Category Archives: Immunology

Bacteriophages may play a role in childhood stunting and be able to help treat it – McGill Newsroom

New research spearheaded by McGill University has discovered that bacteriophages (viruses that infect bacteria) found in the intestinal tracts of children may play a role in childhood stunting, a significant impediment to growth that affects 22% of children under the age of five around the world.

The study, published today in Cell Host & Microbe, also suggests that because they affect the abundance and diversity of bacterial communities in the gastrointestinal tract, these viruses could also be used to improve health. The researchers believe this work offers hope of developing new cost efficient therapies for populations where nutritional interventions, which have been shown to work, are difficult to implement and sustain in vulnerable human populations.

Phages, bacteria and stunting

Earlier studies had suggested that the gut microbiome might play a role in stunting by showing that stunted children have increased numbers of disease-causing bacteriaassociated with impaired digestive and absorption functionsliving in their gastrointestinal tracts.

But while much research has focused on the bacteria present in our gut and the influence they can have on human health, little attention has thus far been paid to other very common residents of our gastrointestinal tract bacteriophages.

Phages or bacteriophages, which are bacterial viruses, are naturally found in every environment where bacteria are found, and the human gut is no exception, says Corinne Maurice, an assistant professor in McGills Department of Microbiology and Immunology and senior author of the new study. Because phages are as abundant as their hosts, they might be involved in regulating them in many ways by killing specific bacteria, transferring virulence or antibiotic resistance genes to them, for example, but we currently dont have a clear understanding of what they do and how they do it. This is a fairly new and exciting field of research.

Distinct viruses in healthy and stunted children

To understand how these viruses might play a role in stunting, Maurices team, in collaboration with the International Centre for Diarrheal Disease Research in Bangladesh, collected fecal samples from 30 non-stunted and 30 unrelated stunted Bangladeshi children aged between 14 and 38 months.

Using a combination of microscopy, ribosomal gene sequencing, and metagenomics, they were able to determine that the phages found in the gut of non-stunted and stunted children are distinct. Furthermore, when gut bacteria from non-stunted children were exposed to phages from the guts of stunted children in vitro, they found that bad bacteria, suspected of being involved in stunting, proliferated.

By showing that phages can change the bacterial community in children between 6 and 23 months, our work shows the potential of phages for reestablishing the gut bacterial community in stunting, says Mohammadali Khan Mirzaei, a former postdoctoral student in the Maurice lab and first author of the new study.

Stunting has lifelong consequences (health/socioeconomic) and can be transferred from mother to child, says Maurice, who is also Canada Research Chair in Gut Microbial Physiology and a CIFAR Azrieli Global Scholar. If phages can change bacterial communities in a specific way and long-term during child development, this could be a cheap treatment with no risk of antibiotic resistance.

Though the findings now need to be validated using a larger sample and in animal models, Maurice says that by understanding interactions between bacteria and viruses in the human gut, we might be able to one day manipulate them to improve human health.

Image caption: Bacteriophages are viruses that specifically infect bacteria.credit:iStock / Getty Images Plus

Bacteriophages isolated from stunted children can regulate gut bacterial communities in an age specific manner by Mohammadali Khan Mirzaei, Anik Ashfaq Khan, Prakash Ghosh, Zofia E. Taranu, Mariia Taguer, Jinlong Ru, Rajashree Chowdhury, Mamun Kabir, Li Deng, Dinesh Mondal and Corinne F. Maurice was published in Cell Host & Microbe.

This study was funded by the Bill and Melinda Gates Foundation and the Canada Research Chair Program.

About McGill University

Founded in Montreal, Quebec, in 1821, McGill University is Canadas top ranked medical doctoral university. McGill is consistently ranked as one of the top universities, both nationally and internationally. It is a world-renowned institution of higher learning with research activities spanning two campuses, 11 faculties, 13 professional schools, 300 programs of study and over 40,000 students, including more than 10,200 graduate students. McGill attracts students from over 150 countries around the world, its 12,800 international students making up 31% of the student body. Over half of McGill students claim a first language other than English, including approximately 19% of our students who say French is their mother tongue.

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Bacteriophages may play a role in childhood stunting and be able to help treat it - McGill Newsroom

Plasma Fractionation Market – 2020 Share, Size, Growth, Trends, Business Insights, Competitive Landscape, Opportunities, Segments, Key Players,…

According to Plasma Fractionation Market 2020 Global Industry Forecast to 2026 Report published by Fortune Business Insights, the Global Plasma Fractionation Market size to reach $9.5 billion at CAGR of 10% by 2026. Market for Plasma Fractionation segmented by Product Type (Instruments and Reagents & Consumables), Technique (Hematology, Immunohistochemistry, Molecular Diagnostics, Diagnostic Imaging, Clinical Biochemistry, and Others), Animal Type (Livestock and Companion), End-user (Veterinary Hospitals & Clinics, Veterinary Reference Laboratories, and Others) and Regional Forecast 2019-2026.

