Category Archives: Immunology

Immunology

Development of Immunotherapy To Treat COVID-19 In Progress – Technology Networks

CEL-SCI Corporation recently announced that it is utilizing LEAPS peptide technology in efforts to develop an immunotherapy against the novel coronavirus caused by SARS-CoV-2.The technology utilizes conserved regions of the SARS-CoV-2 protein to stimulate a protective T cell response, reducing viral load. Furthermore, LEAPS can also be adopted to create peptides with antiviral and anti-inflammatory characteristics for immunotherapeutic applications. Preclinical studies have demonstrated that LEAPS immunogens are able to prevent infection by herpes simplex virus (HSV) and influenza A in animal models.Technology Networks spoke with Daniel Zimmerman, Ph.D. Senior VP of Research, Cellular Immunology at CEL-SCI Corporation, to learn more about the LEAPS technology and its potential application in treating COVID-19.Molly Campbell (MC): For our readers that are unfamiliar, please can you describe what immunotherapy entails?Daniel Zimmerman (DZ): Immunotherapy entails the administration of agents (e.g., cellular alone or better still complexes combined with another immune agent or better still with either proteins, better antibodies alone or even better still specific peptides, etc.) that activate the immune system or act to induce a desired endogenous immune response in the recipient.

Laura Lansdowne (LL): What parallels can be drawn between coronavirus and the other respiratory viruses you have previously dealt with?

DZ: The novel COVID-19 a very close cousin to SARS, and MERS is e like influenza A in that all these infect the lung and initiate tissue damaging inflammatory responses. The LEAPS (Ligand Epitope Antigen Presentation System) technology was previously used to develop immunotherapy for an influenza A (H1N1) in collaboration with the NIAID-NIH. In, these viruses target both the upper respiratory system and the lungs.

Virus replication and inflammatory responses result in the disease-causing tissue damage. Individuals whose immune system cannot defend against the virus quickly, or who overly respond to the virus with inflammation, are at highest risk of serious disease consequences, in addition to other at risk groups including elderly populations.LL: Can you elaborate on how the LEAPS peptide technology could be a tool against the COVID-19 coronavirus?DZ: Immunotherapy can be either antigen-specific or non-specific. In the case of the LEAPS Technology for the COVID-19 coronavirus, we envision an antigen-specific antigen disease specific immune therapy that uses hetero-conjugate of peptides designed to target specific viral epitopes while focusing on stimulation of the immune cells that drive the proper response.

Specific classes or sub-classes of T cells within the CD4 or CD8 categories will be targeted. These cells stimulate and may recruit other immune cells, leading to highly significant reduced virus levels and beneficial changes in cytokine (immunological hormones) profiles in the lung tissues of patients.

They either cells or cytokines may also cause lysis of virally infected cells to decrease the virus load affecting the body. It is equally important to elicit protective immune cellular responses while minimizing tissue damaging inflammation.

Our studies will build on previous immunotherapeutics that were developed against influenza A subtype H1N1 in collaboration with the NIAID-NIH. In this work, LEAPS peptides H1N1 peptides halted the progression of disease, reducing viral presence in the lung tissues and inducing cytokine profiles that provided a balance of pro-inflammatory and anti-inflammatory regulatory responses.

In summary, LEAPS immunotherapy can be designed to stimulate the appropriate immune cells to deal with the virus infection in a balanced manner. We will be able to observe this by monitoring prevention or mitigation of viral disease and the nature of the cytokines that are present in the lung or blood after administration.

This digitally-colorized, negative-stained transmission electron microscopic (TEM) image depicts a number of Influenza A virions. Credit: Unsplash.

MC: The previous studies in collaboration with NIAID showed LEAPS peptides reduced morbidity and mortality in mice with pandemic influenza. As these are animal studies, how translational do you think the findings are to humans?

DZ: The influenza studies built on findings that arose from studies of LEAPS immunotherapies for herpes simplex virus (HSV). In these studies, the LEAPS peptides elicited equivalent immune responses in human and mouse cells. In addition, as for the influenza studies, the antigenic peptides to be selected for the LEAPS immunotherapy will be from highly conserved sequences (i.e., do not change in the virus) that are recognized by the immune systems of both humans and mice.

