Category Archives: 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

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

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/

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

Immunology

‘This thing has taken off like wildfire’: Mayo races with high-powered alliance to produce plasma treatment for coronavirus – Duluth News Tribune

March 24, 2020 medical

With vaccines 18 months away at best, and with coronavirus-targeting antivirals travelling in a clinical trial pipeline that could extend into next year, the results of the so-called convalescent plasma treatment for coronavirus could potentially put a critical bridge therapy into healthcare workers' hands in one month's time.

"There's many if's here," said Mayo Clinic research physiologist and project participant Dr. Michael Joyner. "There's many potential barriers. There's many things that could go wrong or could delay it. But hopefully we would be in a position in a month or so to deliver it to people who can benefit from it."

The project is spearheaded by Dr. Arturo Casadevall, a professor of molecular immunology at the Bloomberg School of Public Health at Johns Hopkins University in Baltimore. "Deployment of this option requires no research or development," Casadevall has recently stated. "It could be deployed within a couple of weeks since it relies on standard blood-banking practices."

"Arturo came up with the idea that as we get more and more people recovered from COVID-19, two or three weeks after they are asymptomatic they are going to have very high levels of antibodies against COVID-19 in their blood or plasma," Joyner said. "We want to collect some of that plasma and use it either for post-exposure prophylaxis (prevention), or to treat people who are sick early in their hospitalization, with the goal of shortening the duration of the disease and keeping them out of the ICU, thus decompressing the healthcare system."

"If we can get these dominoes lined up, and they fall correctly," Joyner said, "as large numbers of people start to recover in the United States, we can harvest plasma from them and give it to patients safely in a way that shortens the course of their disease, or prevents them from getting it in the first place if they've been exposed."

Convalescent plasma is a time-tested pathogen treatment first used against diphtheria in the late 19th century, later against the 1918 influenza, measles, mumps, chickenpox, MERS, SARS, H1N1 and Ebola. Though the immunology of convalescent plasma is well known, its effectiveness with coronavirus is still being determined.

It's limitations involve a small risk of enhanced infection and the necessity of carefully timing the treatment, but otherwise come down to a modest handful of safety issues that apply to the use of all blood products in transfusion medicine, a category of care that has been well-tolerated for decades.

While the biology and safety of passive immunity is well-known, a nation-wide roll out of coronavirus antibody serum poses an administrative and public health challenge like no other. Following an expedited approval of the project via the investigational new drug pathway at the FDA, the campaign will require the wide-scale identification of persons with antibodies for coronavirus, followed by a uniform, population-scaled screening process of potential donors.

That's just for the gathering of plasma. Quickly delivering it to the nation's hospitals will require another set of Herculean logistical and clinical challenges, including the need to quickly communicate to a disparate sea of clinicians an entirely-new protocol for delivering the antibody-containing transfusions. Joyner says this is an area where an infrastructure has already been created, thanks to well-developed supply-chains behind the nation's commercial plasma centers.

"Because of the great skill and capacity of our blood banks across the country, we know how to obtain plasma, prepare it and give it safely," Joyner says. "So if we can give patients plasma that's rich in these antibodies, that can help us hold us off the illness until the biotech cavalry arrives with vaccine and medicines."

Reached for a midday call last week during a break in helping to write the study design "this isn't exactly my wheelhouse but it's close enough that I figured I could take a stab at it" Joyner said his lab had cleared out and begun working from home out of the need for social distancing. "It's like Christmas day, here," he said of his empty surroundings, inactivity that belied the broad and frenetic institutional effort to move the therapy through review and into practice.

Others within Mayo working on the project include an interdisciplinary team of immunology, transfusion medicine, pulmonology, radiology, infectious disease and IRB-affiliated participants, a list Joyner said included Drs. Elitza Theel, Camille van Buskirk, Andrew Badley, Jeff Winters, Jim Stubbs, Philippe Bauer, Jack OHoro, Rickey Carter, numerous fellows, and the clinic's institutional review board staff.

Nationally, the project is utilizing the expertise of participants from 20 institutions, a short list of the nation's research braintrust that includes Johns Hopkins, Washington University of St. Louis, Alfred Einstein University, Duke, the University of Pittsburgh, Michigan State, Stanford and the University of California system. "This thing has taken off like wildfire," Joyner said. "The scientific community has really rallied around Arturo's ideas, and see this as where we can help the fastest."

