Category Archives: Immunology

Immunology

Vaccines Against SARS-CoV-2 Will Have Side Effects That’s A Good Thing – Global Biodefense

Takeaways

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.

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.

ABOUT THE AUTHOR

Matthew Woodruff is an Instructor at the Lowance Center for Human Immunology, Emory University. Woodruff received a BS in biotechnology in 2008 from the Rochester Institute of Technology (RIT). Immediately following, he attended Harvard University as a doctoral candidate in immunology, graduating in 2014 with a thesis describing the earliest phases of immune response following influenza vaccination. In 2014 Woodruff pursued a postodoctoral fellowship at Emory University, again studying the early phases of immune response (specifically antibody selection). He published that work in 2018, and transitioned into a human immunology lab under Dr. Iaki Sanz, specializing in the study of autoimmune diseases. Since the start of the COVID-19 pandemic, Woodruff has refocused almost entirely on studying the immune responses in patients with severe COVID-19. Woodruff is a member of the Scholars Strategy Network, and has a strong interest in public outreach.

This article is courtesy of The Conversation.

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Vaccines Against SARS-CoV-2 Will Have Side Effects That's A Good Thing - Global Biodefense

Immunology

Vaccines Against COVID-19 Will Have Side Effects, But That’s A Good Thing, Expert Says – LevittownNow.com

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

In 2021 hundreds of millions of people will be vaccinated against SARS-CoV-2, which is commonly known as COVID-19. 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 experiencetemporary side effectsfrom these vaccines.

I am an immunologistwho studiesthe 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, immunologistCharles Janewaypublished an articlesummarizing 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 alsowhat 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 withthose specific threats accordingly.It can evenmonitor the level of tissue damagecaused 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 asafe 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 accomplishedin 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 developmentof newadjuvants. 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 theiruncomfortable, 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) andGuillain-Barr Syndrome(nerve damage due to inflammation), occur at a frequency of less than 1 in 500,000 doses.

Early data suggest that themRNA vaccines in development against SARS-CoV-2 are highly effective upwards of 90 percent. 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 percent of the Moderna vaccine recipientsexperienced 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.

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 anddeadly diseasethat results inlong-term health consequencesfor a significant number of otherwise healthy people. It may cost you a few days of feeling sick.

Please choose wisely.

Read the original post:
Vaccines Against COVID-19 Will Have Side Effects, But That's A Good Thing, Expert Says - LevittownNow.com

Immunology

I worked so hard in the lab. I cried when the Covid vaccine news came – The Guardian

From an early age, I was fascinated with the natural world, and in particular how living things work. For me, the interaction between organisms, such as that between a host and a pathogen, is fascinating. I have always been interested in translational research how can what I am doing at the bench have an impact on the health of the general public?

This sentiment has never been more relevant than now. In the time of a pandemic, the rolling out of vaccines that can prevent disease is a public health intervention which will benefit so many lives.

Since April, I have been working on assessing immune responses in the Oxford/AstraZeneca ChAdOx1-nCov vaccine clinical trials. In my role as a post-doctoral immunologist at the Jenner Institute, I had previously worked on clinical trials for outbreak pathogens such as Ebola, Mers-CoV and influenza. My job involved measuring antibody responses induced by these vaccines.

So when the task of undertaking immunology analyses, specifically antibody levels, for the Covid-19 vaccine came around, I had the necessary skills to hit the ground running. Granted, the task in hand for Covid-19 clinical trials would be much bigger than anything that I or any of my colleagues had ever worked on before. Currently, I lead the lab team looking at antibody responses to the vaccine in clinical trial volunteers. We are interested in the level of antibody response to our vaccine antigen for ChAdOx1-nCov that is the Sars-CoV-2 spike protein.

We have investigated the antibody response after one dose of vaccine, and after two doses seen how these compare. We also compared antibody responses in different age groups. Now we want to follow the antibody response over several months to determine whether our vaccine can elicit a long-lasting immune response.