According to Plasma Fractionation Market 2020 Global Industry Forecast to 2026 Report published by Fortune Business Insights, the Global Plasma Fractionation Market size to reach $38.65 billion at CAGR of 6.2% by 2026. Market for Plasma Fractionation segmented by Product Type (Instruments and Reagents and Consumables), Technique (Hematology, Immunohistochemistry, Molecular Diagnostics, Diagnostic Imaging, Clinical Biochemistry, and Others), Animal Type (Livestock and Companion), End-user (Veterinary Hospitals and Clinics, Veterinary Reference Laboratories, and Others) and Regional Forecast 2019-2026.

Plasma Fractionation Industry Key Players Analyzed in Report Are:

CSL, Octapharma, Grifols, S.A., Kedrion S.p.A., Biotest AG, Shire, Baxter, LFB.

Request a Sample Copy of the Research Report: https://www.fortunebusinessinsights.com/enquiry/request-sample-pdf/plasma-fractionation-market-101614

Global Plasma Fractionation Market Insights:

The Global Plasma Fractionation Market is expanding at notable growth rate; this market growth is attributed to factors such as Increasing Prevalence of Congenital Disorders and Rising Usage of Plasma Proteins.

Fortune Business Insights in a new report, titled Plasma Fractionation Market Size, Share and Industry Analysis, By Product Type (Albumin, Immunoglobulin (Intravenous Immunoglobulin and Subcutaneous Immunoglobulin), Coagulation Factors (Factor IX, Factor VIII, Prothrombin Complex Concentrates, Fibrinogen concentrates and Others), Protease Inhibitors and Others), By Application (Immunology and Neurology, Hematology, Critical Care, Pulmonology and Others), By End User (Hospitals and Clinics, Clinical Research Laboratories and Others (Academic Institutes, etc.)) and Geography Forecast, 2019-2026 states that the market was worth USD 24.07 Billion in the year 2018 and is likely to reach USD 38.65 Billion by 2026.

The process of separating several plasma components is called plasma fractionation. These components are separated with the help of processes such as ethanol fractionation and cryoprecipitation. Rising prevalence of congenital disorders is driving the global plasma fractionation market. Unlike pharmaceutical and biopharmaceutical industry, plasma fractionation industry uses human blood plasma or living cells as raw materials to manufacture critical drugs. These life-saver products help in the treatment of severe health conditions caused by congenital metabolic deficiencies, immunological disorders, and trauma. This, along with increasing FDA approvals, will create lucrative growth opportunities for the market.

Plasma Fractionation Market Segmentation:

Plasma Fractionation Market Size, Share and Industry Analysis, By Product Type (Albumin, Immunoglobulin (Intravenous Immunoglobulin and Subcutaneous Immunoglobulin), Coagulation Factors, Protease Inhibitors and Others), By Application (Immunology and Neurology, Hematology, Critical Care, Pulmonology and Others), By End User (Hospitals and Clinics,), and Geography Forecast 2019-2026

Regional Insights:

Report analyzes Global Market for Plasma Fractionation by North America, South America, Asia-Pacific, Europe, Middle East and Africa.

Among regions, North America is anticipated to maintain its dominance in the global plasma fractionation market in the forecast years. As per the research report, the market was valued at USD 10.08 Billion in 2018. The market in this region is expanding with the rising support from government regarding new plasma facilities. Increasing research activities on plasma fractionation processes with well-established healthcare infrastructure majorly contributes to the growth of the market in this region.

Following North America, Europe is the second-most leading region in the market owing to the rising sales of plasma proteins. In addition to this, the increasing prevalence of plasma indications and advanced improvements in the plasma fractionation process are encouraging growth in the market in this region. The market in Asia Pacific is prophesized to rise at a higher CAGR owing to the rising adoption of blood plasma fractionation in countries such as India and China.

Plasma Fractionation Market Growth Factors:

As per the data published by the National Institutes of Health, every year around 40,000 kgs of intravenous immunoglobulin and approximately 5,00,000 kgs of human albumin is produced all across the globe. This shows that the usage of immunoglobulin is increasing at a rapid rate, which is one of the primary factors responsible for driving the market. These immunoglobulins act as antibodies. Moreover, the adoption of immunoglobulins is increasing as play a crucial role in the detection and destruction of viruses and bacteria. They have been tested for the RandD of autoimmune disorders or Alzheimers. The demand for IgG products is fueling across several regions, which in turn, is increasing the sales of these products. All the above mentioned factors are anticipated to contribute to the growth of the market in the

Highlights of the Report:

In-depth analysis of various insights, namely, Plasma Fractionation Market trends, growth drivers, opportunities, and other related challenges.

Comprehensive details of key market players, their core competencies, and Plasma Fractionation Market share.

The potency of suppliers and buyers to make better business decisions.

Lists out the market size in terms of volume.