"What's been amazing is, we had this large conference call yesterday with people that are very well known, and a lot of those people have pretty healthy egos 'I discovered this or I did that.' We had none of that. Everybody is just trying to focus on what's in front of them. We've got people who are the top virologists and experts in transfusion medicine from across the country and all over the world involved. We have commercial partners who are excellent at collecting plasma at sites all over the county reaching out to us."

Even the world's online retailer is said to be chipping in, by building a website to centralize the initiative's internal and external communications. As of press time, Amazon had not responded to a request to clarify their participation. Currently the IRB committee at Johns Hopkins is studying a plan to test coronavirus plasma for preventive use, while Mayo is reviewing a treatment protocol for hospitalized patients who have yet to reach a severe state of sickness.

At the time of the call last week, Joyner had already participated in two nationwide group conference calls, had two more scheduled in the coming days, and was midway through a 20-hour workday. "I took my first call at 4:37 this morning from a colleague at Einstein in New York," he said before brushing aside the topic. "I'll be getting emails about this until midnight but I'm getting some rest. The people on the front lines are the clinicians the nurses, the first responders, the people in the ICU."

How does it feel to fight the worst outbreak in modern times with an old-fashioned method?

"Washing of hands is an old fashioned method too," he said.

As a public service, we've opened this article to everyone regardless of subscription status.

The CDC COVID-19 symptom checklist is here.

MDH COVID-19 hotline: (651) 201-3920. 2,300 calls yesterday

Business impacts hotline: (651) 297-1304 or (800) 657-3504.

School and childcare hotline: (651) 297-1304 or (800) 657-3504.

MDH COVID-19 website: Coronavirus Disease (COVID-19) website.

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'This thing has taken off like wildfire': Mayo races with high-powered alliance to produce plasma treatment for coronavirus - Duluth News Tribune

Immunology

What Will Drive Bristol-Myers Squibbs $42 Billion Revenue In 2020? – Forbes

March 24, 2020 medical

PHILADELPHIA, PA - OCTOBER 06: View of the Bristol-Meyers Squibb booth in the exhibit hall before ... [+] guests arrive at the Pennsylvania Conference for Women 2016 at Pennsylvania Convention Center on October 6, 2016 in Philadelphia, Pennsylvania. (Photo by Marla Aufmuth/Getty Images for Pennsylvania Conference for Women)

Bristol-Myers Squibbs (NYSE: BMY) revenue grew from $19.4 billion in 2016 to $26.1 billion in 2019, and it is estimated to top $42 billion in 2020. This growth will primarily be driven by its oncology drugs portfolio, which will likely get over a 2x boost in 2020, due to the impact of the Celgene acquisition. Bristol-Myers Squibbs oncology drugs segment is expected to be the single-biggest revenue driver with $27.7 billion in revenues (66% of total revenues), which is over 3x the size of Cardiovascular, Bristol-Myers Squibbs second largest business segment, in 2020. Oncology drugs, which includes blockbuster drugs Revlimid and Opdivo, among other drugs, will be the fastest-growing segment adding $19.2 billion over 2017-20 (90% of the $21.3 billion in incremental revenues). Cardiovascular, which includes Eliquis, will add about $4.1 billion over 2017-20 (19% of the $11.5 billion in incremental revenue), and immunology drugs will add $1.0 billion (5% of incremental revenues). This will likely be offset by an expected decline of $3.0 billion (-14% of incremental revenue) in all other drugs segment. In this analysis, BMY Revenues: How Does Bristol-Myers Squibb Make Money?, we focus on Bristol-Myers Squibbs business model, its revenue segments, their historical performance, forecast for 2021, and peer comparison, parts of which are highlighted below.

Bristol-Myers Squibb 2020 Revenues To Surge After Celgene Acquisition

Comparing BMS Sales Growth To Its Peers

BMS Has A Large Oncology Drugs Portfolio, Courtesy of Celgene

BMS Is Gaining Market Share In Cardiovascular Drugs Market

Immunology Portfolio Could See Biosimilar Competition In 2021

All Other Drugs Sales Will Continue To Decline

Impact of Coronavirus

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What Will Drive Bristol-Myers Squibbs $42 Billion Revenue In 2020? - Forbes

Immunology

Ampio is Preparing an Expanded Access FDA protocol to Study Nebulized Ampion as a Treatment for Moderate to Severe Acute Respiratory Distress Syndrome…

March 24, 2020 medical

ENGLEWOOD, Colo., March 24, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a pre-revenue development stage biopharmaceutical company focused on the development of immunology based therapies to treat prevalent inflammatory conditions for which limited treatment options exist, announced today that it is preparing an expanded access FDA protocol to study potential benefit of nebulized treatment with Ampion in SARS-Cov-2 ("COVID-19") induced Acute Respiratory Distress Syndrome ("ARDS"), an immediately life-threatening condition.