MC: What are the key challenges in developing an effective treatment for COVID-19?DZ: The first challenge in developing any immunotherapy is to select the peptides that contain the proper antigenic epitope sequences. These sequences need to be recognizable by the immune system in addition to the LEAPS immune cell binding ligand (ICBL) to drive the appropriate response. This has already been achieved.

Viral peptide sequences were chosen based on protein sequences that are very similar to MERS and SARS coronaviruses. The ICBL was chosen based on experience with HSV and influenza, TB, HIV and other studies, but another ICBL will also be tested as a control and to hedge our bets and expedite the development process.

MC: What are your key priorities in terms of taking a LEAPS/COVID-19 product forward?DZ: The first priority is to demonstrate that appropriate immune responses are elicited against the LEAPS immunotherapies in animal studies and then to demonstrate protection from lethal infection of Covid-19. Discussions have been initiated with several agencies and clinical research organizations (CROs) to develop studies designed to determine the potential of LEAPS immunotherapy against COVID-19 and for producing GMP grade materials for clinical studies after GLP safety studies in animals.

Daniel Zimmerman, Ph.D. Senior VP of Research, Cellular Immunology at CEL-SCI Corporation, was speaking to Molly Campbell and Laura Elizabeth Lansdowne, Science Writers, Technology Networks.

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Development of Immunotherapy To Treat COVID-19 In Progress - Technology Networks

Immunology

Invasive Fire Ant Population Could Explain Why Some States Have Fewer Cases of Red Meat Allergy – Benzinga

MILWAUKEE, March 20, 2020 /PRNewswire-PRWeb/ -- Despite the presence of the lone star tick, which is known to induce alpha-gal syndrome, cases of alpha-gal in Texas and the Gulf of Mexico are low, and it might be due to the invasive fire ant species.

Originally scheduled to be presented for the first time at the 2020 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) before it was cancelled due to the situation with coronavirus disease 2019 (COVID-19), this study was developed due to a "shortage" of cases of alpha-gal syndrome in the region. Alpha-gal refers to having an allergy to a carbohydrate molecule that's found in most mammalian or "red meat" and is known to be caused from the lone star tick. Researchers conducted a survey of allergy clinics to determine if the lack of cases was due to the invasive fire ant species, who are known predators of the lone star tick.

Researchers collected survey data from allergy clinics within and north of the U.S. Department of Agriculture fire ant quarantine zone, looking at the presence of fire ant anaphylaxis cases and alpha-gal syndrome. These cases were plotted on maps that showed county-level fire ant quarantine data from 1931 to 2018. Data from the Centers for Disease Control and Prevention (CDC) on the distribution of lone star ticks was also plotted.

A total of 87 allergy clinics provided data for the study. Before 1974, large numbers of fire ant anaphylaxis cases were reported within the quarantined area. In areas quarantined between 1974 and 2018, the cases became variable with few cases reported outside the quarantined area. Most importantly, researchers found a strong inverse correlation between cases of fire ant anaphylaxis and cases of alpha-gal syndrome within the range of lone star ticks. Essentially this means that the more fire ant anaphylaxis cases there were, the less cases of alpha-gal, and vice versa.

"What we're seeing with this data set is how two different allergy-causing species impact each other, and therefore, the type of reported symptoms we are seeing in regional allergy clinics," said Thomas A.E. Platts-Mills, MD, PhD, FAAAAI, first author of the study. "Studies like this can improve both public health and epidemiology efforts when it comes to pests that cause dangerous allergic reactions. These results may also make it possible to predict future changes in these diseases."

Visit aaaai.org to learn more about fire ant allergy and alpha-gal. This research was published in an online supplement to The Journal of Allergy and Clinical Immunology.

The American Academy of Allergy, Asthma & Immunology (AAAAI) represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has over 7,000 members in the United States, Canada and 72 other countries. The AAAAI's Find an Allergist/Immunologist service is a trusted resource to help you find a specialist close to home.

