaluate the safety in patients with other cancer types. For more information, visit http://www.rakuten-med.com.

About Rakuten Medical's IlluminoxRakuten Medical'sIlluminox is a proprietary, anti-cancer treatment platform that is comprised of drug, device and other related technologies. Transient excitation of a drug, including antibodies conjugated to light-excitable dyes, with non-thermal light is believed to result in anti-cancer activity and in rapid and selective cell killing and tumor necrosis with minimal effects on surrounding normal tissue. It may also lead to the systemic induction of innate and adaptive immunity. RMI's Illuminox is based upon the photoimmunotherapy treatment platform developed at the National Institutes of Health (NIH) and licensed exclusively to Rakuten Medical for commercialization. None of the therapies based on RMI's Illuminox have been approved by any regulatory authority. The RMI Illuminox platform is not a drug nor device on its own and is not the brand name of a drug nor device.

Forward Looking StatementThis press release contains forward-looking statements made pursuant to the safe harbor provisions ofthe (United States) Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties, and assumptions that could cause Rakuten Medical'sactual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. These forward-looking statements include information concerning its proprietary anti-cancer platform known as Rakuten Medical's Illuminox and the commercialization of services related to Rakuten Medical products such as the investigational product ASP-1929 and other initiatives toward regulatory approval for products to be sold and marketed. These products may not successfully be granted regulatory approval to be sold and marketed, or may not be commercially successful. Forward-looking statements suggest potential profitability, efficacy and safety, and the status of the application for approval. Rakuten Medicalhas in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "intends," "potential," "may," "suggest," "plans,""strategizes," "likely", "will", and similar expressions. Such forward-looking statements are based upon Rakuten Medical's current beliefs. Moreover, this press release states an opinion related to clinical research data, hence the use of expressions such as "important," "notable" and "abnormal." Ongoing clinical studies involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty of success in regulatory approval or commercialization of ASP-1929 which may be impacted by, among other things, problems with the manufacturing process for ASP-1929, the occurrence of adverse safety events, failure to demonstrate therapeutic benefit, and the other risks and uncertainties, both reasonable and unreasonable. Rakuten Medicalundertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect new information obtained, events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. In the event of one or more revisions to Rakuten Medical's forward-looking statement, it should not be inferred that such revisions or other forward-looking statements will be further revised.

SOURCE Rakuten Medical, Inc.

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50 years ago, cancer vaccines were a dream – Science News

November 10th, 2019 5:41 am

Immune response and cancer therapy, Science News, November 8, 1969

The dream of a cancer vaccine is still just that a dream. But experimenters at Emory University in Atlanta have shown that the basic mechanism stimulation of an immune response can take place.

Researchers have devised several ways of getting the immune system to prevent or control cancer. Vaccinations against human papillomavirus, or HPV, prevent infections that cause cervical and other cancers. Hepatitis B vaccines may head off some forms of liver cancer.

Other strategies, like CAR-T cell therapy and PD-1 blockade therapy (SN: 7/11/15, p. 14), prompt T cells of the immune system to go after tumors. The U.S. Food and Drug Administration approved the first PD-1 blockade therapy in 2011 and then two CAR-T cell therapies in 2017 for patients with certain types of cancers (SN: 12/23/17 & 1/6/18, p. 29). Overstimulating the immune system can produce severe side effects, so scientists are working to develop safer options (SN: 7/7/18, p. 22).

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Auranta: Boosting the animal immune system – The Irish Times

November 10th, 2019 5:41 am

Dublin-based Auranta has developed a range of animal feed additives which boost the immune system, reduce the need for antibiotics, and significantly reduce mortality. Not only do the additives improve the health of new-born and very young animals, they also enhance their performance in terms of weight gain and other key parameters throughout their lives.

The complementary animal feed products are produced from plant extracts and are designed for calves, poultry and pigs, under the AuraCalf, AuraPoultry and AuraShield brands.