Ampio's Scientific Advisory Board ("SAB") members David Bar-Or, MD, Pablo Rubinstein, MD, and Edward Brody, MD, PhD, determined after a careful review of the published articles on the properties of Ampion, that nebulized Ampion may be suitable to treat another inflammatory indication. Specifically, ARDS, one of the most dreaded complications of COVID-19 is associated with widespread inflammation in the lungs. The underlying mechanism of ARDS involves diffuse injury to cells which form the barrier of the microscopic air sacs (alveoli) of the lung, surfactant dysfunction, and activation of the immune system. The fluid accumulation in the lungs associated with ARDS is partially explained by vascular leakage due to inflammation. Ampion is an aqueous solution that may be delivered through nebulization and may be suitable for suppressing inflammation in the lungs.

Ampion is a human blood derived composition, currently approved for clinical use by the FDA, as an anti-inflammatory, immunomodulating drug. The novel mode of action of Ampion involves multiple biochemical pathways associated with resolving inflammation1 which make it a potential therapy for ARDS as follows:

The anticipated aim of a preliminary protocol for FDA review would be to evaluate patients with moderate to severe ARDS, triggered by COVID-19, for (1) reduced ventilator time; (2) reduction in mortality and (3) improvements in oxygenation parameters compared to non-Ampion treated patients.

1 Bar-Or, et. al., On the Mechanisms of Action of the Low Molecular Weight Fraction of Commercial Human Serum Albumin in Osteoarthritis. Current Rheumatology Reviews, 2019, 15, 189-200.2 Fukunaga, et. al., Cyclooxygenase 2 Plays a Pivotal Role in the Resolution of Acute Lung Injury. Journal of Immunology 2005; 174:5033-5039.3 Gao et al. Resolvin D1 Improves the Resolution of Inflammation via Activating NF-B p50/p50-Mediated Cyclooxygenase-2 Expression in Acute Respiratory Distress Syndrome, 174:5033-5039, J Immunol 2017

About Ampio Pharmaceuticals Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead product candidate, AmpionTM, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and is eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

Forward-Looking StatementsAmpio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," "may", and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

Company ContactDaniel G. Stokely, CFOPhone: (720) 437-6500info@ampiopharma.com

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Company Codes: AMEX:AMPE

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Immunology

Mount Sinai Developing an End-to-End Diagnostics Solution for COVID-19 That Incorporates Diagnosis, Treatment Selection, and Monitoring of Disease…

March 24, 2020 medical

Newswise (New York, NY March 23, 2020) An expert team of researchers and clinicians in microbiology, virology, pathology, molecular science, and immunology at the Icahn School of Medicine at Mount Sinai (ISMMS) and The Mount Sinai Hospital (MSH) have been working together around the clock to design, validate, and implement an end-to-end clinical pathology laboratory solution that will allow for the testing of approximately several hundred people per day in order to rapidly diagnose and help guide the selection of treatment and monitor disease course.

Using a high-throughput, automated molecular assay, The Mount Sinai Hospital Clinical Laboratories are currently testing several hundred patients per day for SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) to identify positive versus negative cases. The testing effort will ramp up to a capacity of 1,000 tests per day. Mount Sinai follows NY State guidelines and is only testing patients with trouble breathing and/or moderate-to-severe respiratory symptoms at this time. (Please consult your physician if you believe you are a candidate for testing.)

For patients who test positive for SARS-CoV-2, a quantitative assay designed and implemented by a multidisciplinary Mount Sinai team is capable of measuring whether the patients viral load is high or low. The viral load findings will be studied to ascertain whether they assist in managing the disease and aiding in the selection of effective treatments. The clinical laboratory efforts are being led by Peter Palese, MD, Horace W. Goldsmith Professor and Chair of Microbiology, and Carlos Cordon-Cardo, MD, PhD, Irene Heinz Given and John LaPorte Given Professor and Chair of Pathology, Molecular and Cell-Based Medicine.

