Category Archives: Immunology

Meet the Black Female Scientist Paving the Way In Race to Develop COVID-19 Vaccine – Atlanta Black Star

March 31, 2020 medical

Dozens of researchers around the world are racing to create a vaccine to eliminate the COVID-19 pandemic. Dr. Kizzmekia S. Corbett, a viral immunologist working with the National Institute of Allergy and Infectious Diseases, is a front-runner in its development.

Corbett is a lead researcher with Dr. Barney Grahams coronavirus team in the Vaccine Research Center in the NIAID, which is part of the National Institutes of Health. (The NIH, an agency within the Department of Health and Human Services, is the federal governments main biomedical research organization.)

Corbetts team has been working in recent weeks to help test and develop An experimental vaccine invented by private biotech company Moderna Inc. Along the way, her teams role was to grow so-called spike protein, a key component of Modernas coronavirus vaccine. (The NIH describes the spikes and virus thusly: Coronaviruses are spherical and have spikes protruding from their surface, giving the particles a crown-like appearance. The spike binds to human cells, allowing the virus to gain entry.)

Years of research into similar viruses had given Corbetts Vaccine Research Center team valuable experience at growing this protein, which they did quickly and sent to Moderna. With they received the first research doses of vaccine from Moderna, Corbett and her fellow scientists immunized dozens of mice. Days later, blood samples that were collected from the mice where checked to see if the mice were producing antibodies against that all-important spike protein.

When her team sent word of the positive results, it was absolutely amazing, Corbett told The Associated Press earlier this month.

The work, which cleared the way for a new phase 1 clinical trial on March 3, couldnt have moved so quickly had it not been for years of behind-the-scenes lab testing of a possible MERS vaccine, Corbett added.

I think about it a lot, how many of the little experimental questions we did not have to belabor this time around, Corbett said. As she saw the first promising mouse tests, she told AP, I felt like there was a beginning of all of this coming full circle.

Corbett had told Dr. Anthony S. Fauci, the NIAID director, it would take about 100 days to move into the trial. The group did it in 66.

Although an actual vaccine wont be ready for another 12 to 18 months, the announcement marks a new record in moving to human testing, Bloomberg reports. The NIH fellow started her work in January, when researchers first learned how infectious and contagious the virus is and how easily it spreads.

Corbett has nearly 10 years of research experience in immunology.

She received a B.S. in biological sciences, with a secondary major in sociology, from the University of Maryland-Baltimore County in 2008. After one year of post-baccalaureate training at NIH, she enrolled at University of North Carolina, from where she obtained her Ph.D. in microbiology and immunology in 2014.

Immunology

Immunology and Numerology | DG Hart – Patheos

March 26, 2020 medical

Lots of people are panicking about the spread and threat of COVID-19. Among those fearful is Angelo Cataldi, a sports-talk radio host on Philadelphias 94WIP. One of the reasons Cataldi and his morning team are still on the air is that Pennsylvanias governor, Tom Wolf, deemed radio stations an essential business. To its credit, the station regularly plays either public service announcements about washing hands (and more) or reports news about the pandemic.

One of the seeming misunderstandings about this virus is the mortality rate. The way Cataldi usually reacts to news that one of his co-works is symptomatic or that a sports celebrity being tested positive (like Rudy Gobert) is as if he had heard that someone heard the sentence of cancer. With governors and health authorities projecting millions of cases, and with largely high-end attention to every single death from the disease (in ways similar to nightly reports by Walter Cronkite about the Vietnam War), Cataldi may be spared of blame. All the news sounds horrible. Thats why the response of shutting down businesses seems proportionate.

The problem is that people are paying attention to a very small range of numbers. Italy is arguably the worst case of the COVID-19 outbreak and so far the nation has almost 70,000 cases with the astounding result of 6,800 deaths. [All of these dates are from March 24, 2020.] That is twice as many deaths as China (3,281), though reporting from the country in which the virus originated is largely unreliable. Compared to the United States (674), Italy has ten times the number of deaths and almost thirty-three percent more cases (the US has almost 50,000 cases). An important data point to keep in mind is the mortality rate. In the case of Italy, the rate is close to 10 percent, which is extraordinarily high. It is not as high as the mortality rates for Ebola (50%), MERS (33%), or polio (20%). But it is much higher than seasonal flu (0.1%). Even so, if you project Italys numbers onto the United States, with .0001 percent (7,000 cases out of 60,000,000 people) of Americans (320,000,000) getting the virus, that results in 320,000 total cases. A death rate of ten percent (roughly) projects to 32,000 deaths from COVID-19 in the United States. Thats a lot. But its also about the same number of people who die in auto accidents each year roughly 31,500. Imagine if newspapers and sports talk show hosts gave daily updates on the number of auto accident fatalities. Some people would likely be afraid to drive.