My job involves much more than performing experiments in the lab. Planning, data analysis, logistics (such as storing thousands of samples), organising both laboratory consumables and managing people are all in a days work. Working on this vaccine, there have been many pressures, including tight turnaround times for performing assays in the lab to make immunology data available as soon as possible after blood samples are taken from volunteers.

I have worked harder in 2020 than ever before, and hopefully more than I will ever have to again! Sometimes the workload becomes frustrating particularly when you think you have completed a task and can have a small breather, but then there is another, often bigger, task a moment later.

For me, the best path forward in such situations is to pull together as a team and work out how to achieve the end-goal using the skillsets of the individuals in the lab. There have been many highs and lows in the last nine months but these have been shared among co-workers, many of whom I would never have had the pleasure of working with if it werent for these trials.

Did I ever worry, What if the vaccine doesnt work? Of course these are the kind of thoughts that would pop into my head when I should have been asleep. However, I had confidence in both the vaccine technology and in the team, who work tirelessly towards a common goal. Thankfully, we were rewarded with the news that ChAdOx1-nCoV is effective at preventing Covid-19.

On hearing this, I promptly burst into tears. Tears of relief, joy, hope and excitement for the future of this vaccine. I am so proud to be a part of this vaccine, and I look forward to how it could benefit people all over the world.

Continued here:
I worked so hard in the lab. I cried when the Covid vaccine news came - The Guardian

Immunology

Vaccines against COVID-19 will have side effects that’s a good thing – Kiowa County Press

A little bit of post-injection soreness is completely normal. Jose Luis Pelaez Inc/DigitalVision via Getty Images

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. That's probably a good thing, and it's 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 immunologist's dirty little secret": Your immune system doesn't 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 patient's 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 system's 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 I'm 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 haven't 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 don't 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. That's not to say that serious side effects don't occur - they do - but they are exceedingly rare. Two of the most discussed serious side effects, anaphalaxis (a severe allergic reaction) and Guillain-Barre Syndrome (nerve damage due to inflammation), occur at a frequency of less than 1 in 500,000 doses.

Side effects are normal.

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. That's a high number under any circumstances, and suggests that these vaccines are potent.

So let's 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 aren't 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 you'll be protected later. It does not mean that the vaccine gave you COVID-19.

[Deep knowledge, daily. Sign up for The Conversation's 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.

Originally posted here:
Vaccines against COVID-19 will have side effects that's a good thing - Kiowa County Press

Immunology

UCLA receives $7.3 million grant to build state-of-the-art facility for developing gene, cell therapies – UCLA Newsroom

UCLA has received a $7.3 million grant from the National Institutes of Health to build a state-of-the-art facility in which to produce gene and cell therapies aimed at treating a host of illnesses and conditions.

The new 13,000-square-foot facility, to be constructed in UCLAs Center for the Health Sciences, will provide a highly regulated environment with features such as systems to manage air flow and filtering, laboratory spaces and bioreactors. The new facility is expected to be ready for use in 2023.

This grant provides critical funds to build a facility that will enable the development of a new generation of cellular therapies for cancer and other deadly diseases, said Dr. AntoniRibas, a UCLA professor of medicine and director of the Parker Institute for Cancer Immunotherapy Center at UCLA.

The new facility will be built according to U.S. Food and Drug Administrationgood manufacturing practices, a set of guidelines intended to ensure that facilities producing products for human use are built to maximize safety and effectiveness, and to reduce the risk for contamination.

It will replace a facility in UCLAs Factor Building that UCLA scientists currently use for similar research. But that space, which was put together by combining existing research laboratories, lacks the capacity to process certain cells and handle other bioengineered products, and it cannot accommodate the growing number of UCLA scientists pursuing research on gene and cell therapies, said Dr. Stephen Smale, vice dean for research at the David Geffen School of Medicine at UCLA and principal investigator of the NIH grant.

The new facility will be larger, so it will be able to support more projects simultaneously, and its design will allow a smooth flow of products into and out of the facility, Smale said. The larger number of rooms is really important because even when a single therapy is being tested, cells from each patient need to be processed in their own room.