Internationally renowned researchers and clinicians from ISMMS and MSH are also tackling some other important tests to help in the fight against COVID-19, including:

A Blood Test That Measures Immunity in Recovered COVID-19 Patients

To help uncover just how widespread the novel coronavirus is within communities, a team led by virologist Florian Krammer, PhD, Professor of Microbiology at the Icahn School of Medicine at Mount Sinai, developed a serological enzyme-linked immunosorbent assay (ELISA) test. This test measures the presence or absence of antibodies to the virus in peoples blood. Similar to the most commonly used tests for other viruses, such as hepatitis B, this test shows whether a persons immune system has ever come into contact with the virus (even months ago). There are three main advantages to this test: providing an accurate picture of how many people have been infected; identifying people with new immunity to SARS-CoV-2 who could care for COVID-19 patients at zero or minimal risk; and identifying newly recovered patients with high antibody levels who can donate their antibody-rich blood, known as convalescent plasma, to potentially save other patients with severe COVID-19. Initially the testing will be limited to potential plasma donors until testing capacity increases.

The team began working on this serological assay in January, before COVID-19 had been seen in the United States. To make this test, the researchers cloned animal cells to produce copies of the telltale spike protein that is present on the surface of SARS-CoV-2. That protein is highly immunogenic, meaning that peoples bodies see it and start making antibodies that can lock onto it. The test involves exposing a sample of blood to bits of the spike protein. If the test lights up, it means that person has the antibodies. Viviana Simon, MD, PhD, Professor of Microbiology at ISMMS, was instrumental in the design and implementation of the test, which has been approved for clinical use by the New York State Wadsworth Laboratory and is currently undergoing validation and urgent implementation. ISMMS medical students are establishing a social media campaign to identify volunteers to be tested.

Our test can pick up the bodys response to infection as early as three days post-symptom onset and it could help locate survivors who are hyper-immune, says Dr. Krammer. Those people could then potentially donate their convalescent plasma to help very sick COVID-19 patients in intensive care units to help boost their immunity.

The sensitive and specific identification of SARS-CoV-2 that ELISA provides will also support screening of health care workers to identify those who have already been exposed and are already immune. Those staff could then be deployed to the front lines to perform the riskiest taskslike intubating a person infected with the viruswithout worrying about getting infected or spreading the disease to colleagues, other patients, or their families. To learn the true extent of infections, the next step will be for researchers to carry out these serological surveys via blood draws from large numbers of people in an outbreak area, which may tell them exactly how many cases have gone unnoticed.

According to Dr. Krammer, efforts by the team at Mount Sinai and a few others developing similar tests (including the U.S. Centers for Disease Control and Prevention) to carry out a wider survey are just getting started, so it will likely be some time before scientists learn just how widespread SARS-CoV-2 is. The Mount Sinai Hospital Clinical Laboratories are also sharing specimens from recovered patients with the New York State Wadsworth Laboratory to assist other facilities in this effort.

A Test That Can Determine When a COVID-19 Patient Is Entering a Dangerous Point in Their Disease and a Drug Trial for a Subset of Those Patients

Mount Sinais Human Immune Monitoring Center, led by Miriam Merad, MD, PhD, Mount Sinai Endowed Professor in Cancer Immunology and Sacha Gnajtic, PhD Associate Professor of Immunology and Hematology/Oncology, are working on a test called the ELLA Cytokine Storm Panel to determine when someone infected with COVID-19 is entering a critical point in their disease. When patients take a turn for the worse, they are experiencing a burst in their bodys immune response, particularly with a group of immune molecules called cytokines. This burst of cytokines, called cytokine release syndrome or a cytokine storm, contributes to the severity of COVID-19, because the cytokines attack the patients organs, which can be fatal in some cases.

Mount Sinai clinical laboratories will use the ELLA Cytokine Storm Panel in COVID-19 patients who have been admitted to the hospital to monitor them and know, in real time, when they are experiencing cytokine storm. The test results are available in a few hours, and can be repeated throughout the course of care to help guide hospital care and to measure the response to experimental drugs given in clinical trials for COVID-19 patients.

Coupled with the Cytokine Storm Panel, Mount Sinais Division of Infectious Diseases, led by Judith A. Aberg, MD, will begin several clinical trials for patients with COVID-19. Their team has analyzed data from China showing that the cytokine release syndrome is killing COVID-19 patients and that inhibiting the storm using therapies tested in cancer patients who received CAR-T cellsmodified immune system cells used to fight cancermay improve their condition. Mount Sinais Human Immune Monitoring Center will be monitoring patients on all experimental trials to identify biomarkers response and guide additional therapeutic strategies.