All of these numbers, though, are remarkably low when it comes to professional sports. Angelo Cataldi was rightly offended yesterday morning that Josh Harris, the owner of the Philadelphia Seventy-Sixers, had decided to cut staff (not players) salaries by twenty percent. The team later reversed its decision. The principal owner of the team, Harris, is reported to be worth $3.5 billion. Not a good look cutting five-figure salaries.

Hargrave: The biggest deal handed out by the Eagles so far was to defensive tackle Javon Hargrave, a three-year, $39 million deal. Over The Cap has the details of that contract.

The cap hits:

2020: $3.4 million

2021: $15.2 million

2022: $15.4 million

The cap hit in 2020 is small, but as you can see, it raises significantly in 2021.

The Hargrave deal costs the Eagles $3.4 million in cap space for 2020, bringing them down to around $40 million.

Rodney McLeod: The Eagles signed Rodney McLeod to a two-year, $12 million deal. The details on the cap hit are not yet known, but if you use the average of the contract, it will cost the Eagles $6 million in salary cap space, bringing them down to around $34 million.

Jalen Mills: Mills is back with the Eagles on a one-year deal that could be worth up to $5 million with incentives. His cap hit is going to be lower than the $5 million the deal could be worth, however, coming in at $4 million. The Mills signing brings the Eagles down to around $30 million in cap space.

$3 million compared to $39 million does seem small. And that is small compared to Tom Bradys $50 million deal with the Tampa Bay Bucs.

But wouldnt you think all those zeros in football player contracts might put 677 in perspective (number of deaths so far from COVID-19 in the US). Might you also be mindful of the astronomic salaries that professional athletes receive, compared to the ninety-nine percent, in an era when a socialist is one of the leading candidates for the Democratic Partys nominee for POTUS? Of course, death is awful and human life is much more valuable than dollars.

But when you are in the habit of counting, numbers could yield perspective. And so the number of deaths from this virus are comparatively small (Heart disease: 647,457; Cancer: 599,108; Accidents (unintentional injuries): 169,936; Chronic lower respiratory diseases: 160,201; Stroke (cerebrovascular diseases): 146,383; Alzheimers disease: 121,404.

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Immunology and Numerology | DG Hart - Patheos

Immunology

Berkeley Lights Announces the Global Emerging Pathogen Antibody Discovery Consortium (GEPAD) to Attack COVID-19 and Other Viruses – Yahoo Finance

March 26, 2020 medical

In collaboration with Vanderbilt University Medical Center, La Jolla Institute for Immunology and Emory University, viral neutralization workflows on the Berkeley Lights platform are under accelerated development in response to the Coronavirus outbreak

EMERYVILLE, Calif., March 25, 2020 /PRNewswire/ --Today Berkeley Lights, Inc., announced the Global Emerging Pathogen Antibody Discovery Consortium (GEPAD) with founding members Dr. James Crowe and Dr. Robert Carnahan at Vanderbilt University Medical Center, Dr. Erica Ollman Saphire at La Jolla Institute for Immunology and Dr. Frances Eun-Hyung Lee at Emory University with the aim to accelerate the discovery of neutralizing antibodies from patient blood samples. Processing precious blood samples and fragile cells can be challenging with traditional technologies. The consortium will leverage Berkeley Lights' Beacon platform for antibody discovery using the blood of recovering patients as the foundation for therapeutics, with COVID-19 as a first target.

(PRNewsfoto/Berkeley Lights)

While researchers around the world are quickly characterizing the SARS-CoV-2 virus, the ability to screen single B cells expressing a SARS-CoV-2 neutralizing antibody remains a significant and time-consuming challenge.The body has billions of B cells. After a patient recovers from SAR-CoV-2, they generate many B cells specific for the virus; however, some B cells will make antibodies that just bind to the virus but are not protective. Hence, finding the special B cells that eliminate or neutralize the virus is exceedingly rare. It is like finding a "needle in a haystack". The existing technologies can only search for binders, not neutralizers so researchers are forced to sequence and re-express the antibody from non-specific B cells wasting significant time and resources. The Beacon system and the viral neutralization assay is designed to address this problem by directly screening single cells for neutralizing function in a single day.

The primary goal of the GEPAD Consortium is to enable the quickest therapeutic response to emerging pathogens. The GEPAD Consortium is requesting that anyone interested in this viral neutralization workflow and advancing the state of the art reach out and join them in forming a defensive barrier worldwide against diseases caused by emerging pathogens. Members will be enabled to rapidly discover potential treatments using small volume blood samples from recovering patientsboth acute and convalescent. The consortium is rapidly iterating and improving the viral neutralization workflow executing on the Berkeley Lights platform and hopes that more collaborators will come forward to participate in fighting this epidemic and be better prepared for the next one.