Dr. Eric Esrailian, chief of theUCLA Vatche and Tamar Manoukian Division of Digestive Diseases, is helping to lead the expansion of UCLAs immunology and immunotherapy efforts. It will be a cornerstone for UCLAs commitments to building on existing strengths in the areas of immunology and immunotherapy and expanding toward the creation of a transformational institute in these fields, he said.

Despite the shortcomings of the current space, UCLA researchers have still produced groundbreaking work in it. These include tumor-targeting therapies developed by Ribas, Dr. Donald Kohn, Dr. Linda Liau, and other UCLA researchers.

Ribas, Kohn and Liau are also members of theUCLA Jonsson Comprehensive Cancer Centerand theUCLA Broad Stem Cell Research Center. Kohn is a distinguished professor of microbiology, immunology and molecular genetics and Liau is chair of UCLAs department of neurosurgery.

Kohn, who alsodeveloped a cure for bubble baby syndrome,said he will welcome the new facility because of its increased capacity for researchers to pursue treatments and cures that could significantly improve the health and quality of life of so many people. For instance, it will have the capacity to produce large batches of viral vectors microbes that make it possible to introduce potentially curative genes into cells for gene therapy studies.

This new facility will allow the innovative cell and gene therapies pioneered at UCLA to be available to a wider number of patients and accelerate the development of novel cures, said Kohn, whose work has also led to an experimental stem cell gene therapy for sickle cell disease that is showing promising early results in clinical trials.

Liau, a neuro-oncologist, said the new facility will enable researchers to create personalized vaccines and cell therapies for a much larger number of patients.

In the current facility, we are only able to enroll one patient at a time in our cell therapy trials, so many eligible patients have had to be turned away, Liau said.With greater capacity to manufacture gene and cell therapy products that meet FDA good manufacturing practice standards, this new UCLA facility will really allow us to further innovate and accelerate our translational research toward a cure for brain cancer.

Excerpt from:
UCLA receives $7.3 million grant to build state-of-the-art facility for developing gene, cell therapies - UCLA Newsroom

Immunology

Frontier Medicines and AbbVie Establish Global Partnership to Discover and Develop Novel Therapies and E3 Degraders Against Difficult-to-Drug Targets…

- Multi-year, multi-program R&D partnership to deliver innovative treatment options across cancer and immunological diseases

- Frontier eligible to receive up to $100 million in upfront and milestone payments within the first 12 months of collaboration

NORTH CHICAGO, Ill. and SOUTH SAN FRANCISCO, Calif., Dec. 2, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, and Frontier Medicines, Corp., a precision medicine company drugging challenging protein targets to develop breakthrough medicines that change the course of human diseases, today announced a global strategic collaboration to discover, develop and commercialize a pipeline of innovative small molecule therapeutics against high-interest, difficult-to-drug protein targets.

Under the multi-year collaboration, AbbVie and Frontier will utilize Frontier's proprietary chemoproteomics platform to identify small molecules for programs directed to novel E3 ligases and certain oncology and immunology targets. Whereas conventional drug discovery methodologies have been primarily successful against a relatively discrete set of target classes, chemoproteomics-based screening in relevant cellular contexts has the potential to enable targeting of a significantly broader range of proteins. By selecting certain immunology and oncology targets for the collaboration that are considered well validated but to date, inaccessible, the collaboration has the potential to develop highly differentiated and efficacious therapeutics.

Under the terms of the agreement, AbbVie will pay Frontier an upfront cash payment of $55 million, and Frontier is eligible to receive additional milestone payments. In addition, AbbVie will reimburse Frontier's R&D costs through defined stages of pre-clinical development. The companies will collaborate on the research and pre-clinical development of programs directed against E3 ligase, immunology and oncology targets. Upon successful completion of defined stages of pre-clinical development, AbbVie will assume full responsibility for global development and commercialization activities and costs for the programs. Frontier will retain an option to share development activities and expenses for certain oncology programs through the completion of Phase 2. Frontier will be eligible to receive success-based development and commercial milestone payments that could potentially exceed $1 billion, in addition to royalty payments on commercialized products. AbbVie retains the right to expand the collaboration in the future by exercising options to a defined number of additional targets. The collaboration excludes all of Frontier's internal programs for which Frontier retains exclusive global rights.

