Category Archives: Immunology

Trending: Antibody Purification Services Market Study for 2020 to 2026 Providing Information on Key Players, Growth Drivers and Industry Challenges -…

June 22, 2020 medical

LOS ANGELES, United States: QY Research has recently published a report, titled Global Antibody Purification Services Market Size, Status and Forecast 2020-2026.The market research report is a brilliant, complete, and much-needed resource for companies, stakeholders, and investors interested in the global Antibody Purification Services market. It informs readers about key trends and opportunities in the global Antibody Purification Services market along with critical market dynamics expected to impact the global market growth. It offers a range of market analysis studies, including production and consumption, sales, industry value chain, competitive landscape, regional growth, and price. On the whole, it comes out as an intelligent resource that companies can use to gain a competitive advantage in the global Antibody Purification Services market.

Key companies operating in the global Antibody Purification Services market include , Thermo Fisher, Detai Bio-Tech Co, Cusabio, Genscript, KMD Bioscience, SouthernBiotech, Pacific Immunology, COVALAB, Envigo, GE Healthcare, Rockland, Creative Biolabs, Abcam, BBI Solutions, Karebay Bio, HuaBio, Antibodies Inc, Davids Biotechnologie GmbH, ProSci Inc, Bio-Rad Antibody Purification Services

Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :

https://www.qyresearch.com/customize-request/form/1596443/global-antibody-purification-services-market

Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global Antibody Purification Services market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Global Antibody Purification Services Market Segment By Type:

, Physicochemical Fractionation, Class-specific Affinity, Antigen-specific Affinity Antibody Purification Services

Global Antibody Purification Services Market Segment By Application:

, Monoclonal Antibodies, Polyclonal Antibodies

Competitive Landscape

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the global Antibody Purification Services market.

Key questions answered in the report:

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TOC

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered: Ranking by Antibody Purification Services Revenue1.4 Market Analysis by Type1.4.1 Global Antibody Purification Services Market Size Growth Rate by Type: 2020 VS 20261.4.2 Physicochemical Fractionation1.4.3 Class-specific Affinity1.4.4 Antigen-specific Affinity1.5 Market by Application1.5.1 Global Antibody Purification Services Market Share by Application: 2020 VS 20261.5.2 Monoclonal Antibodies1.5.3 Polyclonal Antibodies1.6 Study Objectives1.7 Years Considered 2 Global Growth Trends by Regions2.1 Antibody Purification Services Market Perspective (2015-2026)2.2 Antibody Purification Services Growth Trends by Regions2.2.1 Antibody Purification Services Market Size by Regions: 2015 VS 2020 VS 20262.2.2 Antibody Purification Services Historic Market Share by Regions (2015-2020)2.2.3 Antibody Purification Services Forecasted Market Size by Regions (2021-2026)2.3 Industry Trends and Growth Strategy2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Challenges2.3.4 Porters Five Forces Analysis2.3.5 Antibody Purification Services Market Growth Strategy2.3.6 Primary Interviews with Key Antibody Purification Services Players (Opinion Leaders) 3 Competition Landscape by Key Players3.1 Global Top Antibody Purification Services Players by Market Size3.1.1 Global Top Antibody Purification Services Players by Revenue (2015-2020)3.1.2 Global Antibody Purification Services Revenue Market Share by Players (2015-2020)3.1.3 Global Antibody Purification Services Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.2 Global Antibody Purification Services Market Concentration Ratio3.2.1 Global Antibody Purification Services Market Concentration Ratio (CR5 and HHI)3.2.2 Global Top 10 and Top 5 Companies by Antibody Purification Services Revenue in 20193.3 Antibody Purification Services Key Players Head office and Area Served3.4 Key Players Antibody Purification Services Product Solution and Service3.5 Date of Enter into Antibody Purification Services Market3.6 Mergers & Acquisitions, Expansion Plans 4 Breakdown Data by Type (2015-2026)4.1 Global Antibody Purification Services Historic Market Size by Type (2015-2020)4.2 Global Antibody Purification Services Forecasted Market Size by Type (2021-2026) 5 Antibody Purification Services Breakdown Data by Application (2015-2026)5.1 Global Antibody Purification Services Market Size by Application (2015-2020)5.2 Global Antibody Purification Services Forecasted Market Size by Application (2021-2026) 6 North America6.1 North America Antibody Purification Services Market Size (2015-2020)6.2 Antibody Purification Services Key Players in North America (2019-2020)6.3 North America Antibody Purification Services Market Size by Type (2015-2020)6.4 North America Antibody Purification Services Market Size by Application (2015-2020) 7 Europe7.1 Europe Antibody Purification Services Market Size (2015-2020)7.2 Antibody Purification Services Key Players in Europe (2019-2020)7.3 Europe Antibody Purification Services Market Size by Type (2015-2020)7.4 Europe Antibody Purification Services Market Size by Application (2015-2020) 8 China8.1 China Antibody Purification Services Market Size (2015-2020)8.2 Antibody Purification Services Key Players in China (2019-2020)8.3 China Antibody Purification Services Market Size by Type (2015-2020)8.4 China Antibody Purification Services Market Size by Application (2015-2020) 9 Japan9.1 Japan Antibody Purification Services Market Size (2015-2020)9.2 Antibody Purification Services Key Players in Japan (2019-2020)9.3 Japan Antibody Purification Services Market Size by Type (2015-2020)9.4 Japan Antibody Purification Services Market Size by Application (2015-2020) 10 Southeast Asia10.1 Southeast Asia Antibody Purification Services Market Size (2015-2020)10.2 Antibody Purification Services Key Players in Southeast Asia (2019-2020)10.3 Southeast Asia Antibody Purification Services Market Size by Type (2015-2020)10.4 Southeast Asia Antibody Purification Services Market Size by Application (2015-2020) 11 India11.1 India Antibody Purification Services Market Size (2015-2020)11.2 Antibody Purification Services Key Players in India (2019-2020)11.3 India Antibody Purification Services Market Size by Type (2015-2020)11.4 India Antibody Purification Services Market Size by Application (2015-2020) 12 Central & South America12.1 Central & South America Antibody Purification Services Market Size (2015-2020)12.2 Antibody Purification Services Key Players in Central & South America (2019-2020)12.3 Central & South America Antibody Purification Services Market Size by Type (2015-2020)12.4 Central & South America Antibody Purification Services Market Size by Application (2015-2020) 13 Key Players Profiles13.1 Thermo Fisher13.1.1 Thermo Fisher Company Details13.1.2 Thermo Fisher Business Overview and Its Total Revenue13.1.3 Thermo Fisher Antibody Purification Services Introduction13.1.4 Thermo Fisher Revenue in Antibody Purification Services Business (2015-2020))13.1.5 Thermo Fisher Recent Development13.2 Detai Bio-Tech Co13.2.1 Detai Bio-Tech Co Company Details13.2.2 Detai Bio-Tech Co Business Overview and Its Total Revenue13.2.3 Detai Bio-Tech Co Antibody Purification Services Introduction13.2.4 Detai Bio-Tech Co Revenue in Antibody Purification Services Business (2015-2020)13.2.5 Detai Bio-Tech Co Recent Development13.3 Cusabio13.3.1 Cusabio Company Details13.3.2 Cusabio Business Overview and Its Total Revenue13.3.3 Cusabio Antibody Purification Services Introduction13.3.4 Cusabio Revenue in Antibody Purification Services Business (2015-2020)13.3.5 Cusabio Recent Development13.4 Genscript13.4.1 Genscript Company Details13.4.2 Genscript Business Overview and Its Total Revenue13.4.3 Genscript Antibody Purification Services Introduction13.4.4 Genscript Revenue in Antibody Purification Services Business (2015-2020)13.4.5 Genscript Recent Development13.5 KMD Bioscience13.5.1 KMD Bioscience Company Details13.5.2 KMD Bioscience Business Overview and Its Total Revenue13.5.3 KMD Bioscience Antibody Purification Services Introduction13.5.4 KMD Bioscience Revenue in Antibody Purification Services Business (2015-2020)13.5.5 KMD Bioscience Recent Development13.6 SouthernBiotech13.6.1 SouthernBiotech Company Details13.6.2 SouthernBiotech Business Overview and Its Total Revenue13.6.3 SouthernBiotech Antibody Purification Services Introduction13.6.4 SouthernBiotech Revenue in Antibody Purification Services Business (2015-2020)13.6.5 SouthernBiotech Recent Development13.7 Pacific Immunology13.7.1 Pacific Immunology Company Details13.7.2 Pacific Immunology Business Overview and Its Total Revenue13.7.3 Pacific Immunology Antibody Purification Services Introduction13.7.4 Pacific Immunology Revenue in Antibody Purification Services Business (2015-2020)13.7.5 Pacific Immunology Recent Development13.8 COVALAB13.8.1 COVALAB Company Details13.8.2 COVALAB Business Overview and Its Total Revenue13.8.3 COVALAB Antibody Purification Services Introduction13.8.4 COVALAB Revenue in Antibody Purification Services Business (2015-2020)13.8.5 COVALAB Recent Development13.9 Envigo13.9.1 Envigo Company Details13.9.2 Envigo Business Overview and Its Total Revenue13.9.3 Envigo Antibody Purification Services Introduction13.9.4 Envigo Revenue in Antibody Purification Services Business (2015-2020)13.9.5 Envigo Recent Development13.10 GE Healthcare13.10.1 GE Healthcare Company Details13.10.2 GE Healthcare Business Overview and Its Total Revenue13.10.3 GE Healthcare Antibody Purification Services Introduction13.10.4 GE Healthcare Revenue in Antibody Purification Services Business (2015-2020)13.10.5 GE Healthcare Recent Development13.11 Rockland10.11.1 Rockland Company Details10.11.2 Rockland Business Overview and Its Total Revenue10.11.3 Rockland Antibody Purification Services Introduction10.11.4 Rockland Revenue in Antibody Purification Services Business (2015-2020)10.11.5 Rockland Recent Development13.12 Creative Biolabs10.12.1 Creative Biolabs Company Details10.12.2 Creative Biolabs Business Overview and Its Total Revenue10.12.3 Creative Biolabs Antibody Purification Services Introduction10.12.4 Creative Biolabs Revenue in Antibody Purification Services Business (2015-2020)10.12.5 Creative Biolabs Recent Development13.13 Abcam10.13.1 Abcam Company Details10.13.2 Abcam Business Overview and Its Total Revenue10.13.3 Abcam Antibody Purification Services Introduction10.13.4 Abcam Revenue in Antibody Purification Services Business (2015-2020)10.13.5 Abcam Recent Development13.14 BBI Solutions10.14.1 BBI Solutions Company Details10.14.2 BBI Solutions Business Overview and Its Total Revenue10.14.3 BBI Solutions Antibody Purification Services Introduction10.14.4 BBI Solutions Revenue in Antibody Purification Services Business (2015-2020)10.14.5 BBI Solutions Recent Development13.15 Karebay Bio10.15.1 Karebay Bio Company Details10.15.2 Karebay Bio Business Overview and Its Total Revenue10.15.3 Karebay Bio Antibody Purification Services Introduction10.15.4 Karebay Bio Revenue in Antibody Purification Services Business (2015-2020)10.15.5 Karebay Bio Recent Development13.16 HuaBio10.16.1 HuaBio Company Details10.16.2 HuaBio Business Overview and Its Total Revenue10.16.3 HuaBio Antibody Purification Services Introduction10.16.4 HuaBio Revenue in Antibody Purification Services Business (2015-2020)10.16.5 HuaBio Recent Development13.17 Antibodies Inc10.17.1 Antibodies Inc Company Details10.17.2 Antibodies Inc Business Overview and Its Total Revenue10.17.3 Antibodies Inc Antibody Purification Services Introduction10.17.4 Antibodies Inc Revenue in Antibody Purification Services Business (2015-2020)10.17.5 Antibodies Inc Recent Development13.18 Davids Biotechnologie GmbH10.18.1 Davids Biotechnologie GmbH Company Details10.18.2 Davids Biotechnologie GmbH Business Overview and Its Total Revenue10.18.3 Davids Biotechnologie GmbH Antibody Purification Services Introduction10.18.4 Davids Biotechnologie GmbH Revenue in Antibody Purification Services Business (2015-2020)10.18.5 Davids Biotechnologie GmbH Recent Development13.19 ProSci Inc10.19.1 ProSci Inc Company Details10.19.2 ProSci Inc Business Overview and Its Total Revenue10.19.3 ProSci Inc Antibody Purification Services Introduction10.19.4 ProSci Inc Revenue in Antibody Purification Services Business (2015-2020)10.19.5 ProSci Inc Recent Development13.20 Bio-Rad10.20.1 Bio-Rad Company Details10.20.2 Bio-Rad Business Overview and Its Total Revenue10.20.3 Bio-Rad Antibody Purification Services Introduction10.20.4 Bio-Rad Revenue in Antibody Purification Services Business (2015-2020)10.20.5 Bio-Rad Recent Development 14 Analysts Viewpoints/Conclusions 15 Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.2 Data Source15.2 Disclaimer15.3 Author Details

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Immunology

Allogene Therapeutics Announces Publication Highlighting Potential for ALLO-819 In Acute Myeloid Leukemia – BioSpace

June 22, 2020 medical

SOUTH SAN FRANCISCO, Calif., June 22, 2020 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, today announced a publication in Molecular Therapy demonstrating the potential for ALLO-819, an investigational AlloCAR T therapy targeting FLT3 as a novel treatment for acute myeloid leukemia (AML). These preclinical findings were previously presented as a poster at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in December 2019.

While weve seen exceptional clinical efficacy with autologous CAR T therapies in hematological malignancies, the inherent limitations of autologous cell therapies can be more pronounced in a rapidly progressing disease such as advanced AML, said Barbra Sasu, Ph.D., Chief Scientific Officer at Allogene. The high anti-leukemic activity of ALLO-819 seen in preclinical studies, combined with a safety mechanism to mitigate potential off-tumor effects and the benefits of an off-the-shelf option, supports our goal to advance ALLO-819 for a patient population with very few treatment options.

