Category Archives: Immunology

Immunology

Vaccines Against SARS-CoV-2 Will Have Side Effects Thats a Good Thing – Brooklyn Reader

By: Matthew Woodruff, Emory University

Takeaways

Temporary side effects from vaccines are a normal sign of a developing immune response.

Vaccines work by training your immune system to recognize and remember a pathogen in a safe way.

Expected side effects from a COVID-19 vaccine include redness and swelling at the injection site and stiffness and soreness in the muscle.

A potent vaccine may even cause fever. It does not mean that the vaccine gave you COVID-19.

In 2021 hundreds of millions of people will be vaccinated against SARS-CoV-2. The success of that COVID-19 vaccination campaign will heavily depend on public trust that the vaccines are not only effective, but also safe. To build that trust, the medical and scientific communities have a responsibility to engage in difficult discussions with the public about the significant fraction of people who will experience temporary side effects from these vaccines.

I am an immunologist who studies the fundamentals of immune responses to vaccination, so part of that responsibility falls on me.

Simply put, receiving these vaccines will likely make a whole lot of people feel crappy for a few days. Thats probably a good thing, and its a far better prospect than long-term illness or death.

In 1989, immunologist Charles Janeway published an article summarizing the state of the field of immunology. Until that point, immunologists had accepted that immune responses were initiated when encountering something foreign bacteria, viruses, and parasites that was non-self.

Janeway suspected that there was more to the story, and famously laid out what he referred to as the immunologists dirty little secret: Your immune system doesnt just respond just to foreign things. It responds to foreign things that it perceives to be dangerous.

Now, 30 years later, immunologists know that your immune system uses a complex set of sensors to understand not only whether or not something is foreign, but also what kind of threat, if any, a microbe might pose. It can tell the difference between viruses like SARS-CoV-2 and parasites, like tapeworms, and activate specialized arms of your immune system to deal with those specific threats accordingly. It can even monitor the level of tissue damage caused by an invader, and ramp up your immune response to match.

Sensing the type of threat posed by a microbe, and the level of intensity of that threat, allows your immune system to select the right set of responses, wield them precisely, and avoid the very real danger of immune overreaction.

Vaccines work by introducing a safe version of a pathogen to a patients immune system. Your immune system remembers its past encounters and responds more efficiently if it sees the same pathogen again. However, it generates memory only if the vaccine packs enough danger signals to kick off a solid immune response.

As a result, your immune systems need to sense danger before responding is at once extremely important (imagine if it started attacking the thousands of species of friendly bacteria in your gut!) and highly problematic. The requirement for danger means that your immune system is programmed not to respond unless a clear threat is identified. It also means that if Im developing a vaccine, I have to convince your immune system that the vaccine itself is a threat worth taking seriously.

This can be accomplished in a number of ways. One is to inject a weakened what immunologists call attenuated or even killed version of a pathogen. This approach has the benefit of looking almost identical to the real pathogen, triggering many of the same danger signals and often resulting in strong, long-term immunity, as is seen in polio vaccination. It can also be risky if you havent weakened the pathogen enough and roll out the vaccine too fast, there is a possibility of unintentionally infecting a large number of vaccine recipients. In addition to this unacceptable human cost, the resulting loss of trust in vaccines could lead to additional suffering as fewer people take other, safer vaccines.

A safer approach is to use individual components of the pathogen, harmless by themselves but capable of training your immune system to recognize the real thing. However, these pieces of the pathogen dont often contain the danger signals necessary to stimulate a strong memory response. As a result, they need to be supplemented with synthetic danger signals, which immunologists refer to as adjuvants.

To make vaccines more effective, whole labs have been dedicated to the testing and development of new adjuvants. All are designed with the same basic purpose to kick the immune system into action in a way that maximizes the effectiveness and longevity of the response. In doing so, we maximize the number of people that will benefit from the vaccine and the length of time those people are protected.

To do this, we take advantage of the same sensors that your immune system uses to sense damage in an active infection. That means that while they will stimulate an effective immune response, they will do so by producing temporary inflammatory effects. At a cellular level, the vaccine triggers inflammation at the injection site. Blood vessels in the area become a little more leaky to help recruit immune cells into the muscle tissue, causing the area to become red and swell. All of this kicks off a full-blown immune response in a lymph node somewhere nearby that will play out over the course of weeks.

In terms of symptoms, this can result in redness and swelling at the injection site, stiffness and soreness in the muscle, tenderness and swelling of the local lymph nodes and, if the vaccine is potent enough, even fever (and that associated generally crappy feeling).

This is the balance of vaccine design maximizing protection and benefits while minimizing their uncomfortable, but necessary, side effects. Thats not to say that serious side effects dont occur they do but they are exceedingly rare. Two of the most discussed serious side effects, anaphalaxis (a severe allergic reaction) and Guillain-Barr Syndrome (nerve damage due to inflammation), occur at a frequency of less than 1 in 500,000 doses.

Early data suggest that the mRNA vaccines in development against SARS-CoV-2 are highly effective upwards of 90%. That means they are capable of stimulating robust immune responses, complete with sufficient danger signaling, in greater than nine out of 10 patients. Thats a high number under any circumstances, and suggests that these vaccines are potent.

So lets be clear here. You should expect to feel sore at the injection site the day after you get vaccinated. You should expect some redness and swelling, and you might even expect to feel generally run down for a day or two post-vaccination. All of these things are normal, anticipated and even intended.

While the data arent finalized, more than 2% of the Moderna vaccine recipients experienced what they categorized as severe temporary side effects such as fatigue and headache. The percentage of people who experience any side effects will be higher. These are signs that the vaccine is doing what it was designed to do train your immune system to respond against something it might otherwise ignore so that youll be protected later. It does not mean that the vaccine gave you COVID-19.

[Deep knowledge, daily. Sign up for The Conversations newsletter.]