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SOURCE The American Academy of Allergy, Asthma & Immunology

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Invasive Fire Ant Population Could Explain Why Some States Have Fewer Cases of Red Meat Allergy - Benzinga

Immunology

COVID-19 And Social Isolation: An Immunology Expert Weighs In – Yahoo Entertainment

COVID-19, or coronavirus disease 2019, first appeared in late 2019 in Wuhan, China. The illness and the virus that causes it is highly infectious and has spread rapidly across the globe, afflicting thousands worldwide, and prompting the World Health Organization (WHO) to declare the outbreak a pandemic on March 11, 2020.

TELL DR. PHIL YOUR STORY: Are you involved in a story making headlines?

How afraid should we be? What are the facts?

WATCH: Social Epidemiologist Offers Tips To Slow Down The Spread Of Virus That Causes COVID-19

Ive invited some of the leading experts in the medical world to help dispel the myths and bring the facts to the surface so we can remain informed, and above all, safe, says Dr. Phil.

Discussing efforts to curb the spread of the virus through methods such as social isolation, Paula Cannon, Ph.D., professor of molecular microbiology and immunology at USCs Keck School of Medicine, says, If we can do something that may help, we should do it.

In the video above, she and Dr. Patrick Johnson, neurosurgeon and co-director of the Spine Practice at Cedars Sinai Medical Center in Los Angeles, discuss the origins, spread, and containment of the disease.

Check here to find out where you can watch Tuesdays episode as Dr. Phil and his guests address concerns regarding the evolving health crisis.

For the most up-to-date information on COVID-19, please visit the Centers for Disease Control And Prevention (CDC) website at cdc.gov.

TELL DR. PHIL YOUR STORY: Outrageous news story in your town?

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COVID-19 And Social Isolation: An Immunology Expert Weighs In - Yahoo Entertainment

Immunology

Immunology experts slam government’s ‘herd immunity’ approach to tackling Covid-19 – Wales Online

Immunology experts have slammed what they have described as the UK Government's "herd immunity" approach to tackling Covid-19 .

Professor Arne Akbar, president of the British Society for Immunology , has written an open letter to the government to voice "significant questions" about the strategy proposed.

In his letter, Mr Akbar wrote: "The world faces a huge challenge in light of the SARS-CoV-2 outbreak.

"The UKs public health strategy differs from many other countries, with an aim to build herd immunity to protect the population.

"Within the immunology community, we have significant questions about this strategy. The ultimate aim of herd immunity is to stop disease spread and protect the most vulnerable in society.

"However, this strategy only works to reduce serious disease if, when building that immunity, vulnerable individuals are protected from becoming ill, for example through social distancing. If not, the consequences could be severe."

Additionally, Mr Akbar added there are "many unknowns in how the SARS-CoV-2 virus interacts with the human immune system and how this might play into current scenarios".

"For example, we dont yet know if this novel virus will induce long-term immunity in those affected as other related viruses do not," he wrote.

"Therefore, it would be prudent to prevent infection in the first place. More research is urgently needed on this front.

Join our Facebook group to keep up to date with all the latest on coronavirus in Wales.

You can find it here.

"The UK leads the world for the quality of our immunology research. Given our current lack of knowledge on SARS-CoV-2, our community of immunologists have two asks. Firstly, we feel more needs to be done to ensure social distancing to limit the number of COVID-19 cases in the short term, especially for vulnerable members of our communities.

"This will enable us to buy time until we understand the virus better and can begin to develop therapeutics.

"Secondly, to aid efforts, we call on the government to release their modelling data to allow scrutiny from the scientific community to better predict the course of this outbreak.

"We have a small window of opportunity to protect our nation, to learn about this new emerging virus and to deal with this unprecedented threat to global health."

The UK Government has been approached for comment.

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Immunology experts slam government's 'herd immunity' approach to tackling Covid-19 - Wales Online

Immunology

VERIFY: The risk of contracting coronavirus from groceries, mail remains low – WTHR

WASHINGTON (WUSA) 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 lot has been written about the necessity to avoid frequently-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 the 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 Centers for Disease Control and Prevention nor World Health Organization 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 CDC and WHO 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 said.

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 risk is low of catching the virus through your mail or groceries.