Auranta managing director John Cullen explains the innovation by referring to AuraCalf. What we do is produce animal feed additives, he says. Dairy calves are weaned off milk after a couple of days and put on a milk replacer. Using our additives in the replacer boosts the animals gut health. The animals immune system is developed in the gut and how the animal performs over its life is directly related to the early development of the immune system.

A dairy calf is hugely dependent on what happens in the first few months of its life, he adds. How much milk it will produce is directly related to its health during the first two months. Scour and other infections will decide future performance. There is a lot of research to prove that. Our products are aimed at those first few months and go into very young animals.

He explains that the microbiome, the bacteria that inhabit the gut, is unique to every animal. Its like a fingerprint, he says. But when the animal is born there is nothing there. The gut gets colonised after birth.

It is this period of colonisation during which the microbiome is programmed for life that the Auranta product range targets. Our additives are a bit like probiotics, but they are not intended to kill anything. They protect the animal by giving a boost to the immune system. Most other products on the market try to mimic medication by killing pathogens in the gut but their ingredients kill good bacteria as well as bad.

The Auranta products are far more selective, however. They deal with the pathogens while protecting the good bacteria. The mechanism is quite complex but involves action on the gut wall which prevents the pathogens from attaching to it. We allow them go through and do no harm, but we dont do anything to stop the production of good bacteria.

This also helps reduce the use of antibiotics. There is nothing wrong with antibiotics, says Cullen. They are among the greatest discoveries in human history. But they can cause problems if they are overused. New legislation is coming in at the end of 2021 and farmers will not be allowed to use antibiotics to prevent infection or promote growth from them. At the moment, companies like McDonalds and KFC dont want antibiotics in the meat they buy.

Work started on the additives back in 2013. We had been looking at natural extracts from plants to improve the shelf life of food products and it wasnt too long before we started to look at nutritional products. We met with animal nutritionists and vets in the Far East and started looking at ideas for the animal feed area in 2014 and 2015. The lightbulb moment for us was when we found we could go in and just deal with the pathogens while keeping as many good bacteria alive as possible.

That saw the company begin work with Prof Nicolae Corcionivoschi of the Agriculture Food Biotech Institute in Belfast. He is a global expert in the animal microbiome and through him and our work with a group of Thai vets we started developing and testing products. We then carried out research to show what they were actually doing. Once we had the results we developed a product for use in animals.

AuraCalf was launched in 2018 and is now selling in eight markets with distributors appointed in 10 more and discussions ongoing with distributors in eight other countries.

Business is very good, says Cullen. Sales have doubled over the past year. Every penny we make goes back into product development. When we started out, we didnt have hard data to convince people we werent mad. Now that we have that data things are going very well. The calf product will do very well next year and we plan to introduce the poultry [product] in the Far East next year. We have some new products and enhancements in the pipeline, but we are going to stick to the knitting and build on what we have first.

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411 on colds and exercise – The Robesonian

November 10th, 2019 5:41 am

In preparation for my recent trip to Ireland, I made sure I had my annual flu shot since I knew I would be in close quarters on the flight overseas. I very rarely get sick but figured I should error on the side of caution. Despite the flu shot, a combination of airplane air, change of climate, and one of my travel mates bringing her crud along for the trip, I ended up with some kind of chest cold.

Since my return I have tried just about everything to ditch this crud, from riding my Harley Davidson Softail really fast in order to blow the germs away, to sweating it out at CrossFit. I am happy to report that nearly two weeks later I can almost sleep through the night without coughing.

Cold season, unlike flu season, is really a 12-month affair. Anytime you get lots of people together in a space airplane, mall, movie theater, etc. chances are some of them have a cold and the germs are just waiting to jump on you.

Colds are the result of a viral infection, and there are several different types. The one that usually causes a cold in grown-ups like us is called the coronavirus and happens most often in early spring and winter. Colds cause sneezing, coughing, stuffy or runny nose and sometimes fever and chills. For the most part, colds will work their way out in three to five days, but some of the effects may linger longer.