Table of Content:

1.1. Research Scope

1.2. Market Segmentation

1.3. Research Methodology

1.4. Definitions and Assumptions

3.Market Dynamics

3.1. Market Drivers

3.2. Market Restraints

3.3. Market Opportunities

4.1. Number of Cataract Surgeries - For Key Country/Region

4.2. Pipeline Analysis

4.3. Key Industry Developments - Mergers, Acquisitions, and Partnerships

4.4. Technological Advancements in Ophthalmic Surgery

4.5. Introduction of New Products / Approvals (by Major Players)

Continued

About us:

Fortune Business Insights offers expert corporate analysis and accurate data, helping organizations of all sizes make timely decisions. We tailor innovative solutions for our clients, assisting them address challenges distinct to their businesses. Our goal is to empower our clients with holistic market intelligence, giving a granular overview of the market they are operating in.

At Fortune Business Insights we aim at highlighting the most lucrative growth opportunities for our clients. We therefore offer recommendations, making it easier for them to navigate through technological and market-related changes. Our consulting services are designed to help organizations identify hidden opportunities and understand prevailing competitive challenges.

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Ex-Pfizer oncology R&D lead lands at Fierce 15 winner Vividion Therapeutics – FierceBiotech

Pfizers former longtime cancer research head Robert Abraham, Ph.D., has become the new chief scientific officer at a San Diego biotech after leaving the Big Pharma last year.

He moves over to 2017 Fierce 15 winner Vividion Therapeutics, a biotech looking to increase the number of proteins small molecules can target. Last April, it got off a $82 million series B financing round.

Its platform is based on the work of Benjamin Cravatt, Phil Baran and Jin-Quan Yu at the Scripps Research Institute and is designed to identify new sites in the proteomewhich is distinct in each cellthat can be drugged.

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Vividion spun out of Scripps back in 2017; its still pretty quiet on specifics of its pipeline, but it's looking to work on cancer and immunology through its selective small-molecule therapeutic platform.

RELATED: FierceBiotech's 2017 Fierce 15 | Vividion Therapeutics

Abraham will now help lead these efforts. Its a major get for the small biotech and will likely be a bit of a culture shock for Abraham, who joins Vividion from a 10-year tenure at Pfizer where he most recently served as senior vice president and group head, oncology R&D.

He "retired" from Pfizer last year, and was replaced by Calico's Jeff Settleman, Ph.D. last July.

We are delighted to have Bob join the Vividion family. His deep scientific expertise and experience managing a large and complex portfolio at Pfizer will help us successfully advance our broad and promising pipeline of selective small molecule programs, said Diego Miralles, CEO of Vividion.

Our proprietary platform has generated a diverse portfolio addressing several highly sought-after targets in the areas of oncology and immunology, and we look forward to leveraging Bob's insights as we create the small molecules of the future.

I am extremely excited to join the exceptionally talented and innovative team at Vividion," added Abraham.

The success the company has had in generating and progressing multiple compelling programs over such a short period of time is impressive. I look forward to helping Vividion realize the full potential of its technology platform to deliver highly differentiated, impactful medicines to patients.

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Ex-Pfizer oncology R&D lead lands at Fierce 15 winner Vividion Therapeutics - FierceBiotech

Moms Role to Protect From Childhood Allergic Sensitization – Physician’s Weekly

For most children, immunoglobulin E (IgE) sensitization to food and respiratory allergens begins during the first few years of life. However, maternal allergen-specific immunoglobulin G (IgG) is transferred to offspring during pregnancy, thereby possibly averting the evolution of allergic sensitization. Using IgE reactivity profiles from asymptomatic children in early life, it is possible to predict both the likelihood of a child developing symptoms later in life and the severity of those symptoms.

Several factors are known or suspected to have an impact on allergic sensitization in children, both in terms of protection from, and facilitation of, IgE formation, says Christian Lupinek, MD. From allergen-specific immunotherapy (AIT), allergen specific IgG antibodies that block IgE binding to the respective allergen are known to be beneficial, as they can reduce symptom load in an allergen-specific manner when the patient is exposed to an allergen.

For a study published in the Journal of Allergy and Clinical Immunology, Dr. Lupinek and colleagues analyzed IgG reactivity to more than 160 microarrayed allergens in mothers during pregnancy, cord blood samples, breast milk, and infants in the first years of life (6 months, 12 months, and 5 years), exploring whether maternal allergen-specific IgG could protect offspring from IgE sensitization. The samples allowed studying both mother-to-child transferring of allergen-specific IgG and the subsequent production of allergen-specific antibodies in the infant.

Children with IgE-sensitization also have higher IgG levels to the same respective allergen, says Dr. Lupinek. This demonstrates an obviously high general propensity in allergic subjects to mount an antibody response to harmless environmental antigens.