Story continues

"AbbVie is focused on making investments in promising new technologies that assist us in our mission to develop innovative medicines," said Jose-Carlos Gutirrez-Ramos, Ph.D., vice president, Discovery, AbbVie. "One of our key strategic focus areas is targeted protein degradation and chemoproteomics, and this collaboration with Frontier Medicines will be highly synergistic and complementary to our ongoing efforts."

"AbbVie's commitment to innovative therapies makes them an ideal partner in the development and commercialization of new medicines for cancer and immunological diseases," said Chris Varma, Ph.D., Frontier's co-founder, chairman, and CEO. "With our powerful chemoproteomics platform, we are greatly expanding the universe of therapeutic targets that can be accessed with small molecule drugs. This partnership enables us to build a shared pipeline of novel therapeutics with AbbVie, while Frontier continues to independently advance our internal programs into the clinic."

About Frontier MedicinesFrontier Medicines is a precision medicine company that has pioneered a proprietary discovery and development platform to develop medicines against disease-causing proteins previously considered undruggable. The company is deploying its groundbreaking scientific approaches in chemoproteomics, covalent drug discovery, and machine learning to develop medicines to treat a number of debilitating diseases, starting with cancer. In its quest to "drug the undruggable," Frontier Medicines seeks to significantly broaden the therapeutic landscape with novel small molecule alternatives to change the course of a broad range of diseases. For more information, visit http://www.frontiermeds.com and follow us on LinkedIn.

About AbbVieAbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

Frontier Medicines Media:pr@frontiermeds.com

AbbVie Media:Gentry Lassiter(224) 219-6670gentry.lassiter@abbvie.com

AbbVie Investors:Liz Shea(847) 935-2211liz.shea@abbvie.com

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Frontier Medicines and AbbVie Establish Global Partnership to Discover and Develop Novel Therapies and E3 Degraders Against Difficult-to-Drug Targets...

Immunology

Expanding early peanut introduction can increase prevention efforts – Contemporary Pediatrics

Earlypeanut introduction has been recommended to pre-emptively address peanut allergies in at-risk children with positive skin prick tests for some time now, but a new study reveals the potential of peanutintroductionas a preventive tool in other groups, as well.

The Learning Early About Peanut Allergy (LEAP) trial and other studies have shown the benefit ofearly peanut introductionin helping children aged younger than 5 years who are at-risk of developing a peanut allergy. However, these studies have excluded infants whose skin prick tests were greater than 4 mm. Additionally, current guidelines forearly peanut introductionrecommend oral food challenges only in infants who have skin prick tests 7 mm. There is no guidance for infants whose skin prick tests are >7 mm or who have high peanut immunoglobulin E (IgE) levels. Adding to the difficulty in addressing oral food challenges in these populations is the lack of standardized values for skin prick testing and IgE levels in infants with peanut allergies.

A new study, published in theAnnals of Allergy, Asthma, and Immunology, sought to test oral food challenges in a wider group than had previously been allowed under current guidelines.1 Specifically, the research team investigated whethersmaller, 1-gram doses ofpeanutwould be tolerated inchildren who typically are not offered oral food challenges.

We've seen that strict avoidance at a young age does not prevent peanut allergy and may promote it in some at-risk children, says lead author Adora A. Lin, MD, PhD, FAAAAI, principal investigator for the Center for Cancer and Immunology Research at the Childrens National Research Institute and attending physician at Childrens National Hospital in Washington, DC. The exact mechanisms are unknown, but the general idea is that allergen exposure through the gut can lead to a tolerizing immune response, whereas allergen exposure through the skinespecially eczema-inflamed skincan lead to an allergic immune response. We see low dose peanut introduction as a strategy to allow more children get peanut in the diet at a young age to hopefully prevent peanut allergy.