If you are wondering about how colds affect our fitness routine, you are in the right place. Lets look at three questions regarding colds and fitness:

Does exercise prevent colds?

Regular exercise appears to have the advantage of being able to jump-start the immune system, and that can help reduce the number of colds you get. With exercise, the number and aggressiveness of certain immune cells, such as the ones called natural killer cells, increase by as much as 50% to 300%. If you exercise regularly, this temporary increase can help make the immune system more efficient at destroying intruders that cause illness such as colds. In one study reported in the American Journal of Medicine, women who walked for a half-hour every day for one year had half the number of colds as women who did not exercise. In this study, researchers associated regular walking with increasing levels of infection-fighting.

Does too much exercise make you catch a cold?

While for most of us over-exercising is not an issue, for some elite athletes it can be. Research indicates that athletes that participate in high-intensity sports marathon running, triathlons, etc. can actually get more colds. When an athlete trains too hard, the very white blood cells that help prevent illness decrease, leaving the body more vulnerable to getting sick. These ultra-athletes need to be aware and make sure they build in recovery days to their workouts to prevent illness.

Can you exercise with a cold?

Because exercise may help to boost immune function, its usually safe to exercise with a cold as long as you listen to your body. Sometimes cold medications, such as decongestants, can increase your heart rate. In addition, your heart rate is increased with exercise. The combination of exercise and decongestants can cause your heart to pump very hard. You may become short of breath and have difficulty breathing.

If you have a fever with a cold, exercise may stress your body even more. Thats why its important to wait a few days to get back to your regular exercise regimen. Working out too hard with a cold could stress your body, causing you to feel worse. This additional stress may hinder your recovery. It is best to back your exercise down a notch until you are 100%. Consult with your health-care provider if you have any questions or concerns about exercising while you are under the weather.

So there you have it. Exercise to prevent colds, keep exercising a little when you are under the weather, and dont work out so hard that your immune system crashes. My advice is to keep the hand sanitizer handy, dont drink behind your family or friends, and stay out of crowds until the sniffling season passes.

Kathy Hansen has more than 30 years of experience in the health and fitness field. She can be reached via e-mail at [emailprotected]

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‘Shark Tank’ recap: Doctor with virus-fighting supplement isn’t immune to criticism – USA TODAY

November 10th, 2019 5:41 am

Matthew Wilson, Special to USA TODAY Published 10:01 p.m. ET Nov. 3, 2019 | Updated 10:09 a.m. ET Nov. 4, 2019

After 10 seasons and 2,000 pitches, 'Shark Tank' sharks talk about the best, worst and funniest pitches they've heard. Harrison Hill, USA TODAY

On Sundays Shark Tank, a physician was in need of treatment after he felt the wrath of two angry sharks.

Asking for $125,000 for 5% of his company, Sarath Malepati is the inventor of the EZC Pak, a five-day immune support pack made of echinacea, zinc and vitamin C. EZC Pak is a supplement thats supposed to boost the immune system and fight viruses.

As a general surgeon, Malepati said he has noticed increased overuse of antibiotics, which he said have no effect on viruses and can turn bacteria into antibiotic-resistant superbugs.

Over the last 10 years, Ive been dealing with a lot of complex infections, Malepati said. In the beginning, these infectionswe used to be able to treat with antibiotics. Now the antibiotics dont work.

According to Malepati, the cause is rooted in consumer-driven health care, which irked shark Mark Cuban, who was critical of his product.

That is so wrong in every which way, Cuban said. I know family history and what happened in the past is more indicative of what is going to happen to your future than almost anything. So knowing information about yourself is critical.

Sarath Malepati, a surgeon from Los Angeles, presented his formulated immune support pack designed to reduce unnecessary antibiotic use on "Shark Tank."(Photo: Eric McCandless, ABC)

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Malepati disagreed with Cubans assessment: I dont see how any of this is relevant to the patient walking in and requesting antibiotics and walking out with it.