The study showed a high correlation among allergen-specific IgG reactivity profiles in mothers, cord blood, and breast milk. Maternal allergen-specific IgG remained for some children at 6 months. The data clearly visualize the decline of the passively transferred maternal allergen-specific IgG, which are present at birth but hardly remain at 6 months of age, says Dr. Lupinek.

Compared with nonsensitized children, those who were IgE sensitized against an allergen at age 5 showed monumentally elevated allergen-specific IgG levels at the same age. By contrast, mothers with elevated levels of IgG antibodies against an allergen in their blood exceeding 30 ISU-G had children without allergic IgE sensitizations toward that particular allergena finding consistent for all 164 tested allergens. In comparison, only children of mothers with lower allergen-specific IgG antibodies had IgE sensitization to allergens. This implies that induction or passive transfer of allergen-specific IgG in pregnant women may facilitate prevention of allergic sensitization in their offspring, says Dr. Lupinek.

When examining allergens against which children at age 5 were sensitized, the study team observed that to most allergens, no mother had mounted an IgG-response that exceeded a level of 30 ISU-G (Table). According to Dr. Lupinek, This implies that both the spectrum and the level of allergen-specific IgG spontaneously formed in mothers would not be sufficient to convey protection from sensitization to their offspring.

The study produces significant evidence that throughout pregnancy, elevated maternal allergen-specific IgG levels protect offspring from allergic sensitization, potentially providing new solutions in the prevention of allergic diseases. The initial post-natal months appear to be a key period for allergic sensitization, as levels of maternal IgG antibodies transferred to the child are already low at 6 months. The observation that the passive transfer of allergen-specific IgG from mother to child may protect the child from getting sensitized to the respective allergens allows us to develop new strategies for the prevention of allergic sensitization says Dr. Lupinek.

Allergen-specific immunotherapy (via vaccination) and passive immunization with IgG isolated from subjects with elevated levels of allergen-specific IgG can both increase the number of protective IgG antibodies in the plasma of pregnant women. AIT treatment of pregnant women can avert offsprings development of IgE sensitization against correlating allergens. In this context, says Dr. Lupinek, it seems to be relevant for the treatment to be effective that IgG-levels exceed a particular threshold (ie, 30 ISU-G).

Lupinek C, Hochwallner H, Johansson C, et al. Maternal allergen-specific IgG might protect the child against allergic sensitization. J Allergy Clin Immunol. 2019;144(2):536-548. Available at https://www.jacionline.org/article/S0091-6749(19)30106-X/fulltext.

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Moms Role to Protect From Childhood Allergic Sensitization - Physician's Weekly

‘We’re responding to this threat’: University of Alberta works to help stop novel coronavirus – Calgary Herald

The University of Albertas Li Ka Shing Institute of Virology says a drug once used in an Ebola outbreak could fight the novel coronavirus.

Remdesivir will be tested against the virus, known as 2019-nCoV, at the institute in Edmonton. Although there are regulatory hurdles related to getting samples of the coronavirus into the country, lab work has already begun, said D. Lorne Tyrrell, founding director of the Li Ka Shing Institute of Virology.

The prospects for developing an antivirus that can be used in patients is very good, and it may happen in the next few weeks and be readily available some compounds that are already on the market for their viruses that might work (against) this virus, said Tyrrell.

The institute is aiming to raise up to half a million dollars in funding, including rapid response grants from the Canadian Institute of Health Research, to go towards work on the novel coronavirus, Tyrrell said.

No one at the institute specializes in coronavirus at the moment. That is going to change very quickly, said Tom Hobman, professor of medical microbiology and immunology at the university, who noted that experts on coronaviruses have been recruited.

Since it can take years to get a brand new drug to market, researchers at the institute hope to find a drug thats already been developed to fight the virus.

Remdesivir, one of the drugs they will test, was used in the emergency treatment of patients with Ebola virus infection in the Democratic Republic of the Congo. The drug has shown activity in animal models against the viral pathogens MERS and SARS, which are coronaviruses that are structurally similar to the novel coronavirus, and has been used on a small number of patients.

Since the outbreak of the new coronavirus, it was just logical to ask whether this drug will work against the new coronavirus. The good thing was that its been tested, with tons of pre-clinical data, as well as in very difficult clinical settings, said Matthias Gtte, chair of the department of medical microbiology and immunology.

We are interested, always, not in the entire virus, but in the little machines the enzymes that help the virus to propagate. As soon as you shut down the machine, you shut down the virus, and you have a drug, said Gtte. Now, the goal is to see if the mechanism works the same way against the novel coronavirus.

If youre trying to respond very quickly to an outbreak, you dont really have the luxury of time to develop something completely new, said Dave Evans, professor of medical microbiology and immunology.

The challenge with all drug development is making sure it works and is safe, so its a common approach to test drugs that are known to be safe on new viruses, said Evans.

Viruses change, and new viruses are always emerging, said Tyrrell.

