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Tauriga Sciences, Inc. Introduces its Product Line of CBD Infused Bath Bombs Under the Tauri-Gum Brand
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Genmab Announces that Janssen has Submitted a Biologics License Application to U.S. FDA for Amivantamab in Non-small Cell Lung Cancer
NANTES, France, Dec. 03, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE), and Nantes University Hospital (CHU de Nantes) today announced that the French National Agency for Medicines and Health Products Safety (ANSM) and the French Central Ethics Committee (CPP) approved the initiation of a Phase 1/2 trial evaluating first administration of FR104, a monoclonal antibody CD28 antagonist, in patients undergoing renal transplant. This study will be conducted as part of a collaboration agreement between OSE Immunotherapeutics and the University Hospital of Nantes.
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Issuance of a 4th tranche of €1.5 million of notes convertible into new shares
SOUTH SAN FRANCISCO, Calif., Dec. 03, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced that it will host a research and development call on the Company’s systemic complement regulator programs on Monday, December 14, 2020 at 12:00 pm Eastern Time.
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Catalyst Biosciences Hosting Research & Development Call on Systemic Complement Regulator Programs
SALINAS, Calif., Dec. 03, 2020 (GLOBE NEWSWIRE) -- Indus Holdings, Inc. ("Indus” or the “Company”) (CSE:INDS; OTCQX: INDXF), a leading, vertically-integrated, California-focused cannabis company, announces updated guidance for the fourth quarter ending December 31, 2020. All figures stated are in US Dollars.
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BioCryst Announces FDA Approval of ORLADEYO™ (berotralstat), First Oral, Once-daily Therapy to Prevent Attacks in Hereditary Angioedema Patients
CHICO, Calif. -- It's the holiday season, and this Thanksgiving, most people engaged in activities that can lower immunity, like eating a lot of sugar, drinking alcohol in excess, in addition to experiencing increased stress due to the holidays.
Dr. Rand McClain, an expert in restorative and regenerative health and the Chief Medical Officer of LCR Health, shows us how Thanksgiving traditions and habits could be harmful to our immune systems and what we can do to get our immune systems back on track and stay healthy.
Here are a few of his suggestions:
1) Adequate sleep Aim for regular sleep 7 9 hours nightly and during roughly the sameperiod (ex. 11p 7a each night rather than at varying times, especially as occurs with"shift work").
2) Daily exercise Anything is better than nothing but ideally a minimum of 30 minutes, 3times per week of effort that amounts to brisk walking. 5 6 times per week would beeven better, and efforts of an hour each time would be even better. However, morethan that is not necessarily better.
3) Proper nutrition This includes staying hydrated, eating a balanced array of whole, non-processed foods, and spending the time to find what diet works best for you (one dietdoes not fit all). In addition, avoid overeating. Most people eat more than is necessaryfor good immune health. Keep sufficient fiber in the diet to maintain regular bowelmovements and a healthy gut microbiome now considered a major factor inmaintaining healthy immune function.
4) Modulate and avoid excess stress Breathing exercises and other methods (eg,meditation and yoga) of reducing stress (and excess cortisol levels) can help keep theimmune system functioning at its best.
5) Avoid excess alcohol consumption and smoking both known to have negative effectson immune function.
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Recover your immune system through the holidays - Action News Now
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.
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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Vaccines against the coronavirus will have side effects and thats a good thing - PBS NewsHour
Shawn stepped into the UCLA Vine Street Clinic in Hollywood with confidence. He offered up his arm. The UCLA doctor injected him. It took seconds; there was barely a sting.
Twenty-four hours after the first of two shots, given 28 days apart, he suffered the headaches and fatigue associated with a milder case of COVID-19. But Shawn remained calm, resolved to honor the memory of his mother, a nurse who had died in May 2020 from an unrelated cause.
The 57-year-old nonprofit worker had been thinking about the challenges of COVID-19 for a long time, and he decided to go through the lengthy consent process for the medical trial. It gave me something to do with my anger that was so much better than yelling at someone for not wearing a mask, he says. And [at UCLA] I felt I was in good hands.
Shawn is one of many volunteers who have stepped up to participate in medical trials at UCLA, which is part of a global network thats determined to help find a vaccine against the novel coronavirus.
The stakes are huge. More than 250,000 Americans have already died, and there have been more than 1 million deaths around the world. Economies have been brought to their knees, social tensions have disrupted communities and emotional maladies are on the rise.
In response, doctors and scientists have been challenged to be resilient and ingenious. Theyre taking an array of different approaches, knowing that public confidence in vaccines hangs in the balance.
In addition, it has been a challenge to create a vaccine in such a short amount of time similar efforts have taken five to 10 years. Pharmaceutical giant Pfizer and biotech firm Moderna have both reported remarkable progress, announcing in November that their vaccine candidates were more than 90% effective. All of which has raised questions about the next steps, such as how the vaccines will be distributed.
I dont want to make a vaccine to protect against mild disease, says Dr. Marcus Horwitz, distinguished professor of medicine and microbiology, immunology and molecular genetics at the David Geffen School of Medicine at UCLA. I want to protect people who are going to get severe disease.
Horwitz has already developed vaccines against the bacteria behind tuberculosis, anthrax and the tick-borne disease tularemia, but he has never tried to create a vaccine against a virus. When faced with a worldwide pandemic, we thought we might be able to make a contribution, he says.
Vaccines work by training the immune system to recognize and fight disease-causing pathogens, such as viruses or bacteria. Doctors introduce the bodys immune system to antigens, which are molecules from the virus or bacteria, and the immune system responds by making proteins called antibodies and immunity-building T cells, which both neutralize the pathogen.
The delivery of these antigens requires a delicate calculus: It must provoke the immune system, but not go so far as to make the patient ill. You need a vector that will wake up the immune system of the host, but not cause any further harm, Horwitz says.
The vaccine approach by Horwitz and his team, including lead investigator Qingmei Jia, is a medical outlier: They adapted an existing antibacterial platform to build protection against SARS-CoV-2, the virus that causes COVID-19. The team has shown that their vaccine candidate protects hamsters, which develop severe disease in a way similar to humans.