Malepati and Cuban continued to trade barbs. You said part of the problem were facing in America today is a consumer-driven health care, Cuban said. So you think its a bad thing that consumers have more information about their health?

Malepati clarified his statement, saying he thinks products are marketed to consumers who may not have adequate health literacy to determine whether or not they are effective.

Holding up the EZC Pak, Cuban agreed: Thats why this (expletive) gets sold. Because thats why theres tons of these out there.

Shark Robert Herjavec came to Malepatis defense: I dont think thats fair, Mark. I think the way he said it is fair.

But it was obvious even as Malepati continued his pitch, his thoughts were still on Cuban. He drew the anger of shark Lori Greiner, a big zinc advocate, by ignoring her.

Why are you ignoring what Im saying? Thats odd to me. I am talking to you, and youre looking over at Mark, Greiner said. I was the customer. Ive been taking zinc for years. Im a believer in this. I am the one talking about antibiotic resistance and how important it is. But the fact that when I talk to you, you dont even look at me Im out.

Sarath Malepati, a surgeon from Los Angeles, presented his formulated immune support pack designed to reduce unnecessary antibiotic use on "Shark Tank."(Photo: Eric McCandless, ABC)

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Offended, Greiner cut off fellow shark Kevin OLeary, who was more interested in the companys sales than the drama unfolding in the tank. Malepati tried to apologize to her, but she wasnt ready to forgive.

As a woman in business, I think its very important for women to speak up for themselves and to stand up for themselves in a respectful way, Greiner said. I looked right at you maybe you were shaken by what Mark said, I dont know. But what I do know is when you came out here, you were looking at everybody else, not really me. I just sense some chauvinism here.

But guest shark Daniel Lubetzky thought Malepati didnt have an issue with women, he had an issue with Cuban. The two continued to argue, leading Herjavec to interject: Why are you poking the bear?

Despite the rocky pitch, OLeary decided to make Malepati an offer, in part because of the companys $1.2 million in sales for the past year with 80% margins. His offer was $125,000 for a 5% stake, with a royalty of 60 cents per unit in perpetuity.

Malepati countered with $125,000 for 5% but a $1 royalty per unit for 36 months. The two finally decided on a royalty of $1 per unit until OLeary made $450,000.

All right, doctor, OLeary said shaking Malepatis hand. Maybe it wasnt the most pleasant journey.

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Live Well: Six supplements to boost immunity | Health – Colorado Springs Gazette

November 10th, 2019 5:41 am

Fall and winter. The time of the year when it can feel like somebodys put a pox on your house.

First the little people drag home all those germs from their classrooms, then cortisol-ridden (the stress hormone) adults catch them and cart them off to work, where they spread the plague with co-workers. Its a vicious cycle until the world thaws out, the sun shines and were all spending more of our time outdoors and on vacation.

With the holidays and kids back in school and the weather changing, people have more stress and might not be sleeping as well as usual, says Dawn Franz, a nutritional health coach at Natural Grocers. Its important to ramp up your stress-coping toolbox. Supplements can support your immune system, as well as being able to balance your stress response.

And heres a more esoteric tip, if you tend to lean in that direction, as I do. Author and alternative medicine proponent Deepak Chopra has a way to reframe the narrative that I particularly like. When you feel that early symptom you know the one, maybe your nose is a little tingly and runny or your throat hurts first thing in the morning when it was fine the night before it means something is running amok in your body. This is the time to take those potions that help you fight off a virus, such as umcka or oil of oregano, two of my favorites. But Chopra says its not the time to lament to yourself and anyone within hearing distance that youre getting a cold and youll probably be out of commission for the next week. Instead, tell yourself your immune system is simply working overtime right now to fend off intruder germs, not that youre about to get sick. Its more proactive, less victim.

Here are six supplements to try over the next few months, as recommended by Franz. Take one or all of them as a daily tonic. If youre prone to getting sick, you might want to take the more, the merrier approach, but its not necessary, says Franz.

