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Biotechs Working on COVID 19 – TheBull.com.au

By Stem Cell Medicine

14 June 2020 9min read

On 11 June Aussie investors got a wake-up call from the chairman of the US Federal Reserve, Jerome Powell, sending the ASX 200 plunging 3%, its worst close in six weeks. US markets followed suit, dropping 4.25% by midday on the 11th and closing down 6.9%, dropping 1,861 points. However, although the ASX closed the week lower down 1.89% the buyers returned to US markets on the last day of trading there, sending the Dow Jones Industrial Average up by 1.95%.

With countries all over the world getting back to business and concerns about the spread of COVID-19 fading from the public consciousness in general and investor consciousness in particular, global share markets remained confident in anticipation of a quick v-shaped recovery.

Powell threw water on that argument, in the official statement released by the Fed:

Skeptical investors may have noticed the tendency of market participants to accentuate whatever bits of positive news comes out, often ignoring negative undertows. Reaction to this announcement reversed the trend, grabbing on to the phrases in the statement ongoing public health crisis and medium term economic outlook despite statements the US economy would recover eventually.

The Chairman clearly linked the economic recovery to the coronavirus, citing issues like the length of time for treatments and a virus as well as rises in the number of infected as social distancing practices fall by the wayside.

The key point investors need to bring into focus is that despite declining cases in most countries and the accompanying willingness of the public to ignore warnings, COVID-19 has not gone away, even here in Australia.

While the numbers by state might be cause for optimism in most of the country, the push for a full reopening of Australian businesses and the easing of travel restrictions suggest at the very least the possibility of increasing cases here.

In the US 16 states are seeing increases in COVID-19 cases in the double digits, raising the alarm among some in that country that the dreaded second wave is soon at hand.

With COVID-19 still very a factor looming over economic recoveries everywhere, biotech stocks involved in any way in the search for a vaccine or treatments for the virus could prosper in the medium term if successful.

The ASX has one of its flagship stocks, CSL Limited (CSL) in a position to increase its already stellar reputation through its partnership role in the CoVIg-19 Plasma Alliance, comprised of leading experts from the industry. In addition, CSL is developing COVID-19 Immunoglobulin, a plasma product with the potential to treat people in the Australian market with respiratory complications due to COVID-19.

There are a number of small cap biotechs that merit attention, along with long time large cap heart breakers Mesoblast Limited (MSB). The following table lists them by market cap, along with price information.

Four of these stocks have turned in stellar year over year share price appreciation for their investors.

Mesoblast is involved in regenerative medicine with its three proprietary technologies Mesenchymal Precursor Cells (MPCs), culture-expanded Mesenchymal Stem Cells (MSCs), Dental Pulp Stem Cells (DPSCs) and expanded Hematopoietic Stem Cells (HSCs).

These technology platforms address complex medical issues involving inflammation and damaged tissue. The company has five treatments in various stages of clinical trials, with one Ryoncil approaching registration status with a launch in the US on the horizon. Ryoncil, or Remestemcel-L, treats inflammatory conditions of the kind associated with COVID-19 acute respiratory distress stress syndrome (ARDS). After a successful pilot trial the US FDA (Food and Drug Administration) cleared Remestemcel-L for a randomized controlled Phase 3 Trial involving 300 patients in 30 different sites across the US. Confident of a successful trial, Mesoblast has already concluded a capital raise totaling $138 million dollars to go towards the eventual manufacture of the treatment.

Atomo Diagnostics (AT1) is virtually a newborn on the ASX, listing on 30 April of 2020 with a first day closing price of $0.48, declining steadily to reach the current $0.30 per share. The company entered the ASX with both a professional use rapid diagnostic test (RDT) and a self-testing device for the HIV virus. Atomo, working with French in vitro diagnostic specialist NG Biotech SAS, has developed an RDT platform for professionals to test for the presence of antibodies in response to COVID-19. NG Biotech has granted exclusive distribution rights to Atomo for Australia, New Zealand, and other South East Asian countries, following NGs purchase of 1.5 million tests for use in France.

Dimerix Limited (DXB) got a huge boost on 4 June when the stock price jumped 54% with the announcement its lead candidate to treat kidney disease DMX-200 had been selected to join a global study (REMAP-CAP) on treatments for COVID-19 induced ARDS. The study is funded by both government and non-government organisations with an endorsement from the WHO (World Health Organisation).

The company listed on the ASX in 2015 following a reverse merger. Dimerix has another DMX-200 treatment for kidney scarring in clinical trials and another DMX-700 for COPD (chronic obstructive pulmonary disease) starting pre-clinical studies.

Cynata Therapeutics (CYP) is developing a platform using Cymerus technology for manufacturing mesenchymal stem cells (MSCs) for therapeutic use. The technology could be disruptive in that it could allow manufacture of stem cells for therapeutic use in commercial scale quantities from a single donation of a single cell.

The company has completed successful preclinical studies targeting different diseases, including asthma, heart attack, sepsis, and cytokine release syndrome (an inflammatory condition with infections.) FUJIFILM Corporation has licensed the technology from Cynata to treat graft-versus-host disease in people following a successful Phase 1 clinical trial.