It all comes down to this: Some time in the coming months, you will be given a simple choice to protect yourself, your loved ones and your community from a highly transmissible and deadly disease that results in long-term health consequences for a significant number of otherwise healthy people. It may cost you a few days of feeling sick.

Please choose wisely.

Matthew Woodruff, Instructor, Lowance Center for Human Immunology, Emory University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

This coverage of coronavirus is a special to BK Reader. We are asking for your help in keeping our coverage and database current with any helpful references and news tips. Please send all tips to [emailprotected]. With your help, Brooklyn will emerge stronger and more unified as a borough. Thank you.

Continued here:
Vaccines Against SARS-CoV-2 Will Have Side Effects Thats a Good Thing - Brooklyn Reader

Immunology

AstraZeneca to buy Alexion in US$39b immunology deal – New Zealand Herald

Business

12 Dec, 2020 07:09 PM4 minutes to read

AstraZeneca has agreed to buy US biotechnology group Alexion in a US$39b deal. Photo / Kirsty Wigglesworth

Anglo-Swedish drugmaker AstraZeneca has agreed to buy US biotechnology group Alexion in a US$39 billion ($55.02b) deal, marking the biggest agreement struck by a pharmaceutical company since the start of the Covid-19 pandemic.

The cash-and-stock takeover will deepen AstraZeneca's core focus on immunology, by bringing a pipeline of experimental drugs that target rare diseases as it races to develop a coronavirus vaccine.

For Alexion, the sale follows pressure from activist hedge fund Elliott Management, which in May demanded the company sell itself, citing management missteps.

The transaction announced on Saturday comes after months of speculation that AstraZeneca chief executive Pascal Soriot was hunting for a large target, seeking to take advantage of a soaring share price that has seen the UK drugmaker become one of the largest listed businesses on the FTSE 100.

The transaction values Alexion at US$175 per share, a 45 per cent premium to its closing price on Friday. Alexion shareholders will own about 15 per cent of the combined company.

Under the terms of the transaction, Alexion shareholders will receive US$60 in cash and 2.12 shares from AstraZeneca's US-listed entity for each share they hold.

The acquisition is the biggest transaction in pharmaceuticals since 2019, when AbbVie acquired Allergan for US$63b, and the largest deal to target a US company in any sector this year.

Alexion focuses on diseases that are caused by an uncontrolled activation of a part of the immune system known as the complement system that spurs antibodies' abilities to clear microbes and promotes inflammation. Alexion has a pipeline of 11 molecules that AstraZeneca will help to build on.

The UK-based company believes this approach can also be applied to more common diseases.

Soriot said Alexion would strengthen AstraZeneca's position in the US where it has been rebuilding its presence in recent years, notably in oncology. The benefits flowed both ways, he indicated. Alexion had only a limited foothold in emerging markets "and almost zero presence in China", both areas in which AstraZeneca is strong, allowing for more effective globalisation of Alexion's portfolio.

Soriot said talks began "a few months ago" and that AstraZeneca was not aware of rival bidders. "To our knowledge there was not a competitive process," he said.

Analysts at SVB Leerink said: "While we have long suggested that US$175 was the right range for an acquisition, in today's inflated market we believe investors could demand more from AstraZeneca, or another acquirer."

They added: "This is such a scarce and high-quality asset that in this instance, the final transaction price may need to reach US$200 to satisfy Alexion's shareholders, or to be based more in cash, rather than predominantly stock."

AstraZeneca is targeting US$500m in pre-tax synergies from the deal, which Soriot said would partly come from headcount reduction in general administrative functions. Alexion has about 3,000 employees, while AstraZeneca has about 70,000.

The companies said they expected the acquisition to close in the third quarter of next year.

"When you conclude that the combination is going to be good and is going to work well you do it when the opportunity arises," Soriot said when asked about the interplay of the coronavirus pandemic and the deal.

AstraZeneca became Oxford university's partner for the development of a vaccine for coronavirus earlier this year. It has pledged to sell it at cost during the pandemic, and at no profit to developing nations in perpetuity. It has no native vaccine business, focusing instead on R&D in such areas as oncology.

Peer reviewed data released this month showed a pooled average efficacy of 70 per cent, less than for vaccines made by competitors. Observers have questioned the data, though any one vaccine with efficacy greater than 50 per cent is still set to be approved by European and US regulators.

Soriot said he expected AstraZeneca to be able to file for regulatory approval for the vaccine in the US within six weeks and that approval for some jurisdictions was expected before the end of the year.

Evercore and Centerview Partners were lead financial advisers to AstraZeneca, while Ondra provided capital markets advice. Morgan Stanley, JPMorgan and Goldman Sachs will help AstraZeneca finance the deal. Freshfields was AstraZeneca's legal adviser. Bank of America advised Alexion and Wachtell provided legal advice.

Read more:
AstraZeneca to buy Alexion in US$39b immunology deal - New Zealand Herald

Immunology

Pre-existing influenza immunity impacts antibody quality following seasonal infection and vaccination – Newswise

Newswise New research by scientists at the University of Chicago suggests a persons antibody response to influenza viruses is dramatically shaped by their pre-existing immunity, and that the quality of this response differs in individuals who are vaccinated or naturally infected. Their results highlight the importance of receiving the annual flu vaccine to induce the most protective immune response.

The researchers found that most of the initial antibodies stimulated after both influenza infections and influenza vaccinations came from old B cells a type of white blood cell that secretes antibodies indicating the immune systems memory plays a major role in how the body responds early on to a viral infection. These antibodies displayed higher reactivity toward strains of influenza that circulated during an individuals childhood compared to more recent strains.

The study, published December 10, 2020 in the journal Science Translational Medicine, provides those working on a universal influenza vaccine further understanding of how pre-existing immunity affects the development and performance of neutralizing and non-neutralizing antibodies following infection and vaccination. Any effective universal influenza vaccine will depend on scientists identifying conserved parts of the influenza virus that do not mutate over time and that antibodies can target to prevent infection.