Some of the potential vaccines for SARS-CoV-2 use a weakened form of an adenovirus, which causes the common cold, to deliver the S protein that is found on the surface of the SARS-CoV-2 virus. Horwitzs vaccine stands out from the pack because it uses a weakened bacterium to deliver two SARS-CoV-2 proteins, the M and N proteins.
That difference could have a tremendous impact. Billions of COVID-19 vaccine doses are needed, and bacteria, unlike viruses, are easy and cheap to produce and transportable.
The success of a COVID-19 vaccine also depends on the immune system, which can be less robust in older people.
This is a problem that has driven Song Li, chair of the bioengineering department at the UCLA Samueli School of Engineering, who has focused his career on cell and tissue engineering. Adapting a concept from cancer immunotherapy, Li is developing a biomaterial vaccine booster using artificial cells that could improve the immune systems ability to generate long-term protection.
When the immune system encounters a destructive pathogen, it produces cells that are designed to attack the invader. A small number of those cells, called T memory stem cells, can stay in the system for years ready for a future invasion. Unfortunately, our ability to produce T memory stem cells declines as we get older. Li hopes his booster, in combination with a vaccine, can help fragile immune systems effectively fight against the SARS-CoV-2 virus.
My goal at the outset was to help the elderly population, Li says. But it could be useful for any person whose immune system needs help generating protection from the virus.
Another UCLA team led by Bogdan Pasaniuc, Dr. Manish Butte and Dr. Daniel Geschwind, the Gordon and Virginia MacDonald Distinguished Professor of Human Genetics at the Geffen School of Medicine is trying to find out why the virus significantly impacts some, but leaves others relatively unscathed.
We know age is a major factor, but we see older people who get infected and do quite well, Geschwind says. We have a limited ability to predict how sick someone will get. His team hopes that studying whole-genome sequences from thousands of COVID-19 patients will reveal hidden factors that make some more vulnerable than others. The research could help identify people who are at higher risk for infection as well as develop new treatment and prevention strategies.
Dr. Brigitte Gomperts, professor of pediatrics and pulmonary medicine and a member of the UCLA Broad Stem Cell Research Center, is studying how COVID-19 affects lung tissue. By using stem cellderived clusters of lung cells, known as organoids, she can rapidly screen thousands of prospective treatments. Because the organoids are grown from human cells and reflect the cell types and architecture of the lungs, they can offer insights into how the virus infects and damages the organ.
At UCLA medical centers around Los Angeles County, physicians are ensuring that their medical trials include diverse groups of people and women of all ages.
COVID-19 has hit the African American and Latino communities particularly hard, says Dr. Jesse Clark, associate professor-in-residence in the department of medicine at the Geffen School of Medicine. We have to make sure that any vaccine has been determined to be safe and effective in all populations that will receive it.
COVID-19 has hit the African American and Latino communities particularly hard. We have to make sure that any vaccine has been determined to be safe and effective in all populations that will receive it.
Dr. Jesse Clark, associate professor-in-residence in the department of medicine at the David Geffen School of Medicine at UCLA
Clark is medical director of the UCLA Vine Street Clinic, which is involved in the Moderna clinical trial. Notably, Modernas vaccine works differently from a typical vaccine, because it doesnt contain the virus at all. Instead, it uses messenger RNA, or mRNA, which uses the bodys genetic code to produce antibodies against the virus.
CNN mentioned that the vaccine trials were having trouble finding minorities to participate, says Roderick, a 37-year-old IT manager and father of two, who is participating in the Moderna trial. Being Black and Mexican, and knowing how hard my demographic has been hit, I just went ahead and signed up online. Its worth doing to help out.
Meanwhile, Dr. Katya Corado, an infectious disease specialist at Harbor-UCLA Medical Center in Torrance, has been enrolling patients in a phase 3 clinical trial of an adenovirus vector vaccine thats under development by the University of Oxford and the biopharmaceutical company AstraZeneca.
All vaccines undergo three phases of clinical trials, according to rules set by the Food and Drug Administration. Phase 1, which involves 20 to 100 volunteers, tests the safety and dosage of the vaccine. Phase 2 tests the drugs efficacy and side effects among several hundred participants, and phase 3 gathers more information about a vaccines safety and effectiveness by studying thousands of volunteers.
In the phase 3 trial, we focus on studying how effective the vaccine is in populations that need it most, Corado says.
Clark and Corado are both hopeful that their work can protect the most vulnerable, which includes people over 65, patients with chronic conditions, those facing economic disadvantages and essential workers.
Inoculations have eradicated past epidemics, such as smallpox. But public faith in vaccines has wavered, especially when a now-disproven report in 1998 suggested that the measles, mumps and rubella vaccine was linked to autism spectrum disorder. That has led to U.S. outbreaks of measles, which had been previously eliminated. So scientists recognize the importance of getting the COVID-19 vaccine right.
There are other factors to consider as well. Vaccine distribution will be high on the agenda of the incoming White House administration, but if supply is limited, the Centers for Disease Control and Prevention recommends prioritizing certain groups, such as medical workers.
Also, some vaccines currently in development need to be stored in ultra-cold conditions. For example, Pfizers vaccine must be stored at minus 70 degrees Celsius, while Modernas vaccine must be kept at minus 20 degrees Celsius the temperature of a regular freezer. These factors will affect how the vaccines are distributed.
Some lawmakers have advocated letting the virus run its course in the hopes of achieving herd immunity, which is when enough people have become immune to an infectious disease, either through being infected or vaccination. Since the COVID-19 vaccine is still pending, a majority of people will need to be infected in order to achieve herd immunity and that comes at a terrible cost.
According to Dr. Robert Kim-Farley, professor-in-residence of epidemiology at the UCLA Fielding School of Public Health, up to 2 million Americans would have to die before the country reached herd immunity.
He argues that vaccines work, even if they are not perfectly safe or perfectly effective, as proven by the near-eradication of polio. But approving vaccines prematurely to buckle under the pressure of politics or profit could cause a terrible backlash against being vaccinated, which could lead to future outbreaks.
We want to make sure we are not cutting corners, Kim-Farley says, that we are getting the best vaccine that has the highest efficacy, the longest duration, the fewest number of side effects [with] the fewest number of doses.