"We have long sought to study the antiviral capacity of antibodies secreted by single human B cells, but the instruments and protocols for doing those studies didn't exist. Partnering with Berkeley Lights on developing innovative approaches to this single-cell biology task is now becoming a reality," said Dr. James Crowe, MD, Director of the Vanderbilt Vaccine Center.

"We have developed a specialized survival media for plasma cells and envision the use of it for rapid upfront selection of a rare target monoclonal antibody," said Dr. Lee. "Berkeley Lights together with this consortium will make this method a reality for COVID-19 neutralizing antibodies. We hope this helps in this pandemic to save lives."

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"There's an opportunity here to quickly mobilize something that could protect frontline workers or treat those who have been infected," explained Dr. Saphire. "Vaccines aren't available yet. Providing some immediate immunity using antibodies could be lifesaving for those who haven't been vaccinated or can't be vaccinated, or if the eventual vaccines aren't completely protective."

"COVID-19 is a serious threat to our health, our way of life, and the world economy," said Dr. Eric Hobbs, CEO of Berkeley Lights. "We are committed to doing our part by developing assays and workflows that researchers and therapeutic developers can use to rapidly discover antibodies that are key to treatments."

About Vanderbilt University Medical CenterVanderbilt University Medical Center (VUMC) is one of the nation's largest academic medical centers. As part of its research enterprise, in partnership with the Vanderbilt University School of Medicine, the Vanderbilt Vaccine Center is participating in the US Defense Advanced Research Projects Agency's (DARPA's) Pandemic Protection Platform (P3) program, a five-year cooperative agreement to develop protective antibody treatments that can be rushed to health care providers within 60 days after the outbreak of viral diseases anywhere in the world.

About La Jolla Institute for Immunology La Jolla Institute for Immunology is dedicated to understanding the intricacies and power of the immune system so that we may apply that knowledge to promote human health and prevent a wide range of diseases. Since its founding in 1988 as an independent, nonprofit research organization, the Institute has made numerous advances leading towards its goal: life without disease.

About Emory UniversityEmory University is one of the world's leading research universities. Its mission is to create, preserve, teach and apply knowledge in the service of humanity. The Emory effort is led by Dr. Lee of the Pulmonary, Allergy, Critical Care & Sleep Division, The Lowance Center for Human Immunology and the Emory Vaccine Center. She contributes culture methods developed in her lab that greatly improve the survival of B cells and plasma cells thereby facilitating the isolation of extremely rare cells producing the antibodies of interest.Dr. Lee's work is supported by NIH, the Lowance Center, Gates Foundation, and the Georgia Research Alliance.

About Berkeley LightsHere at Berkeley Lights, we think cells are awesome! Cells are capable of manufacturing cures for diseases, fibers for clothing, energy in the form of biofuels, and food proteins for nutrition. So the question is, if nature is capable of manufacturing the products we need in a scalable way, why aren't we doing more of this? Well, the answer is that with the solutions available today, it is hard. It takes a long time to find the right cell for a specific job, costs lots of money, and if you have picked a suboptimal cell line, has a very low process yield. Berkeley Lights has the complete solution to find the best cells by functionally screening and recovering individual cells for antibody discovery, cell line development, T cell analysis, and synthetic biology. Our proprietary technology, including the Beacon and Lightning platforms accelerate the rate you can discover and develop cell-based products in a fraction of the time and at a fraction of the cost of conventional, legacy research methods. Using our tools and solutions, scientists can find the best cells, the first time they look. For more information, visit http://www.berkeleylights.com.

Berkeley Lights' Beacon and Lightning systems and Culture Station instrument are:

For Research Use Only. Not for use in diagnostic procedures.

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Berkeley Lights Announces the Global Emerging Pathogen Antibody Discovery Consortium (GEPAD) to Attack COVID-19 and Other Viruses - Yahoo Finance

Immunology

Harvard Prof.: Don’t Count On A COVID-19 Vaccine In 12 To 18 Months – WBUR

March 26, 2020 medical

Take a step back from the breakneck COVID-19 news cycle and it doesn't take much to wonder: How long is this pandemic going to last and ultimately, what can be done to stop it?

To better-understand the long-term outlook for the novel coronavirus and the trade-offs inherent in our current social-distancing strategy, WBUR spoke with Michael Mina, an assistant professor of epidemiology at Harvard specializing in immunology and infectious diseases.

Minas research focuses on the life-history of infectious pathogens, and he begins with the concept of herd immunity."