On 11 March of 2020, the company announced it was in active discussions with international pharmaceutical companies to use the Cymerus technology platform to treat COVID-19 patients with severe symptoms.

On 8 May Cynata announced approval to begin a clinical trial in Australia to determine the efficacy of its stem cells from its Cymerus technology platform to treat ICU (intensive care unit) COVID-19 patients.

Impression Healthcare (IHL) is a custom fit dental products company that got involved in medical marijuana, with clinical trials for the treatment of gingivitis and gum disease. On 1 May the company announced a preclinical animal study to test its cannabinoid drug IHL-675A for treating a leading cause of deaths from COVIOD-19 sepsis-related ARDS. The trial began on 2 June. On 3 June Impression announced it was abandoning its oral device business to focus on medical marijuana in anticipation of significantly higher revenue for the June Quarter for its existing Icannex branded cannabinoids.

PharmAust Limited (PAA) has a business model aimed at a newer approach to drug development repurposing drugs approved for other treatment conditions. In the past, discoveries that a given drug to treat condition X could also treat condition Y were accidental. PharmAusts lead drug Monepantel (MPL) is a cancer treatment that has successfully completed Phase 1 clinical trials for use in both humans and dogs. The treatment for dogs is starting Phase 2 trials. The company also has a portfolio of cancer treatments in preclinical stages.

On 4 June, the company announced it had expanded its portfolio enhancement efforts to include a preliminary study on the effects of Monepantel on COVID-19 patients. Following positive results potential suppression of the virus by up to 95% PharmAust filed a patent application for the use of Monepantel in COVID-19 cases. The share price went up 40% on the news.

In yet another example of an ASX small cap biotech discovering treatments developed for other purposes could help in treating COVID-19, Noxopharm Limited (NOX) announced on 1 April it too was ready to get into the race to find effective treatments.

The companys lead candidate is a late stage cancer treatment primarily targeting prostate cancer idronoxil with the brand name Veyonda. Examining their preclinical work on the drug, Noxopharm found idronoxil suppressed the cytokine molecules responsible for triggering inflammation of the type affecting the respiratory systems of COVID-19 patients.

On 21 April, the company announced it was applying for US FDA (food and drug administration) approval to conduct a clinical study for Veyonda.

All of the companies listed here are developing treatments that may fade away at some time in the unknown future. Interested investors should also consider the potential of the companys other offerings as even with success in the treatments developed, their revenue generating potential could be short-lived.

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Biotechs Working on COVID 19 - TheBull.com.au

Houston coronavirus updates: What you need to know about June 14 – msnNOW

By Stem Cell Medical Center

9:16 a.m.

Texas reported a record high of 2,242 COVID-19 hospitalizations on Saturday, according to Texas Health and Human Services.

Last week, Texas set a new record for COVID-19 hospitalizations in four of the five days, climbing to 2,166 on Friday.

Health officials are concerned that the increase may strain hospital capacity. Dr. James McCarthy, Chief Physician Executive of Memorial Hermann warned about the recent COVID-19 surge and hospital capacity.

"We need to protect hospital capacity for important healthcare needs," McCarthy said, "The one thing we don't want to see is where hospital capacity is strained in a way where the rest of the patients can't be cared for. Important surgeries still need to go on." Read more details of his interview here.

In an in-depth report by Houston Chronicle's Jenny Deam, Houston hospitals are now ramping up the number of beds and ventilators available. There are nearly 18,000 beds available statewide, an increase of about 4,700 from Thursday. Read more of her in-depth report here.

9:05 a.m.

As of Sunday morning, there are now 7,817,064 cases of the novel coronavirus worldwide, according to Johns Hopkins University. The death toll now has climbed to 430,605. The U.S. currently leads the world with 2,074,749 confirmed cases.

According to Texas Health and Human Services, there are now 86,011 cases reported across the state. Harris County leads the state, reporting 16,188 confirmed cases.

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Houston coronavirus updates: What you need to know about June 14 - msnNOW

UofL researchers to study health impacts of vaping, nicotine on youth – The Lane Report

By Stem Cell Medical Center

LOUISVILLE, Ky. The American Heart Association is investing nearly $17 million to fund a two-year research initiative, ENACT (End Nicotine Addiction in Children and Teens), led by a national network of scientists focusing on the health impacts of e-cigarettes and other nicotine delivery systems on youth and young adults.

As part of this network, researchers at the University of Louisville Christina Lee Brown Envirome Institute will conduct studies to better understand youth vaping. Institute researcher Joy Hart, professor in the UofL Department of Communication, will lead a team engaging local youth to learn about what drives youth to use e-cigarettes, the health effects of this use and how to motivate young people to stop using these products.

This investment is the latest in a multipronged, ongoing commitment announced last fall by the American Heart Association to fight the growing epidemic of youth vaping.