This is a very high-stakes game, and its important to get it right, without recalls or playing into the [anti-vaccination] narrative. What still concerns me is the equitable distribution of vaccines to make sure that countries that are not as wealthy as us have access to these life-saving vaccines. We are all members of one global community.
The new collection includes Immune Therapy, Stress Therapy, and Gut Therapy that synergistically nourish the gut microbiome, nervous system, gut-lung axis, and gut-brain axis.
The formulations are the culmination of immune research and over four decades of experience from Co-Founder Paul Schulick. As the companys formulator, Schulick launched For The Biome after parting ways with New Chapter, a company he founded in 1982 which was later acquired by Procter & Gamble in 2012.
We identify For The Biome as a wellness company and although we launched with skincare, my intention has always been to expand into ingestibles. We like to say that you have to treat as a whole to heal as a whole so its only natural that we offer products designed for internal and topical use. The choice to move into immunity was simply nature calling. It was an opportunity to make a contribution, which is what I am here to do, said Schulick.
The master herbalist explained that the products target specific biomarkers to bring an exhausted or overactive immune system back to balance.
We looked at a panel of cytokines, both pro and anti-inflammatory, and a window of immediate effects and response to the exposure of the products. We wanted to see the acute effects and what was moving the needle, said Schulick.Examples of the biomarkers include IL-1B, IL-Ra., IL-2, CD69, CD25, and G-CSF, which help modulate inflammation, signal an immune response, and support renewal. We also looked at the CAP-e antioxidative capacity for the product, or its ability to get into the cells and protect them from the inside out.
Schulick said the Immune Therapy and Stress Therapy are both backed by clinical studies and the probiotic strains in Gut Therapy are backed by several clinical studies as well, adding, We invest heavily to conduct ongoing research and will share this with our customers as it breaks.
In-vitro testing suggests that Immune Therapy balances immunomodulating markers within 2 hours as it coats the mouth and gut microbiome with a protective liquid infusion.
Stress Therapy is a restorative infusion that delivers stress relief by soothing the immune system, nervous system, and supporting the gut microbiome.
The company said Gut Therapy is a first-to-the-world fermentate featuring clinically studied prebiotics, postbiotics, para-probiotics, and live probiotics that support a resilient gut microbiome and its connection to immune, respiratory, and emotional health.
We select the most healing and restorative prebiotic, whole-food, and certified organic botanicals for the digestive system (eg., flax, chaga, aloe, and moringa) and then utilize the power of fermentation to further amplify their benefits. This is no ordinary fermentation process. It is a dual-stage process using the yeast Saccharomyces cerevisiae and two of the most researched probiotic strains from Lactobacillus and Bifidobacteria genera, GG and BR03. These strains produce many important immunologically active peptides also known as postbiotics.
Schulick added that Gut Therapy then completes the formulation with a therapeutically validated, live dose of Lactobacillus plantarum DR7, a probiotic with multiple positive effects on immunity (NK cell upregulation, respiratory protection), stress response (cortisol, serotonin) and cognition (enhanced learning and social emotional reasoning).
When formulating these products, I referenced groundbreaking research that focused on advancements in immune support around the world. This research, coupled with my passion for herbalism, guided me as I chose plants, mushrooms, and probiotics renowned for their ability to support a wiser immune response.
Schulick told NutraIngredients-USA that his goal was to source the best possible forms of these components and introduce some of them for the first time to North America. One of the most remarkable is the herb Cistus incanus, popular in the Mediterranean, and known for its remarkable restorative and protective abilities. Its featured in Immune Therapy because of its notable ability to signal immune response and recovery. Whats more is that, while this ingredient is phenomenal on its own, its even more effective when paired with symbiotic nutrients. We saw increased activity of Cistus incanus when we paired it with vitamin C-rich black currant leaves and rose hips, and birch-grown chaga with betulinic acid. All three of our formulas deliver these kinds of extraordinary synergies.
Schulick said identifying the ingredients is the easier part. Getting the level of efficacy and quality that meets our standards is another story.
For the most part, this has always been the case, COVID or not. Certainly, this period of time during COVID has made that more difficult and weve had to search around the world two or three times, sometimes, to find what we needed. We then independently test and confirm for levels of active compounds to deliver what we are seeking.
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For the Biome makes leap from skin to immune health - NutraIngredients-usa.com
December 2, 2020
Arizona State University has been awarded a $12.5 million multiyear subcontract from the Frederick National Laboratory for Cancer Research (FNL), operated by Leidos Biomedical Research on behalf of the National Cancer Institute, to join the NCIs Serological Sciences Network (SeroNet), the nations largest coordinated effort to study peoples immune response to COVID-19.
SeroNet was enacted as a result of $306 million in emergency supplemental funding from the U.S. Congress for the NCI to study serological sciences related to COVID-19.
ASU is one of just four Capacity Building Centers (CBCs) selected nationally for SeroNet. The goal is to develop high performance serological tests to determine a persons previous exposure to SARS-CoV-2. The network aims to combat the ongoing COVID-19 pandemic by improving the ability to test for an antibody response to infection, especially among diverse and underserved populations, and to accelerate the development of treatments and vaccines aimed at preventing COVID-19 and improving patient outcomes.
This award will now establish Arizona State University as the most comprehensive COVID testing research center in the Southwest, and is a testament to our commitment and scientific capabilities to be offered the opportunity to join SeroNet and to provide a critical service to our community and nation, said ASU Biodesign Institute Executive Director Dr. Joshua LaBaer. It builds upon the great successes of our innovative antibody testing platform, robust biomarker discovery and diagnostic assay development capabilities; our extensive experience at successfully completing large federal contracts, grants and FDA emergency use authorizations; and our response to this pandemic through large-scale PCR-based SARS-CoV-2 testing of saliva samples.
According to ASU Biodesign Institute Executive Director Dr. Joshua LaBaer, ASU hopes to develop a simple, FDA-approved COVID-19 antibody test to detect for previous SARS-CoV-2 exposure and to better understand a persons immune response to COVID-19.
The NCI, FNL and ASU were able to pivot to support COVID-19 research because of their deep experience in virology and immunology research, including research on viruses that cause cancer, such as HPV, and experience in immunotherapy.