In this study, healthy donor T lymphocytes were engineered to express CARs that bound to different domains of the FLT3 protein. These CARs were then tested for their ability to mediate specific killing of FLT3-expressing cells without off-target activity. A CAR construct was selected based on exhibiting minimal potential for exhaustion and potent antitumor activity in vitro and in vivo models.The lead candidate was then engineered to contain an off-switch responsive to rituximab, resulting in ALLO-819.

ALLO-819 utilizes Cellectis technologies. Allogene holds global development and commercial rights for this investigational candidate. This pre-clinical research was conducted in collaboration with both Cellectis and Pfizer Cancer Immunology Discovery.

About Acute Myeloid LeukemiaAcute myeloid leukemia (AML) is a form of cancer that is characterized by infiltration of the bone marrow, blood, and other tissues by proliferative, clonal, abnormally differentiated, and occasionally poorly differentiated cells of the hematopoietic system.i AML is the second most common type of leukemia diagnosed in adults and children, but most cases occur in adults, making up 32% of all adult leukemia cases.ii Patients with relapsed or refractory AML often have a poor prognosis and limited treatment options, and is typically only curable in 5 to 15% of patients who are older than 60 years of age.iii

About Allogene TherapeuticsAllogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit http://www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to further research and develop ALLO-819 for the treatment of AML, the potential benefits of ALLO-819, the ability to manufacture ALLO-819, the ability to develop allogeneic CAR T therapies for cancer and the potential benefits of AlloCAR T therapy. Various factors may cause differences between Allogenes expectations and actual results as discussed in greater detail in Allogenes filings with the SEC, including without limitation in its Form 10-Q for the quarter ended March 31, 2020. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

AlloCAR T is a trademark of Allogene Therapeutics, Inc.

Allogene Media/Investor Contact:Christine CassianoChief Communications Officer(714) 552-0326Christine.Cassiano@allogene.com

_____________________

i Dhner H, Weisdorf D, Bloomfield C. Acute Myeloid Leukemia. N Engl J Med. 2015; 373:1136-1152.ii Leukemia - Acute Myeloid - AML: Statistics. Retrieved from https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/statistics.iii Dhner H, Estey E, Amadori S, et al. Blood. 2010; 115 (3): 453474.

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Immunology

We Thought We Had COVID-19 In January, But What Do Our Antibodies Say? – KPBS

June 21, 2020 medical

You probably know someone who thinks they had COVID-19 back in January. I happen to know someone like that pretty well.

My husband Seth was really sick in mid-January. I recently asked him what he remembered.

"It came on very suddenly, I woke up one morning, started getting ready for work, never made it to work," he said. "I was coughing so long and to such a degree that I had to force myself to stop coughing to gasp for breath."

He also had the chills so bad that he was sleeping in multiple layers of clothes under several blankets. Though he never took his temperature, despite strong suggestions from his wife.

After three weeks of this, I finally convinced him to go to urgent care. He got an inhaler and some antibiotics.

Then, about a month later, the coronavirus showed up in the U.S. It didnt take long for Seth to connect the dots.

"I would kind of wonder if this sudden, unusual illness could be attributed to that disease," he said.

I thought it was a possibility because Seth's symptoms so closely matched the COVID-19 symptoms. And a week after he got sick, I was knocked out for two days with complete exhaustion and body aches.

Of course, I wanted it to be true if we really had already survived coronavirus, while we'd still be cautious, it would feel like a huge worry had been lifted for ourselves and our almost 3-year-old son.

Then I heard about this study happening at the La Jolla Institute for Immunology. Researchers there are searching the world for antibodies from people whove survived COVID-19. The institute usually just runs antibody tests on people who had already tested positive for COVID-19, but they agreed to test Seth and me for this story.

RELATED: La Jolla Institute Leading Global Hunt For Antibodies To Coronavirus

When we showed up a nurse took blood samples from both of us, put them in a centrifuge and passed them off to Dr. Jen Dan, an infectious disease researcher. She began what's called an ELISA, a way of testing the blood samples to see whether they contained specific antibodies.

Dan would compare our blood to other samples from both people whove survived COVID-19 and people who hadn't been infected. If we had the same antibodies as the survivors, then we also very likely had the disease.

The test would take 24 hours to complete, so we'd have to wait another day to know whether our suspicions were founded.

Right now, antibody tests are pretty easy to find. You can buy them over the counter or on the internet, and many blood banks have started to offer them for free. But epidemiologists are heaping lots of caution on both the tests and their results. Some arent approved by the U.S. Food and Drug Administration and they can be wrong, even giving false positives.

Plus, even if you had antibodies, you don't know for sure whether you're immune, said Dr. Erica Ollmann Saphire, the director of a global antibody consortium at La Jolla Institute for Immunology.

"We think that most people that have been infected will have made an antibody response, but there may have been some that didn't," she said. "What we most need to know is whether the antibody response is protective, whether having those antibodies will mean that you won't get sick again."

The evidence suggests people with antibodies likely have immunity, but they don't know how much or how long it lasts, Saphire said. The research she's leading is working to find the very best antibodies from COVID-survivors, which will be used to treat COVID and hopefully prevent it in the first place.

With those best-of-the-best antibodies, Saphire hopes to make drugs that can treat COVID and help people from catching it in the first place.

The next day, Seth and I came back to the institute and watched Dan, the infectious disease researcher, finish the test. During the last step, she added a colorless solution to reveal the presence of antibodies. If there were antibodies, the mixture would turn blue.

The top two rows on her plate had the samples from the known coronavirus survivors, and those little wells of liquid quickly turned blue. Underneath those were Seth and my samples. I kept peering over them, hoping for two blues.

Dan had a great poker face, and not just because she was wearing a mask. She took the samples away to analyze them on her computer.

After what seemed to us like a long time, she came back and went over the results with Dr. Shane Crotty, an infectious disease expert at the institute. Crotty pulled up them on his computer. Suddenly, he seemed like a doctor who was very good at giving bad news.

"These are the positives," he said, pointing at several dots on a graph. "Today, here are the negatives that she ran, and here's Seth and here's Claire."

Our marks sat on the graph below all the other negatives. We were super negative. Meaning we definitely had not had COVID-19.

"We're below negative, not even negative," I said with a laugh.

"Yeah, you are," Crotty said.

But, our results make sense, he said.

"This certainly fits with the timeline in California, that there weren't any confirmed cases in California at the time you were sick," he said. "And even right now when people get (antibody) tests, you can see the numbers that are reported are 10% positive, which means nine out of 10 people who thought they were infected are frequently turning out that, no it wasn't."

So, the upshot from our little adventure is that despite what your friend, your neighbor or your husband might be telling you and what you might be telling yourself its highly unlikely that anyone in San Diego had COVID-19 before February.

KPBS' daily news podcast covering local politics, education, health, environment, the border and more. New episodes are ready weekday mornings so you can listen on your morning commute.

Claire Trageser Investigative Reporter

As a member of the KPBS investigative team, my job is to hold the powerful in San Diego County accountable. I've done in-depth investigations on political campaigns, police officer misconduct and neighborhood quality of life issues.