Most interestingly, we found that people who were actively sick with influenza had old antibodies that predominantly targeted parts of the virus that dont change but those antibodies specifically targeted non-neutralizing sites, said Haley Dugan, co-first author of the study and a PhD candidate in immunology. When we tested these same antibodies in mice, they werent able to protect them from being infected with influenza.

In contrast, the researchers found that influenza vaccinations boost antibodies that tended to target conserved yet neutralizing regions of the virus, which suggests vaccinations can draw upon pre-existing immunity to prompt more protective responses. Vaccinated individuals also generated many antibodies that targeted new and mutated regions on the virus, suggesting these vaccine-induced antibodies are more adaptable.

Immune system memory ensures a rapid and specific response to previously encountered pathogens. Vaccinations work by exposing the immune system to a small amount of virus, which causes B cells to develop a biological memory to the virus. If the body encounters the same virus later, the immune system is alerted to attack and eliminate the virus.

But in order to be protected, the viral proteins of the infecting strain must typically match those of the strain used in the vaccine. The memory B cells are like keys that fit and bind to the locks the viral proteins. These memory B cells can survive for decades, providing long-lasting protection from future infections. But if the virus mutates and is significantly different, the memory B cells can no longer recognize the viral proteins, potentially leading to infection.

For this reason, the human body is pitted in an evolutionary arms race with the flu. Because influenza viruses rapidly evolve and mutate each season, our immune system has trouble recognizing the viral surface proteins on new influenza strains. As a result, our bodies often rely on old antibodies to fight new influenza strains; this is possible because some parts of the influenza virus that are critical to its structure or function do not change, remaining familiar to our immune system.

Researchers now understand that specific structural and functional parts of the influenza virus that do not change are better for antibodies to target than others. Antibodies that bind to one of these neutralizing sites are able to prevent infection, while antibodies that target non-neutralizing sites often cannot. Scientists believe a persons age, history of exposure to the influenza virus and type of exposure either through infection or vaccination all shape whether their immune system antibodies target neutralizing or non-neutralizing sites on a virus.

In the UChicago study, scientists sought to address a major knowledge gap: Which conserved viral sites are preferentially targeted following natural infection versus vaccination in people, and how does pre-existing immunity play a role in shaping the landscape of neutralizing and non-neutralizing antibodies?

For people who have caught the flu, their pre-existing immunity may make them susceptible to infection or increase the severity of their influenza symptoms if their antibodies are targeting bad or non-neutralizing viral sites, said co-first author and Immunology postdoctoral fellow Jenna Guthmiller, PhD.

By contrast, vaccination largely induces neutralizing and protective antibodies, old and new, highlighting the importance of receiving the seasonal influenza vaccine.

This study provides a major framework for understanding how pre-existing immunity shapes protective antibody responses to influenza in humans, said Patrick Wilson, PhD, a professor of immunology and lead author of the study. We need more studies to determine whether the targeting of specific neutralizing and non-neutralizing viral sites directly impacts a persons likelihood of becoming ill.

The researchers are now examining how early exposure to the influenza virus in children shapes their immune response later in life as a follow-up to this work.

Preexisting immunity shapes distinct antibody landscapes after influenza virus infection and vaccination in humans was written by Patrick Wilson, Haley Dugan, Jenna J. Guthmiller, Philip Arevalo, Min Huang, Yao-Qing Chen, Karlynn Neu, Carole Henry, Nai-Ying Zheng, Linda Yu-Ling Lan, Micah Tepora, Olivia Stovicek, Dalia Bitar, Anna-Karin Palm, Christopher Stamper, Siriruk Changrob, Henry Utset and Sarah Cobey of the University of Chicago and Lynda Coughlan and Florian Krammer of the Icahn School of Medicine at Mount Sinai. The study was funded in part by the National Institute of Allergy and Infectious Disease and the University of Chicago Committee on Immunology.

###

About the University of Chicago Medicine & Biological Sciences

The University of Chicago Medicine, with a history dating back to 1927, is one of the nations leading academic health systems. It unites the missions of the University of Chicago Medical Center, Pritzker School of Medicine and the Biological Sciences Division. Twelve Nobel Prize winners in physiology or medicine have been affiliated with the University of Chicago Medicine. Its main Hyde Park campus is home to the Center for Care and Discovery, Bernard Mitchell Hospital, Comer Childrens Hospital and the Duchossois Center for Advanced Medicine. It also has ambulatory facilities in Orland Park, South Loop and River East as well as affiliations and partnerships that create a regional network of care. UChicago Medicine offers a full range of specialty-care services for adults and children through more than 40 institutes and centers including an NCI-designated Comprehensive Cancer Center. Together with Harvey-based Ingalls Memorial, UChicago Medicine has 1,296 licensed beds, nearly 1,300 attending physicians, over 2,800 nurses and about 970 residents and fellows.

Visit UChicago Medicines health and science news blog at http://www.uchicagomedicine.org/forefront.

Twitter @UChicagoMed Facebook.com/UChicagoMed

Facebook.com/UChicagoMedComer

Here is the original post:
Pre-existing influenza immunity impacts antibody quality following seasonal infection and vaccination - Newswise

Immunology

Immunology expert says lockdowns could be a thing of the past by end of January – RSVP Live

A top Irish immunology expert said lockdowns could be a thing of the past by the end of February 2020 once the most vulnerable groups get vaccinated.

Trinity Biochemistry Professor Luke O'Neill said getting a million people vaccinated by the beginning of March is the goal and that once this happens, people will no longer have to live in 'fear' of Covid-19.

He said: "We want to get a million people vaccinated by the end of February, thats the goal we want to get a lot of people vaccinated as quickly as we can really."

Speaking to Claire Byrne on her RTE Radio 1 show, the respected immunologist continued: "Its the vulnerable that has to go first, so we have to have the people in nursing homes, older people, people with underlying health conditions and the healthcare workers.