From an allergist's perspective, many allergists are fearful to offer peanut food challenges to infants with larger peanut skin prick tests, and require them to consume doses larger than 1 gram to "prove" that they are not allergic, Lin reveals.

We see peanut food challenges with a lower dose as an opportunity to facilitate peanut introduction in some at-risk patients, she says.

Lin referenced a 2019 survey that showed several barriers to peanut introduction in infants, including fear of reactions, choking, and a lack of infant-safe forms of peanut.

In the same survey, only 60% of physicians provided recommendations consistent with National Institute of Allergy and Infectious Disease (NIAID) guidelines, with physician-perceived barriers of parental acceptance of guidelines and fear of giving peanut, and identified educational handouts and access to infant-safe forms of peanut as needed resources, Lin says. The data suggest that both families and physicians would benefit from further education on practical aspects of peanut introduction.

The research team tested the tolerance of a one-gram peanut challenge in infants regardless of skin prick testsizeorpeanutIgE results over a 2-year period in the retrospective study. Of the infants with a skin prick test equal to or smaller than 4 mm, 97% were tolerant of low-dose challenges. In children with skin prick tests larger than 4 mm, 63% were low-dose tolerant. Additionally, the researchers found that Ara h2 IgE levels were significantly lower in the children who did well with the tests compared to those who were not tolerantto the oral challenge. This suggests that Ara h2 IgE levels might be predictive to tolerance of oral food challenges in some infants, the study notes. In this regard, the study concludes that low dose peanut oral food challenges with a gradual increase in dosing may help prevent peanut allergies in a larger number of children at risk of developing these allergies.

Current NIAID guidelines for early peanut introduction recommend peanut introduction orsupervisedoral food challenge for infants with peanut skin prick tests 7 mm in size and do not specifically address management of infants with peanut skin prick tests 7 mm, Lin says. Based on previous studies, these infants are typically advised to avoid peanut. However, in our study, we showed that over 50% of these infants can tolerate a low dose of peanut and can increase the dose at home.

This means that supervised introduction of a low dose of peanut can be done safely for a wider population of infants than previously thoughtpotentially benefiting a larger population of infantsand that families can gradually increase the dose of peanut their infants eat at home, Lin says.

Multiple studies have provided evidence that early introduction of peanut can decrease the incidence of peanut allergy, leading to guidelines from NIAID, the American Academy of Pediatrics, and clinical organizations around the world to recommend early introduction of peanut. However, due to certain risk factors and test results, many physicians may be hesitant to offer introduction of peanut to certain infants, Lin notes. In addition, infants developing feeding skills and preferences may have difficulties eating larger quantities of solid food. We encourage allergists to consider offering supervised introduction of peanut to infants with large peanut skin prick tests, and present the low1 gramdose and home increase in the dose as a strategy that will allow incorporation of peanut into the diet in a developmentally accommodating manner.

New guidelines from the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology are on the way, Lin reveals, adding that she hopes the report will encourage allergists to offer oral food challenges to infants with large skin prick tests who would otherwise be advised to avoid oral food challenges.

Although risks still exist, our approach allows a wider population of infants to undergo dietary introduction of peanut in a supervised setting, with continued dietary incorporation at home and potentially decreasing the risk of developing peanut allergy in more infants, Lin says.

Reference

1. Lin A, Uyguygil B, Robbins K, Ackerman O, Sharma H. Low-dose peanut challenges can facilitate infant peanut introduction regardless of skin prick test size. Annals of Allergy, Asthma & Immunology. 2020;125(1):97-99. doi:10.1016/j.anai.2020.03.026

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Immunology

Enthera Pharmaceuticals Appoints Kazumi Shiosaki to Its Board of Directors and Lisa Olson to Its Scientific Advisory Board to Push Forward Company…

Enthera Pharmaceuticals ("Enthera"), a biotech company developing disease-modifying biologics to transform the therapeutic paradigm of specific autoimmune conditions by re-establishing stem cell capabilities in a non-traditional way, announces that it has appointed Kazumi Shiosaki to its Board of Directors, and Lisa Olson to its Scientific Advisory Board.