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We Thought We Had COVID-19 In January, But What Do Our Antibodies Say? - KPBS

Immunology

The 3 Best Coronavirus Stocks to Buy for Long-Term Investors – The Motley Fool

June 21, 2020 medical

Let's face it: Some companies that are receiving a lot of hype right now about their COVID-19 programs won't have staying power. Small biotechs claiming to have a game-changing treatment on the way could run into the harsh realities of clinical testing. Diagnostic test makers with all of their chips on COVID-19 could be left in the dust a couple of years from now when the pandemic has run its course.

The stocks of such companies might be OK for traders to buy to make a quick buck in the short run. But they're unsuitable for investors seeking to generate big gains over the long run. Here are my picks for the three best coronavirus-related stocks to buy for long-term investors.

Image source: Getty Images.

Abbott Labs (NYSE:ABT) quickly rolled out several COVID-19 diagnostic tests after the coronavirus hit with full force earlier this year. Its ID NOW test, which received FDA Emergency Use Authorization (EUA) in late March, attracted significant attention because it offered the fastest results of any COVID-19 test available.

I expect that COVID-19 testing will continue to fuel sales growth for Abbott over the next few years. However, there are several more important growth drivers for the company.

Put Freestyle Libre at the top of the list. Abbott recently won FDA clearance for a new version of the continuous glucose monitoring (CGM) system that supports integration with other medical devices. My prediction is that Freestyle Libre 2 will enjoy skyrocketing consumer demand and be a resounding success for Abbott.

Wall Street analysts project that Abbott will be able to deliver average annual earnings growth of more than 10% over the next five years. I think that estimate is realistic. Throw in Abbott's reliable dividend, and you've got a blue chip stock with a COVID-19 focus that's likely to beat the total returns of the S&P 500 over the long run.

Gilead Sciences (NASDAQ:GILD) has been at the center of the coronavirus world since its antiviral drug remdesevir was first touted as a potential treatment for COVID-19. With late-stage clinical studies now supporting the safety and efficacy for remdesivir, Gilead is well positioned to remain a fixture in the fight against the novel coronavirus.

However, it's Gilead's treatment for another virus -- HIV -- that has been and will continue to be its biggest opportunity. The biotech's lineup includes multiple blockbuster HIV drugs. Gilead is evaluating a long-acting HIV therapy in phase 2 clinical studies that could be its greatest commercial success yet. Looking further down the road, the company could even have a cure for HIV on the way.

Thanks to its strategic partnership with Galapagos, Gilead is poised to make its mark in immunology. The company awaits U.S. and European regulatory approvals for filgotinib in treating rheumatoid arthritis. It also is likely to become an even bigger player in the oncology market with new indications for CAR-T therapy Yescarta potentially on the way and the acquisition earlier this year of cancer-focused biotech Forty Seven.

My view is that Gilead's COVID-19, HIV, immunology, and oncology programs will enable the big biotech to deliver solid growth over the long run. That growth will be bolstered by one of the most attractive dividends in the healthcare sector: Gilead's dividend yield currently stands at nearly 3.7%.

While lots of small biotechs have scrambled to develop COVID-19 therapies, I've kept my eyes onEli Lilly (NYSE:LLY). The big drugmaker has moved at breakneck speed with its partners to advance two COVID-19 antibody therapies into clinical studies. It's also evaluating blockbuster rheumatoid arthritis drug Olumiant and pipeline candidate LY3127804 in treating COVID-19.

I won't be surprised if Lilly achieves success with at least one of its coronavirus efforts. In the meantime, the company's diabetes drug franchise continues to rock along thanks primarily to strong sales for Jardiance and Trulicity. Lilly is also a top contender in the immunology market with Olumiant and Taltz.

The company's greatest growth opportunity, though, could be in oncology. Lilly recently announced overwhelmingly positive results from a late-stage study of Verzenio in treating early-stage breast cancer. It won FDA approval in May for Retevmo in treating lung and thyroid cancer. Cyramza also continues to pick up momentum in treating several solid tumors.

Analysts think that Lilly could deliver average annual earnings growth of nearly 13% over the next five years. That level seems quite attainable to me, considering the company's solid current lineup and promising pipeline. With Lilly's dividend yield of 1.8% included, I think the pharma stock should easily outperform the overall market's total returns over the long run.

Immunology

How does the body fight COVID-19? U of T researcher’s work could aid vaccine development – News@UofT

June 18, 2020 medical

JenGommerman, an immunologist at the University of Toronto, wants everyone to know one important point about the COVID-19 pandemic: The human immune system is working to fight off this novel coronavirus.

Many thousands of people have died from the virus. But many more thousands have contracted it and survived. That is because when the virus first enters your body, usually through your nose or mouth, it triggers the immune system to send antibodies in response. Antibodies are proteins in your blood that your body uses to fight infection. In diseases such as chicken pox, the antibodies usually prevent you from getting the illness again. The formal term for the generation of antibodies is a humoral immune response.

But COVID-19 the illness caused by the SARS-CoV-2 virus is puzzling scientists with some challenging questions: If a person recovers from COVID-19, will the antibodies keep that person from being infected again? Why dont some people show symptoms? What happens as soon as the virus enters the body?

Gommerman, a professor in the department of immunology in the Faculty of Medicine, has received support from the Ontario COVID-19 Rapid Research Fund to conduct research in collaboration with an interdisciplinary team of scientists to answer these and other questions.

She emphasizes that the greatest challenge in understanding anything to do with COVID-19 is the fact that it is new.

Understanding how SARS CoV-2 induces a humoral immune response is vital to scientists eventually developing a vaccine, she says. But the world has only known about this virus since December or January. It is brand new. The science community doesnt fully understand yet how the immune system responds to the virus.

So my teams work will shed some light on that, which, in turn, could help with the development of a vaccine.

The provinces rapid research fund is also supporting the work ofJean-Philippe Julien, senior scientist in molecular medicine at the Hospital for Sick Children and an assistant professor in biochemistry and immunology at U of T. His projectwill usemolecular technology to develop a potent and broad antiviral treatment.

As forGommerman, she will be developing an assay (the scientific term for a test or experiment) to identify antibodies in saliva in the hopes of better understanding the early immune response when the virus enters the oropharyngeal tract (a part of the throat behind the mouth and nasal cavity).

Like so much of the COVID-19 research being conducted now, the work being spearheaded byGommermanis a collaboration with a number of other scientists at U of T and the universitys partner hospitals.

Gommermansresearch into saliva, for example, will be compared with assays being done byAnne-Claude Gingras, a senior investigator at Sinai Healths Tanenbaum Lunenfeld Research Institute and a professor of molecular genetics at U of T.

Gingras has led the development of a blood test that can detect antibodies in the immune system of infected patients. The test has the potential to enable hospitals and other institutions to screen up to 10,000 samples at once. This type of analysis is called serosurveillance the study of blood serum, especially as it relates to the work of the immune system response to pathogens entering the body.

Serosurveillanceis an important weapon in our fight against COVID-19,Gommermansays. It has the power to tell us what is the true scope of the pandemic. This is what the blood experiments at Mount Sinai get us.