Public health efforts to contain the novel coronavirus have been more challenging than in other outbreaks, including SARS, but the mortality rate is so far much lower, he said. There have been at least 40,000 confirmed cases of the novel coronavirus worldwide, and 910 deaths, according to The World Health Organizations latest numbers.

(The institute) has been designed to look after major outbreaks in the world like this, and I just want you to know that were responding to this threat, said Tyrrell.

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'We're responding to this threat': University of Alberta works to help stop novel coronavirus - Calgary Herald

Sihuan Pharmaceutical and Hetero Labs Limited Reached A Framework Cooperation Agreement in Pharmaceutical Manufacturing Area – Yahoo Finance

HONG KONG, Feb. 12, 2020 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd.(HKEX: 0460) ("Sihuan Pharmaceutical" or the "Company", together with its subsidiaries, the "Group") is pleased to announce that the Group and Hetero Labs Limited ("Hetero"), a company registered under the laws of India, reached a framework cooperation agreement (the "Cooperation") in the pharmaceutical manufacturing area after several rounds of discussion.

Under the terms of the framework cooperation agreement, the Cooperation includes research and development ("R&D"), product registration, technology transfer, raw materials supply and local manufacturing and commercialization of drugs in the fields of cardiovascular, cerebrovascular, neurology and anti-infectives including novel coronavirus (2019-nCoV), etc.

Backed by over 25 years of expertise in the pharmaceutical industry, Hetero is the world's leading producer of anti-retroviral drugs for the treatment of HIV/AIDS. Hetero caters about 40% of the identified HIV/AIDS patients globally through around 30 anti-retroviral products combinations. In addition, Hetero is growing as a reliable partner in the industry specializing in major therapeutic categories such as oncology, cardiovascular, neurology, hepatitis, nephrology, urology, diabetes, ophthalmology and immunology, etc., with around 300 products in the portfolio.

The signing of this framework cooperation agreement will achieve a win-win situation in which the two parties complement each other's strengths and jointly accelerate their development. On one hand, Hetero's anti-viral and anti-infection products will be introduced to China by Sihuan Phamaceutical which is equipped with standardized production capacity and strong marketing capabilities for local production and sales. This will also enrich the Group's R&D and product pipeline. On the other hand, Hetero will explore the great potential in the China market.

Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical said, "Based on the prevalence of the novel coronavirus infection pneumonia in China, both parties agreed to take the introduction, development and production of new coronavirus drugs as a priority issue, giving priority and contributing to China's fight against the pandemic ! "

-End -

About Hetero Labs Limited

Headquartered in Hyderabad, India, Hetero is one of India's leading generic pharmaceutical companies and one of the world's largest producers of anti-retroviral drugs for the treatment of HIV/AIDS. Backed by over 25 years of expertise in the pharmaceutical industry, Herero's strategic business areas spread across APIs, generics, biosimilars, custom pharmaceutical services and branded generics. Hetero is globally recognized for its strengths in research and development, manufacturing and commercialization of a wide range of products. Hetero caters about 40% of the identified HIV/AIDS patients globally through 30+ ARV products combinations . Hetero has 36 state-of-the-art manufacturing facilities strategically located worldwide, audited and approved by stringent regulatory authorities like U.S. FDA, EU, TGA-Australia, MCC-South Africa and others. Hetero is growing as leader and reliable partner of choice in the major therapeutic categories such as HIV/AIDS, oncology, cardiovascular, neurology, hepatitis, nephrology, urology, diabetes, ophthalmology, hepatology and immunology etc., with over 300 products in the portfolio.

About Sihuan Pharmaceutical Holdings Group Ltd.

Founded in 2001, Sihuan Pharmaceutical is a pharmaceutical group with 21 subsidiaries and integrated R&D, production and marketing and sales capabilities. Because of the continuing efforts over the past decade, Sihuan Pharmaceutical has formed a R&D platform with over 1,000 researchers conducting more than 110 pharmaceutical research projects currently. More than 300 patents on innovative drugs were granted in China and over 80 are PCT patents, covering pipeline projects including important areas of diabetes, oncology, anti-infectives and non-alcoholic steatohepatitis etc.

SOURCE Sihuan Pharmaceutical Holdings Group Ltd.

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Sihuan Pharmaceutical and Hetero Labs Limited Reached A Framework Cooperation Agreement in Pharmaceutical Manufacturing Area - Yahoo Finance

Immune Therapeutics Inc. Provides Updates and Guidance on Reverse Stock Split and Name Change – Yahoo Finance

Awaiting completion of FINRA approval process

Orlando, Florida--(Newsfile Corp. - February 11, 2020) - Immune Therapeutics, Inc. (OTC Pink: IMUN) ("Immune" "IMUN" or the "Company"), a clinical late stage biopharmaceutical company focused on the development of therapies for the treatment of autoimmune diseases, inflammatory diseases today announced an update on the pending 1000 to 1 reverse stock split and name change of Immune Therapeutics.