"Now thats a really important group if we get those vaccinated the fear begins to go away from this virus, the death rate plummets you have less people getting sick you have less illness.

"So if we can just get the vaccine to that group that is a triumph."

Getting the rest of the population immunised will take a lot longer, he said - but vaccinating the most vulnerable people should reduce the need for severe restrictions and lockdowns.

Keep up-to-date with all the very latest celebrity, health, beauty, parenting and entertainment news with the RSVPLive.ie app

Only select news that interests you by picking the topics you want to display on the app's homepage.

Plus, our enhanced user experience includes live blogs, video, interactive maps and slick picture galleries.

Download it now and get involved.

Click here to download from the app store. or here for Google Play.

Luke said: "The fact is if we can get this first group vaccinated, were in a much better place in terms of this virus and some of the fear goes away and the government then cant justify lockdown in that situation."

"Can you imagine if we get to the end of January and half a million people are vaccinated? These worries will go away but we have to be patient.

"With the HSE this is tricky, it will take a little bit of time weeks to a couple of months.

In the meantime however, he reminded listeners that there is no vaccine in Ireland and how important it to stick to current guidelines.

"We must keep wearing the masks and the hand washing and things for the foreseeable future," he said.

"Weve got to keep banging that drum for the next three, six months plus maybe keep wearing masks, keep an eye on this thing. We can relax a little bit here and there but follow the public health guidelines, especially in the next two or three weeks that is essential.

"If we take our eye off the ball in the next two or three weeks itll be really worrying.

Read the original here:
Immunology expert says lockdowns could be a thing of the past by end of January - RSVP Live

Immunology

Boehringer Ingelheim to Acquire Labor Dr. Merk & Kollegen to Strengthen its Next Generation Cancer Immunology Program – Business Wire

INGELHEIM, Germany & OCHSENHAUSEN, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today announced the execution of the agreement on the acquisition of Labor Dr. Merk & Kollegen. The acquisition will enable Boehringer Ingelheim to further expand and accelerate its comprehensive program for the development of ATMP-based immuno-oncology therapies including the Vesicular Stomatitis Virus (VSV) with modified glycoprotein (GP) platform and cancer vaccines platforms. Labor Dr. Merk & Kollegen has outstanding experience in process development, manufacturing and analytical characterization in virology besides expertise in microbiology and cell culture. Labor Dr. Merk & Kollegen has already worked in close collaboration with Boehringer Ingelheim on viral-based therapy development since 2015.

The acquisition of Labor Dr. Merk & Kollegen is strengthening our promising pipeline with diverse potential first-in-class cancer immunology and cancer cell directed therapies for patients with hard-to-treat cancer, said Dr. Michel Pairet, member of Boehringer Ingelheims Board of Managing Directors with responsibility for the companys Innovation Unit. The trusting and highly effective collaboration between our scientists and the Labor Dr. Merk & Kollegen team has already contributed significantly to our progress in viral-based cancer therapies. We will welcome the Labor Dr. Merk & Kollegen team and look forward to jointly advancing our program in this area.

Boehringer Ingelheim is taking cancer on by strengthening its position in cancer immunology, with a focus on cancer vaccines, oncolytic viruses, T-cell engagers, stromal modulators and myeloid cell modulators by combining its world-class, in-house research and development with that of highly innovative external companies. The addition of Labor Dr. Merk & Kollegens site will enable Boehringer Ingelheim to further strengthen its oncolytic virus and cancer vaccine development capabilities and capacities by establishing an end-to-end fully integrated center of excellence for virus development and clinical manufacturing. It will add to a series of strategic acquisitions and collaborations over the past years, including the acquisition of ViraTherapeutics and AMAL Therapeutics, which are contributing assets that will be further developed at Labor Dr. Merk & Kollegens site.

Labor Dr. Merk & Kollegen is a privately-held company founded in 1971. It is headquartered in Ochsenhausen, Germany, close to Boehringer Ingelheims Biberach R&D site. As a center of excellence in virology, Labor Dr. Merk & Kollegen has a long track record in GLP and GMP certified biosafety testing. In recent years Labor Dr. Merk & Kollegen established its GMP-virus manufacturing facility. With around 130 highly qualified and specialized employees, the company has built considerable expertise in process development, manufacturing and analytical characterization of viral therapeutics and oncolytic viral therapeutics. Labor Dr. Merk & Kollegen will be integrated with all employees as a new unit into Boehringer Ingelheims Development organization and continue to operate at its Ochsenhausen site. A future expansion is planned.

Following our successful strategic partnership, we are really excited to join forces with Boehringer Ingelheim, said Dr. Ingrid Rapp, CEO at Labor Dr. Merk & Kollegen. Boehringer Ingelheim is a truly global pharmaceutical company with excellent R&D capacities. We look forward to taking our next development step in oncology as part of this outstanding team.

The companies did not disclose the financial terms of the deal. The transaction is subject to the approval of the competition authorities in Germany. Closing will follow thereafter.

Please click on the following link for Notes to Editors:

http://www.boehringer-ingelheim.com/press-release/agreement-acquire-labor-dr-merk

See original here:
Boehringer Ingelheim to Acquire Labor Dr. Merk & Kollegen to Strengthen its Next Generation Cancer Immunology Program - Business Wire

Immunology

Immunology Drug Market: Rising threat of immunological and autoimmune diseases across the globe is expected to drive the market – BioSpace

Immunology Drug Market: Snapshot

The rising threat of immunological and autoimmune diseases across the globe and the escalating awareness about ways to overcome these diseases may help the immunology drug market may gain substantial growth across the assessment period of 2020-2030.

The immune system is one of the most important components of the human body. It protects and guards the body against diseases and foreign bodies. It detects threats like viruses, parasites, and bacteria. When the immune system is weak or becomes incapable of protecting the body from diseases or disorders, it leads to autoimmune diseases and cancer.