On how "herd immunity" works

Herd immunity is actually quite a simple idea, in that once there are enough people in the population who have been exposed to the virus or perhaps in other cases, a vaccine so that they are immune, then each one of those people that is immune becomes almost like a firebreak for preventing spread.

So if you walk into a room, for example, and everyone is susceptible to a virus and you bring that virus in, then there's no herd immunity. And on average, you'll infect two or three people. But if 90% of the room is immune already, then it's unlikely that when you walk into that room, you'll infect more than one person because most of the people you bump into will already be immune.

On whether the coronavirus that causes COVID-19 is susceptible to herd immunity

Absolutely. That's one of the great things about herd immunity, is that as long as people can individually become immune to the virus, then herd immunity is possible. And for this particular virus, it's about 65% of the population that might need to be immune before we actually can really inhibit further spread of the virus.

On the importance of establishing herd immunity vs. social distancing

That's a very good and somewhat controversial question. Essentially, a different way to put it is, 'Could we just get lots of younger people infected with this virus so that they can no longer necessarily transmit it?' And because we know that younger people maybe don't experience as severe a disease as older people, that would be a benefit.

The problem there is we know that actually, younger people can still get very sick and can die. But I think that there are some takeaways that we could get from this idea: One small slice of that question might be: 'Well, if we know that there are a number of young people who have already been infected and are immune, then maybe they can be the ones who are the nurses for people in a nursing home,' for example.

But I think it is a controversial idea to just say that all young people should go out and get infected in order to confer greater herd immunity because we know that it still is a dangerous virus even for the young people in this population.

On the balancing act we need to achieve to prevent spread

That's one of the real dilemmas we find ourselves in today. I've been astounded to see just how much social distancing is happening, at least in some of our states and cities; and this is really terrific. This is what is needed at this moment in time to prevent ... a collapse of the health care system, if you will, in terms of the hospitals getting overridden with people.

But the problem with doing such a good job right now is that we might come out of this wave of the epidemic with less than 2% of the population infected. And as a population, we'll be just as susceptible, say, come the fall, as we were a few months ago.

On the necessity of social distancing at this particular point in time

Because this virus came into our population pretty quickly and then we kind of squandered a couple of months in figuring out how to deal with it ... now we're trying to catch up, if you will, to really control some of our essential services, like ensuring that we have enough ICU beds and ventilators for all the people who might need them. We just are trying to buy some time so that we can deal with it more appropriately in a more prepared way, maybe in a few months from now.

On whether an effective vaccine is likely in 12 to 18 months

Twelve to 15 months has been a timeframe that's been passed around as a minimum that it could take to develop a vaccine and bring it to market. But there's a caveat out there. That 12-to-15-month timeframe assumes that the vaccine actually works and protects us. But that's actually really the hard part ... finding the right combination of things to put in the vaccine to make sure that it elicits a good amount of immunological protection. And so it could be that 12 months from now, we're starting back at ground zero with a new trial.

I think that 12 to 15 months is probably not the most realistic timeframe. I anticipate that it will be quite a bit longer, if ever. And it's important to remember that we don't have any useful vaccines currently for many of the seasonal viruses that we see every year.

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Harvard Prof.: Don't Count On A COVID-19 Vaccine In 12 To 18 Months - WBUR

Immunology

Beyond the Surface – Uncovering the Layers of Immune Cell Complexity – Technology Networks

March 26, 2020 medical

Application NoteMar 25, 2020

Immunology and infectious disease research continues to advance our understanding of significant health issues including cancer, autoimmune diseases, and emerging pathogens. However, the field faces significant challenges due to the complex nature of the immune system and the limitations of prevailing research tools.

In order to comprehensively understand the immune response, scientists need the ability to characterize cell types and functional states in individual cells at high throughput.

In this app note, discover flexible solutions to the challenges of immunological studies, allowing you to:

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Beyond the Surface - Uncovering the Layers of Immune Cell Complexity - Technology Networks

Immunology

Gossamer Bio Announces Fourth Quarter and Full-Year 2019 Financial Results and Provides Business Update – Yahoo Finance

March 26, 2020 medical

Clinical trial results for all four clinical-stage product candidates in target areas of immunology, inflammation and oncology expected in 2020

Cash, cash equivalents and marketable securities totaled $401.8 million at year-end 2019

Gossamer Bio, Inc. (Nasdaq:GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced its financial results for the fourth quarter and year ended December 31, 2019 and provided a business update.

"Our hearts are with the patients, families, caregivers and medical professionals suffering and sacrificing in the ongoing Covid-19 viral pandemic. We are monitoring the situation on a daily basis to understand the impact on Gossamer and our programs and are taking the necessary actions now to do what is best for our patients, employees and company," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer Bio.