Some of the best researchers in the world, giants on the frontier of the fields of infectious disease, microbiology, emerging pathogens, and immunology, are here at the Icahn School of Medicine at Mount Sinai and The Mount Sinai Hospital. Since the COVID-19 pandemic began, they have been tracking the data coming out of China and Italy to mount a response that will help diagnose and treat ill patients, says Dennis S. Charney, MD, Anne and Joel Ehrenkranz Dean, Icahn School of Medicine at Mount Sinai, and President for Academic Affairs, Mount Sinai Health System. Our health system has fast-tracked funding and approvals for these tests and clinical trials to help patients not just within our own community, but to help people around the globe.

To support COVID-19 research and response efforts, visit https://www.mountsinai.org/covid19research.

About the Mount Sinai Health System

The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality carefrom prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty by U.S. News & World Report.

For more information, visithttps://www.mountsinai.orgor find Mount Sinai onFacebook,TwitterandYouTube.

Immunology

Secarna Pharmaceuticals announces the acquisition of LNAplus(TM) based antisense drug candidates by Lipigon Pharmaceuticals – Benzinga

March 24, 2020 medical

MUNICH and MARTINSRIED, GERMANY / ACCESSWIRE / March 23, 2020 / Secarna Pharmaceuticals GmbH & Co. KG ("Secarna"), a biopharmaceutical company focusing on the discovery and development of next generation antisense oligonucleotide (ASO) therapies to address challenging or previously undruggable targets via its LNAplusTM platform, today announced that the Company signed a Research, Development and Transfer Agreement with Lipigon Pharmaceuticals AB ("Lipigon"). Under this agreement, Lipigon acquires certain antisense drug candidates, which were developed with Secarna's proprietary LNAplusTM platform, including the corresponding patent portfolio. The antisense oligonucleotide candidates targeting the ANGPTL gene family for the treatment of cardiovascular and metabolic diseases were previously generated by Secarna and Lipigon under a target validation and drug discovery collaboration. Going forward, Lipigon will fund and continue the development of the acquired assets and Secarna receives payments customary for such a transaction. Financial details were not disclosed.

Inhibiting the ANGPTL gene family members ANGPTL3 and ANGPTL4 with Secarna's LNAplusTM based antisense oligonucleotides has shown to positively affect plasma lipid levels. Therefore, safe and effective drug candidates addressing these targets have the potential to become novel treatments of orphan diseases such as Familial Chylomicronaemia Syndrome or Homozygote Familial Hypercholesterolemia, but also more common cardiovascular, metabolic liver, kidney diseases or diseases as dyslipidaemia.

"For the past two years, we have collaborated with our colleagues at Lipigon under a highly productive discovery and research partnership. We are excited that Lipigon has selected therapeutic lead candidates generated from Secarna's LNAplusTM platform and will now swiftly progress them through the next stages of development", said Jonas Renz, Managing Director and Co-founder of Secarna Pharmaceuticals.

"Antisense-based therapeutics have gained strong industry interest over the past five to seven years as evidenced by major licensing and acquisitions transactions. We are very pleased that our successful collaboration with Secarna has generated fully optimized, patented LNAplusTM antisense drug candidates ready to enter late stage pre-clinical development and GMP manufacturing," said Stefan K. Nilsson, CEO and Co-founder of Lipigon.

About Secarna's proprietary drug discovery platform, LNAplusTM

Secarna's proprietary third-generation antisense oligonucleotide (ASO) platform, LNAplusTM, which encompasses all aspects of drug discovery and pre-clinical development, enables the company to discover novel antisense-based therapies for challenging or currently undruggable targets.Secarna's platform and ASOs have previously been validated by numerous in-house projects as well as in several academic and industry collaborations. With over 15 development programs focusing on targets in indications such as immuno-oncology, immunology, ophthalmology, as well as viral-, neurodegenerative- and cardiometabolic diseases, where antisense-based approaches have clear benefits compared to other therapeutic modalities, Secarna is the leading independent European antisense drug discovery and development company.