For the saliva experiments, we will learn more about what is happening early in the immune response in asymptomatic patients in the oropharyngeal tract where the virus is first introduced. This has the potential to reveal what aspects of the immune response might confer protection to those people who never show symptoms or only show mild symptoms.

Key to understanding the early immune response is a collaboration withDarrell Tan, an infectious diseases physician and clinician-scientist at St. Michaels Hospital. Tan, who is also an assistant professor in U of Ts Faculty of Medicine and at the Institute of Health Policy, Management and Evaluation at the Dalla Lana School of Public Health, is enrolling 1,000 subjects, via contact tracing, who have been linked to patients infected with COVID-19. Tan and his team will test the saliva of these people regularly over a number of weeks.

The contacts are called a ring of associates.

Because the people in that ring have a higher chance of contracting COVID-19 than the general public, we will presumably have people who are just getting infected, saysGommerman. This will allow us to learn why some people dont show symptoms but still have the illness and how the early immune response actually works.

BothGommermanand Gingras are using proteins produced by U of TsJames Rini, professor in the departments of molecular genetics and biochemistry. The proteins are highly purified pieces of the SARS-CoV-2 virus that are used as bait to catch antibodies in the saliva or in the blood so that the researchers can measure them.

Without Jims work on these proteins, we wouldnt be able to go further in our research, saysGommerman. Hes been studying coronavirus proteins since SARS first hit North America in 2003. The science community doesnt know nearly as much about coronaviruses as we do, for example, influenza.

We owe a lot to researchers like Jim who have been building up a knowledge base about coronaviruses. Were relying on them now.

Further to the collaborative nature of the research,Gommermansteam is using saliva samples from patients who have had the virus, andwho have recovered. The samples were collected by:Mario Ostrowski, a professor in the departments of medicine, immunology and laboratory medicine and pathobiology at U of T;AllisonMcGeer, director of the Infectious Diseases Research Unit at Mount Sinai Hospital and a U of T professor in the departments of medicine and laboratory medicine and pathobiology (LMP), as well as at the Dalla Lana School of Public Health; andSamiraMubarekaan assistant professor in the department of laboratory medicine and pathobiology who is at Sunnybrook Health Sciences Centre.

The multidisciplinary nature of the research is what enabledGommermanto pivot from her usual work on autoimmune diseases, especially multiple sclerosis, and gut immunology. The ability to draw on the skills and experiences of members of her team was also key.

Our research associate, Dr.Olga Rojas, had worked on saliva antibodies to a disease called rotavirus when she was studying in Columbia, South America.

Also key to the pivot were three first-year doctoral students BaweletaIsho,Annie PuandMichelle Zuo.

I didnt want to pull more senior students from their doctoral work, so I asked these first-year students to help with the work,Gommermansays. Theyve been amazing, as well as our project manager, Dr.Gary Chao,who organized all the samples and made sure we were compliant from a biosafety and ethics perspective. This was urgent work and they all rose to the occasion under a lot of pressure.

with files from Amanda Ferguson

Immunology

Want to Avoid Another Shutdown? Wear a Mask, Experts Advise – Duke Today

June 18, 2020 medical

DURHAM, N.C. -- If youre in public and see someone wearing a mask, that person is doing it for your benefit.

So return the favor.

That was one of several themes to emerge Thursday from a media briefing featuring two Duke medical scholars with vast expertise in vaccines, immunology and the spread of infectious diseases like COVID-19.

Drs. Sallie Permar and Cameron Wolfe took questions for an hour on myriad issues. Here are excerpts:

Dr. Cameron Wolfe, infectious disease specialist

The scientific consensus is actually quite clear. The consensus exists on both the types of masks and their protective efficacy of the individual wearing it, and also the collective benefit for the community.

That second part has really not been emphasized sufficiently. People have sort of viewed a mask as something designed to protect them. While that may be true in a hospital ward in the community the drive is very clearly to protect everyone else.

We understand now very clearly this virus has a pre-symptomatic phase of shedding. Even though I may not be symptomatic today, even though I may have no idea of the fact I may become sick in a day or two I can pass it to other people unwittingly. So my wearing a mask fundamentally protects you when I dont know Im sick or infectious. That part of the science is actually pretty clear.

The wearing of any mask, including cloth masks that folks will now see for sale widely, is very satisfactory at me preventing you getting sick. Thats the public health part of this. When I walk down the street wearing a mask, Im doing that for other folk around me, not fundamentally for me.

Dr. Sallie Permar, pediatric infectious disease specialist

The data has really shown that wearing a mask and preventing those respiratory droplets from spreading on other people is really effective.

The masks are super useful in protecting those that you are around. You wear a mask to prevent infecting others. It does play some role in protecting yourself as well. When we think about requiring masks I think its something that the benefit versus the inconvenience weighs towards the benefit.

Permar

Its hard to remember to wear a mask, and its uncomfortable, so the more you see other people doing it, the more youll be reminded to do it.

I went out and bought some designer masks. I think everyone can show their personality in what masks they choose. The more we require masks, the more it will become normal in our everyday lives.

Wolfe

A lot of it is about good leadership and good example-setting. That is something I wish we could do better on as a community. We have almost politicized mask-wearing. That is some sort of dystopian reality where the wearing of a mask has become something that can be judged.

It comes from political leaders buying into this, it also comes from state and federal politics, with leaders visibly taking this to heart. That has not yet happened, and that needs to change if we want people to buy into this.

Wolfe

Being prepared to put a pause on things should be the first step. Im heartened that our state health departments are finally talking about the implications of what a pause to phase 3 for us would look like. If we consider ourselves to be data-driven and we see the data heading in the wrong way, its nonsense to think we can continue doing the same thing and expect that trajectory to change.

Re-crunching down can still be avoided if you put your efforts into the right mitigation strategies.

If you want to keep opening and if we want to allow businesses to function, an individual choice on behalf of our collective, for me to wear a mask, seems like a smaller move than closing down again.

Permar

School reopening is a really difficult decision that were facing. We will dig into the data that shows that children have a very different course of the infection. They are mostly asymptomatic. Whats really important to understand is how much do they transmit the virus? How much do they transmit virus to their peers? How much do they transmit virus to the staff and teachers? What about when we wear masks? Can we reduce that risk?

What I hope will transpire over the next couple months is the development of child-specific metrics. How many children who are presenting with routine health care test positive? How many children are testing positive in our community? Another example might be absenteeism for influenza-like illness.

What I hope is that the education leaders and the public health leaders can think about schools differently than how we treat bars and restaurants. The appropriate metrics for opening up the community in many places where adults are going to congregate -- the number that are hospitalized, the percent testing positive every day -- I dont know (if) we should apply those same metrics to children and schools.

We know that as much as teachers try and as much as parents try, the virtual learning will not be the same, especially (for) the youngest children who really need the face-to-face interaction.

Wolfe

Many of us, frankly, are starting to see some fatigue in the community. I think that fatigue expands to many things. It extends to mask-wearing, it extends to social-distancing fatigue. Those things have played into disease transmission. Unfortunately, the phased reopening has, I suspect, encouraged a little bit of a letdown of folks guard. You really are seeing that steady march of increasing cases, increasing hospitalizations. Weve got to figure out a way to turn that around.