Kazumi brings experience as both an entrepreneur and an investor within the field of biotechnology. She is currently the CEO of Twentyeight-Seven, a biotech company focused on novel RNA biology that she co-founded alongside prominent Harvard investigators. Kazumi was also a co-founder and CEO of Mitobridge, a start-up company developing mitochondrial drugs for the treatment of muscle and kidney diseases, until its acquisition by Astellas Pharma in 2018. Prior to Mitobridge, she was a co-founder and start-up CEO of Epizyme (NASDAQ:EPZM), a leader in novel epigenetic therapeutics for cancer. She has also been a Managing Director at MPM Capital.

Lisa is a senior pharmaceutical executive with more than 20 years of experience in research and drug discovery. She is currently Chief Scientific Officer and Head of Research at Magenta Therapeutics, where she provides strategic direction, oversight and execution for research and discovery efforts. Lisa joined Magenta after 15 years in leadership positions at the AbbVie Bioresearch Center, most recently as Vice President, Immunology Discovery and Site Head, where she was responsible for all immunology discovery scientific and portfolio decisions. Prior to AbbVie, Lisa served as a Research Fellow and Group Leader in Inflammation & Immunology at Pfizer.

Kazumi and Lisa will work closely with the leadership team and other Board and Scientific Advisors to support the growth and development of Enthera.

Giovanni Amabile, CEO of Enthera, commented: "The appointment of Kazumi Shiosaki and Lisa Olson will greatly benefit Enthera. Kazumi is a biotech veteran with an outstanding track record in corporate development and fundraising across both European and US markets, while Lisa brings extensive experience in drug discovery and development from roles at Magenta Therapeutics, AbbVie and Pfizer. The support of Kazumi and Lisa will be instrumental as we progress our pipeline and take Enthera to the next level."

Story continues

Kazumi Shioshaki, newly appointed Board member of Enthera, stated: "Enthera Pharmaceuticals is an exciting young biotech, with an innovative and unique approach to treating underserved autoimmune disorders. The recent Series A financing round was a great achievement, and I look forward to working with the Enthera team as we push onwards and use these funds to build a world-class international company with first-in-class therapeutics."

Lisa Olson, newly appointed Scientific Advisory Board member, added: "I look forward to supporting Giovanni and the rest of the Enthera team in the progression of their clinical assets. The Companys lead product is a promising biologic candidate for type 1 diabetes and gastrointestinal diseases, with the wider pipeline offering potential treatments for several underserved autoimmune conditions."

Enthera recently closed a EUR 28 million funding, with investment from renowned investors Sofinnova Partners, AbbVie and JDRF T1D Fund. The funds will be used to accelerate the Companys lead program, Ent001, to clinical proof-of-concept.

Kazumi started her career at AbbVie (then Abbott Labs) and from there joined Millennium (now part of Takeda), where she worked in senior functions in both research and corporate development. She is also a Board member of the Sandford Burnham Prebys Institute. Kazumi holds a PhD in Synthetic Chemistry from UC Berkeley.

Lisa began her career as Assistant Professor at Washington University School of Medicine, following a post-doctoral cardiovascular fellowship at the University of Chicago. She holds a PhD from the University of Illinois at Urbana-Champaign, and a Bachelor of Science from Iowa State University.

ENDS

High-resolution photos of Kazumi Shiosaki and Lisa Olson are available upon request.

Notes to Editors

About Enthera

Enthera Srl is a biotech company developing first-in-class biologics to transform the treatment paradigm of specific autoimmune conditions by re-establishing stem cell capabilities in a non-traditional way. The Companys primary target indications are type 1 diabetes (T1D) and inflammatory bowel disease (IBD).

Enthera's pioneering approach capitalizes on the key discovery of the IGFBP3/TMEM219 pathway, which is involved in beta cell and stem cell apoptosis in pancreas and gut, respectively.