Immune Therapeutics originally submitted the reverse and name request for a corporate action to FINRA and paid the applicable fees on November 27, 2019. Since then, the company has responded to FINRA's requests for further information multiple times, and we continue in our efforts to work diligently and cooperatively with FINRA to process the reverse and name change. Please note that the Company has no control of the FINRA approval process and as such the timing of any decisions our not in the Company's control.

Michael K. Handley, CEO of Immune, said, "We are disappointed in the delay in processing the reverse and name change and remain fully committed to the restructuring and success of IMUN. I would personally like to thank all of our shareholders for their patience in this process. We realize this delay has eroded share value, and confidence however, based on the extensive review by FINRA, we are optimistic that their approval could be given soon, at which time we will certainly inform shareholders immediately. Immune would like to thank our shareholders for standing behind us, as we continue to work in your interests with a commitment to the reverse and merger with Aletheia as soon as possible."

ABOUT Immune Therapeutics Inc.

Immune Therapeutics, Inc. is a late-stage biopharmaceutical company focused on the development and commercialization of highly innovative therapies for use in oncology, immunology and anti-inflammatory disease. Immune Therapeutics is actively developing T-cell activation immunotherapies in combination with other drug candidates to achieve immunomodulation in patients with cancer, auto-immune disease and inflammatory diseases.

FORWARD LOOKING STATEMENTS

This release may contain forward-looking statements. Actual results may differ from those projected due to a number of risks and uncertainties, including, but not limited to, the possibility that some or all the matters and transactions considered by the Company may not proceed as contemplated, and by all other matters specified in the Company's filings with the Securities and Exchange Commission. These statements are made based upon current expectations that are subject to risk and uncertainty. The Company does not undertake to update forward-looking statements in this news release to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking information. Assumptions and other information that could cause results to differ from those set forth in the forward-looking information can be found in the Company's filings with the Securities and Exchange Commission (www.sec.gov), including its recent periodic reports.

Contact:

Immune Therapeutics:Michael K. Handley(888) 613-8802 Ext. 100

http://www.immunetherapeutics.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/52312

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Immune Therapeutics Inc. Provides Updates and Guidance on Reverse Stock Split and Name Change - Yahoo Finance

Lilly and Incyte Announce Positive Top-Line Results from the North American Phase 3 Study (BREEZE-AD5) of Oral Selective JAK Inhibitor Baricitinib in…

TORONTO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- Eli Lilly and Company and Incyte announced that baricitinib met the primary endpoint in BREEZE-AD5, an investigational Phase 3, randomized, placebo-controlled study evaluating the safety and efficacy of baricitinib for the treatment of adult patients with moderate- to severe atopic dermatitis (AD). The primary endpoint was defined by the proportion of patients achieving at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) at Week 16.

"Atopic dermatitis is chronic skin condition which affects approximately one to three percent of adults worldwide.6 We appreciate the distressing impact this condition can have on a person's quality of life and the need for additional treatment options," says Dr. Doron Sagman, Vice President, R&D and Medical Affairs, Eli Lilly Canada. "We are pleased that baricitinib met the primary endpoint in the BREEZE-AD5 study, and we will continue to focus on patient-centered solutions."

BREEZE-AD5 is a multicenter, double-blind, randomized, placebo-controlled study designed for and conducted in North America and which evaluated the efficacy and safety of the 1-mg and 2-mg doses of baricitinib monotherapy for the treatment of adult patients with moderate- to severe AD. In this study, the 2-mg dose of baricitinib met the primary endpoint as defined by the proportion of participants achieving EASI75 at Week 16. Baricitinib also met key secondary endpoints including another measure of skin inflammation defined by clear or almost clear skin and at least 2 points improvement on the validated Investigator's Global Assessment for AD (vIGA 0 or 1 at Week 16), and it reduced itch severity.

P n.s. * P 0.05, and *** P 0.001 for baricitinib compared to placebo by analysis unadjusted for multiplicity. Non-responder imputation upon rescue with Topical corticosteroid (TCS). avIGA = validated Investigator's Global Assessment.

The safety profile in BREEZE-AD5 was consistent with the known safety findings of baricitinib in AD. The most common treatment-emergent adverse events (TEAEs) included upper respiratory tract infections, nasopharyngitis, and diarrhea. No venous thromboembolic events (VTEs) or deaths were reported in the trial. The full results from the BREEZE-AD5 study will be disclosed at future scientific venues and in peer-reviewed journals.

"These positive top-line results show that baricitinib could be an effective treatment option for patients living with moderate- to severe AD whose needs have remained unmet," says Dr. Gooderham, Dermatologist and study investigator.