In March, LaBaer, a medical oncologist by training who co-discovered breast cancer biomarkers included in a CLIA-approved breast cancer test with colleague Dr. Karen Anderson, shifted his laboratory to become a CLIA-certified clinical laboratory to fully support COVID-19 testing.
In May 2020, LaBaer and Vel Murugan, an ASU associate research professor and co-principal investigator on the SeroNet CBC subcontract, created the first saliva-based COVID-19 test in the Western United States.
To date, ASU has provided more than 300,000 free saliva tests to the general public, first responders, doctors, nurses and medical personnel, and the entire ASU community to help Arizona in the response to keep individuals safe and healthy during the pandemic.
As part of the national SeroNet, ASUs interdisciplinary team of expert scientists and researchers at the Biodesign Institute, led by LaBaer, will establish the ASU Biodesign Capacity Building Center (ABCBC). Other key individuals involved in this project are Ji Qiu, Jin Park, Femina Rauf, Lusheng Song, Mitch Magee and Michael Fiacco.
Through this latest project, we hope to develop a simple, FDA-approved COVID-19 antibody test to detect for previous SARS-CoV-2 exposure and to better understand a persons immune response to COVID-19, said LaBaer. We ultimately want to develop a test for any exposures people may have had to all known human coronaviruses and other respiratory pathogens in order to improve patient outcomes.
The core of the technology builds upon a novel ASU platform (called MISPA) that uses rapid DNA sequencing to monitor many patients immune responses to multiple viral proteins simultaneously, via a molecular barcoding. ASU has tested the platform on cancer subtypes caused by HPV. Now, they want to adapt the same technology for understanding COVID-19.
This system exploits the power of DNA next-generation sequencing (NGS) technology to quantify COVID virus antigens and their interactions with antibodies produced in the body to fight the infection, said Murugan. With this assay, we 'barcode' individual proteins called antigens within the virus with unique DNA sequences that interact in solution with patient serum, followed by quantification of the antibody-bound barcodes by NGS.
Unlike current commercially available serological tests, the MISPA-based test is designed to be quantitative about the strength of the immune response while providing information about responses to multiple proteins and eventually, multiple viruses simultaneously. In addition, because individual reactions can also be indexed (or barcoded) in parallel, thousands of patient samples can be combined, and all the results determined in a single NGS run (many barcoded patients versus many barcoded proteins).
MISPA will also be deployed through a similar high-throughput, fully automated test that can process thousands of samples per day as we have successfully demonstrated from our COVID-19 saliva test, said Murugan.
Initial tests will rely on a testing pool of individuals who have recovered from the infection. Potential sites for serological tests include: ValleyWise, Midwestern/Abrazo hospital networks, Dignity Health hospital network, Columbia University, Colorado River Indian Tribal community through their tribal government, ASU students and population, other universities in Arizona and essential infrastructure partners.
Should the test validation and FDA EUA become approved, testing will expand to essential infrastructure employees, health care professionals and residents in long-term care facilities or other congregate living settings, including prisons and shelters. Community surveillance for asymptomatic population will be conducted at a lower priority when needed.
The lessons learned from ASUs role in SeroNet research could be applied immediately to the COVID-19 pandemic crisis and may prove valuable to public health beyond the pandemic.
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While having a robust immune response to coronavirus infection may sound helpful, a new study shows the opposite may be true.
To better understand how variations in early host immune responses affect disease outcomes, researchers at the Tulane National Primate Research Center followed the course of disease in the four weeks following COVID-19 infection in non-human primates.
They discovered robust early immune responses to the virus and a recruitment of immune cells from the blood to the lungs. They also found that certain cytokinei.e., cell-signaling proteins that help to regulate pro- and anti-inflammatory responsesmay prove helpful in predicting disease outcomes.
These results suggest that in these early weeks post-infection, the stronger the initial host immune response, the worse the disease outcome, says Monica Vaccari, associate professor of microbiology and immunology at the Center and lead author of the study in Nature Communications.
Vaccari explains that while the body mounts a pro-inflammatory innate immune response as a first line of defense to protect against the spread of infection and heal damaged tissue, it is a dysregulated or over-reactive immune response that can cause severe damage. Too much inflammation in the lungs, for example, can result in decreased oxygen.
A pro-inflammatory response is usually our bodys first line of defense, and it can be a very helpful mechanism. But what were seeing with coronavirus infection is that somewhere down the line, there is uncontrolled inflammation. We want to know when and why this happens, Vaccari says.
Understanding what happens in the immune system during this short period following infection will be essential in developing effective therapeutics against COVID-19. While immune functions can be modulated, scientists want to avoid turning off immune responses that may be critical to fighting infection.
One of the most vexing aspects of the novel coronavirus is the broad spectrum of disease outcomes associated with it. A disease that causes few or mild symptoms for most also has the capacity to cause severe and lasting damage or death for others.
While scientists and clinicians have long suspected that it is the hostor person that acquires the diseasethat dictates disease severity, they have not known which specific individual immune markers are harmful and which are protective, particularly in the earliest stages of disease.
This new study identified variations in early host immune responses that may be predictive of COVID-19 disease severity.
Source: Tulane University
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Stronger early immune reaction might make COVID worse - Futurity: Research News
By Graham Lawton
Ted Shaffrey/AP/Shutterstock
UK regulators have authorised a covid-19 vaccine created by Pfizer and its partner BioNTech for emergency use, meaning that vaccine rollout is planned to begin soon. Here, we answer questions about the science of the vaccine, who will get it first, how confident we can be in the authorisation process and the logistics of vaccinating everyone in the UK.
How effective is the vaccine?About 95 per cent. The phase 3 trials of the Pfizer/BioNTech vaccine involved 42,000 people, about half of whom got the experimental vaccine and the rest a placebo. In total, 170 people fell ill with covid-19. Only eight of them were in the vaccine group; 162 had received the placebo. So around 5 per cent of cases were in the vaccine group, which is where the 95 per cent figure comes from. That is a very healthy number: the World Health Organization (WHO) has said it would be happy with 50 per cent.