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VERIFY: The risk of contracting coronavirus from groceries, mail remains low - WTHR

Immunology

How to keep your immune system healthy during the coronavirus pandemic, according to experts – The Philadelphia Inquirer

Dont get your hopes up that theres any over-the-counter fix that will leave you unscathed by the new pandemic. Three immunologists Timothy Craig, a professor of medicine and pediatrics in allergy and immunology at Penn State Health Milton S. Hershey Medical Center; Cathryn Nagler, a mucosal immunologist at the University of Chicago and distinguished fellow of the American Association of Immunologists, and John Wherry, director of the Institute of Immunology at Penn Medicine said theres no strong evidence that any herb or supplement, including vitamin C, will prevent coronavirus. Like drinking water, taking most of them probably wont hurt you, but also wont help. Probiotics also wont save you. Colloidal silver can be harmful.

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How to keep your immune system healthy during the coronavirus pandemic, according to experts - The Philadelphia Inquirer

Immunology

Multi-food Oral Immunotherapy Found to Be Safe and Effective – Benzinga

MILWAUKEE, March 19, 2020 /PRNewswire-PRWeb/ --Combining multiple food allergies into a single oral immunotherapy course is as safe and effective as single food immunotherapy, according to research scheduled for presentation at the 2020 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting before it was cancelled due to the situation with coronavirus disease 2019 (COVID-19).

A retrospective review was used to complete the study, looking at patients who started peanut oral immunotherapy (OIT) from April 2014 through September 2018 and patients undergoing multi-food OIT from February 2015 through September 2018. Diagnostic allergy testing was encouraged every year and reactions requiring epinephrine were recorded.

Multi-food patients were treated with an average of 2.4 foods (with individual options ranging from two to four foods in one OIT course). Patients on both forms of therapy were placed on a dosing schedule with the eventual goal of reaching maintenance dosing. According to the study, 85% of peanut OIT patients reached their maintenance dose compared to 80% of those on multi-food OIT. The median amount of time it took to reach the maintenance dose was 245 days for peanut OIT and 231 days for multi-food OIT patients.

"What we discovered is that instead of cycling through multiple six to 10 month single food courses, we can safely combine multiple foods into one OIT course," said Hugh H. Windom, MD, FAAAAI. "This gives patients with multiple food allergies more options when it comes to treatment plans."

Epinephrine was used in 13% of patients undergoing peanut OIT and 8% of multi-food OIT patients during the first year of treatment. This is consistent with published reports, and there were no reports of severe anaphylaxis. The most common reason for stopping OIT in both groups was non-compliance and delayed gastrointestinal symptoms. This further indicates that overall, there were little differences in effectiveness and safety when comparing single food OIT to multi-food OIT.

Visit aaaai.org to learn more about OIT. This research was published in an online supplement to The Journal of Allergy and Clinical Immunology.

The American Academy of Allergy, Asthma & Immunology (AAAAI) represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has over 7,000 members in the United States, Canada and 72 other countries. The AAAAI's Find an Allergist/Immunologist service is a trusted resource to help you find a specialist close to home.

SOURCE The American Academy of Allergy, Asthma & Immunology

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Multi-food Oral Immunotherapy Found to Be Safe and Effective - Benzinga

Immunology

AbbVie Is Your Egg In The Basket Now – Seeking Alpha

Summary

AbbVie (NYSE:ABBV), the pharmaceutical giant, recently took a knock from the delay in the proposed acquisition of Allergan (NYSE:AGN) amid fears of an anti-trust case. But if approved, the impending takeover of $63 billion is likely to take place later in the year after the preliminary investigations by the FTC. The investigation seeks to evaluate if the new entity, will create an uneven playing field within its industry through gaining too much power over the competition.

AbbVie has seen its revenues of Humira declining in Europe as the company faces biosimilar competition in the region, with the trend expanding into the third quarter, which has reinforced the need to diversify. If Allergan is onboarded, we believe AbbVie would be able to attain single-digit top-line growth in the coming years, and the new portfolio will set the company for a healthy mix of more modern medicines.

The Allergan merger: Bought at a discount and already approved by the EU.