If youre under a lot of stress, do reishi and vitamin D-3, she says. Colostrum is good for athletes who put their body through a lot of stress. It keeps them healthy and from getting sick as frequently.

Be sure to give each supplement a fair shot. Franz suggests sticking to each for a month, and if you dont notice anything, try a different one. Though she likes to give her body a break from the supplements every now and again, she says its also OK to take them year-round. Come spring and summer, however, you might naturally feel a desire to go pill-free, if youre feeling good and not as stressed.

The mushroom is considered the queen of immunity by folks at Natural Grocers. Its been a staple of traditional Chinese medicine for more than 2,000 years, and is known for its ability to strengthen life force, calm the mind, help with sleep and treat and support respiratory conditions.

Reishi is the original chill pill, said Franz. It helps with the stress response and enhances the immune function and active immune function. There are a variety of ways to take reishi (pronounced ray-shee), including in tea, liquid extract, powder and capsules.

Mushrooms, in general, are a boon for your body, even those simple white button mushrooms you see at the grocery. Also good are shiitake and lions mane mushrooms.

Franz likes the Host Defense brand for mushrooms. The products are organic and grown in the U.S.

Yes, this is made from a milky fluid thats released from a cows udder after shes given birth. Try to not think about that too much, as according to some noteworthy studies, colostrum is a great friend to the immune system. It helps boost secretory IgA, which in turn increases the lining of our intestinal cells, one of our first lines of defense against pathogens. Its available in capsules, chewable pills and powder.

This amino acid complex is important for creating glutathione, an antioxidant that protects the cells and supports normal detoxification. It helps break up mucus in the lungs and works to protect tissue in the lungs and respiratory tract. Its mostly available in capsules. This supplement might be contraindicated with certain medications youre taking. Check with your doctor if you have concerns.

Reliable providers include Now and Carlson.

Every cell in your body has a receptor site for vitamin D. Its important for modulating how the immune system works, so its not over-reactive or under-reactive. When its over-reactive, you feel really sick. If its under-reactive ,youll get everything that comes around. Vitamin D regulates the immune system and acts as an antioxidant. You can get it in gels, liquids or chewables.

Especially in Colorado, even if you get out, you need UVB rays to create vitamin D in body, said Franz. But from November to February, we dont get UVB rays at our altitude. Its essential to supplement.

Reliable providers include Now and Carlson.

Theres a reason cranberries appear so regularly at this time of year: Theyre rich in the same compounds blueberries are known for, and have a regulatory affect on immune cells that primes them to fight off an infection. The compounds are beneficial to immune barriers, such as the gastrointestinal tract and mouth. You can drink tea or use it in its fresh or dried form. Allow it to inspire you to concoct organic cranberry sauce, but find a recipe that doesnt require sugar, which is definitely not a friend of the immune system.

This is the essential mineral that can be obtained by munching two to three Brazil nuts every day. Its important for immune function and helps the body fight off pathogens. Studies show a deficiency in selenium results in a decrease of the immune system to kill the yucky things. If you dont like the nuts, take it in pill form. Many multivitamins have it. Get about 200 micrograms per day.

Contact the writer: 636-0270

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Create emotional health for pets – Lifestyle – The Times – The Times

November 10th, 2019 5:41 am

Animals, like people, need love, security, consistency and fulfillment in living a purpose. Without those needs being met, all of us will experience sadness, disconnect and depression emotionally and physically.

Several years ago, a man visited my office with a large, 4-year-old, male Doberman. Magnum appeared healthy, but suffered from a skin condition that caused hair loss and itching.

He had previously been diagnosed with allergies and was put on prednisone, but when he didn't improve, the veterinarian advised stopping the steroids and referred his owner to my office.

At his first visit, all of Magnums blood tests, urinalysis and heart function tests were perfect. We checked his heart, because young male Doberman's are prone to a condition called cardiomyopathy, which can decrease blood flow to other organs.