The Company is building a pipeline of inhibitory monoclonal antibodies (mAbs) and fusion proteins targeting the pathway via multiple angles. Its lead program Ent001 is the only drug in development with the potential to restore the endogenous pancreatic stem cell compartment in T1D as well as the original intestine structure in IBD, in order to re-stablish organ function.

Enthera is a private company headquartered in Milan, Italy and founded in 2016 by Prof Paolo Fiorina and Dr Francesca DAddio at BiovelocITA, an Italian biotech accelerator. The Company is backed by Sofinnova Partners and JDRF T1D fund. Entheras discovery engine and assets are protected by a broad portfolio of patents.

For more information, visit https://www.entherapharmaceuticals.com/

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Contacts

Enthera Pharmaceuticals Giovanni Amabile, CEOE: info@entherapharmaceuticals.com

Instinctif Partners (media enquiries) Dr Christelle Kerouedan / Siobhan Sanford / Kiki ZaccagniniTel: +44 20 7457 2020E: enthera@instinctif.com

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Enthera Pharmaceuticals Appoints Kazumi Shiosaki to Its Board of Directors and Lisa Olson to Its Scientific Advisory Board to Push Forward Company...

Immunology

Allergy experts weigh in on prevention strategies – Contemporary Pediatrics

The American Academy of Allergy, Asthma, and Immunology (AAAAI) has unveiled new guidelines on preventing allergies and asthma in children.1 The guidance, updated in September, reviews a number of strategies to prevent, or even delay, the development of several types of allergies.

Food Allergies

Food allergies are a big deal in children, who arent always able to be choosy when it comes to what they eat. Children can have a difficult time discerning the content of some foods, and parents cant always be with them. This makes prevention key when it comes to food allergies, which can be triggered by a number of foods like peanuts, cows milk, eggs, and more.

Infants who have a sibling or at least 1 parent with an allergic condition are particularly at risk of developing food allergies, especially if they already show symptoms of foods allergies like atopic dermatitis, allergic rhinitis, or asthma.

There are a number of methods that helpand others that dontthat were reviewed in the guidance.

Environmental Allergies

There are a number of environmental factors that can trigger allergies, too. However, unlike foods, early contact with environmental allergens can make allergies worse. Research is the most robust when it comes to dust mites, according to AAAAI, which suggests working to control dust mites early to prevent allergy problems. Some solutions to control environmental allergens recommended in the guidance include:

Pet are different, though, according to AAAAI, with recent research suggesting that early exposure to pets can actually help protect children from developing allergies.

When You Need Help

The AAAAI also offered guidance on when to get help and where. If possible, the organization recommends finding an allergist specifically, as they have received specialized training in allergy and immunology. Allergy testing by a specialist can give detailed information about an allergy, and the best methods for treatment, according to AAAAI. On the other hand, AAAAI recommends against massive allergy screening tests done in retail sites, applied kinesiology, or testing through muscle relaxation, cytotoxicity testing, skit titration, provocative and neutralization testing, or sublingual provocation.

Kari Christine Nadeau, MD, PhD, Naddisy Foundation Endowed Professor of Medicine and Pediatrics and director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford University in Palo Alto, California says its important that advice be given on science and epidemiological studies. In terms of allergy prevention, research studies show that a diversification of diets with a variety of proteins from different food sources introduced all at oncerather than staged as suggested by AAAAIcan decrease the risk of allergy and asthma development.

There are a number of other tips she offers for allergy prevention, including:

Nadeau also makes it clear that vaccination avoidance is not a prevention strategy for allergens, and that allergy prevention can begin at any age.

Reference

1. American Academy of Allergy, Asthma & Immunology. Prevention of allergies and asthma in children. Reviewed September 28, 2020. Accessed December 2, 2020. https://www.aaaai.org/conditions-and-treatments/library/allergy-library/prevention-of-allergies-and-asthma-in-children.