These drugs help in curing autoimmune diseases. The drugs also assist in killing the cancer cells and have become the preferred choice of many. Thus, this factor can serve as a vital growth factor for the immunology drug market.

Request Brochure of Report - https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=80391

Immunology drugs are segmented into various classes such as immunosuppressive medication, monoclonal antibodies, interferon and cytokine therapies, and antibody-drug conjugates. The utilization of immunology drugs across cancer research centers, cancer institutes, hospitals, and clinics will assist in boosting the growth of the immunology drug market.

The study on the immunology drug market helps the stakeholder to eliminate the barriers of fake information and offers a total analysis of varied segments. The report offers a five-factor (latest trends, industry analysis, a detailed study on the regions, prominent players, and recent developments) advantage to the stakeholder. This factor plays a crucial role in imparting the right information to the stakeholder.

Furthermore, the study pays attention to the effect of the SARS-CoV-2 pandemic and also on the dangers that may hurt the growth of the immunology drug market. The detailed study conducted by the researchers also sheds light on the opportunities and challenges that the immunology drug market may face between 2020 and 2030.

Request for Analysis of COVID-19 Impact on Immunology Drug Market - https://www.transparencymarketresearch.com/sample/sample.php?flag=covid19&rep_id=80391

Immunology Drug Market: Industry Prospects

The immunology drug market has numerous players that are involved in fierce competition. These players increase competition through novel product launches. The introduction of new drugs with enhanced features enables the players to rake in good revenues. For discovering new insights into the immunology drug landscape and formulating drugs, the players invest heftily in research and development activities.

Mergers, acquisitions, joint ventures, collaborations, and partnerships play a crucial role in cementing the foothold of the players in the immunology drug market. This factor eventually brings profitable growth.

Pre Book Immunology Drug Market Report at https://www.transparencymarketresearch.com/checkout.php?rep_id=80391&ltype=S

Expansion activities and advertising are also among the top priorities of the players in the immunology drug market. Expansion activities lead to the exploration of untapped opportunities while advertising helps the players to generate awareness about their drugs among the target consumer base.

Key players in the immunology drug market are GlaxoSmithKline plc, Active Biotech, Pfizer, Inc., Abbott Laboratories, Sanofi Aventis LLC, Seattle Genetics, Inc., Eli Lilly and Company, and Genentech, Inc.

Read more information here:

https://www.transparencymarketresearch.com/immunology-drug-market.html

Immunology Drug Market: Key Trends

The alarming statistics about the prevalence of autoimmune diseases around the world may serve as the prominent growth factor for the immunology drug market. The increasing spending of the government on enhancing the healthcare infrastructure, investments across various spheres and the rise in the prevalence of different types of cancer are proving to be significant growth factors for the immunology drug market.

About Us

Transparency Market Research is a next-generation market intelligence provider, offering fact-based solutions to business leaders, consultants, and strategy professionals.

Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories.

TMR believes that unison of solutions for clients-specific problems with right methodology of research is the key to help enterprises reach right decision.

Contact

Mr. Rohit BhiseyTransparency Market Research

State Tower,

90 State Street,

Suite 700,

Albany NY - 12207

United States

USA - Canada Toll Free: 866-552-3453

Email: sales@transparencymarketresearch.com

Website: https://www.transparencymarketresearch.com/

View original post here:
Immunology Drug Market: Rising threat of immunological and autoimmune diseases across the globe is expected to drive the market - BioSpace

Immunology

Pursuing Precision Immunotherapy for Cancer: Approaches and Challenges – Technology Networks

Technology Networks recently had the pleasure of speaking with Prof. Stephen Schoenberger of La Jolla Institute for Immunology to learn more about his laboratorys work, directed towards achieving a comprehensive mechanistic understanding of the generation and regulation of T-cell responses in the context of infection and cancer development.Schoenberger discusses the concept, promise and challenges of precision immunotherapies, and explains how synthetic biology approaches can be used to develop such therapeutics.

Q: What is the goal of precision immunotherapy, and how does this approach differ to other immunotherapeutic approaches?A: Broadly speaking, immunotherapy involves the application of strategies through which various components of the immune system can be directed to eradicate cancer. To-date, this has involved both leveraging positive signals, such as cytokines that promote growth/effector functionality in specific cellular subsets or antibodies that engage costimulatory pathways, as well as methods of uncoupling inhibitory signalling pathways that otherwise restrain the anti-tumor immune response. Although each of these approaches has had a degree of success in specific settings, their effects are not universal across all cancer types, and often come with an appreciable risk of undesired immune damage to normal tissues. This is perhaps understandable when one unleashes the power of the immune system but does not control its targeting. Precision immunotherapy seeks to address this critical issue of tumor-specific targeting to ensure that the potency of the immune system is directed specifically at the cancer cells while minimizing collateral damage to normal cells. The surest way to achieve that at present is to target features that are specific to the tumor.

Q: How can synthetic biology be leveraged to aid the development of precision immunotherapies?A: I believe that the greatest impact of synthetic biology will be in the development of more powerful and precise therapeutic vaccines. Cancer is a genetic disease, meaning it results from specific gene mutations, that alter cells normal functioning and can give rise to neoantigens. These antigens, encoded by tumor-specific mutated genes, are displayed exclusively on the surface of transformed cells. A key goal of precision immunotherapy is to identify the subset that can serve as neoantigens that are recognized by a patients T cells and then to activate/amplify this response. Synthetic biology, and specifically nanoengineering, offer entirely new possibilities for leveraging the potential of the immune system to mount a powerful and coordinated attack on the tumor that is both achievable on a patient-specific basis and scalable. The challenge now is to understand the components of a rationally-designed synthetic vaccine that can induce the desired therapeutic response from the natural biology of a cancer patients immune system.