About Secarna Pharmaceuticals GmbH & Co. KG

Secarna Pharmaceuticals is the next generation antisense oligonucleotide (ASO) company with multiple innovative antisense therapies in various stages of pre-clinical development in the areas of immuno-oncology, immunology, ophthalmology, as well as viral-, neurodegenerative- and cardiometabolic diseases. Secarna's mission is to maximize the performance and output of its proprietary LNAplusTM antisense oligonucleotide discovery platform, as well as to develop highly specific, safe, and efficacious best-in-class antisense therapies for challenging or currently not druggable targets. http://www.secarna.com

About Lipigon Pharmaceuticals

Lipigon are lipid biology experts focusing on developing novel therapeutics for patients with lipid- related disorders. The company is a spin-off from Umeå University, Sweden, based on five decades of lipid research. Our primary focus is orphan lipid disorders and in addition to the ANGPTL antisense program, Lipigon's pipeline, including a project for gene therapy treatment of lipodystrophy. This program is partnered with Combigene AB (publ). http://www.lipigon.se.

Contact

Jonas RenzManaging Director and Co-founderJonas.Renz@secarna.com

Secarna Pharmaceuticals GmbH & Co. KGAm Klopferspitz 1982152 Planegg/MartinsriedTel.: +49 (0)89 215 46 375

For media enquiries:

Anne HenneckeMC Services AGanne.hennecke@mc-services.euTel.: +49 (0)211.52 92 52 22

SOURCE: Secarna Pharmaceuticals GmbH & Co. KG via EQS Newswire

View source version on accesswire.com: https://www.accesswire.com/582058/Secarna-Pharmaceuticals-announces-the-acquisition-of-LNAplusTM-based-antisense-drug-candidates-by-Lipigon-Pharmaceuticals

Original post:
Secarna Pharmaceuticals announces the acquisition of LNAplus(TM) based antisense drug candidates by Lipigon Pharmaceuticals - Benzinga

Immunology

VERIFY: The risk of contracting coronavirus from groceries, mail remains low – WUSA9.com

March 24, 2020 medical

WASHINGTON QUESTION:

Is there a high risk of contracting the novel coronavirus from your groceries or mail?

ANSWER:

No, the risk of coming into contact from your groceries or mail remains low, according to health experts. After touching any surface, you should wash your hands before touching your face.

SOURCES:

Dr. Sanjay Maggirwar- Chair of George Washington University's Department of Microbiology, Immunology and Tropical Medicine

Dr. Robin Petal- Director of the Infectious Diseases Research Laboratory, Chair of the Division of Clinical Microbiology and Director of its Bacteriology Laboratory at Mayo Clinic.

World Health Organization

Centers for Disease Control and Prevention

USPS spokesperson

UPS spokesperson

FedEx spokesperson

PROCESS:

A lots been written about the necessity to avoid high-touched surfaces and emphasizing the need to wash your hands.

Health officials have underscored the need to disinfect tables, doorknobs, light switches, phones and sinks regularly. But what about surfaces that are less obvious like letters and packaged food from the grocery store?

A viewer reached out to Verify team and asked if she should be disinfecting things like packaged food or letters

So were verifying: Is there a high risk of catching coronavirus from your groceries or mail?

Our Verify researchers spoke with two microbiology experts Dr. Sanjay Maggirwar from the George Washington University and Dr. Robin Patel of Mayo Clinic.

"All the surfaces at this point, we should consider as infected or contaminated," Maggirwar said.

Dr. Sanjay Maggirwar leads George Washington's Department of Microbiology, Immunology and Tropical Medicine.

He says compared to something like a public doorknob, groceries are a much lower risk.

Most likely it was handled just once or twice by the person, and these days the person is probably wearing gloves," Maggirwar said. "So the level of the virus to an infectious state would be a lot less.

Patel agreed that contracting the virus from packaged food or mail was "extraordinarily unlikely as a root of transmission."

"You don't become infected just by touching surfaces," Patel said. "You become infected because you touched a surface and the virus got on your hand and then you inoculated your mouth, your nose or eyes with that virus."

That's why it's crucial to avoid touching your face and practicing good hygiene, like washing your hands.

Right now neither the CDC nor WHO say anything about wiping down your groceries with disinfecting wipes.

What about touching mail?

Our Verify researchers spoke with the U.S. Postal Service, UPS and FedEx. Theyre all looking to leaders like the Centers for Disease Control and Prevention and World Health Organization for guidance.

The WHO and CDC say coronaviruses dont survive very long on objects, such as letters or packages.