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Immunology

Contract Research Organizations (CROs) Market to Reach $64.4 Billion by 2027, Growing at a CAGR of 6 – PharmiWeb.com

LONDON, Dec. 4, 2020 /PRNewswire/ -- A contract research organization (CRO), also known as a clinical research organization, is a service provider organization, which supports pharmaceutical and biotechnology companies for drug development and medical device companies by providing outsourcing services.In recent years, pharmaceutical companies have increased their investment in outsourcing clinical activities, which further supported the growth of the contract research organizations market.

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Meticulous Research,in its latest publication, titled "Contract Research Organizations (CRO) Marketby Services (Clinical Research [Phase II, Phase III], Pre-Clinical [Pharmacokinetics, Toxicology], Laboratory Services, and others), Therapeutic Area (Oncology, Immunology), End User (Pharma and Biotech, Medical Device), and Geography - Forecast to 2027",states that the contract research organizations (CROs) market is poised to grow at a CAGR of 6.5% from 2020 to 2027 to reach $64.4 billion by 2027.

The growth of the contract research organizations market is mainly attributed to the rising demand for biopharmaceuticals, increasing number of clinical trials, and growing government support for biopharmaceutical manufacturing. Also, significant opportunities from emerging markets, increasing demand for biosimilars, and continuous advancements in bioprocessing techniques offer growth opportunities for the players operating in the contract research organizations market.

To provide efficient analysis, Meticulous Research has segmented the overall CROs market based on service (clinical research [phase II and phase III], pre-clinical [pharmacokinetics and toxicology], laboratory services, and others), therapeutic area (oncology and immunology), end user (pharma & biotech and medical device), and geography (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa).

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Geographically, in 2020, North America is estimated to command the largest share of the global contract research organizations market, followed by Asia-Pacific. The major share of this region is mainly attributed to the growing investments in the pharmaceutical and biopharmaceutical industries, greater adoption of advanced technologies, rising prevalence of non-communicable diseases, growth in drug development programs, and the presence of key service providers. Further, the growth during the forecast period will be driven by the expected rise in the demand for biosimilars - due to the patent expiry of many innovators' molecules in the next 5 to 10 years.

In terms of service, the clinical research services segment is estimated to account for the largest share of the overall CROs market in 2020. The large share of this segment is mainly attributed to an increase in the number of clinical trials globally, growth in outsourcing activities to conduct clinical trials at low costs, and growth in collaborations between key players and clinical service providers to reduce failures.

Based on therapeutic area, the oncology segment is estimated to account for the largest share of the overall contract research organizations market in 2020. The large share of this segment is mainly attributed to an increase in the number of oncology clinical trials globally, growth in government investments for the development of personalized medicines for oncology, and high demand for biosimilars for cancer.

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By end user, the pharmaceutical and biotechnology companies segment is estimated to account for the largest share of the overall CROs market in 2020. The major share of this segment is primarily attributed to an increase in R&D investments for drug development, growing collaborations of pharmaceutical companies with CROs to conduct clinical trials, and government initiatives to support the growth of pharmaceutical companies.

The report includes a competitive landscape based on extensive assessment of the key strategic developments by leading market participants in the industry over the past four years. The key players profiled in the global contract research organizations market report are IQVIA Holdings Inc. (U.S.), Laboratory Corporation of America Holdings (U.S.), Charles River Laboratories International, Inc. (U.S.), Wuxi Apptec Co., Ltd. (China), Medpace Holdings, Inc. (U.S.), PRA Health Sciences, Inc. (U.S.), Syneos Health, Inc. (U.S.), PARAXEL International Corporation (U.S.), Envigo RMS LLC (U.S.), ICON plc (Ireland), PPD, Inc. (U.S.), and SGS S.A. (Switzerland).

To gain more insights into the market with a detailed table of content and figures, click here:https://www.meticulousresearch.com/product/CRO-market-5129/

Scope of the Report:

Contract Research OrganizationsMarket, by Service

Contract Research Organizations Market, by Therapeutic Area

Contract Research Organizations Market, by End User

Contract Research OrganizationsMarket, by Geography

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Contract Research Organizations (CROs) Market to Reach $64.4 Billion by 2027, Growing at a CAGR of 6 - PharmiWeb.com