What is in the vaccine?The active ingredient is messenger RNA that carries instructions for making the viruss spike protein, which it uses to gain entry to cells. The mRNA is synthetic, not extracted from actual viruses. It is delivered in a tiny sphere of inert fatty material called a lipid nanoparticle.
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The RNA-bearing nanoparticles are suspended in saline solution and injected into muscle tissue in the upper arm. The mRNA is then taken up by specialist immune cells, which follow its instructions to make the spike protein, just as they would do if they had become infected with the actual virus.
The spike protein is recognised as foreign by the immune system, which mounts an attack against it. Antibodies, B cells and T cells are activated, according to Uur ahin, the chief executive of the small German company BioNTech that co-developed the vaccine with US drug giant Pfizer. An immune memory is also laid down, he says, which means the immune system has learned how to defeat the pathogen and is primed to mount a swift response if it encounters the coronavirus again.
How long does the immune memory last?Its hard to say at this point, because the clinical trials werent set up to answer that question, and in any case, they only began dispensing second doses of the vaccine four months ago. The WHO says that a minimum of six months would be acceptable. It will become clearer as time marches on and the volunteers continue to be monitored. Sahin says he expects protection to last months or even years. Given what we know about natural immunity that looks about right, says Eleanor Riley at the University of Edinburgh in the UK. She envisages people needing annual boosters, at worst.
How long does it take for immunity to develop fully after vaccination?The trial began assessing immunity seven days after the second shot. We know that protective immunity builds up within four weeks of the first dose, but Sahin says that it appears to develop earlier than that. Further details will be published in a matter of days, he says.
What happens to the mRNA in the body?It is active for a few days then decays rapidly.
Its a two-shot vaccine, so what happens if people miss their second shot? Is a single shot still protective?Two shots are needed, and the second shot is required to attain immunity. The gap between doses in the trial ranged between 19 and 42 days. Only 2 per cent of people in the trial missed their second dose so it isnt entirely clear what happens under those circumstances.
Are there any side effects?Sometimes, but they are mild. In the trial, the vaccine was generally well-tolerated, and an independent data monitoring committee reported no serious safety concerns. The worst side effects were fatigue and headaches after the second dose. About 4 per cent of people reported fatigue and 2 per cent a headache. Other side effects were pain at the injection site and muscle pain. These are common reactions you would have with vaccination, says zlem Treci, chief medical officer at BioNTech. Older adults reported fewer and milder side effects.
Does it work in older people?Yes. Trial participants were aged up to 85, and the efficacy in people over 65 was 94 per cent a tiny bit lower than the overall number but still very protective, and much higher than some vaccine experts feared. The vaccine hasnt been tested in people aged over 85.
What about other vulnerable groups?The vaccine appears to be equally effective regardless of recipients age, sex and ethnicity, according to BioNTech. It has been tested extensively in people who have already had the virus and doesnt cause any ill effects. It has also been tested in people with stable pre-existing conditions also known as comorbidities including diabetes, cancer, hepatitis B, hepatitis C and well-managed HIV. Their response was as good as anyone elses.
People with serious or worsening comorbidities will also be eligible for the vaccine. BioNTech says it has data on this group and will release it in a matter of days.
Does it protect everyone?No. In the trials, out of about 20,000 people who were given the vaccine, eight caught covid-19 and one became seriously ill. In contrast, 164 people who received the placebo fell ill, nine severely. It isnt known why some people didnt respond to the vaccine. But a success rate of 95 per cent is about as good as it gets with any vaccine.
Does it stop people from catching and transmitting the virus?We still dont know. The trial was designed to test for symptomatic covid-19 and confirmed infection with the virus. Assessing whether the vaccine prevents transmission which is probably a prerequisite for attaining vaccine-induced herd immunity is much harder. But Pfizer says it is carrying out more studies on this important question and will release information soon.
Some vaccines can paradoxically make a disease worse through a process called antibody-enhanced disease. Is that a risk?Yes, theoretically. But it hasnt been seen with this vaccine or any other against covid-19, and hasnt occurred naturally, as sometimes happens with other viruses.
Has the the full data from the trial been published yet?No, it hasnt, but there is nothing sinister about that. Companies can release news to the market as soon as they have it, which is a much speedier process than preparing a scientific manuscript. According to Pfizer, every last detail of the science will be submitted to a top-ranking peer-reviewed journal as soon as it is ready. It will then be up to the journal how long it takes to publish.
Who is first in the queue in the UK?When a vaccine is approved it is customary to first offer it to people who took part in the clinical trial but received the placebo. However, as the trial wasnt done in the UK, there is nobody in this category.
Care home residents and their carers have the highest priority, according to a priority system devised by the UKs Joint Committee on Vaccination and Immunisation. But there are problems with delivering this particular vaccine to care home residents because it needs to be transported at very cold temperatures in special cases that carry around 1000 doses. These cases cannot be broken up for distribution, which makes it very hard to get the required doses into individual care homes.
Next in line are people aged over 80 and frontline healthcare workers, followed by people aged over 75, then people in increasingly younger age groups and/or with underlying health conditions.
Will anyone be excluded from the vaccine programme?Yes. Pregnant women and children under 16 wont be eligible, at least at first. The vaccine hasnt been tested on pregnant women or children under 12, and there isnt enough data on children age 12 to 15. But trials in those groups are ongoing or planned.
Everyone else can get it?Yes, but most will have to wait their turn. According to Sean Marett at BioNTech, the exact delivery schedule depends on how fast the factories can churn it out and where else the vaccine is approved, as the company is committed to equitable access. We will deliver as many doses as we can as quickly as we can, he says.
What does temporary authorisation for emergency use mean?Exactly what it says on the tin. The UKs Medicines and Healthcare products Regulatory Agency (MHRA) has expedited the approval process in recognition of a public health emergency, and could rescind the approval just as quickly. But that is highly unlikely as it says it has done a thorough assessment of the safety and efficacy data and has seen nothing to give it reason not to approve.
Will the vaccine inevitably progress from temporary to full authorisation?Probably, but it isnt a given. Pfizer says it expects so, but that is in the hands of the regulators.