"The likelihood of an infected person contaminating commercial goods is low and the risk of catching the virus that causes COVID-19 from a package that has been moved, traveled, and exposed to different conditions and temperature is also low," WHO writes.

Dr. Nancy Messonnier, the director of CDCs National Center for Immunization and Respiratory Disease, addressed the question of packages specifically.

She said, In general, because of the poor survivability of these coronaviruses on surfaces, thats in the range of hours, theres likely a very, very, very low if any risk of spread from products or packaging that is shipped over a period of days or weeks in ambient temperatures.

So we can Verify, no, there is a low risk of catching the virus through your mail or groceries.

RELATED: VERIFY: Are some masks better than others amid coronavirus spread?

RELATED: VERIFY: No, hand dryers will not kill the coronavirus; They won't spread it either

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RELATED: VERIFY: Will the coronavirus die out when it gets warm?

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VERIFY: The risk of contracting coronavirus from groceries, mail remains low - WUSA9.com

Immunology

Possible COVID-19 treatment: transfusion of antibodies from recovered patients’ blood – Washington University School of Medicine in St. Louis

March 24, 2020 medical

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Century-old idea applied to modern pandemic

A laboratory worker removes plasma from a vial of blood. Researchers at Washington University School of Medicine in St. Louis and elsewhere are investigating whether transfusions of blood plasma from people who have recovered from COVID-19 can prevent or treat the disease. The approach was used with some success during the 1918 influenza pandemic.

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, said Jeffrey P. Henderson, MD, PhD, an 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,a 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.

Clinical teams ready; research for vaccines, drugs underway

Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

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Possible COVID-19 treatment: transfusion of antibodies from recovered patients' blood - Washington University School of Medicine in St. Louis

Immunology

Sydney-born immunologist Sotiris Tsiodras, the ‘voice’ of coronavirus in Greece – Neos Kosmos

March 24, 2020 medical

Australias response to the crisis has been mild compared to Greeces stringent lockdown. Despite the fact that there have been just 17 deaths and 695 cases, the government is acting as though the numbers are high. A protagonist in Greeces battle against coronavirus is Sydney-born immunologist Sotiris Tsiodras, the government spokesperson for coronavirus-related measures.

Mr Tsiodras is the father of seven children and a CV that runs over 27 pages. He is dubbed the new beloved of Greeks by Le Figaro, and he holds the burden of informing Greeks of what is in store in the war against Covid-19.

Relatively unknown to the general public until now, Mr Tsiodras is now the man of the moment. Greek sociologist Andreas Drymiotis writes: Greeks particularly appreciate his calm, his knowledge on the matter, and his deep respect for all victims and the fact that he has an unbreakable dedication to nursing staff.

Born in Sydney on 13 October, 1965, his family later moved to Greece where he finished his studies at the senior high school of Kypseli. Following studies in Athens, he later specialised in immunology at the Beth Israel Deaconess Medical Centre as well as Harvard Medical School, where he was a researcher.

His medical skill was seen at the inspections of the Olympic Games in Salt Lake City in 2002 as well as the Athens Games in 2004. In Greece, he advised authorities on H5N1, West Nile Fever and more.

READ MORE:Greek government bans gathering of groups of 10 in open spaces as coronavirus numbers rise to 418

Greek Prime Minister Kyriakos Mitsotakis was alerted to the danger Greece faced as soon as the first cases were noted in Italy, when Mr Tsiodras asked him to take drastic action. The article in Le Figaro also refers to the success of Mr Tsiodras in getting the powerful Greek church to collaborate in the fight against coronavirus. A devout Christian himself, he wakes up on Sundays to go to his parish and is an adept Byzantine chanter a passion he has had for many years.

Though a man with deep faith, he advised for the suspension of every service. It was a difficult decision for a country that claims to be 98 per cent Greek Orthodox in faith, and even more staggering bearing in time that the great feast of Orthodoxy is around the corner.

READ MORE:We are at war, says Greek Prime Minister Kyriakos Mitsotakis and says more measures will be necessary

There have already been 2,000 doctors and nurses drafted and there are fears that the disaster will exceed the countrys capacity to manage following a decade-long financial crisis that shrunk the countrys GDP by 25 per cent as well as a local infrastructure that is already tested by a refugee crisis.

Something that Mr Tsiodras is respected for, however, is his ability to contain the virus.

Link:
Sydney-born immunologist Sotiris Tsiodras, the 'voice' of coronavirus in Greece - Neos Kosmos