E-cigarettes are being marketed as a healthy option to traditional cigarettes, but no one knows if vaping is safe in the long run because e-cigarettes havent been around long enough to be studied deeply. Some diseases can take years and even decades to develop, so there is more work needed to fully understand all the dangers, said Dr. Robert A. Harrington, AHA president, Arthur L. Bloomfield professor of medicine and chair of the department of medicine at Stanford University. Theres certainly plenty of indication theyre harmful for growing minds and bodies because we know e-cigarettes contain nicotine and we know the harmful effects of nicotine, but its important we grow that overall body of scientific evidence.

Harrington said theres a sense of urgency because, at a time when regular cigarette smoking has reached an all-time low, young people are turning to e-cigarettes at epidemic proportions with nearly one in four high school students reportedly vaping. Thats why these research projects will be high-impact and fast tracked, only two years in length and funded at levels among the highest individual grants awarded in the associations history. The initiative is designed to produce turnkey programs to support youth as well as provide clear evidence to inform policy decisions.

The UofL research project is part of the Rapidly Advancing Discovery to Arrest the Outbreak of Youth Vaping Center (VAPERACE) at Boston University. Hart will spearhead community outreach activities and will work with other center investigators to understand the health impact of vaping on youth and to develop new approaches to vaping cessation. The research team includes Kandi Walker, Rachel Keith and Aruni Bhatnagar, director of the Envirome Institute.

Tobacco use causes health issues for many Kentuckians, and is particularly concerning in young people. We are pleased that researchers in the UofL Christina Lee Brown Envirome Institute will contribute to this significant effort by the American Heart Association and hopefully reduce the negative health effects of tobacco use on the next generation, said Neeli Bendapudi, president of the University of Louisville.

Studying vaping among youth has always been important. It became even more important with widespread lung illness among young people, Bhatnagar said. Now, in context of the COVID-19 pandemic, it appears that those who use nicotine may be at greater risk of serious COVID-19 illness.

In addition to UofL, VAPERACE at Boston University includes projects by Johns Hopkins University and Stanford University. The projects supported by the center include: basic research using human-induced pluripotent stem cell samples to test e-cigarette component toxicity, mobile health technology to measure the physiological cardiovascular impacts of e-cigarettes on youth in real-world settings and a virtual reality and text messaging-delivered e-cigarette cessation program for youth developed by combining social media methods with focus groups.

Two additional projects funded by the AHA as part of the network are based at Ohio State University and Yale University. Overall, network researchers will work to identify the biological impacts of vaping on multiple organ systems (heart, brain, lungs, vascular system, etc.), behavioral factors and specific social influencers of health to reverse these trends.

The rapid pace of e-cigarette products entering the market and targeting our youth requires an ambitious, aggressive approach beyond the incremental pace achieved through traditional research mechanisms. Policymakers, regulators, medical professionals and schools are looking to enact strategies, policies and solutions but theres inadequate evidence to inform these efforts, Harrington said. The American Heart Association is proud to be on the forefront of bringing together some of the best minds in their fields to conduct the research, development and testing to bring bold and innovative results to address the growing epidemic of youth vaping in our commitment of longer, healthier lives for all.

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UofL researchers to study health impacts of vaping, nicotine on youth - The Lane Report

Gene Therapy and Editing : Novel options for inherited retinal blindness – ETHealthworld.com

By Stem Cell Doctors

(Representative image) by Dr. Indumathi MariappanResearch Scientist, LV Prasad Eye Institute, Hyderabad

Retinal Blindness

Millions of people the world over suffer visual disability as a result of retinal dystrophy that involves the death of retinal cells that are important for the light sensing function of the eye. Enormous progress has been made in other blinding conditions involving the cornea, lens, among others. However, the retinal dystrophies and optic nerve atrophies do not have any proven therapy till date. The major forms of retinal dystrophies such as Age-related macular degeneration (AMD), retinitis pigmentosa (RP), Lebers congenital amaurosis (LCA), Stargardts disease etc. are either inherited disorders or developed with aging. In most cases, the retinal cells are present at birth, but undergo gradual death during the later stages of life. It is typically characterized by initial symptoms of low vision and night blindness during early childhood, which progresses to severe visual impairment and total blindness at different stages of adulthood. Inherited defects in many genes involved in retina-specific functions and vitamin A metabolism are linked to various forms of retinal dystrophies. These genetic defects affect the normal cellular functions of the retina, leading to gradual cell death and ultimately the patient becomes legally blind.

Recent Technologies and Novel Treatment Options

The current modalities for the treatment of such patients mainly include dietary supplements, visual aids and rehabilitation support. However, a radical approach is required either to preserve or to restore visual function in these patients. Some of them include the replacement of either the lost retinal cells or the defective genes within the surviving, but non-functional retinal cells. This has been the principle behind the massive efforts involved in the development of cell and gene-based therapies. They are currently at different stages of product development and clinical trial evaluation. In cell therapy, normal retinal cells are prepared from specialized stem cells and are injected into the eye to replace the lost cells and to restore retinal functions. Clinical safety trials using cell therapy are ongoing in many countries such as USA, Japan, UK and others (Weblinks 1-4). In gene therapy, the prime strategy is to introduce a normal copy of the affected gene into the surviving retinal cells of the patient, to restore normal cellular functions and improvements in vision. This is achieved by engineering safe viral vectors to carry a normal copy of the desired gene as their cargo. When injected into the eye, the viruses can infect the retinal cells once and deliver the normal gene to restore cellular functions (Weblinks 5-7). A step further is an advanced method of DNA microsurgery, wherein, the defective part of the retinal cell DNA is precisely edited to correct the genetic defect and to restore cellular functions. This could be achieved using the latest gene editing tools such as ZFNs, TALENs, CRISPR/Cas systems etc. These are naturally occurring molecular scissors, employed as host defense mechanism and immune memory to combat viral infections in different species of bacteria. These systems are now engineered to enable DNA and RNA editing in almost any living cells. Such tools are now combined with either cell therapy or gene therapy to develop novel drugs for the treatment of various inherited genetic diseases (Weblink 8).