It all happened very quickly, can we be confident corners werent cut?Yes. The MHRA is an independent body and so is the Commission on Human Medicines, which also had a say in the decision to approve the vaccine in the UK. Even though the MHRA only received the full clinical trial data just over a week ago, the vaccine developers have been submitting information since October, which has been subject to ongoing review.
The European Medicines Agency, the drug regulator that approves covid-19 vaccines for the European Union, said in a statement that its process for assuring the safety and efficacy of the vaccine is based on more evidence and more checks than the emergency authorisation used in the UK.
According to the vaccine developers, the MHRA asked for exactly the same amount of information as any other regulatory agency. It has been working 24/7 to assess it, says Treci.
Are other countries likely to approve the vaccine soon as well?Yes. Pfizer/BioNTech have also applied for approval in the US, EU, Australia, Canada, Japan and New Zealand, and say they are preparing to submit applications to other regulatory agencies around the world. Decisions are expected from the US and EU this month.
How many doses is the UK getting?In total, the UK government has pre-ordered 40 million single doses, which is enough for 18 million people assuming double dosing and about 10 per cent wastage. But it wont get all 40 million at once. The full order will be delivered in batches over the course of 2020 and 2021.
When will the vaccine reach the UK?The first batch is currently being packaged at Pfizers vaccine factory in Puurs, Belgium, and will be dispatched to the UK by lorry and plane as soon as it is ready possibly as early as the coming weekend. UK health minister Matt Hancock has said he expects the UK to receive 800,000 doses over the next few days.
When will vaccination start?Again, as soon as possible.
Doesnt the vaccine require complicated cold storage?Yes and no. For long-term storage meaning for six months or so the vaccine has to be kept at -70 C, which requires specialist cooling equipment. But Pfizer has invented a distribution container that keeps the vaccine at that temperature for 10 days if unopened. These containers can also be used for temporary storage in a vaccination facility for up to 30 days as long as they are replenished with dry ice every five days. Once thawed, the vaccine can be stored in a regular fridge at 2C to 8C for up to five days.
Could the supply chain be disrupted by the UKs formal departure from the EU as of 1 January?Possibly. But according to Marett, if there is disruption we will find another route.
Where will people be vaccinated?The usual places: GP surgeries, health centres and hospitals. People will be invited by the NHS. The entire supply is going to the various NHS bodies in the UK and nobody will be able to jump the queue by buying a vaccine privately, according to Pfizer.
Could something still go wrong?Yes, but that is highly unlikely. Vaccine effectiveness in the real world is almost always lower than efficacy in trials, but the drop-off would have to be spectacular to dip below the 50 per cent threshold accepted by the WHO.
There could still be rare severe adverse effects down the road, especially as mRNA vaccines are a new technology and have never been rolled out on a massive scale before.
Vaccine clinical trials arent big or long enough to rule out rare but serious side effects, which sometimes appear months or even years after vaccination. People who have been vaccinated will be followed up for two years to ensure that there are no serious adverse effect waiting in the wings.
But these are small, theoretical risks. As Fiona Watt at the UK Medical Research Council (MRC), said: This is great news.
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For those who have a family history of chronic diseases, this is great news because it means that you can take control of your future by taking control of your health. Furthermore, you can focus your attention on lifestyle factors that you can control as opposed to the genetics that you cant control.
Seriously, stop it.
The fact is that your favorite snacks, fast food meal, and other processed foods are rich in sugar, salt, and trans fats all of which greatly increase your risk for chronic diseases that include cancer, heart disease, hypertension, and diabetes.
You are what you eat and if you want to be the epitome of longevity, then you need to eat foods that improve your lifespan, not shorten it. Adopting a plant-based diet is a great way to ensure that your body gets all the nutrients it needs to keep itself healthy in the coming years. Having said that, eating healthy doesnt mean that you need to say goodbye to all of your favorite treats. They can still be enjoyed, just in moderation.
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15 Things To Stop Doing If You Want To Live To 100 - Longevity LIVE - Longevity LIVE
Significant bonuses from Fleckvieh calves and cull cows have been important cash flow tools in a rain-fed Victorian dairy herd this year.
This has come on top of the Fleckvieh attributes of longevity, fertility, robustness and temperament for Richard Humphris of Beech Forest.
Dr Humphris left consulting work as a veterinarian 20 years ago to go full-time dairying.
He milks 200 cows off 110ha set in a 2000mm rainfall zone comprising clay loam soils.
Richard has 69ha of lower rainfall country for growing out the rising one-year-old and two-year-old heifers.
Originally we had a fair proportion of stud Holstein-Friesians in the herd but when we moved (from South Australia) to this high rainfall climate, it was a fair challenge for standard Jersey and Friesian cows, Dr Humphris said.
We ran into problems with fertility and mastitis so we moved to a Jersey/Friesian cross using New Zealand sires.
With the low milk prices, I thought I needed to do something different and saw an advertisement for dual-purpose Fleckviehs about eight years ago.
It was ideal a dual-purpose cow producing milk with the value-added beef component.
Dr Humphris initially used Fleckvieh semen over selected cows and has graded up to the point where matings are 100 per cent Fleckvieh.
Most of the milking herd is now three-quarter-bred Fleckvieh.
Dr Humphris was visited on-farm in 2015 by Dr Thomas Grup of Bayern-Genetik, Germany, and South African researcher Dr Carel Muller.
Dr Muller encouraged him to do simple comparative trials of the Fleckvieh crosses against other crossbreeds through herd testing on longevity and lifetime production.
We get much greater longevity from the Fleckviehs due to better fertility, less mastitis and a better recovery if mastitis does occur, Dr Humphris said.
The Saputo suppliers have transitioned to once-a-day milking to reduce stress on the family and herd, and leave extra time for essential farm maintenance and pasture production.
The move also meant they could use the existing 20-a-side swing-over dairy, avoiding extra capital costs.
In the first year of once-a-day milking, the herd produced 75,000kg of milk solids and had jumped to 99,000kg by the third season.
The herd averages 3932 litres, 4.9 per cent butterfat, 3.8 per cent protein and 348kg of milk solids across 287 days.
Last herd test, the highest daily lactation was Flekmaid at (once-a-day milking, second lactation) 31.8 litres, 4.5 per cent butterfat, 3.2 per cent protein and 2.45kg of milk solids.