Since the announcement in June last year, the company saw a retreat in the market as the stock price went down. And it has yet to recover from the sentiment around the takeover. But the impending takeover of Allergan will certainly position AbbVie at the top of the market and as a leader in immunology. With the EU has approved the merger, the ball is now with the US Federal Trade Commission (FTC) as they review the transaction. The company is, however, confident that the deal will be concluded in the second half of the year; a prediction that we support.

Based on our view, the justification for the takeover is that AbbVie needs to diversify and become less dependent on Humira as the market will not be able to wade off competition beyond 2023. AbbVie also seems to have gotten Allergan at a hugely discounted price. The Allergan stock has suffered a devaluation on the stock market since its 2015 glory. With a failed merger with Pfizer (NYSE:PFE), AbbVie is getting in for less than a fraction of what Pfizer would have paid. And taking into consideration all the synergies that this merger poses to AbbVie, we believe this deal can turn out to be a real winner for the company.

New drugs approvals keep coming in

Another win for the company has been the approval by the Food and Drug Administration (FDA) of the new rheumatoid arthritis drug, Rinvoq, which widens the portfolio for AbbVie. The new pill will see the company sharing the pie with Pfizer's Xeljanz and Eli Lilly's (NYSE:LLY) Olumiant. AbbVie also has a chance to successfully launch its plaque psoriasis treatment Skyrizi. If the company successfully spins the launch and also adds the cosmetic solution from Allergan to the mix, the company will have the recipe for accelerated growth and a potential rebound of its stock.

Botox and other cosmetic products might surprise

If the merger is approved, we also believe that the wrinkle eraser Botox could result in higher than expected growth for AbbVie as the target market presents fewer challenges than those facing the pharmaceutical industry as products are paid off by clients, not their medical insurance, and less regulated. The fact is that AbbVie plans to launch a subsidiary for these types of products, Allergan Aesthetics, under the umbrella of the AbbVie-Allergan merger. The business will pave the way for increasing sales of cosmetic Botox as well as products such as dermal fillers, and chin-fat-fighters.

Hence, there are several benefits from the pending merger. First, we have the synergies related to the increased dominance of AbbVie in immunology. Secondly, we'll see the resources and sales channels to boost revenue streams across all product portfolios. Thirdly, we expect aesthetics products from Allergan to strengthen the brand recognition of the new entity. We also see improved sales of aesthetics as resources are concentrated in a special subsidiary, Allergan Aesthetics, and can make use of more powerful distribution channels.

The synergistic benefits of the merger will likely exceed expectations as the company enters into a new therapeutic area, aesthetics, and it is unlikely that competitors will have such a broad portfolio to boast of.

Figure 1: AbbVie Income Statement and Balance Sheet

Source: Morningstar

AbbVie has witnessed marginal revenue growth over the period from 2017. The revenue is dominated by the top three brands, which are Humira, Imbruvica, and Mavyret, which contributed around 82% of the revenue, and there is a need to diversify as the company's largest revenue earner soon will face increased competition from cheaper alternatives in the U.S.

Through diversification, concentration risk will decrease, which, in turn, will benefit the company in the long run. The balance sheet has also grown over the period. However, there is a reliance on debt as it has almost doubled from the 2017 value of $37 billion to $66 billion.

AbbVie also lost 10% shortly after the announcement of the Allergan deal, which is somewhat favorable as Bristol-Myers Squibb (NYSE:BMY) and Takeda (NYSE:TAK) were down by 16% and 32%, respectively, shortly after they made their respective M&A advances.

Figure 2: AbbVie Cash Flow

Source: Morningstar

AbbVie maintained the operating cash flow within the same band for 2018 and 2019 but saw a drastic decline in its financing cash flow from a 2017 figure of -$5 billion to a 2018 figure of -$14 billion satisfying a buyback strategy authorized in January 2018. The buyback indicates strength in the company's liquid resources and signals the potential for a rebound for its stock. As seen in Figure 3, AbbVie is certainly a share buyback leader of its industry. This is something we highly appreciate.

Figure 3: AbbVie share buybacks

Source: Gurufocus

The share buybacks should have a positive impact on the share price, as share buybacks increase the ownership proportion per share.

The strategic position of AbbVie together with recent approvals with regards to new products should set the company on a growth path. However, the path of the general stock market is currently highly dependent on the resolution of the coronavirus pandemic.