"2019 was a year of execution for Gossamer Bio, as we continued to advance all four of our clinical-stage product candidates in our target areas of immunology, inflammation and oncology. Notwithstanding the Covid-19 pandemic, we expect to continue our momentum in 2020, with data from all of our candidates expected this year. We are committed to advancing our product candidates and the field of medicine for the betterment of patients and their families, and we look forward to providing updates on these efforts throughout the year."

Clinical-Stage Product Candidate Updates

GB001: Oral DP2 Antagonist for Eosinophilic Asthma and Chronic Rhinosinusitis (CRS)

GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

GB004: Oral HIF-1 Stabilizer for Inflammatory Bowel Disease

GB1275: Oral CD11b Modulator for Oncology Indications

Financial Results for Quarter and Full Year Ended December 31, 2019

About Gossamer Bio

Gossamer Bio is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology. Its goal is to be an industry leader in each of these therapeutic areas and to enhance and extend the lives of patients suffering from such diseases.

Forward-Looking Statements

Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Companys current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the anticipated timing of initiation and enrollment of clinical trials for our product candidates; plans to rapidly advance our product candidates; expectations on the timing of data readouts from our clinical studies; the potential clinical benefits of our product candidates; the indications we intend to pursue and our related business strategies; the expected timeframe for funding our operating plan with current cash, cash equivalents and marketable securities; and access to the Companys senior debt facility. The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Gossamers business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from the recent global outbreak of the Covid-19 pandemic; the Companys dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Gossamers clinical trials and preclinical studies for its product candidates; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of the Companys product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Gossamers ability to obtain and maintain intellectual property protection for its product candidates; Gossamers ability to comply with its obligations in collaboration agreements with third parties or the agreements under which it licenses intellectual property rights from third parties; the risk that the funding under the senior debt facility may not be completed on the timeframe Gossamer expects, or at all, including as a result of Gossamer's failure to meet the conditions required for such funding or failure to comply with the affirmative and negative covenants under the credit facility; and other risks described in the Companys prior press releases and the Companys filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Companys annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Gossamer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

GOSSAMER BIO, INC.

CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA

(UNAUDITED; IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)

Three months ended December 31,

Year Ended December 31,

STATEMENTS OF OPERATIONS DATA:

2019

2018

2019

2018

Operating expenses:

Research and development

42,596

25,872

143,403

55,283

In process research and development

1,600

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Gossamer Bio Announces Fourth Quarter and Full-Year 2019 Financial Results and Provides Business Update - Yahoo Finance

Immunology

How Cornell Departments Are Helping in the Fight Against Coronavirus – Cornell University The Cornell Daily Sun

March 26, 2020 medical

With the spread of COVID-19 affecting communities across the nation and recently even Cornells campus itself a wide range of academic departments are doing what they can to help during the pandemic.

Labs in the College of Veterinary Medicine run by Profs. Brian VanderVen and David Russell, microbiology and immunology have donated over 600 respirator masks to Cayuga Medical Center amid a national shortage of protective medical gear.

VanderVen explained that they had started stockpiling masks earlier in the year, fearing that a future supply-chain problem could result in a lack of necessary protection for those in the lab.

However, the lab ultimately found alternate ways of protecting themselves and donated the masks to physicians on the front lines.

We certainly could still use them, VanderVen said. But the clinicians are going to need them more than us.

The lab is still exploring ways of helping Cayuga Medical beyond its initial donation, according to VanderVen. For instance, longer-term, faculty across Cornells immunology department are looking at new ways to diagnose and treat coronavirus, he said.

Other University labs have been asked to donate supplies in the fight against COVID-19, including one run by Prof. Maureen Hanson, molecular biology, whose lab donated 3,000 pairs of nitrile gloves to be distributed as necessary by the Tompkins County Health Department.

After hearing about the nationwide mask shortage, Prof. C.C. Chu, fiber science and apparel design, emailed colleagues with an idea.

I thought, we have a design component to the department, maybe they can use their knowledge and expertise to make surgical masks? he said.

Beyond developing more efficient mask design, Chu hopes to see a prior research interest of his revived in the fight against the pandemic. In the late 2000s, his lab developed a family of pseudo-protein biomaterials that a company eventually licensed to develop synthetic vaccines.

The synthetic vaccine technology based on my labs pseudo-protein biomaterials is still there, Chu said. If someone would have enough resources, this synthetic vaccine technology can be reactivated again to help the fast development of the COVID-19 vaccine.

Some Cornell labs are also doing their part by continuing ongoing research.