Rurex daughter Joygirl showed what Fleckvieh crossbreds are capable of under Australian conditions by producing 6209litres, five per cent butterfat, 3.8 per cent protein, and 569kg of milk solids across the 305 day lactation (once a day).
Components over the spring months in the herd are four per cent protein and 4.7 per cent butterfat, increasing to 4.2 per cent protein and five per cent butterfat over the summer.
The most important thing is their temperament, they are beautiful cattle to work with and they have the other option of beef income, Dr Humphris said.
Due to the once-a-day milking and the environment, we find we do need excellent udders with a particular emphasis on udder depth and suspensory ligament.
If a Fleckvieh has to leave the herd it will mainly be due to a low-slung udder.
We are getting some really good uddered cows coming through now and that has helped our udder health.
If they do get mastitis, I have observed Fleckviehs have a better ability to recover they are sturdy, robust cows in this harsh Victorian climate where it can snow in the winter.
Where another cow may produce more on an individual daily basis, these cows have the ability to go on for a lot longer than our traditional Australian genetics in terms of fertility, lack of mastitis and survivability.
We have very few problems with lameness compared with our earlier years with other breeds but once a day milking does contribute to this reduced lameness.
Dr Humphris said the Fleckvieh added frame to the smaller crossbred females.
Fleckvieh fertility and once-a-day milking results in high conception rates with 80 per cent on the first service in the August-calving herd.
The couple joins 100 per cent of the herd to Fleckvieh sires, and they have daughters of Round Up, Rijeka, Waldoer, Reumut, Mahango, Waldbrand and Walfried.
We mop up with Fleckvieh beef bulls the calves have been one of the most exciting complements to the whole exercise, Dr Humphris said.
This year I did not sell one calf for slaughter at five days of age they all went for pasture finishing to adult animals in the local area.
I either sold them at one week of age or at eight weeks of age as a reared calf.
This gives a significant cash flow at the beginning of lactation through the sale of those calves for continuing beef production.
This results in the equivalent of 50kg of milk solids start on any other cow in terms of profitability.
Dr Humphris said the value of cull cows was a bonus on top.
I recently sold Jersey/Friesian cross cows for $850 compared to $1200 for the Fleckvieh crosses, he said.
During his career as a vet, Dr Humphris has experienced a range of calving difficulties in cattle.
At the beginning I was rather cautious about what I would have to face up to with the Fleckviehs calving, he said.
But they dont require assistance unless there is a malpresentation.
We dont select sires on calving ease but rather for production, udders and milk quality.
Our heifers are calved at two years of age we are not convinced this is the best but it suits our system.
The milkers are rotationally grazed across perennial rye-grass pastures and fed a mixed grain ration of 2.5kg in the bail.
Dr Humphris and his wife Christine have travelled to Bavaria, in Germany, to experience the Fleckvieh breed in its native environment and inspect sires.
We aim to select the highest TMI bulls with a big focus on udder, shape and function, he said.
It was enlightening going over there, talking to the breeders and seeing 100 per cent Fleckvieh herds.
Offering dual-purpose flexibility, they are a breed well worthwhile considering as we face these different economic and climatic challenges.
We love our Fleckviehs. They have strength, vitality and production of milk and meat, and live for the moment.
The Fleckviehs have a wonderful temperament they live life to the full full of grass, full of milk and full of meat. They cycle full-on and conceive full-on.
For more information on Bayern Genetik, phone George Cassar on 0265507661.
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Ticking the boxes in a rain-fed dairy system - Dairy News Australia
NEW YORK, Dec. 03, 2020 (GLOBE NEWSWIRE) -- IN8bio, Inc., a clinical-stage biotechnology company focused on developing innovative allogeneic, autologous and genetically modified gamma-delta T cell therapies for the treatment of cancers (IN8bio or the Company), today announced an upcoming presentation that provides an update of the ongoing Phase I clinical trial of their product candidate INB-100 at the 62nd American Society of Hematology Annual Meeting & Exposition (ASH), which will take place virtually from December 5 to 8, 2020. INB-100 is designed for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation with haploidentical donors.
The poster and accompanying narrated slide presentation is titled, First-in-Human Phase I Trial of Adoptive Immunotherapy with Ex Vivo Expanded and Activated gamma delta T-Cells Following Haploidentical Bone Marrow Transplantation and Post-BMT Cyclophosphamide and reviews the study design and provides a brief update on enrollment and patient status.
The company reported that, as of abstract submission, three female subjects with acute leukemia had been enrolled in the INB-100 Phase 1 trial, of whom two had been dosed, and that no treatment-related adverse events had been recorded. The trial is continuing to enroll and treat patients. The abstract for the presentation can be found at https://ash.confex.com/ash/2020/webprogram/Paper142876.html.
The poster and slide presentation are jointly authored by the scientific and physician investigators from IN8bio and The University of Kansas Cancer Center (KU Cancer Center), and will be presented by the studys Principal Investigator, Dr. Joseph McGuirk, Schutte-Speas Professor of Hematology-Oncology, Division Director of Hematological Malignancies and Cellular Therapeutics and Medical Director, Blood and Marrow Transplant at KU Cancer Center.
This preliminary data report from KU Cancer Center with our allogeneic product candidate, INB-100, demonstrates the absence of significant GvHD in these initial patients, said William Ho, Chief Executive Officer of IN8bio. This suggests that gamma delta T-cells delivered as an off-the-shelf allogeneic cell therapy may be well tolerated and have significant potential to treat patients with serious and life-threatening cancers.
Dr. McGuirk, commented, Potentially curative stem cell transplants using partially matched donors -- called haploidentical transplants have greatly expanded access to stem cell transplantation. The infusion of donor-derived gamma delta T-cells from the stem cell donor, offers the hope of diminishing this risk of relapse and curing more patients.
About IN8bioIN8bio is a clinical-stage biotechnology company focused on developing novel therapies for the treatment of cancers, including solid tumors, by employing allogeneic, autologous and genetically modified gamma-delta T cells. IN8bios technology incorporates drug-resistant immunotherapy (DRI), which has been shown in preclinical studies to function in combination with therapeutic levels of chemotherapy. IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma, which is a difficult to treat brain tumor that progresses rapidly, and INB-100 for the treatment of patients with acute leukemia undergoing hematopoietic stem cell transplantation. For more information about the Company and its programs, visit http://www.IN8bio.com.