Gene therapy products approved for clinical use:

LUXTURNATM (Weblink 5)

This is the first commercial gene therapy drug approved by the US-FDA and European Commission for the treatment of an early childhood retinal dystrophic condition called the Leber Congenital Amaurosis 2 (LCA2). This disease is caused due to genetic defects in the gene called RPE65. LUXTURNA (AAV2-hRPE65v2 or Voretigene neparovec-rzyl) is an engineered adeno-associated virus 2 (AAV2) vector carrying a normal copy of the human RPE65 gene. This product was developed and marketed by Spark Therapeutics, a US-based startup now owned by Roche, a Swiss pharma company.

This drug has been tested on 20 patients, aged 3 years or older, in a randomized, controlled, open label, phase 3 interventional clinical trial at two sites in the US from June 2015. All treated individuals showed significantly improved functional vision, with no product-related serious adverse events or deleterious immune responses. The treated patient will be followed for further 15 years until March 2030 to assess the long-term retinal gene expression and stable maintenance of functional vision. It is administered as a onetime injection behind the retina of an eye of patients genetically diagnosed to carry mutations in RPE65 gene and also have sufficient viable retinal cells. It is priced at $850,000 for two eyes in the US and UK, which translates to about 6.5 crores in Indian rupees.

Many such gene therapy vectors are currently under clinical trial evaluation for the delivery of other retinal gene such as REP1, PDE6B, RPGR, OAT (Ornithine aminotransferase), MERTK, sFLT1etc.

EDIT101 (Weblink 8)

This is the first gene editing based drug approved by US-FDA, for the treatment of another early childhood retinal dystrophic condition called LCA10, caused by defects in the CEP290 gene. Here, it is important to understand that a gene editing approach is different from a gene therapy. In gene therapy, a normal copy of entire gene is delivered to the retina to complement the defective gene. In CRISPR/Cas9 based gene editing, only the mutated region of the gene is edited/corrected in situ inside the target cells. This is an attractive approach for correcting a variety of gene mutations, especially those in large genes which exceed the cargo capacity of the commonly used AAV-based gene therapy vectors.

EDIT101 (AGN-151587) is an engineered adeno-associated virus 5 (AAV5) vector carrying a CRISPR/Cas9 based DNA editing machinery to locate and remove a specific mutation hotspot within the intron 26 of human CEP290 gene. When injected behind the retina, the virus will infect the surviving photoreceptor cells and deliver the CRISPRs to enable mutation editing. Successful DNA edits in photoreceptor cells would inactivate a spurious splice site created by the mutation and restore normal protein expression and retinal function.

Preclinical testing in mice and monkey eyes has proved significant edit efficiency of up to 28%, which was above the expected 10% threshold required for clinical efficacy in human trials. This drug was developed by the gene editing company, Editas Medicine, Inc. and is being tested in 18 participants in a Phase 1/2 clinical trial sponsored by Allergan, at four sites in the US from March 2019 and the outcomes are awaited.

Similar gene editing strategy is being explored at different centers for mutation correction in other retinal genes such as KCNJ13, RP1, USH2A, MYO7A, RDH12 etc.

Who can benefit?

Both gene therapy and gene editing approaches have opened up newer hopes for the treatment of various genetic condition affecting different cell types of the body. However, only a small subset of patients can benefit from such therapies at the moment. Such treatment considerations require a thorough genetic screening/genotyping to confirm the identity of the gene affected in a specific patient. Further, the patients should retain some viable cells in the retina for the treatment to be clinically effective.

Research efforts in India

Many labs in the country are developing gene therapies and gene editing based therapeutics for the treatment of various diseases affecting the blood, retina, liveretc. Researchers at the CMC, Vellore, CSIR-IGIB, Delhi, CSIR-CCMB, Hyderabad are developing gene therapeutics for the treatment of different forms of blood disorders. Narayana Nethralaya, Bangalore is engaged in developing AAV-based gene therapies for various retinal dystrophies. Our lab at the LV Prasad Eye Institute is collaborating with the research teams at IIT-Kanpur and CSIR-IGIB, Delhi to develop modified gene therapy vectors for retinal gene delivery and cell-based therapies using CRISPR edited stem cells and retinal cells respectively.