Prof. Matthew DeLisa, chemical and biomolecular engineering, said his lab is working on National Institutes of Health-funded research that could assist in efforts to better model and understand the spread of COVID-19.

Insight gained here could guide vaccine design and development, DeLisa said.

DeLisas colleague, Prof. Susan Daniel, chemical and biomolecular engineering, runs a lab whose research is so relevant right now that she applied for an exemption that will enable her to continue work despite the campus shutdown.

The focus of this project is to understand how coronavirus enters its host cell and specifically how the spikes that decorate the virus facilitate that entry, Daniel explained.

Stemming from that work, her lab is now screening drugs that could inhibit the virus infection, developing antibodies and small molecules that could more effectively block its entry into human cells.

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How Cornell Departments Are Helping in the Fight Against Coronavirus - Cornell University The Cornell Daily Sun

Immunology

Possible COVID-19 treatment: transfusion of antibodies from recovered patients’ blood | The Source – Washington University in St. Louis Newsroom

March 26, 2020 medical

With no drugs or vaccines yet approved for COVID-19 and the number of U.S. cases increasing by the thousands every day, doctors are looking to revive a century-old therapy for infectious diseases: transfusing antibodies from the blood of recovered patients into people who are seriously ill.

During the Spanish flu pandemic of 1918, doctors were faced with a deadly illness and no specific treatments. Recognizing that people who had recovered were immune to the infection, some doctors tried treating their patients with blood serum from recovered flu patients. In many cases it worked.

Giving serum from newly recovered patients is a stone-age approach, but historically it has worked, saidJeffrey P. Henderson, MD, PhD, associate professor of medicine and of molecular microbiology at Washington University School of Medicine in St. Louis. This is how we used to prevent and treat viral infections like measles, mumps, polio and influenza, but once vaccines were developed, the technique understandably fell out of favor and many people forgot about it. Until we have specific drugs and vaccines for COVID-19, this approach could save lives.

Henderson was reminded of the technique by Arturo Casadevall, MD, PhD, the chair of molecular microbiology and immunology at Johns Hopkins Bloomberg School of Public Health in Baltimore. Casadevall began championing the idea of using plasma from convalescing patients to treat COVID-19 in early March. Plasma and serum are both the clear fluid portion of blood, and both contain antibodies, but plasma also contains some other proteins lacking in serum.

Plasma transfusion was used experimentally to treat small numbers of people during the SARS outbreak of 2002 and 2003. SARS, which stands for severe acute respiratory syndrome, is caused by a coronavirus closely related to the one that causes COVID-19. In one study, SARS patients who received plasma transfusions recovered faster than those who did not.

Henderson, Casadevall and Michael Joyner, MD, a physiologist at the Mayo Clinic in Rochester, Minn., quickly joined forces and leveraged the resources at their three institutions to test the approach. Their efforts resulted in an investigational new drug application to the Food and Drug Administration that was filed March 18. If the application is approved, they plan to move rapidly to a clinical trial.

This is something that can be done very quickly, much faster than drug development, because it basically involves donating and transfusing plasma, Henderson said. As soon as we have individuals who have recovered from COVID-19 walking around, we have potential donors, and we can use the blood bank system to obtain plasma and distribute it to the patients who need it.

The plan is to ask patients who recover from COVID-19 to donate their blood, from which plasma would be isolated. After screening for toxins and viruses, the plasma would be transfused into people ill with or at high risk of COVID-19. The procedure for isolating plasma is a long-established technology that can be performed using equipment normally found in blood-banking facilities, and receiving plasma from these donors is as safe as any other plasma transfusion, Henderson said.

The concept is simple, but the execution is more complicated. The scientists still need to determine how much antibody is in the blood of recovered patients, and how much antibody needs to be given to effectively treat or prevent COVID-19.Brenda Grossman, MD, professor of pathology and immunology at Washington University School of Medicine and director of transfusion medicine at Barnes-Jewish Hospital, was brought on board to help navigate the complex regulations surrounding blood donations and transport of blood products across state lines.

The idea is catching fire.

Last week, it was the three of us on a conference call, Henderson said. This week, we had people from all over the country I dont even know how many. Everyones excited about this. If it works, it could provide a lifeline at this early stage of the pandemic.

WashU Response to COVID-19Visit coronavirus.wustl.edu for the latest information about WashU updates and policies. See all stories related to COVID-19.

Originally published by the School of Medicine

Immunology

Gossamer Bio Announces Fourth Quarter and Full-Year 2019 Financial Results and Provides Business Update – BioSpace

March 24, 2020 medical

SAN DIEGO--(BUSINESS WIRE)-- Gossamer Bio, Inc. (Nasdaq:GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced its financial results for the fourth quarter and year ended December 31, 2019 and provided a business update.