Our valuation analysis considers three different scenarios for AbbVie for the projected timeline: (i) high-growth period (2020-2024); (ii) convergence to a mature growth (2025-2029); and (iii) a perpetual growth, considering inflation rate and GDP growth.

We used the 10-Year Discounted Free Cash Flow to Shares Model with the following inputs:

FCF to Shares was calculated based on the free cash flow and corresponding shares outstanding in 2019, $12.772 billion and 1.485 billion, respectively, resulting in a ratio of 8.60.

The discount rate was assumed to be Damodaran's average cost of equity from the pharmaceutical industry in the United States.

We have established three different growth rates for our timeline, taking into consideration the resumption of growth described in our catalyst analysis due to the recent developments and the probable and lucrative acquisition deal, which would increase the company's cash flow substantially in the next years.

For the initial five years (2020-2024), we believe AbbVie could perform, at least, equal to the 5-year Damodaran's average net income CAGR from the pharmaceutical industry. Hence, we mixed the global and United States rates in a proportion of 50%/50%, resulting in a high-growth scenario of 6.34%.

From 2025 to 2029, we forecast AbbVie to converge to mature growth. This is partly because industries tend to be more competitive over time, especially for pharmaceuticals. We, therefore, use a growth rate equal to half of the growth from the high-growth scenario, meaning 3.17%. Perpetual growth is set at 2.5%, below global GDP projections to account for a long-run slowdown.

Table 1: Discounted FCF to Shares

Source: HedgeMix Limited

Our valuation model yields a target price of $222. Hence, based on our valuation, the stock is currently trading at a considerable discount.

However, it's important to notice that the current market conditions are extraordinary due to the current coronavirus crisis and that macroeconomic developments will affect the performance of the stock market. Hence, for risk-averse investors, a potential strategy could be to create a market-neutral stock portfolio where you hold a short position in the overall market index of equal size as your primary portfolio. This can be a viable option at the moment.

The rhetoric over potential drug pricing charges poses a legitimate risk associated with investing in pharmaceutical stocks right now. While there is a possibility of the risk materializing, the company is also making strides to ensure that price hikes are maintained within single-digit increments.

While the European Commission has given the green light to the AbbVie-Allergan merger, the US counterparts are still reviewing the possibility of an anti-competition position, and the findings may prolong the integration if other conditions are set.

The pending integration with Allergan certainly also presents unforeseen problems as the two entities are culturally different, which can result in a culture clash. The risks associated with a merger can be overcome by effectively managing the integration and relationship aspects of the merger.

This month came with positive news for AbbVie as the coast is clearer with regards to the pending merger with Allergan (it just received the final EU approval).

The purpose of the acquisition is for AbbVie to ensure that the company diversifies and successfully complements its primary revenue earner Humira with an arsenal of new products. On top of this, we expect powerful synergies in distribution, brand recognition, and market position to prevail.

Currently, AbbVie is heavily reliant on Humira, which accounted for nearly 58% of sales in 2019, and in 2023, it will lose its patent protection. Hence, the timing of the merger would be perfect. A diversified AbbVie has the chance to remain a leader in immunology, and with a solid pipeline of new cancer drugs, it certainly will increase market share in oncology. Venclexta is likely to open avenues for AbbVie as it picks up additional approvals in the treatment of leukemia.

Finally, AbbVie has maintained a robust share buyback strategy, making it a share buyback leader of its industry. This should have a positive impact on the share price, as share buybacks increase the ownership proportion per share.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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AbbVie Is Your Egg In The Basket Now - Seeking Alpha

Immunology

AAAAI: Highlights of Atopic Dermatitis Research – MedPage Today

Atopic dermatitis, a.k.a. eczema, remains a major clinical problem despite a growing number of agents approved to treat it. At the now-cancelled American Academy of Allergy, Asthma, and Immunology's annual meeting (shuttered because of COVID-19), many of the scheduled research presentations addressed the topic. Here are some of the most interesting.

Many Patients May Need Long-Term Crisaborole

When treatment with topical crisaborole (Eucrisa) was discontinued, some people with mild to moderate atopic dermatitis saw rebound of their disease, researchers reported (abstract #608).