The way forward

As of May 2020, the RetNet database lists about 271 genes to be associated with different forms of retinal dystrophies. This requires a larger library of gene delivery vectors to be developed and made available at affordable costs for the treatment of a large number of patients. This mandates the need for developing indigenous and cost-effective therapeutics and ICMR has set up a dedicated task force on gene therapy research, to identify and support promising research ideas in this newly emerging area of biomedical research. A national guideline for gene therapy product development and clinical trials has been jointly formulated and released by the DBT and ICMR in 2019. It is hoped that the streamlined regulatory framework would fast track our basic and translational research efforts into developing novel and cost-effective treatment options in the near future.

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Gene Therapy and Editing : Novel options for inherited retinal blindness - ETHealthworld.com

Why Do Some People Get Sick All the Time, While Others Stay in Freakishly Good Health? – Discover Magazine

By Stem Cell Doctors

This originally appeared in the July/August issue ofDiscovermagazine as "Titans of Immunity." Support our science journalism by becoming asubscriber.

For years, Melanie Mussons friends have marveled at her superpower: staying healthy no matter what germs are making the rounds. Colds and flu felled plenty of Mussons dormmates in college, but the viruses always seemed to pass her by. I never got sick once, she says. I got about five hours of sleep a night, I finished school in three years, and I worked 30 hours a week throughout. My best friends labeled me the machine.

Mussons ironclad immune system also set her apart at her first job. While she was working at an assisted living facility, her co-workers succumbed to a stomach virus that was running rampant. Undaunted, Musson offered to cover their shifts. There I was, the brand-new employee, getting as much overtime as I wanted. I wasnt worried that Id catch [the virus], because it just doesnt happen.

While the rest of us battle seasonal flu, chronic allergies and back-to-back wintertime colds, Musson and other immune masters glide through with scarcely a sniffle something University of Pittsburgh immunologist John Mellors sees all the time. People get exposed to the same virus, the same dose, even the same source. One gets very sick, and the other doesnt.

Its only natural to wonder: Why do some people always seem to fall on the right side of this equation? And could our own immune systems approach the same level with the right tuneup?

Doctors have noted natural variations in the immune response among people since Hippocrates time, but the reasons remained elusive for centuries. New research, however, is starting to illustrate just how your genes, habits and past disease exposures affect the character and strength of your immune response. These discoveries are helping to define the parameters of a race in which people like Musson have a head start and others have much more ground to cover.

The moment a virus, bacterium or other invader breaches your cells walls, your body rolls out a tightly choreographed defense strategy. The main architects of this process are a set of human leukocyte antigen (HLA) genes, which code for molecules that fine-tune the bodys immune response. So when a bacterium gets into one of your cells, your HLA genes churn out proteins that flag the cell as infected so that specialized immune cells will swarm in to destroy it. Other HLA genes activate cells that rein in the immune response, so it doesnt destroy more than necessary.

Like fingerprints, everyones HLA gene assortment is unique. Your HLA genes give you a broad repertoire of immune defense tactics, but that repertoire may be great for some microorganisms and lousy for others, Mellors says. Its not like theres one HLA type thats highly immune to everything. This genetic variation helps explain why you might catch every cold virus going around but havent gotten a stomach bug in decades. A Massachusetts General Hospital study found that some so-called HIV controllers immune stalwarts who dont develop AIDS from the virus HIV have HLA gene variants that prompt specialized cells to swarm in and attack proteins key to the virus function.

But your HLA genes arent the only ones that shape your immune resistance. The Human Genome Project has identified tens of thousands of gene variants that are more common in people who develop specific diseases and less common in people without these conditions.

Flagging these kinds of gene-disease links is a relatively simple matter, says immunologist Pandurangan Vijayanand of the La Jolla Institute for Immunology. After researchers identify a gene sequence thats linked to disease, however, they need to figure out what it is actually doing, says Vijayanand. How is this change in the sequence impacting the cell or causing the susceptibility [to disease]?

To answer this question, Vijayanand and his team are creating what they call an atlas, to catalog which proteins each gene produces and how these proteins change the function of different cell types. For example, he has identified a gene variant that makes people more prone to asthma a condition in which the body attacks its own healthy airway cells by driving high production of proteins that rev up the immune response. Other gene variants appear to help people fight lung tumors by prompting their tissues to produce more T lymphocytes, specialized immune shock troops that kill cancer cells.

While a dizzying number of genetic differences remain to be cataloged, immunologists agree that, in general, these differences help explain why resistance to some pathogens can seem to run in families. People like Melanie Musson probably get a genetic leg up to some degree Musson says her mother, father and siblings rarely get sick. Conversely (and unfairly), you might instead inherit a tendency to develop diabetes, recurrent strep infections or autoimmune diseases.

However anemic or hardy your innate immune arsenal, it supplies only the broad contours of your bodys resistance to threats. Environmental influences fill in the details, from where you live to your sleeping patterns to your history of previous infections.

In a 2015 Cell study, researchers studied more than 100 pairs of identical twins and how their immune systems responded to the flu shot. About three-quarters of the differences they saw were driven by environmental factors rather than genetic ones. The differences in twins immune systems also grew more pronounced the older they got, suggesting that outside influences continue to shape our immune potential over time.