Q: Can you please elaborate on your lab's work focused on exploring the mechanistic underpinnings of T-cell responses, both in response to infectious pathogens and during cancer development?A: Im fortunate to have received my training in immunology at a time when the fundamental rules that govern the response of T cells to both infectious pathogens and normal self were first being understood at the cellular and molecular level. Since my post-doctoral training with Prof. Kees Melief at the University of Leiden, Ive sought to apply this emerging knowledge to explore whether the same mutations that define the transformed state in cancer cells could be targets for immune recognition and destruction by CD4+ and CD8+ T cells. To approach this, I first needed to understand how T cells work, and have pursued this goal in the context of experimental models of microbial infection, autoimmunity and cancer for over 20 years. During that time, my lab has made contributions to the understanding of CD4+/CD8+ T cell regulation and have identified some of the genes and pathways that govern this. In parallel, remarkable progress in the field of immunology has produced a body of knowledge that enables an integrated and holistic view of immunity and the parameters that influence the class, magnitude, specificity and regulation of immune responses. The emerging view is that tumors occupy a special niche within the context of immunity. They are clearly different than normal cells because of the mutated proteins they express, and should therefore be recognizable by the immune system, but lack the molecular features of infectious pathogens that are needed to initiate and amplify that response.

Q: Can you talk to us about the concept of a vaccine design for certain types of cancer, and how the work of your lab helps to inform research in this space?A: The work in my lab towards vaccine design has proceeded along two main paths: targeting and delivery. Through the first path, we have pursued methods of identifying which mutations expressed in a tumor represent therapeutically-actionable targets; which mutations can serve as neoantigens, in other words. The advent of rapid and cost-effective genomic sequencing has made the routine identification of expressed mutations in cancer widely possible, and much effort in the field of immuno-oncology has been applied towards determining which of these can be "seen" by the patients immune system, with the overwhelming majority of these taking a predictive computational approach. We have taken a different tack on this, and one based on the assumption that within the cancer patient, the immune system has already mounted a physiological T-cell response to a subset of the expressed mutations that is quantitatively small and therapeutically ineffective, but which can be expanded and empowered through vaccination to eradicate disseminated metastases. The second arm of this effort is focused on methods to improve the specificity, potency and durability of therapeutic vaccine-induced T-cell responses based on an integrated holistic view of the immune system. These efforts involve coordination of the innate and adaptive arms of the immune system, synergies between CD4+ and CD8+ T cells, and evaluating vaccine formulations that are both potent and cost-effective, and which can be produced rapidly enough to meet clinical needs of the patient. There are a number of challenges, but I am convinced that these can be overcome to make the routine and reliable delivery of effective personalized cancer vaccines a clinical reality.

Q: What key challenges remain in pursuing precision immunotherapy?A: Progress in the research space has raised the hypothetical foundations of precision immunotherapy to the level of proof it is now clear that when properly targeted and delivered in sufficient numbers, T cells can eradicate disseminated metastatic cancer. The main challenges, to me, are to understand the mechanistic details underlying successful immunotherapy, to learn the reasons why it works and under what conditions, and then to devise ways in which this information can be applied widely in the setting of community-level oncology. This will require approaches that can quickly move academic discoveries to clinical evaluation and, if successful, to a manufacturing process that is rugged and scalable. This will take new thinking at every level to ensure that scarce resources are directed to not only that which is possible but almost from inception to that which is feasible.

Q: How do you envision your research focus and the technologies that you adopt might evolve over the forthcoming years?A: A central feature of science is that new and often unanticipated technologies can enable huge leaps forward in whats possible, and Ive witnessed this numerous times in my own field in the form of flow cytometry, peptide/MHC tetramers, transgenic mice, laser-confocal microscopy, next-generation sequencing and CRISPR-based genome engineering among others. Although we do not usually focus on their development, Ive tried to stay aware of new technologies and incorporate them into our research when I can understand and appreciate their potential. At heart, however, Im a relatively simple biologist who tends to focus on one question at a time, and at present, that is to understand whether cancer patients possess within their own immune system the capacity to recognize the mutations that define and distinguish cancer and eradicate it based on those differences.

Technologies that will aid in answering that question, and do so for the clinical benefit of cancer patients, will be those that allow insights into the mutations expressed by the cancer and the immune response, earlier, with greater sensitivity and in a less-invasive manner than whats currently possible. A fundamental change in my approach to this scientific problem has been necessarily compelled with the switch from experimental clinical models to our current situation, in which every case we study is a fellow human who has a reasonable expectation to benefit from technological advances to make their treatment more precise, effective and tolerable. Towards that, Im encouraged by advances in the imaging of cancer, liquid biopsy technologies and single-cell sequencing that can allow unprecedented insights into the cancer genome and the T-cell response, and expect that progress in these areas will be crucial to our research goals.

Professor Stephen Schoenberger was speaking with Molly Campbell and Laura Elizabeth Lansdowne, Science Writers, Technology Networks.

Visit link:
Pursuing Precision Immunotherapy for Cancer: Approaches and Challenges - Technology Networks

Immunology

AbbVie’s arthritis hotshot Rinvoq grabs a win in ulcerative colitis – FiercePharma

AbbVies next-gen immunology med Rinvoq has been turning heads with its rheumatoid arthritis launch, but it was never meant to stop there. While attention has largely been focused on its atopic dermatitis prospects, the drug posted data Wednesday that showed its coming to play in ulcerative colitis (UC), too.

In a phase 2b/3 study, Rinvoq topped placebo at helping previously untreated UC patients achieve remission by the eight-week mark. Twenty-six percentof those in the trials Rinvoq arm hit that benchmark, versus just 5% of those on placebo.

The drug also hit a range of secondary endpoints, including topping placebo at producing any benefit among patients; 73%of Rinvoq patients responded to treatment at eight weeks, compared with 27% of placebo patients.