Forward Looking StatementsCertain statements herein concerning the Companys future expectations, plans and prospects, including without limitation, the Companys current expectations regarding the curative potential of its product candidates, constitute forward-looking statements. The use of words such as may, might, will, should, expect, plan, anticipate, believe, estimate, project, intend, future, potential, or continue, the negative of these and other similar expressions are intended to identify such forward looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond the Companys control. Consequently, actual future results may differ materially from the anticipated results expressed in such statements. Specific risks which could cause actual results to differ materially from the Companys current expectations include: scientific, regulatory and technical developments; failure to demonstrate safety, tolerability and efficacy; final and quality controlled verification of data and the related analyses; expense and uncertainty of obtaining regulatory approval, including from the U.S. Food and Drug Administration; and the Companys reliance on third parties, including licensors and clinical research organizations. Do not place undue reliance on any forward-looking statements included herein, which speak only as of the date hereof and which the Company is under no obligation to update or revise as a result of any event, circumstances or otherwise, unless required by applicable law.
Contact:IN8bio, Inc.Kate Rochlin, Ph.D.+1 646.933.5605info@IN8bio.com
Investor Contact:Julia Balanova+ 1 646.378.2936jbalanova@soleburytrout.com
Media Contact:Ryo Imai / Robert Flamm, Ph.D.Burns McClellan, Inc.212-213-0006 ext. 315 / 364Rimai@burnsmc.com/rflamm@burnsmc.com
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IN8bio announces first-in-human Phase 1 trial Update from The University of Kansas Cancer Center using INB-100, IN8bio's Gamma Delta T-cell product...
The feasibility of a precision medicinebased approach was demonstrated for patients with newly diagnosed acute myeloid leukemia (AML), according to findings from a phase 1/2 clinical trial reported in Nature Medicine.
The current standard of care for the treatment of patients diagnosed with AML involves prompt initiation of intensive induction chemotherapy, such as 7 days of standard-dose cytarabine and 3 days of daunorubicin, or administration of a hypomethylating agent for those deemed unable to tolerate standard induction therapy, to prevent rapid progression of disease in this predominantly older patient population.
Hence, time for comprehensive molecular characterization of the disease is not built into typical treatment protocols for patients with newly diagnosed AML. However, long-term outcomes of patients with newly diagnosed AML treated with intensive chemotherapy without autologous hematopoietic stem cell transplantation have been shown to be poor, and hypomethylating agents are not a curative approach in the setting of AML.
This nonrandomized, open-label, multicenter, umbrella protocol study sponsored by the Leukemia & Lymphoma Society (BEAT AML Master Trial; ClinicalTrials.gov Identifier: NCT03013998) enrolled adult patients with suspected AML prior to the administration of frontline treatment.
During a 7-day period prior to treatment assignment, bone marrow biopsy specimens of eligible patients were subjected to cytogenetic analysis, comprehensive molecular profiling using next-generation sequencing, and a FLT3-ITD ratio testing. On the basis of these results, patients with a dominant AML clone characterized by an actionable alteration were assigned to 1 of multiple molecularly defined substudy treatment arms, whereas those without evidence of such an alteration were assigned to the marker-negative subgroup.
In describing the purpose of this study, the investigators stated that they collaboratively implemented a new prospective clinical trial approach aimed at facilitating frontline treatment assignments to specific genomic-defined AML subtypes.
Of the 395 eligible patients, approximately 95% were assigned to treatment within 7 days of bone marrow biopsy collection. Of note, only 26 of these patients exhibited evidence of rapid disease progression necessitating initiation of therapy during the 7-day testing window.
The most common mutational drivers identified were DNMT3A (22.7%), TET2 (19.6%), TP53 (19.1%), ASXL1 (19.1%) and SRSF2 (18.4%).
Regarding molecularly based treatment assignment, the study authors commented that these data show that there were few co-occurring dominant mutations that could have been used for an alternative therapeutic assignment.
Only 224 (56.7%) of patients agreed to receive treatment according to their assigned BEAT AML substudy treatment arm, with 103, 28, and 38 patients selecting standard-of-care treatment, alternative investigational therapy, and palliative care, respectively.
Patients were encouraged to select an alternative therapy (alternative investigational therapy, [standard of care] or palliative care) if the patient with their health-care providers deemed this a better option, the study investigators noted.
A key finding from this study was the 30-day mortality of patients starting at initial study enrollment was 3.7% for patients enrolled on the BEAT AML trial protocol and 20.4% for those who choose to receive standard-of-care therapy.
Furthermore, rates of 1-year overall survival were 54.7%, 27.6%, 11%, and 57.4% for patients treated on the BEAT AML protocol, or with standard-of-care therapy, palliative care, and alternative investigational therapy, respectively.
However, the study investigators noted that while our study demonstrates the feasibility of precise molecular treatment assignment in older adults with AML, it does not clearly differentiate the benefit of treatment assignment based on a molecular target from better outcome that occurs simply from enrolling on a clinical trial.
They also emphasized that this approach requires a detailed team-coordinated effort by investigators, patients and caregivers, genomic laboratories, cytogenetic laboratories and a central treatment assignment team.
In their concluding remarks, the researchers commented that randomization of specific large genomic groups to targeted therapy versus [standard of care] or, in less common genomic groups, comparison of treatment with targeted therapy to either real-world data or synthetic controls, will be required to determine the comparative effectiveness of a precision medicine-based approach vs standard-of-care therapy in patients with newly diagnosed AML.
Reference
Burd A, Levine RL, Ruppert AS, et al. Precision medicine treatment in acute myeloid leukemia using prospective genomic profiling: feasibility and preliminary efficacy of the Beat AML Master Trial. Nat Med. Published online October 26, 2020. doi:10.1038/s41591-020-1089-8
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Possible Role for Comprehensive Molecular ProfilingBased Treatment Selection in Newly Diagnosed AML, Study Suggests - Cancer Therapy Advisor