Some of these influences show up in early childhood and may be hard to offset later on. Researchers have long known that children who live on farms are less likely to develop autoimmune diseases like asthma and allergies. An Ohio State University study from July 2019 hints at one reason why: Farm kids have a more diverse array of gut microbes than city kids, and the presence of some of these gut microbes predicts lower frequencies of immune cells that create allergic inflammation. Broad microbial exposure, in short, appears to train the immune system not to overreact to substances like animal dander.

But regardless of where you grew up, if youre unlucky enough to catch certain disease-causing bugs, they can throw your immunity off balance for years. Cytomegalovirus, a relative of the virus that causes chicken pox, stages its attack by reprogramming the human immune system. Some of the virus proteins latch onto certain immune cells, interfering with their ability to fight invaders. Other proteins, according to research from the University Medical Center Utrecht, interfere with the expression of key human HLA genes. And since cytomegalovirus infections are chronic, the resulting immune deficits can go on indefinitely.

Naturally, you cant control where youre raised or what random pathogens you acquire. But you can control your daily routine, what you put into your body and how you shield yourself against germs. In recent years, scientists have begun a full-fledged push to find out which lifestyle habits actually foster a robust immune system and which may be more hype than substance.

While the overall picture of how diet shapes immunity is still blurred, new studies do hint at the immune-strengthening effects of certain types of foods. Garlic, for instance, contains a sulfur compound called allicin, which spurs production of disease-fighting immune cells like macrophages and lymphocytes in response to threats.

(Credit: Lucky_Find/Shutterstock)

Researchers also report that specific bacteria-containing foods such as sauerkraut, kimchi and kefir produce an immunologically active substance called D-phenyllactic acid. This acid appears to signal immune cells, called monocytes, to report for duty by binding to a receptor protein on the cells surfaces. When people eat sauerkraut, very soon afterward, we see in the blood that theres an increase in the level of this substance, says Leipzig University biologist Claudia Stubert. In future studies, she hopes to clarify exactly how the acid affects monocytes activity in the body.

In addition to tweaking their diets, many titans of immunity embark on intense exercise regimens to keep their health robust. I swim and snorkel year-round in the ocean, up to a mile at a clip, from New England to Miami and a few secluded points in between, says Baron Christopher Hanson, a business consultant who claims he almost never gets sick. But so far, scientific proof that exercise improves immunity is limited. While a new study in rats shows that regular exercise changes the prevalence of different types of immune cells, it isnt clear whether these changes make you less likely to get sick.

Getting your daily quota of shut-eye, however, does seem to boost your immunity. Repeated studies show that sleep revs up your immune response, and a recent one from Germanys University of Tbingen reports that it does so in part by preparing disease-fighting T cells to do their jobs more effectively. Thats because your body churns out more integrins proteins that help T cells attach to germ-infected cells and destroy them while youre asleep.

But while getting more sleep could help snap your streak of winter colds, squirting your palms with hand sanitizer may not. In numerous studies, plain old soap and water was shown to kill germs better than sanitizer does. Hand sanitizer is great for alcohol-susceptible bugs, but not all bugs are susceptible, Mellors points out. Whats more, using sanitizer wont have any lasting effects on your immunity. The moment you touch another germy surface, your thin layer of protection will vanish.

Getting plenty of sleep is one way to boost your immune health: The body preps disease-fighting cells while youre asleep. (Credit: Realstock/Shutterstock)

Champions of immunity tend to credit their daily habits with keeping them healthy. But many have also lucked into an ideal balance between effector T cells, the frontline immune soldiers that fend off pathogens, and regulatory T cells, which keep the bodys immune arsenal in check so it wont over-respond to threats. An overactive immune system can be just as troublesome as an underactive one autoimmune conditions like rheumatoid arthritis, multiple sclerosis and allergies all stem from an immune response thats too forceful and sustained.

Last year, scientists at Kyoto University in Japan and elsewhere described one potential way to redress this kind of imbalance: turning effector T cells into regulatory T cells in the lab. Autoimmune episodes are triggered by antigens binding to [a] receptor on effector T cells, says molecular biologist Shuh Narumiya, one of the papers authors. When Narumiya and his colleagues used an inhibitor chemical to block an enzyme that controls cell development, cells that would normally develop into effector T cells turned into regulatory T cells instead a tweak that dialed down harmful autoimmune responses in mice.

While not everyone needs such immune fine-tuning, some people could potentially benefit from a treatment based on this technique, Narumiya says. Filling out the ranks of regulatory T cells could someday help keep a range of disabling autoimmune conditions under control.

Regardless of your T cell balance or your immune track record, theres a hefty dose of serendipity involved each time your immune system faces a threat. You might consider yourself forever prone to the flu or sniffles, but an X-factor a cross-country move, a dietary tweak, a new therapy can unexpectedly realign things and boost your immune potential.

By the same token, no matter how stalwart your HLA gene arsenal, how sound your sleep or how scrupulous your hygiene, you can end up knocked flat with a nasty bug when you least expect it. Immune health is like a gigantic roulette wheel. You throw the ball down and where it lands is a matter of chance, Mellors says. You have an encounter with a pathogen, and at the time you get exposed, your front line is not up to snuff. Even titans of immunity can have Achilles heels and even immune systems that seem licked at the beginning can pull off unlikely victories.