In the 28-day hiatus in treatment after receiving good results with crisaborole, 20% or more patients regressed, reported Mark Lebwohl, MD, of Icahn School of Medicine at Mount Sinai in New York City.

He said that 77% of patients were able to achieve a clear or almost clear score (0-1) on the Investigator's Static Global Assessment with one cycle of treatment with crisaborole, but after the four-week interruption, only 51% of those 133 patients remained clear or almost clear.

Lebwohl said the pattern held for patients who, in a 48-week open-label extension trial, required two cycles of treatment to reach a 0-1 score. In the trial, 76.3% of patients reached the goal with two cycles, but after a 28-day stoppage, just 36.7% of the group remained clear.

Similar patterns were seen among patients receiving crisaborole for three or four cycles to achieve the clear-skin goal followed by a 28-day hiatus.

"Continuous long-term treatment with crisaborole beyond 28 days may be necessary to maintain control of atopic dermatitis symptoms in some patients with mild-to-moderate atopic dermatitis," he suggested.

Crisaborole is indicated for topical treatment of mild to moderate atopic dermatitis in patients age 2 and older. The trial was sponsored by the drug's manufacturer, Pfizer.

Rhinitis Has No Effect on Dupilumab

Efficacy of the atopic dermatitis agent dupilumab (Dupixent) was not compromised in adolescents with a co-history of allergic rhinitis, researchers said (abstract #611).

In a double-blind, placebo-controlled, phase III trial, some 250 patients ages 12-17 were randomized in equal numbers to receive placebo or dupilumab at 200 mg or 300 mg every other week, reported Lawrence Sher, MD, of Peninsula Research Associates, Rolling Hills Estates, California. About three-quarters of each group also had a history of allergic rhinitis.

After 16 weeks, more patients in the dupilumab groups achieved a 0-1 score on the Investigator's Global Assessment than did those on placebo, irrespective of allergic rhinitis status.

Among patients with allergic rhinitis, 22% achieved the clear or nearly clear observation in the 200 mg group, as did 25.4% of patients in the 300 mg group; only 3.5% of the placebo group achieved the goal. A similar pattern was seen in participants with no history of allergic rhinitis.

The story was much the same for an outcome of a 4-point or greater improvement in pruritus on the Numerical Rating Scale, and a 6-point or greater improvement from baseline in the Children's Dermatology Lie Quality Index, Sher reported.

"Dupilumab improved atopic dermatitis signs and symptoms in adolescents with moderate-to-severe disease regardless of history of allergic rhinitis," he reported.

The trial was supported by Regeneron and Sanofi-Genzyme.

Baricitinib Studies Show Benefits

Patients diagnosed with moderate to severe atopic dermatitis were more likely to get relief with baricitinib (Olumiant) than placebo, according to Andreas Wollenberg, MD, of Ludwig-Maximilian University, Munich, Germany, and colleagues (abstract #610).

Their report described results pooled from two similar phase III trials, BREEZE-AD1 and BREEZE-AD2 with a total of about 1,240 patients.

"In patients with moderate-to-severe atopic dermatitis with an additional comorbid atopic condition, baricitinib treatment resulted in clinically meaningful improvements in skin symptoms and itch without a differential safety profile," Wollenberg reported.

At week 16, among patients with atopic comorbidities, significantly more patients in the baricitinib groups (4-mg, 2-mg, and 1-mg, respectively) versus placebo had Investigator's Global Assessment rated mild or less ratings of less than 2. About 30% of the patients on the 4-mg dose met the goal, as did 25% of those receiving a 2 mg dose and 18.6% of those assigned to a 1 mg dose, compared to 9.8% of patients on placebo (P<0.01 for all comparisons with placebo).

An improvement of 4 or more points in the pruritus scale was achieved by 21.6% of patients on the 4-mg dose; 16.6% of those on 2 mg baricitinib and 10.2% of patients on the 1-mg dose compared with 4.4% of patients on placebo (P<0.05). There were no significant treatment effect differences in patients with or without atopic comorbidities. Wollenberg noted.