About BREEZE-AD5BREEZE-AD5, a multicenter, double-blind, randomized, placebo-controlled, Phase 3 study in adult patients with moderate- to severe atopic dermatitis (AD). BREEZE-AD5, which was designed for and conducted in North America, evaluated the efficacy and safety of the 1-mg and 2-mg doses of baricitinib monotherapy for the treatment of adult patients with moderate to severe AD. The primary endpoint was defined by the proportion of participants achieving Eczema Area and Severity Index 75 (EASI75) at Week 16. BREEZE-AD5 completes the read out from the BREEZE development program, following the recent topline results from BREEZE-AD4. BREEZE-AD1, -AD2 and -AD7 results were disclosed in 2019.

About OLUMIANTOLUMIANT (baricitinib), in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms of moderate- to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs). OLUMIANT can be used as a monotherapy in cases of intolerance to MTX.1

OLUMIANT is believed to interfere with the activity of an enzyme called Janus Kinase (JAK). Normally JAK enzymes help turn on your immune system when you need it. The immune system then causes swelling and tenderness. This is called inflammation. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.1 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.

About Atopic DermatitisAtopic dermatitis (AD), or atopic eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.2 AD is a heterogeneous disease both clinically and biologically, but may be characterized by chronic baseline symptoms of itch, redness and skin damage that are often punctuated with episodic, sometimes unpredictable, flares or exacerbations.3,4 AD affects approximately 1-3% of adults worldwide.5

Moderate- to severe AD is characterized by intense itching, resulting in visibly damaged skin.6 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.7

About Lilly in DermatologyBy following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

About Eli Lilly CanadaEli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto, which eventually produced the world's first commercially-available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at http://www.lilly.ca.

For our perspective on issues in healthcare and innovation, follow us on twitter @LillyPadCA

About IncyteIncyteis aWilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information onIncyte, please visit Incyte.com and follow @Incyte.

Media Contact: Samira RehmanRehman_Samira@lilly.com 647-617-1994

REFERENCES

1 OLUMIANT Product Monograph2 Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. The Journal of Allergy and Clinical Immunology. 2006;118: 226-32.3 Thijs JL, Strickland I, Bruijnzeel-Koomen C, et. al. Moving toward endotypes in atopic dermatitis: identification of patient clusters based on serum biomarker analysis. The Journal of Allergy and Clinical Immunology. 2017.4 Langan SM, Thomas KS, Williams HC. What is meant by "flare" in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006;142:1190-1196.5 Nutten S. Atopic dermatitis: global epidemiology and risk factors. Annals of Nutrition and Metabolism. 2015;66(suppl 1): 8-16.6 Yosipovitch G, Papoiu AD. What causes itch in atopic dermatitis? Current Allergy and Asthma Reports. 2008;8:306-311.7 Weidinger, S, Novak, N. Atopic dermatitis. The Lancet Volume 387. 2016;10023:1109-1122.

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Lilly and Incyte Announce Positive Top-Line Results from the North American Phase 3 Study (BREEZE-AD5) of Oral Selective JAK Inhibitor Baricitinib in...

IONpath Launches Research Services Offering Multiplexed Tissue Analysis to Empower Pharmaceutical Discovery and Development Programs – BioSpace

MENLO PARK, Calif., Feb. 11, 2020 /PRNewswire/ -- Ionpath Inc., today announces the launch of a dedicated service business providing access to their proprietary MIBIscope multiplexed imaging platform and its team of experts to support pharmaceutical and biotechnology companies working in immuno-oncology.

IONpath has previously provided custom research services to leading academic and pharmaceutical organizations as part of an Early Access Program. Now the company has formalized its intentions to become a partner of choice to those interrogating the tumor microenvironment to understand therapeutic mechanism of action and identify responder populations.

"We started this company because we love doing great science and working with great scientists," said Harris Fienberg, chief executive officer and co-founder, IONpath. "Our team is incredibly excited to enable the next generation of immunotherapy development on a massive scale."

Based in their global headquarters in Silicon Valley and serving clients from around the world, an expert team of engineers, pathologists and data scientists are leveraging the proprietary MIBIscope platform to help solve the most complex problems in immuno-oncology. The MIBIscope can simultaneously image forty or more individual proteins on a single slide with the reproducibility needed for large clinical studies. IONpath is building the capacity to stain, image and analyze over 15,000 highly multiplexed slides a year by the end of 2020. The company hopes to unlock valuable data about co-expression levels, proximity of cell populations and correlations to outcomes observed in patients to meaningfully contribute to the development of immunotherapies for partners across industry and academia.

If you or your company would be interested in learning more about what Research Services can do for your program, please contact us at research@ionpath.comto talk to our expert team or request a quote.

About IONpath, Inc.IONpath, Inc. is revolutionizing tissue imaging to accelerate medical discovery and improve human health. The company's MIBIscope System, which utilizes Multiplexed Ion Beam Imaging (MIBI) technology, represents a transformative step in tissue imaging by simultaneously multiplexing 40+ markers with single cell resolution. Leading research institutes and biotech and pharmaceutical companies are using the MIBIscope in immuno-oncology, immunology and neuroscience research where high-fidelity multiplexed imaging data is needed. In addition to the MIBIscope System IONpath empowers the research and development initiatives of academic, biotech and pharmaceutical partners through IONpath Research Services.