Permar

I often think about what are going to be the impacts on children now and for the future. They are the ones who will be living with the impacts of this virus the longest.

Its a respiratory virus where children are not often severely affected during the acute infection. However, one thing that has been very new and still developing is seeing this post-infectious syndrome that happens almost exclusively in children. Theres an inflammatory syndrome that can be very severe.

It can land children in the hospital. Were still really understanding what that post-infectious syndrome is. But it has reminded us that children are not completely unaffected by this pandemic.

We know that despite them being a minority of the hospitalizations, they have been impacted majorly when it comes to their development, their education and even their routine health care that has fallen behind in this time.

As we look towards a vaccine, the vaccine is being developed at a most amazing speed. As a vaccinologist, I never thought Id see a vaccine developed within a year. Thats being solely focused on adults, and I think we need to consider adding children to that vaccine development as well. We know children are the targets of most vaccines.

They, of course, are often routes to adults becoming infected as well. Adding children into vaccine development is very important for us to think about now rather than waiting until all adults are vaccinated.

Wolfe

Id be nave not to be concerned. I think it is going to be really incumbent upon public health leaders and federal government leaders to demonstrate a clarity of message here that needs to be uniquely available and visible to the public. Yes, I am worried about skepticism. We have to continue to reiterate active demonstrations of safety.

Permar

If we roll out a vaccine to a large percent of the population and then have a safety concern, that will diminish the faith in vaccines. While were going at this with the most rapid speed because the pandemic is not ending until we have a vaccine, we are also facing the challenge of making sure its the safest vaccine we can put out in a rapid fashion.

Faculty Participants

Dr. Sallie PermarDr. Sallie Permarisa professor of pediatric infectious disease, immunology and molecular genetics atthe Duke School of Medicine. Permar can address how COVID-19 affects mothers and children, how viruses transmit between people and general questions on vaccine development. Read her USA Today op-ed.sallie.permar@duke.edu

Dr. Cameron WolfeDr. Cameron Wolfeis an associate professor of medicine and who can discuss transplant-related infectious diseases, general infectious diseases, biological and emergency preparedness for hospital systems, and influenza and respiratory viral pathogens.cw74@duke.edu

Duke experts on a variety of other topics related the coronavirus pandemic can be found here.

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Want to Avoid Another Shutdown? Wear a Mask, Experts Advise - Duke Today

Immunology

Asthma Not Associated With Increased Risk of Hospitalization Among COVID-19 Patients – PR Web

June 18, 2020 medical

More studies must be done to look at the underlying immune modulation caused by asthma or asthma treatment to see what impact it may have on COVID-19 outcomes. - Anju T. Peters, MD, MSCI, FAAAAI

MILWAUKEE (PRWEB) June 18, 2020

According to research from The Journal of Allergy and Clinical Immunology (JACI), patients with asthma were not more likely to be hospitalized due to COVID-19 than those without asthma. This finding comes despite asthmatics being more prevalent in the studys cohort than would be expected given the estimates of asthma prevalence nationwide.

This study set out to examine the prevalence of asthma and comorbidities in asthmatics with COVID-19. In addition, researchers determined the risk of hospitalization due to COVID-19 in asthmatics and looked at inhaled corticosteroid use and risk of hospitalization due to COVID-19.

The retrospective study was conducted across 10 hospitals affiliated with NorthwesternMedicine via automated chart review using Northwestern Medicines Enterprise Data Warehouse, an electronic repository of health records. In total, 1,526 patients with COVID-19 were identified and used in the study. Of those, 220 (14.4%) had asthma, which is significantly higher than the national asthma prevalence rate of eight to nine percent. These numbers were in line with published U.S. data from the Centers for Disease Control and Preventions Morbidity and Mortality Weekly Report during the study period.

Two models were used to examine if asthma was a risk for hospitalization due to COVID-19. The first model adjusted for demographic data including age, gender, and ethnicity, while the second model also adjusted for multiple risk factors, including smoking and obesity. In both models, there was no significant difference in the risk of hospitalization between asthmatics and non-asthmatics.

The prevalence of many comorbidities including obesity, hypertension, sleep apnea, COPD, and gastroesophageal reflux disease was higher in patients with asthma and COVID-19 than in non-asthmatics with COVID-19. However, these comorbidities did not translate to a higher rate of hospitalization in asthmatics compared to non-asthmatics with COVID-19. Patients with asthma also had a higher prevalence of allergic rhinitis, rhinosinusitis, and immunodeficiencies. Interestingly, rhinosinusitis was associated with a lower risk of hospitalization.

Dramatic racial disparities have been reported during the COVID-19 pandemic and this was true in this study. Non-Hispanic African Americans and Hispanics or Latinos comprised a significant proportion of the asthma cohort with COVID-19 and had higher likelihood of COVID-19 related hospitalizations in general.

Chart review was completed to document which asthmatic patients with COVID-19 had a prescription of an inhaled corticosteroid (ICS), combination inhaled corticosteroid plus long-acting beta-agonist (ICS/LABA), and/or systemic corticosteroids. Only one patient was on a biologic. Just under half (48.2%) of the patients were prescribed the aforementioned medications, and in general the risk of hospitalization for these patients was not significantly greater than for those not on them.

There was also no observable difference in mortality rates between patients with COVID-19 who had asthma and those who did not. Laboratory assessment actually saw lower levels of biomarkers used to identify COVID-19 severity in patients with asthma, though additional studies must be performed to understand why this is and if asthmatics may have any protection against the virus.

We would usually expect for asthmatic patients to have worse outcomes, as viral illness often can set off asthma exacerbations, said Anju T. Peters, MD, MSCI, FAAAAI, corresponding author of the study. More studies must be done to look at the underlying immune modulation caused by asthma or asthma treatment to see what impact it may have on COVID-19 outcomes.

Another limitation of the study, according to Dr. Peters, was that they were not able to assess the contribution of asthma severity or asthma endotypes to COVID-19 disease severity and cautioned that healthcare workers need to be vigilant of older patients, those with certain comorbidities, African Americans, and Hispanics as they are at increased risk of hospitalization in general due to COVID-19.

You can learn more about asthma and COVID-19 on the American Academy of Allergy, Asthma & Immunology website, aaaai.org.

The American Academy of Allergy, Asthma & Immunology (AAAAI) represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has more than 7,100 members in the United States, Canada and 72 other countries. The AAAAIs Find an Allergist/Immunologist service is a trusted resource to help you find a specialist close to home.

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Asthma Not Associated With Increased Risk of Hospitalization Among COVID-19 Patients - PR Web

Immunology

Peter Svennilson Elected to RAPT Therapeutics Board of Directors – GlobeNewswire

June 18, 2020 medical

SOUTH SAN FRANCISCO, Calif., June 18, 2020 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical companyfocused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, today announced the election of Peter Svennilson, Managing Partner of The Column Group, to its Board of Directors. Mr. Svennilson will replace David Goeddel, Ph.D., who did not stand for reelection to RAPTs Board of Directors due to other responsibilities, but will remain a member of RAPTs Scientific Advisory Board (SAB).