Our hearts are with the patients, families, caregivers and medical professionals suffering and sacrificing in the ongoing Covid-19 viral pandemic. We are monitoring the situation on a daily basis to understand the impact on Gossamer and our programs and are taking the necessary actions now to do what is best for our patients, employees and company, said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer Bio.

2019 was a year of execution for Gossamer Bio, as we continued to advance all four of our clinical-stage product candidates in our target areas of immunology, inflammation and oncology. Notwithstanding the Covid-19 pandemic, we expect to continue our momentum in 2020, with data from all of our candidates expected this year. We are committed to advancing our product candidates and the field of medicine for the betterment of patients and their families, and we look forward to providing updates on these efforts throughout the year.

Clinical-Stage Product Candidate Updates

GB001: Oral DP2 Antagonist for Eosinophilic Asthma and Chronic Rhinosinusitis (CRS)

GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

GB004: Oral HIF-1 Stabilizer for Inflammatory Bowel Disease

GB1275: Oral CD11b Modulator for Oncology Indications

Financial Results for Quarter and Full Year Ended December 31, 2019

About Gossamer Bio

Forward-Looking Statements

Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Companys current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the anticipated timing of initiation and enrollment of clinical trials for our product candidates; plans to rapidly advance our product candidates; expectations on the timing of data readouts from our clinical studies; the potential clinical benefits of our product candidates; the indications we intend to pursue and our related business strategies; the expected timeframe for funding our operating plan with current cash, cash equivalents and marketable securities; and access to the Companys senior debt facility. The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Gossamers business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from the recent global outbreak of the Covid-19 pandemic; the Companys dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Gossamers clinical trials and preclinical studies for its product candidates; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of the Companys product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Gossamers ability to obtain and maintain intellectual property protection for its product candidates; Gossamers ability to comply with its obligations in collaboration agreements with third parties or the agreements under which it licenses intellectual property rights from third parties; the risk that the funding under the senior debt facility may not be completed on the timeframe Gossamer expects, or at all, including as a result of Gossamer's failure to meet the conditions required for such funding or failure to comply with the affirmative and negative covenants under the credit facility; and other risks described in the Companys prior press releases and the Companys filings with the Securities and Exchange Commission (SEC), including under the heading Risk Factors in the Companys annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Gossamer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

GOSSAMER BIO, INC.

CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA

(UNAUDITED; IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)

Three months ended December 31,

Year Ended December 31,

STATEMENTS OF OPERATIONS DATA:

2019

2018

2019

2018

Operating expenses:

Research and development

42,596

25,872

143,403

55,283

In process research and development

1,600

3,600

49,659

General and administrative

11,591

13,935

39,136

44,051

Total operating expenses

55,787

39,807

186,139

148,993

Loss from operations

(55,787

)

(39,807

)

(186,139

)

(148,993

)

Other income, net

1,089

1,013

5,832

2,024

Net loss

(54,698

)

(38,794

)

(180,307

)

(146,969

)

Net loss per share, basic and diluted

(0.89

)

(4.92

)

(3.29

)

(22.59

)

Weighted average common shares outstanding, basic and diluted

61,282,084

7,878,824

54,740,170

6,504,871

December 31,

BALANCE SHEET DATA:

2019

2018

Cash, cash equivalents, and marketable securities

401,829

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Gossamer Bio Announces Fourth Quarter and Full-Year 2019 Financial Results and Provides Business Update - BioSpace

Immunology

CEL-SCI to Develop LEAPS COVID-19 Immunotherapy in Collaboration with University of Georgia Center for Vaccines and Immunology – BioSpace

March 24, 2020 medical

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation(NYSE American: CVM) announced today it has signed a collaboration agreement with the University of Georgias Center for Vaccines and Immunology to develop LEAPS COVID-19 immunotherapy. CEL-SCIs immunotherapy candidate aims to treat patients at highest risk of dying from COVID-19. The collaboration will commence with pre-clinical studies based on the experiments previously conducted with LEAPS immunotherapy in collaboration with the National Institutes for Allergies and Infectious Diseases (NIAID) against another respiratory virus, H1N1, involved in the 2009 H1N1 flu pandemic. Those successful studies demonstrated that LEAPS peptides, given after virus infection has occurred, reduced morbidity and mortality in mice infected with H1N1.

It is suggested, based on studies with H1N1, that a LEAPS coronavirus - SARS-CoV-2 immunotherapy may reduce or arrest the progression of the SARS-CoV-2 virus infection and prevent tissue damage from inflammation resulting from lung infection by the virus. By stimulating the correct immune responses to the COVID-19-causing virus without producing unwanted inflammatory responses associated with lung tissue damage, LEAPS immunotherapy may be particularly beneficial in those patients who are at highest risk of dying from COVID-19.