Magnum was diagnosed with demodectic mites or mange. This condition is not contagious to people or other dogs. All dogs have a limited number of mites around the eye, but when the immune system is suppressed, microscopic mites can spread to other areas and become a chronic problem, causing hair loss, inflamed skin and itching, even after they've moved to a new area of skin.

Most dogs that have the problem are affected as puppies, and then, when they are through rapid growth, eating a good diet and in a stable home situation, they typically stop having mite spread.

Many veterinarians manage mites with drug therapy, but often, changing the diet, avoiding allergens and excessive vaccines (vaccinations are meant for the healthy body, so they should be given after the dog is back to normal skin/immune function), and supplementing with immune health herbs, will bring about skin healing without limited drug usage.

My staff and I treated Magnum's immune and nutritional health, and when he showed only mild improvement over three weeks, we added traditional Western drug therapy.

Unfortunately, after four months of treatment, Magnum had only improved about 50 percent. I could not find a medical reason for his lack of return to complete health.

I started to consider other reasons for poor response to treatment: an autoimmune or immune dysfunction, either acquired or genetic; environmental toxins; or chronic emotional distress/abuse.

On the fourth visit, I gained insight into the home dynamics. I happened to be outside when the owner parked his car and witnessed his verbal and emotional harshness toward both the dog and his wife. It went beyond being short tempered and having a bad day, and I suspected, but didn't witness, actual physical abuse.

The wife's and the dog's reaction to the owner were very typical of those who are in unpredictable and abusive situations.

The owner did not know that I witnessed his actions, but when he asked me why the dog wasn't improving, I suggested that among other reasons, stress at home can be reason for family members and pets to have weakened immune function.

Magnum's owner thought my idea was ridiculous. He felt that Magnum could not possibly be stressed, because he got food, water, walks and grooming. What else could he need, besides medicine to treat his problem?

Magnum, like each person and animal on this planet, needed love, security, consistency and fulfillment in living his purpose. Without those needs being met, all of us will experience sadness, disconnect and depression emotionally and physically.

If you are looking for ways to maintain your pets health, prevent cancer, allergies and other chronic immune disorders, creating a loving and consistent home life is the best foundation.

Try these tips for creating emotional wellness:

1. Create independence early in life by giving your pet a home within your home (crate), and instead of carrying new pets constantly, give them independent times in their enclosure.

2. Avoid separating puppies from the litter and their mothers too early. How early is too early? It varies with each pet, but by eight weeks most pets can adjust to their new home.

3. For pets who suffer from separation anxiety, work with a veterinarian to establish a good diet and either supplements or medications to keep the condition from escalating. At the same time, consult with a behaviorist to recondition your pet's anxiety.

4. Create a harmonious home with soothing music and limited stress. If you or other family members suffer from high anxiety, exercise, do yoga or meditation to bring your stress down a level.

5. Like children, pets need physical play time daily to keep them from getting into trouble.

6. Create exercise and stimulation for pets surrounding feeding times. Rather than putting food in a single bowl, use multiples and allow pets to sniff out their food throughout the home and yard.

In addition to creating a harmonious home, pets need to fulfill their purpose. For cats that may be hunting. For a herding dog, the purpose is to round up or herd animals or kids.

Owners should observe the natural drive an animal has and either create a job or playtime activities that allow fulfillment of that desire.

Dr. Cynthia Maro is a veterinarian at the Ellwood Animal Hospital in Ellwood City and the Chippewa Animal Hospital in Chippewa Township. She writes a biweekly column on pet care and health issues. If you have a topic youd like addressed, please email ellwoodvet@msn.com.

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Critical Protein That Could Unlock West Nile/Zika Virus Treatments Identified by Researchers – Georgia State University News

November 10th, 2019 5:41 am

ATLANTAA protein that is critical in controlling replication of West Nile and Zika viruses and could be important for developing therapies to prevent and treat those viruses has been identified by a Georgia State University biologist and his research group.