Peter has been integrally involved with RAPT over the course of the last several years, helping to steer our strategic direction and expanding our network within the industry, and we welcome his consistent counsel as an active Board member moving forward, said Brian Wong, M.D., Ph.D., President and CEO of RAPT Therapeutics. On behalf of the Board and the entire Company, Id like to thank David for his guidance and strategic direction, as well as his mentorship over the course of the last five years. We very much appreciate his contributions and are thrilled he will continue his involvement with RAPT through our SAB.

Mr. Svennilson was elected to the Board of Directors at RAPTs Annual Stockholder Meeting on Thursday, June 18, 2020. He is currently Managing Partner and Founder of The Column Group, a San Francisco-based biotechnology venture capital firm. Prior to founding The Column Group, Mr. Svennilson founded Three Crowns Capital, where he served as Managing Partner, and before that was Associate Managing Director in charge of European Investment Banking Origination at Nomura Securities in London. In addition to serving on RAPTs Board of Directors, Mr. Svennilson serves on the Boards of Directors of ORIC Pharmaceuticals, Inc., Ribon Therapeutics, Circle Pharma and Revolution Medicines, Inc. Previously, he served as Chairman of the Board of Directors of Seragon Pharmaceuticals, Inc. and Aragon Pharmaceuticals, Inc. Mr. Svennilson also served as a member of the Boards of Directors of Gritstone Oncology, Inc., Constellation Pharmaceuticals, Inc., NGM Biopharmaceuticals, Inc., PTC Therapeutics, Inc., Immune Design, Rosetta Inpharmatics LLC, ChemoCentryx, Inc. and Somalogic, Inc. and as Board Observer of Arcus Biosciences. Mr. Svennilson is currently a Trustee for The Institute for Advanced Study in Princeton, New Jersey. He received his M.B.A. from the Stockholm School of Economics and Finance.

Im delighted to join the Board of Directors at this exciting time in RAPTs history, commented Mr. Svennilson. With proof-of-concept data expected for both FLX475 and RPT193 this year and a robust early-stage portfolio of small molecules advancing through development, the Company is poised for growth. I look forward to working with the experienced management team to support the Companys evolution and advancement across a number of segments and therapeutic areas within our industry.

AboutRAPT Therapeutics, Inc.RAPT Therapeutics is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases. Utilizing its proprietary discovery and development engine, the Company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. RAPT has discovered and advanced two unique drug candidates, FLX475 and RPT193, each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of cancer and inflammation, respectively. The Company is also pursuing a range of targets, including hematopoietic progenitor kinase 1 (HPK1) and general control nonderepressible 2 (GCN2), that are in the discovery stage of development.

Forward-Looking Statements

This press release contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about clinical development progress and the timing of results from clinical trials of FLX475 and RPT193. Detailed information regarding risk factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in RAPTs Form 10-Q filed with the Securities and Exchange Commission on May 14, 2020 and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements.

Media Contact:Angela Bittingmedia@rapt.com(925) 202-6211

Investor Contact:Sylvia Wheelerswheeler@wheelhouselsa.com

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Peter Svennilson Elected to RAPT Therapeutics Board of Directors - GlobeNewswire

Immunology

Biomarker combo forecasts improved survival with antiPD-1/L1 agents in bladder cancer – Urology Times

June 18, 2020 medical

The dual biomarker of ARID1A mutations and CXCL13 expression at baseline predicted improved overall survival (OS) in patients with advanced bladder cancer, according to a retrospective analysis published in Science Translational Medicine.1,2

Researchers have struggled to develop predictive biomarkers for outcomes with immune checkpoint agents in patients with metastatic urothelial carcinoma. Single-biomarker research with PD-L1 level and tumor mutation burden (TMB) status have shown potential, but each has its pitfalls.

Most biomarker studies have been limited to a single biomarker, such as tumor mutational burden or PD-L1 expression, leadstudy author Sangeeta Goswami, MD, PhD, assistant professor ofGenitourinary Medical Oncology at The University of Texas MD Anderson Cancer Center, stated in a press release. Our study indicates that combinatorial biomarkers that reflect both the tumor mutational status and immune response will improve predictive capability of the biomarker and may enable better patient selection for treatment with immune checkpoint therapy.

For the discovery component of their research, the investigators used tumor samples from 2 clinical trials (NCT02387996 and NCT01928394) obtained at MD Anderson Cancer Center. Using these samples in multiplatform analyses with mouse models, the researchers found strong clinical activity with checkpoint inhibitors in patients whose tumors cells had ARID1Amutations and enriched expression of CXCL13 in surrounding immune cells

The researchers followed this discovery by retrospectively assessing data from the IMvigor210 and CheckMate-275 trials to independently confirm the predictive value of the biomarkers. The single-arm phase 2 IMvigor210 study (NCT02108652) examined atezolizumab (Tecentriq) in patients with locally advanced or metastatic urothelial cancer. The IMvigor210 study supported the FDA accelerated approval of atezolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are cisplatin ineligible.

The phase 2 single-arm CheckMate-275 trial (NCT02387996) explored nivolumab (Opdivo) in patients with metastatic or unresectable bladder cancer who progressed or recurred after treatment with a platinum agent. The CheckMate-275 trial supported the FDA accelerated approval of nivolumab for use in this setting.

Analysis of the IMvigor210 data showed that the median OS was 7.2 months higher in patients with ARID1A mutations versus those without, at 15.4 versus 8.2 months, respectively. The median OS in patients with high versus low CXCL13 expression was 17.1 versus 8 months, respectively. The median OS was 17.8 months in patients who had both biomarkers. Among those without either ARID1A mutations or CXCL13 expression, the median OS was only 7.1 months.

Similar outcomes were observed in the CheckMate-275 trial data. The median OS was 11.4 versus 6 months in patients with and without ARID1A mutations, respectively. The median OS was improved by 7.8 months in patients with high versus low CXCL13 expression, at 13.5 versus 5.7 months, respectively. The median OS increased to 19.1 months in patients with both biomarkers. Patients without either biomarker had a median OS of just 5.3 months.

We hope that our study will highlight the importance of developing combinatorial biomarkers that consider both tumor cells and immune cells, corresponding author Padmanee Sharma, MD, PhD, professor of Genitourinary Medical Oncology and Immunology at MD Anderson, stated in the press release. This approach may identify better biomarkers that can reliably predict response to immune checkpoint therapy across various tumor types.

Regarding next steps the investigators plan to launch a prospective study to assess the dual biomarker in patients receiving immune checkpoint therapy.

References

1. Combination biomarker predicts response to immune checkpoint therapy in patients with advanced bladder cancer. Published June 18, 2020. https://bit.ly/2AGKzt8. Accessed June 18, 2020.