(Credit: Andrii Vodolazhskyi/Shutterstock)

Its a recurring theme of the COVID-19 crisis: Those infected with the virus develop vastly different symptoms. Some barely feel anything a scratchy throat, if that while others spend weeks in the ICU with ravaged lungs, unable to breathe on their own. This wide variation in how people respond to SARS-CoV-2 stems, in part, from each persons unique genetic and lifestyle factors that affect their immune function.

Genes: Scientists in Sydney and Hong Kong have found a particular gene variant tied to high rates of severe symptoms of SARS, a coronavirus related to the one that causes COVID-19. Because the novel coronavirus only recently appeared in humans, we dont know exactly which genetic quirks might make us more susceptible to it. Scientists are now investigating whether other specific genes might give some people higher or lower degrees of protection against the virus.

Age and Immune Health: In some older people, or in those who have underlying immune deficits from chronic conditions, regulatory T cells which usually keep immune responses under control do not function normally. When these people get COVID-19, so-called cytokine storms may cause excessive inflammation in the lungs, leading to life-threatening symptoms. A study conducted by researchers in China found that COVID-19 patients with severe illness had lower levels of regulatory T cells in their bloodstream. Children may be less prone to disabling symptoms because their immune systems are better regulated and they have fewer underlying conditions.

Smoking Habits: SARS-CoV-2 uses a cell surface receptor called ACE2 to enter the cells that line your respiratory tract. New research shows that in smokers, these receptors are more prevalent in the lungs, creating more potential access routes for the virus. If you smoke, says Boston Childrens Hospital immunologist Hani Harb, the virus will be able to enter more cells in higher numbers.

Elizabeth Svoboda is a science writer in San Jose, California. Her most recent book is The Life Heroic: How To Unleash Your Most Amazing Self.

Originally posted here:
Why Do Some People Get Sick All the Time, While Others Stay in Freakishly Good Health? - Discover Magazine

Stem Cell Therapy Market Growth Trends, Key Players, Competitive Strategies and Forecasts to 2026 – Jewish Life News

By Stem Cell Treatment

Stem Cell Therapy Market Overview

The Stem Cell Therapy market report presents a detailed evaluation of the market. The report focuses on providing a holistic overview with a forecast period of the report extending from 2018 to 2026. The Stem Cell Therapy market report includes analysis in terms of both quantitative and qualitative data, taking into factors such as Product pricing, Product penetration, Country GDP, movement of parent market & child markets, End application industries, etc. The report is defined by bifurcating various parts of the market into segments which provide an understanding of different aspects of the market.

The overall report is divided into the following primary sections: segments, market outlook, competitive landscape and company profiles. The segments cover various aspects of the market, from the trends that are affecting the market to major market players, in turn providing a well-rounded assessment of the market. In terms of the market outlook section, the report provides a study of the major market dynamics that are playing a substantial role in the market. The market outlook section is further categorized into sections; drivers, restraints, opportunities and challenges. The drivers and restraints cover the internal factors of the market whereas opportunities and challenges are the external factors that are affecting the market. The market outlook section also comprises Porters Five Forces analysis (which explains buyers bargaining power, suppliers bargaining power, threat of new entrants, threat of substitutes, and degree of competition in the Stem Cell Therapy) in addition to the market dynamics.

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Leading Stem Cell Therapy manufacturers/companies operating at both regional and global levels:

Stem Cell Therapy Market Scope Of The Report

This report offers past, present as well as future analysis and estimates for the Stem Cell Therapy market. The market estimates that are provided in the report are calculated through an exhaustive research methodology. The research methodology that is adopted involves multiple channels of research, chiefly primary interviews, secondary research and subject matter expert advice. The market estimates are calculated on the basis of the degree of impact of the current market dynamics along with various economic, social and political factors on the Stem Cell Therapy market. Both positive as well as negative changes to the market are taken into consideration for the market estimates.

Stem Cell Therapy Market Competitive Landscape & Company Profiles

The competitive landscape and company profile chapters of the market report are dedicated to the major players in the Stem Cell Therapy market. An evaluation of these market players through their product benchmarking, key developments and financial statements sheds a light into the overall market evaluation. The company profile section also includes a SWOT analysis (top three companies) of these players. In addition, the companies that are provided in this section can be customized according to the clients requirements.

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Stem Cell Therapy Market Research Methodology

The research methodology adopted for the analysis of the market involves the consolidation of various research considerations such as subject matter expert advice, primary and secondary research. Primary research involves the extraction of information through various aspects such as numerous telephonic interviews, industry experts, questionnaires and in some cases face-to-face interactions. Primary interviews are usually carried out on a continuous basis with industry experts in order to acquire a topical understanding of the market as well as to be able to substantiate the existing analysis of the data.