The researchers found Z-DNA binding protein 1 (ZBP1) is a sensor that plays a significant role in triggering a robust immune response when it detects a viral infection within cells. The Georgia State study, published in the journal Frontiers in Microbiology, found ZBP1 is essential for restricting both West Nile and Zika virus replication, and that it prevents West Nile-associated encephalitis (inflammation of the brain) in mice. The absence of ZBP1 in mice leads to 100 percent mortality when infected with even a non-disease-producing strain of West Nile Virus, the study found.

Its significant because you take a virus that has never been shown to kill anything and if you block this protein the virus will just kill everything, said Mukesh Kumar, assistant professor of biology and senior author of the study. We discovered that when cells are infected with viruses such as Zika and West Nile, they respond by triggering necroptosis, a form of programmed cell death, via ZBP1 signaling. This inhibits viral replication and spread, allowing the immune system to clear the virus.

Kumar said the findings could present new treatment strategies for viruses that can infect the central nervous system by modulating ZBP1 expression. Subsequent research by Kumars team will explore effectiveness against similar viruses such as Eastern Equine Encephalitis and Powassan virus.

West Nile Virus is the leading mosquito-born disease and cause of viral encephalitis in the United States, with more than 50,000 people affected, including 480 cases reported in Georgia, according to the Centers for Disease Control and Prevention. There have been 2,330 associated deaths since it first reached the country in 1999. The Culex species of mosquito responsible for spreading it is common throughout the world.

Zika, which is spread by the Aedes mosquito that has been found as far north as Florida and Texas, can cause serious neurological diseases such as Guillain-Barre syndrome, which causes the bodys immune system to attack the nervous system. Birth defects such as microcephaly, an abnormally small head and brain can result. Most people who get Zika or West Nile dont get sick thanks to the bodys natural immune response and may not know theyve been infected, meaning their cases probably dont get reported.

Of the West Nile cases reported in the U.S., nearly 50 percent invade the nervous system leading to life-threatening or -altering consequences such as encephalitis. Drug treatments are often ineffective once a virus reaches the brain, but Kumar hopes enhancing host ZBP1 expression within the central nervous system could clear the virus from the brain and prevent severe disease associated with neuroinvasive viral infections such as West Nile and Zika.

If you try to open barriers to the brain you may be making it worse, Kumar said. Thats why we try to modulate some part of the host immune response. Manipulating a host protein already inside the genome to trigger the bodys natural immune response is a better way of fighting viruses already in the brain.

Co-authors of the study included Georgia State postdoctoral research associates Hussin A. Rothan and Komal Arora. For the full text of the article Z-DNA-Binding Protein 1 Is Critical for Controlling Virus Replication and Survival in West Nile Virus Encephalitis, go to: https://www.frontiersin.org/articles/10.3389/fmicb.2019.02089/full

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Genetic Variations Help Explain Why Immunotherapy Works Differently in Different People – On Cancer – Memorial Sloan Kettering

November 10th, 2019 5:41 am

Summary

A study reports on a new way to determine who is most likely to benefit from immunotherapy. It may help explain why immunotherapy works differently in people around the world.

Since 2011, the immunotherapy drugs called checkpoint inhibitors have become an increasingly important treatment for certain cancers. This is especially true for people with melanoma and lung cancer.

Early on, investigators observed that these drugs are extremely effective for some people, even eliminating their cancer entirely. Unfortunately, they dont work at all for many others. Considerable research has tried to understand why this is the case and exactly how these drugs work.

Checkpoint inhibitors work by releasing a natural brake on your immune system so that immune cells called T cells recognize and attack tumors.

Memorial Sloan Kettering physician-scientist Timothy Chan has focused on these efforts. He is one of the corresponding authors of a study published November 7, in Nature Medicine that reports a new way to determine who is most likely to benefit from immunotherapy. The findings may help explain why immunotherapy works differently in people around the world.