2. Goswami S, Chen Y, Anandhan S, et al. ARID1Amutation plus CXCL13 expression act as combinatorial biomarkers to predict responses to immune checkpoint therapy in mUCC. Sci Transl Med. 2020;12(548):eabc4220. doi: 10.1126/scitranslmed.abc4220

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Biomarker combo forecasts improved survival with antiPD-1/L1 agents in bladder cancer - Urology Times

Immunology

Tonix Pharmaceuticals and Southern Research Announce Expansion of COVID-19 Vaccine Collaboration – BioSpace

June 18, 2020 medical

NEW YORK, June 18, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today an expansion of its strategic collaboration with Southern Research to include a study of T cell immune responses to SARS-CoV-2 in volunteers who have recovered or remain asymptomatic after exposure to COVID-19. The research is part of an ongoing and broader collaboration between Tonix and Southern Research to develop and conduct animal testing of Tonixs TNX-1800, which is a live replicating virus vaccine designed to protect against COVID-19. The data will support the interpretation of animal trial results with TNX-1800, which are expected in the fourth quarter of 2020 and subsequent human trials.

More than 200 years of vaccine experience, beginning with Dr. Edward Jenners landmark discoveries with horsepox and cowpox vaccines, have shown that T cell eliciting vaccines are particularly effective against viruses, said Seth Lederman, M.D., President and CEO of Tonix. We believe that protective vaccines against the SARS-CoV-2 virus will be similar in that regard. The data we plan to collect from recovered and asymptomatic COVID-19 volunteers will inform vaccine development on how to safely provide to vaccine recipients the same immune responses that others got from recovering from actual CoV-2 infection. If approved by the U.S. Food and Drug Administration (FDA) for use in healthy, non-pregnant adults without moderate or severe eczema, TNX-1800 would feature single-dose immunity without the use of adjuvants, ease of manufacturing on readily available systems, and glass-sparing distribution since we believe 100 doses of TNX-1800 could be packaged in a single vial. Our goal with TNX-1800 is to develop a vaccine that is well tolerated, produces strong, long-lasting immunity, and can be rapidly and broadly deployed.

Dr. Lederman, a former tenured professor at Columbia Medical School, who has made original contributions to immunology and virology, continued, Tonixs TNX-1800 is based on a virus that we believe is closely related to Dr. Jenners first vaccine. Vaccines that descended from Dr. Jenners vaccine were used to eradicate smallpox globally, the only virus ever successfully eradicated. Smallpox was spread through the respiratory route, but it was eradicated with a vaccine administered in the arm. Tonixs lead COVID-19 vaccine candidate, TNX-1800, is designed to elicit a predominant T cell response, with some antibody response, while three other early candidates in the Companys vaccine portfolio are designed to elicit almost pure T cell responses. Dr. Lederman added, The features of a protective immune response to SARS-CoV-2 remain unknown. But since SARS-CoV-2 is a virus, we believe that T cell responses, in particular T Helper Type 1, or TH1 responses, will play an important if not dominant role in protecting against serious illness from COVID-19. These studies will provide us with a blueprint for interpreting the results of planned animal and human studies with TNX-1800.

Raj Kalkeri, Ph.D., from Southern Research and technical lead for this study, said, This is groundbreaking research with regards to COVID-19. As scientists, we know that the most successful vaccines mimic and potentiate how the immune system responds to an invader. This additional work we are doing with Tonix will add focus to that objective. We are looking forward to a timely completion of this study, utilizing readouts from a variety of assays that can provide information about TH1 or other types of immunity.

An expert team of scientists from Southern Research, including Raj Kalkeri, Ph.D., Elizabeth Wonderlich, Ph.D., John Farmer, Ph.D. and Fusataka Koide, Director of Virology, is working on this collaboration.

About TNX-1800, TNX-1810, TNX-1820, TNX-1830 and TNX-801*

TNX-1800 is a live modified horsepox virus vaccine for percutaneous administration that is designed to express the Spike protein of the SARS-CoV-2 virus that causes COVID-19 and to elicit a predominant T cell response. TNX-1810, TNX-1820 and TNX-1830 are modified horsepox viruses that are designed to express different SARS-CoV-2 proteins than Spike and to elicit almost pure T cell responses. TNX-801 is a live horsepox virus vaccine 1. Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice1. TNX-801 vaccinated macaques showed no overt clinical signs after monkeypox challenge2. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, which can be manufactured on conventional cell culturing systems, with the potential for mass scale production.

1Noyce RS, et al. (2018) PLoS One. 13(1):e01884532Noyce, RS, et al. Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox* Presented as a poster at the American Society of Microbiology BioThreats Conference - January 29, 2020, Arlington, VA. (https://content.equisolve.net/tonixpharma/media/10929ac27f4fb5f5204f5cf41d59a121.pdf )

*TNX-801 and TNX-1800 are in the pre-IND stage and have not been approved for any indication

About Southern Research

Founded in 1941, Southern Research (SR) is an independent, 501(c)(3) nonprofit, scientific research organization with more than 400 scientists and engineers working across four divisions: Drug Discovery, Drug Development, Engineering, and Energy & Environment. SR supports the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries. SR works on behalf of the National Cancer Institute, National Institutes of Health, the U.S. Department of Defense, the U.S. Department of Energy, NASA, major aerospace firms, utility companies, and other private and government organizations. SR pursues entrepreneurial and collaborative initiatives to develop and maintain a pipeline of intellectual property and innovative technologies that positively impact real-world problems. SR is developing 18 drugs to combat various forms of cancer, ALS, Alzheimers, diabetes, kidney disease, Parkinsons and tuberculosis, among others. SR has developed 20 other drugs, including seven FDA-approved cancer drugsa number rivaling any other U.S. research institute. SR is headquartered in Birmingham, Alabama with additional laboratories and offices in Wilsonville, Alabama; Frederick, Maryland; Cartersville, Georgia; and Houston, Texas.

Further information about SR can be found at https://southernresearch.org

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonixs portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonixs lead vaccine candidate, TNX-1800*, is based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox and serves as the vector platform on which TNX-1800 is based. Tonixs lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects results from an unblinded interim analysis in September 2020 and topline data in the first quarter of 2021. TNX-102 SL is also in development for agitation in Alzheimers disease and alcohol use disorder (AUD). The agitation in Alzheimers disease program is Phase 2 ready with FDA Fast Track designation, and the development program for AUD is in the pre-Investigational New Drug (IND) application stage. Tonixs programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonixs preclinical pipeline includes TNX-1600 (triple reuptake inhibitor) , a new molecular entity being developed as a treatment for PTSD, TNX-1500 (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions, and TNX-1700 (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

*TNX-1800, TNX-801 and TNX-1300 are investigational new biologics and have not been approved for any indication.

**TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.

This press release and further information about Tonix can be found at http://www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as anticipate, believe, forecast, estimate, expect, and intend, among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (the SEC) on March 24, 2020, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Jessica Morris (corporate)Tonix Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 688-9421

Travis Kruse (media)Russo Partnerstravis.kruse@russopartnersllc.com(212) 845-4272

Peter Vozzo (investors)Westwickepeter.vozzo@westwicke.com(443) 213-0505

Continued here:
Tonix Pharmaceuticals and Southern Research Announce Expansion of COVID-19 Vaccine Collaboration - BioSpace