How metabolomics powers up multi-omics workflow across pre-clinical, first-in-human, and late stage clinical trials: A biopharma success story

Join Derek Solum, Ph.D., Associate Director, Product Development at United Therapeutics, and Brian Keppler, Ph.D., Director, Discovery and Translational Sciences, Metabolon, Inc., as they share how metabolomics helped United Therapeutics enhance its multi-omics platform and improve decision-making across all phases of drug development.

RELATED:AbbVie pegs growth to booming Skyrizi, Rinvoq in post-merger future. But neurology could be a 'sleeper'

The results are important, given that many UC patients still do not achieve disease control despite the wealth of treatment options available on the market, Michael Severino, M.D., AbbVie vice chairman and president, said in a statement.

Those options include Humira, AbbVies aging anti-TNF megablockbuster whose sales the company is trying to replace with Rinvoq and fellow new launch Skyrizi. They also include Pfizers Xeljanzwhich, along with Rinvoq, is part of the JAK inhibitor classand Johnson & Johnson's IL-12/IL-23 giant Stelara. And soon, they could feature Bristol Myers Squibbs Zeposia, an S1P receptor modulator, which earlier this year hit the scene in multiple sclerosis.

But the way SVB Leerink analyst Geoffrey Porges sees it, Rinvoq outperformed at least a few of those options. "We are impressed by the strong efficacy shown by Rinvoq, which seems to be superior" to Xeljanz and the other JAK inhibitor that's been studied in UCGilead's filgotinib"as well as the biologicals including TNFs and IL-12/23s," he wrote in a Thursday note to clients.

Bernstein analyst Ronny Gal felt similarly about how Rinvoq looked relative to its future Pfizer rival, writing in his own note to clients that the data show "clear efficacy signal, better than Xeljanz, and within the ballpark of what has been seen across the UC field."

RELATED:AbbVie's Rinvoq scores pivotal trial win in eczema. But do dermatologists trust JAK inhibitors?

UC isnt the only disease area where Rinvoq is threatening. It came through in two pivotal atopic dermatitis trials over the summer, most recently showing it could spur a 75% reduction in symptoms at 16 weeks in 60% of study patients.

Of course, competition isnt exactly light in that field, either, with Sanofi and Regenerons blockbuster Dupixent running the show. But between those indications and a raft of others where AbbVie is currently trialing the drug, analysts figure Rinvoq can build on its current rheumatoid arthritis sales to eventually hit $2.2 billion in 2023.

For now, the med is right where it needs to be for AbbVie, which is gearing up to lose Humira exclusivity. In the third quarter, Rinvoq and Skyrizi combined to post $650 million in sales, keeping the duo on pace to generate more than $2 billion for the year.

See more here:
AbbVie's arthritis hotshot Rinvoq grabs a win in ulcerative colitis - FiercePharma

Immunology

AbbVie’s Rinvoq tops Dupixent in eczema showdown, but safety issues will limit use, analysts say – FiercePharma

Sanofi and Regeneron blockbuster Dupixent has set a high efficacy bar for all who dare to challenge it in atopic dermatitis, or eczemabut AbbVies Rinvoq has leapt right over it. Unfortunately for the Illinois drugmaker, though, analysts expect safety issues to hobble its sales potential.

In a phase 3b head-to-head study, Rinvoq showed it could help more patients hit a score of 75 on the EczemaArea and Severity Index (EASI) than its competitor could by Week 16. Seventy-one percent of Rinvoq patients reached the benchmark, compared with just 61% of Dupixent patients.

Rinvoq also came out on top for a range of secondary endpoints. For one, it helped patients show improvements faster: After a week of treatment, 44% of those in the Rinvoq arm had reached EASI 75, versus 18% of those taking Dupixent. And Rinvoq reduced itch by 31%a figure that easily beat Dupixents 9%.

How metabolomics powers up multi-omics workflow across pre-clinical, first-in-human, and late stage clinical trials: A biopharma success story

Join Derek Solum, Ph.D., Associate Director, Product Development at United Therapeutics, and Brian Keppler, Ph.D., Director, Discovery and Translational Sciences, Metabolon, Inc., as they share how metabolomics helped United Therapeutics enhance its multi-omics platform and improve decision-making across all phases of drug development.

RELATED:AbbVie's Rinvoq scores pivotal trial win in eczema. But do dermatologists trust JAK inhibitors?

But the AbbVie drug was also dogged by the same safety issues that have cropped up in its past.

The study examined the med at a 30-mg dosetwice as high as the 15-mg dose thats currently approved in rheumatoid arthritis. And that higher dose previously had come along with increased risk of serious side effects, including infections, gastric perforation and cancer, Bernstein analyst Ronny Gal noted.

AbbVie has been developing both the 15 mg and the 30 mg, with the thinking that with (a) younger and healthier patient population, higher dosethat could deliver better efficacywould still be safe enough, Gal wrote in a note to clients.

In the head-to-head tilt, Rinvoqs rate of serious side effects wasnt all that much higher than Dupixents2.9% versus 1.2%but AbbVie did report one case of death that it pinned on severe infection, a known issue associated with Rinvoq use.

Now, the approvability of the 30 mg dose is probably a question because of the risk-reward, Gal said, especially given that atopic dermatitis is a non-progressive disease that may not justify even a less frequent fatality.

Overall, Gal sees Rinvoq becoming a treatment for patients who have already received Dupixent; SVB Leerink analyst Geoffrey Porges agreed in his own note to clients, adding that the drug may see some modest frontline use in patients that are needle-phobic or -avoidant. Still, Rinvoq could hit $3 billion in atopic dermatitis sales, Gal figures, given the markets massive size.

RELATED:AbbVie's arthritis hotshot Rinvoq grabs a win in ulcerative colitis

Now back to the good news for AbbVie, which is working to build up Rinvoq and fellow new immunology loss Skyrizi as it prepares to hemorrhage sales for best-seller Humira: Rinvoq is emerging as a potent immunology product that can step up to the plate as Humiras value erodes, Porges wrote, pointing to positive ulcerative colitis data that AbbVie unveiled earlier this week.