Our results help solve part of the mystery of why there is such a large variation in the effectiveness of immune checkpoint drugs, says Dr. Chan, who leads the Immunogenomics and Precision Oncology Platform at MSK. Its important that future clinical trials of immune checkpoint drugs take our discovery into account. This is especially important for international phase III trials.

For decades, the human leukocyte antigen (HLA) genes have been known to govern how the immune system responds to foreign substances in the body. Over thousands of generations, as early humans migrated out of Africa and around the planet, they evolved variations in their HLA genes. These changes protected them from infectious organisms that were found in different parts of the world.

The classic battle between pathogens and the human immune system plays out in the HLA genes, Dr. Chan says. A 2017 study from Dr. Chan was the first to show that HLA genes are important for the bodys ability to see cancer after immunotherapy as well. That study reported that people who had a greater number of different copies, or alleles, in their HLA-1 genes responded better to immunotherapy compared with those whose HLA-1 genes had fewer alleles. The new study builds on this previous work.

To quantify how efficient the immune system is at detecting cancer, the researchers looked at the HLA genes from more than 1,500 people who had received immune checkpoint drugs as part of clinical trials at MSK and other hospitals. Most of those included in the study had melanoma or non-small cell lung cancer, but other kinds of cancer were also represented.

Study Uncovers Genetic Reasons Why Some People Respond to Immunotherapy Better than Others

Immunotherapy drugs called checkpoint inhibitors have been a game changer for some people with cancer. But for most patients, these drugs have been disappointing. Researchers are trying to figure out why.

People inherit one copy of HLA-1 from each parent. For each person analyzed, the team found that the more molecularly diverse, or different from each other, the two copies of each of their HLA-1 genes were, the more likely someone was to respond to treatment and survive their cancer. The investigators developed a novel way to measure this difference, which they call HLA evolutionary diversity (HED).

Dr. Chans co-corresponding author on the Nature Medicine paper, Tobias Lenz of the Max Planck Institute for Evolutionary Biology in Germany, is an expert in the evolution of the human immune system and the HLA genes. Research fellow Diego Chowell and graduate student Chirag Krishna from Dr. Chans lab and graduate student Federica Pierini from Dr. Lenzs lab were the co-first authors.

Dr. Chan has also looked at other factors that make immune checkpoint drugs more effective. In 2014, he led the first studies finding that patients who responded to these drugs tended to have a large number of gene mutations in their tumors. This is known as having a high tumor mutational burden (TMB). When tumors have a greater number of mutations, it is more likely that they will produce proteins that the immune system hasnt seen before.

For checkpoint inhibitor drugs to be effective, the immune system needs to be able to recognize cancer cells as foreign, Dr. Chan says. High TMB and diverse HLA genes are two sides of the same coin. Both make it more likely that the immune system will see the cancer.

The researchers note in their study that high TMB and high HED are independent of each other, but the combined outcome of the two led to benefits from immunotherapy drugs that were greater than either of these effects on their own. These are the yin and yang of T cellbased immune checkpoint treatment, Dr. Chan says. High TMB is less useful if a person is unable to present the mutations to the immune system. Having a high HED allows that to happen.

Our results help solve part of the mystery of why there is such a large variation in the effectiveness of immune checkpoint drugs.

Recent immunotherapy clinical trials have begun to include TMB in their evaluation of how effective checkpoint inhibitors are, Dr. Chan notes. But among different trials, there is great variation in the role that TMB plays. No one has been able to figure out whats going on, he says. It turns out, we should also be looking at HLA diversity. This finding may account for the unexplained variation thats seen in the role of TMB in immunotherapy trials.

He adds that it may also account for the different response rates that have been observed in different parts of the world. HED can vary dramatically depending on where someone lives.

The investigators are now working to develop a standardized way to report HED, so that it can be incorporated into future clinical studies. Dr. Chans team is in the process of evaluating HED with industry partners using global phase III trial data. They hope that this measure can eventually become a regular part of cancer diagnosis and be used to match people with cancer with the most personalized treatments.

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