BREEZE-AD1 and BREEZE-AD2 were independent 16-week randomized, double-blind, parallel-group, placebo-controlled trials conducted at 173 sites in Europe, Asia, Latin America, and Australia. Patients were randomized 2:1:1:1 to once-daily placebo or the three baricitinib doses. The trial was supported by Eli Lilly.

Atopy Severity Tied to Staph Bacterial Persistence

The presence of Staphylococcus aureus was associated with atopic dermatitis in children, and was more persistent in moderate to severe atopy than in milder cases, researchers reported (abstract #625).

Among all of the 163 children in the study who had at least two clinic visits in the Mechanisms of the Progression of Atopic Dermatitis to the Asthma in Children (MPAACH) cohort, S. aureus colonization decreased over time from 27.0% to 12.3% (P<0.001) from the first to the second visits, reported Tammy Gonzalez, an MD/PhD student at Cincinnati Children's Hospital.

Children with persistent moderate-to-severe atopic dermatitis were more likely to be colonized with S. aureus at both visit 1 (41.9% vs 23.5%, P=0.037) and visit 2 (25.8% vs 9.1%, P=0.011) when compared to children without persistent moderate-to-severe disease.

Atopic dermatitis is a chronic inflammatory skin condition marked by barrier dysfunction and has previously been associated with S. aureus skin colonization, the researchers noted. However, the relationship between S. aureus colonization and persistent moderate-to-severe pediatric atopic dermatitis was less clear.

"We aimed to determine the association between S. aureus colonization at visits 1 and 2 and persistent moderate-to-severe atopic dermatitis in children using the MPAACH," the group's abstract stated.

"We demonstrate that S. aureus colonization in pediatric atopic dermatitis decreases over time regardless of severity," it continued. "However S. aureus colonization remains higher in children with persistent moderate-to-severe atopic dermatitis, suggesting a potential relationship between S. aureus and the stability of atopic dermatitis severity."

Link:
AAAAI: Highlights of Atopic Dermatitis Research - MedPage Today

Immunology

The Exercise Training Modulatory Effects on the Obesity-Induced Immuno | DMSO – Dove Medical Press

Nakisa Soltani,1 Sayed Mohammad Marandi,1 Mohammad Kazemi,2 Nafiseh Esmaeil3

1Department of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Isfahan, Iran; 2Department of Genetics and Molecular Biology, Isfahan University of Medical Sciences, Isfahan, Iran; 3Department of Immunology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran

Correspondence: Nafiseh EsmaeilDepartment of Immunology, School of Medicine, Isfahan University of Medical Sciences, Isfahan 81744-176, IranTel +98 31 37929097Fax +98 3113 7929031Email nafesm5@gmail.comSayed Mohammad MarandiDepartment of Exercise Physiology, Faculty of Sport Sciences, University of Isfahan, Isfahan, IranTel +983137932358Fax +983136687572Email smmarandi2001@yahoo.com

Abstract: Reduced physical activity rate in peoples lifestyle is a global concern associated with the prevalence of health disorders such as obesity and metabolic disturbance. Ample evidence has indicated a critical role of the immune system in the aggravation of obesity. The type, duration, and production of adipose tissue-released mediators may change subsequent inactive lifestyle-induced obesity, leading to the chronic systematic inflammation and monocyte/macrophage (MON/M) phenotype polarization. Preliminary adipose tissue expansion can be inhibited by changing the lifestyle. In this context, exercise training is widely recommended due to a definite improvement of energy balance and the potential impacts on the inflammatory signaling cascades. How exercise training affects the immune system has not yet been fully elucidated, because its anti-inflammatory, pro-inflammatory, or even immunosuppressive impacts have been indicated in the literature. A thorough understanding of the mechanisms triggered by exercise can suggest a new approach to combat meta-inflammation-induced metabolic diseases. In this review, we summarized the obesity-induced inflammatory pathways, the roles of MON/M polarization in adipose tissue and systemic inflammation, and the underlying inflammatory mechanisms triggered by exercise during obesity.

Keywords: exercise training, immune system, adipose tissue, toll-like receptors, macrophage polarization, obesity, meta-inflammation

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The Exercise Training Modulatory Effects on the Obesity-Induced Immuno | DMSO - Dove Medical Press