With potential approvals in AD, ankylosing spondylitis, and psoriatic arthritis in 1H 2021, we believe Rinvoq, along with Skyrizi, will continue to impress with strong sales growth in 2021, serving as positive catalysts for the stock throughout the year, he said.

Visit link:
AbbVie's Rinvoq tops Dupixent in eczema showdown, but safety issues will limit use, analysts say - FiercePharma

Immunology

New Clinical Trials Focus on Boosting Lung Tumor Response to Immunotherapy – NYU Langone Health

Although immunotherapy has dramatically improved lung cancer responses over the past decade, substantially less than half of all treated patients see a significant improvement in survival, even with combination therapies. A large new phase II clinical trial and separate phase I trial, both led by multidisciplinary teams at NYU Langone Health, could point the way toward boosting that response rate through novel approaches that aim to alter the tumor microenvironment and sensitize the malignant cells to immunotherapy.

Within the tumor microenvironment, specific cellular components and products may prevent malignant cells from appropriately responding to immunotherapy. Daniel H. Sterman, MD, the Thomas and Suzanne Murphy Professor of Pulmonary and Critical Care Medicine and director of the Division of Pulmonary, Critical Care, and Sleep Medicine at NYU Langone, says manipulating that microenvironment by injecting a compound directly into the tumor could yield a much better response rate.

A phase II clinical trial known as LuTK02 is testing that concept using a therapy called gene-mediated cytotoxic immunotherapy (GMCI) and has begun treating patients, with a goal of enrolling 111 people in about a dozen medical centers nationwide. The trial is recruiting patients with lung cancer who tolerate their existing immunotherapy but are not responding to it; their cancer is either stable, rebounding after an initial response, or growing unabated. Dr. Sterman says the academicindustry sponsorship with Advantagene, Inc. (Candel Therapeutics) represents the culmination of a long collaboration with the companys research in thoracic malignancies. It is one of the first clinical trials delivering immunotherapy directly into patients lung tumors, and we are excited about this new modality, he says.

As the trials lead site, NYU Langone is managing multiple aspects of the effort, including the immunological analysis of all blood and tumor tissue samples. Its a really important initiative of our new Lung Cancer Center at Perlmutter Cancer Center and highlights the multidisciplinary nature of the Lung Cancer Center, Dr. Sterman says. The clinical research, he adds, is drawing on the extensive expertise of collaborators in the divisions Interventional Pulmonology Program, as well as NYU Langones Precision Immunology Laboratory and Division of Thoracic Imaging and Perlmutter Cancer Centers Thoracic Oncology Disease Management Group. Its a wonderful collaboration of all of these different elements and a really exciting paradigm in which NYU Langone can take a lead role in the logistics and the biological analysis of large trials, Dr. Sterman says.

For lung cancer, researchers have developed two minimally invasive ways to deliver GMCI. One strategy is to use bronchoscopy for the intra-tumor delivery; the other is via a percutaneous injection directly into the tumor mass, guided by CT or ultrasound imaging. Both methods are being used in the LuTK02 trial. We have been working on this concept for several years here at NYU Langone, and this is the first time that we have actually implemented it in lung cancer patients who are refractory to immunotherapy, Dr. Sterman says.

GMCI is a combination biologic that uses a recombinant viral vector, a replication-incompetent adenovirus, to deliver the herpes simplex virus thymidine kinase gene, HSVTK, to the tumor cells. HSVTK gene expression in lung tumor cells may spur a mild immune response on its own, but the effect is dramatically heightened by subsequent treatment with the antiherpes simplex drug valacyclovir.

When you give the patient valacyclovir for two weeks by mouth, the drug in the tumor site is converted into a toxic metabolite that kills tumor cells and activates, together with the thymidine kinase gene, a robust immune response, Dr. Sterman says. It acts not only locally where you do the injection, but anywhere in the body where tumor cells may be. After their first course of GMCI therapy and two weeks of valacyclovir, the trial participants receive a second round five to seven weeks later. Imaging every nine weeks, biopsies, and a battery of immunological tests will allow the collaborators to look for signs of tumor response at local and distant sites.

For me, this has certainly been the culmination of a lot of collaborative work that we have been doing over the last 20 years, Dr. Sterman says. The great hope is that we will have less invasive, safer, and more effective ways of treating lung cancer in the future.

In a separate clinical trial, Dr. Sterman and colleagues are testing another method for delivering immunotherapy directly to lung tumor cells. The phase I feasibility study of bronchoscopic cryo-immunotherapy (BCI) in peripheral lung tumors, funded by the National Cancer Institute, is enrolling 15 patients with advanced non-small cell lung cancer. The collaboration, Dr. Sterman says, includes NYU Langones Section of Interventional Pulmonology, Division of Thoracic Surgery, and Precision Immunology Laboratory.

To perform BCI, clinicians advance a flexible cryoprobe through a bronchoscope to reach a peripheral tumor and freeze a portion of the lesion. Preclinical data suggest that the procedure activates a local and systemic immune response. We are the first in the world to investigate this novel form of cancer immunotherapy, which is conducted in patients undergoing standard-of-care bronchoscopy for known or suspected advanced lung cancer, Dr. Sterman says. Blood samples taken before and after the procedure will allow the clinicians and scientists to assess antitumor activation signals within the patients lymphocytes.

In effect, Dr. Sterman says, using BCI or GMCI is a way of vaccinating patients against their own tumor via a minimally invasive procedure. These techniques may serve as in situ vaccines, he says. The strategy, if successful, could open the door to more combinational approaches. Maybe we can kill some tumor cells by freezing them and then even in the same procedure inject into them a substance that will further activate the immune response, he says. If given in addition to systemic therapy, surgery, or radiation, the multistep scheme could offer an important new method for controlling or reversing tumor growth.

Read more from the original source:
New Clinical Trials Focus on Boosting Lung Tumor Response to Immunotherapy - NYU Langone Health