We are eager to commence these studies, which if successful, may lead to clinical trials in humans to address the immediate and critical need to treat COVID-19 in the most vulnerable patients. We are very pleased and honored to partner with Dr. Ted M. Ross and his team and the University of Georgia Center for Vaccines and Immunology. Their world-renowned expertise and world-class facilities will accelerate the development of LEAPS COVID-19 immunotherapy, stated CEL-SCI CEO Geert Kersten.

The University of Georgia (UGA) Center for Vaccines and Immunology (CVI) brings together a diverse, world-renowned team of experts in the areas of infectious disease, veterinary medicine, ecology and public health. The universitys world-class biocontainment research resources are coupled with the expertise of CVI investigators who focus on translational studies to test and assess the efficacy of vaccines and immunotherapies in development by industry, governmental and academic institutions. CEL-SCIs COVID-19 studies at UGA will be led by Principal Investigator Ted M. Ross, PhD, Director of the Center for Vaccines and Immunology, Georgia Research Alliance Eminent Scholar, and Professor of Infectious Diseases at the University of Georgia. Dr. Ross is a world renowned key opinion leader in new vaccine technologies intended to protect against all strains for influenza and life threatening viruses. Dr. Ross has published more than 160 papers and book chapters on infectious disease and vaccine development. He has been an invited speaker at more than 130 national and international conferences, and he participates in several vaccine working groups, including at the U.S. National Institutes of Health, U.S. Centers for Disease Control and Prevention and the World Health Organization.

Dr. Ross commented, LEAPS has the potential to be a powerful tool against SARS-CoV-2, the causative agent of COVID-19, based on its dual anti-viral and anti-inflammatory properties. Combining the prior pre-clinical data of LEAPS against H1N1 with our advancing knowledge of COVID-19, we aim to rapidly evaluate this technologys potential to meet the urgent need to treat patients at greatest risk of dying from this global pandemic. The University of Georgias biocontainment labs at the Center for Vaccines and Immunology are ideally suited for these studies, and will serve as critical assets in this collaboration with CEL-SCI.

CEL-SCIs studies will utilize the LEAPS peptide approach that is unique in its proven ability in animals to elicit both a cell mediated antiviral response and an anti-inflammatory immunomodulating response by activating CD8 T lymphocytes. Previous studies showed that LEAPS immunogens can prevent lethal infection by herpes simplex virus (HSV) and influenza A (H1N1) and stop the inflammatory disease progression of rheumatoid arthritis in animal models. LEAPS peptides against HSV demonstrated that the T cell response was sufficient to prevent viral disease, and if there was residual virus production, anti-viral antibody was generated to further control the spread of the virus.

The proposed LEAPS peptides for the COVID-19 study are directed towards antigens within the NP protein of SARS-Cov-2 virus that elicit cytolytic T cell responses. Unlike the viral glycoprotein spike antigens which are important for antibody-based vaccines, these NP-antigens are less variable between viral strains and less likely to change in response to antibodies elicited by prior infection or other vaccines. Cytolytic T cell responses attack the virus infected cellular factories within the infected host in order to eliminate the source of virus and help subdue the infection.

About LEAPS

The Ligand Antigen Epitope Presentation System (LEAPS) platform technology has demonstrated in several animal models the ability to design antigen-specific immunotherapeutic peptides that preferentially direct the immune response to a cellular (e.g., T-cell), humoral (antibody) or mixed response and are also capable of enhancing important T-regulatory (Treg) responses. Therefore, the LEAPS technology provides the opportunity to develop immunotherapeutic products for diseases for which disease associated antigenic peptide(s) sequences have already been identified, such as: a number of infectious diseases, some cancers, autoimmune diseases (e.g., RA), allergic asthma and allergy, select CNS diseases (e.g., Alzheimer's) and the COVID-19 associated virus.

The Company's LEAPS technology is currently also being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by $1.5 million grant for IND enabling studies from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study CEL-SCI treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with Multikine* first, BEFORE they received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

CEL-SCI's Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study's protocol, newly diagnosed patients with advanced primary squamous cell carcinoma are treated with the Multikine treatment regimen for 3 weeks prior to the Standard of Care (SOC) which involves surgery, chemotherapy and/or radiation. Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby thought to better able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body's immune system prior to SOC. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events have occurred among the two main comparator groups.

The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K/A for the year ended September 30, 2019. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200323005336/en/

Excerpt from:
CEL-SCI to Develop LEAPS COVID-19 Immunotherapy in Collaboration with University of Georgia Center for Vaccines and Immunology - BioSpace