Visit http://www.ionpath.com to find out more.

Contact:Terri Hnatyszyn305-803-0824media@ionpath.com

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SOURCE IONpath, Inc.

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IONpath Launches Research Services Offering Multiplexed Tissue Analysis to Empower Pharmaceutical Discovery and Development Programs - BioSpace

INmune Bio, Inc. Awarded $500000 Grant for Development of Novel Treatment to Reprogram Innate Immune System in People Living with ALS – BioSpace

Grant will fund proof-of-concept studies for XPro1595 therapy

LA JOLLA, Calif. , Feb. 10, 2020 (GLOBE NEWSWIRE) -- INmuneBio, Inc. (NASDAQ: INMB), an immunology company developing treatments that reprogram the patients innate immune system to fight disease, today announced that it has been awarded a $500,000 grant from The ALS Association. The grant will fund proof-of-concept studies for XPro1595, a novel therapy targeting innate immune dysfunction and chronic inflammation as a cause of Amyotrophic lateral sclerosis (ALS). The endowment was awarded through the Associations The Lawrence and Isabel Barnett Drug Development Program and will be allocated over two years.

We are honored to receive this grant from The ALS Association, the pre-eminent organization supporting novel treatments for ALS, said R.J. Tesi, M.D., Chief Executive Officer of INmune Bio. As an immunology company, we focus on the role that innate immune dysfunction and neuroinflammation play in the progression of neurodegenerative diseases such as ALS. This award supports our approach and moves the companys ALS program closer to the clinic.

While our knowledge of ALS has increased dramatically in the past few years, there are currently no disease modifying therapies, said CJ Barnum, Ph.D., Director of Neuroscience for INmune Bio. The innate immune system plays a central role in the development and progression of ALS. We believe precision targeting of the innate immune system by targetinginflammationwith XPro1595may be an effective treatment strategy inalleviating ALS. This award allows INmune Bio to take the first step to determine whether XPro1595 has therapeutic potential for ALS patients.

We believe INmune is on a path to unlocking some of the mystery around the immune system and how it responds to the kinds of inflammation that we know plays a role in ALS progression, said Kuldip Dave, Ph.D, vice president of research at The ALS Association. This grant will greatly accelerate proof of concept and advance our knowledge of immune dysfunction and neuroinflammation in people living with ALS.

About INmune Bio, Inc.INmune Bio, Inc. is a publicly traded (NASDAQ: INMB) clinical-stage biotechnology company developing therapies targeting the innate immune system in cancer. INmune Bio is developing two products platforms that reengineer the patients innate immune systems response to their disease - immune priming platform and DN-TNF platform. The immune priming platform is a Natural Killer (NK) cell therapeutic that primes the patients NK cells to attack residual disease the cause of cancer relapse. The DN-TNF platform includes programs in cancer, neurodegenerative disease and NASH. INB03 modifies the tumor microenvironment which often cause resistance to immunotherapy, such as anti-PD1 checkpoint inhibitors and trastuzumab. XPro1595 targets microglial activation, nerve cell death and synaptic dysfunction associated with neurodegenerative disease. LivNate modifies metabolic and immunologic pathology that contributes to the development and progression of NASH. To learn more, please visit http://www.inmunebio.com.

About The ALS AssociationThe ALS Association is the largest private funder of ALS research in the world. The Association funds global research collaborations, provides assistance for people with ALS and their families through its nationwide network of chapters and certified clinical care centers, and advocates for better public policies for people with ALS. The ALS Association builds hope and enhances quality of life while urgently searching for new treatments and a cure. For more information about The ALS Association, visit our website at http://www.alsa.org. For more information about The Lawrence and Isabel Barnett Drug Development Program, please visit: http://www.alsa.org/research/our-approach/call-for-abstracts/barnett-drug-development-request-for-proposals-081619.html

Forward-Looking Statements

There is no guarantee that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INBO3, LivNate, INKmune and XPro1595 are still in clinical trials and have not been approved and there cannot be any assurance that they will be approved or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Companys ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Companys business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Companys filings with the Securities and Exchange Commission, including the Companys Annual Report on Form 10-K for the year ended December 31, 2018, the Companys Quarterly Reports on Form 10-Q and the Companys Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

INmune Bio Contact: David Moss, CFO(858) 964-3720DMoss@INmuneBio.com

The ALS Association Contact:Brian Frederick,Ph.D. Executive Vice President, Communications(202) 464-8612bfrederick@alsa-national.org

Media Contact:David Schull(212) 845-4271David.Schull@russopartnersllc.com

Investor Contact:James CarbonaraHayden IR(646)-755-7412james@haydenir.com

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INmune Bio, Inc. Awarded $500000 Grant for Development of Novel Treatment to Reprogram Innate Immune System in People Living with ALS - BioSpace