Subject matter expertise involves the validation of the key research findings that were attained from primary and secondary research. The subject matter experts that are consulted have extensive experience in the market research industry and the specific requirements of the clients are reviewed by the experts to check for completion of the market study. Secondary research used for the Stem Cell Therapy market report includes sources such as press releases, company annual reports, and research papers that are related to the industry. Other sources can include government websites, industry magazines and associations for gathering more meticulous data. These multiple channels of research help to find as well as substantiate research findings.

Table of Content

1 Introduction of Stem Cell Therapy Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology of Verified Market Research

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Stem Cell Therapy Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Stem Cell Therapy Market, By Deployment Model

5.1 Overview

6 Stem Cell Therapy Market, By Solution

6.1 Overview

7 Stem Cell Therapy Market, By Vertical

7.1 Overview

8 Stem Cell Therapy Market, By Geography

8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Stem Cell Therapy Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

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Stem Cell Therapy Market Growth Trends, Key Players, Competitive Strategies and Forecasts to 2026 - Jewish Life News

Bit Bios enter button for the keyboard to the software of life nabs the company $41.5 million – TechCrunch

By Stem Cell Treatment

Bit Bio, the new startup which pitches itself as the enter button for the keyboard to the software of life only needed three weeks to raise its latest $41.5 million round of funding.

Originally known as Elpis Biotechnology and named for the Greek goddess of hope, the Cambridge, England-based company was founded by Mark Kotter in 2016 to commercialize technology that can reduce the cost and increase the production capacity for human cell lines. These cells can be used in targeted gene therapies and as a method to accelerate drug discovery at pharmaceutical companies.

The companys goal is to be able to reproduce every human cell type.

Were just at a very crucial time in biology and medicine and the bottleneck that has become really clear is a scalable source of robust human cells, said Kotter. For drug discovery this is important. When you look at failure rates in clinical trials theyre at an all time high thats in direct contradiction to the massive advancements in biotechnology in research and the field.

In the seventeen years since scientists completely mapped the human genome, and eight years since scientists began using the gene editing technology known as CRISPR to edit genetic material, theres been an explosion of treatments based on individual patients genetic material and new drugs developed to more precisely target the mechanisms that pathogens use to spread through organisms.

These treatments and the small molecule drugs being created to stop the spread of pathogens or reduce the effects of disease require significant testing before coming to market and Bit Bios founder thinks his company can both reduce the time to market and offer new treatments for patients.

Its a thesis that had investors like the famous serial biotech entrepreneur, Richard Klausner, who served as the former director of the National Cancer Institute and founder of revolutionary biotech companies like Lyell Immunopharma, Juno, and Grail, leaping at the chance to invest in Bit Bios business, according to Kotter.

Joining Klausner are the famous biotech investment firms Foresite Capital, Blueyard Capital and Arch Venture Partners.

Bit Bio is based on beautiful science. The companys technology has the potential to bring the long-awaited precision and reliability of engineering to the application of stem cells, said Klausner in a statement. Bit Bios approach represents a paradigm shift in biology that will enable a new generation of cell therapies, improving the lives of millions.

Photo: Andrew Brookes/Getty Images

Kotters own path to develop the technology which lies at the heart of Bit Bios business began a decade ago in a laboratory in Cambridge University. It was there that he began research building on the revolutionary discoveries of Shinya Yamanaka, which enabled scientists to transform human adult cells into embryonic stem cells.

What we did is what Yamanaka did. We turned everything upside down. We want to know how each cell is defined and once we know that we can flip the switch, said Kotter. We find out which transcription factors code for a single cell and we turn it on.

Kotter said the technology is like uploading a new program into the embryonic stem cell.

Although the company is still in its early days, it has managed to attract a few key customers and launch a sister company based on the technology. That company, Meatable, is using the same process to make lab-grown pork.

Meatable is the earliest claimant to a commercially viable, patented process for manufacturing meat cells without the need to kill an animal as a prerequisite for cell differentiation and growth.

Other companies have relied on fetal bovine serum or Chinese hamster ovaries to stimulate cell division and production, but Meatablesays it has developed a processwhere it can sample tissue from an animal, revert that tissue to a pluripotent stem cell, then culture that cell sample into muscle and fat to produce the pork products that palates around the world crave.

We know which DNA sequence is responsible for moving an early-stage cell to a muscle cell, says Meatable chief executive Krijn De Nood.

If that sounds similar to Bit Bio, thats because its the same tech just used to make animal instead of human cells.

Image: PASIEKA/SCIENCE PHOTO LIBRARY/Getty Images

If Meatable is one way to commercialize the cell differentiation technology, Bit Bios partnership with the drug development company Charles River Laboratories is another.

We actually do have a revenue generating business side using human cells for research and drug discovery. We have a partnership with Charles River Laboratories the large preclinical contract research organization, Kotter said. That partnership is where we have given early access to our technology to Charles River They have their own usual business clients who want them to help with their drug discovery. The big bottleneck at the moment is access to human cells.

Drug trials fail because the treatments developed either are toxic or dont work in humans. The difference is that most experiments to prove how effective the treatments are rely on animal testing before making the leap to human trials, Kotter said.

The company is also preparing to develop its own cell therapies, according to Kotter. There, the biggest selling point is the increased precision that Bit Bio can bring to precision medicine, said Kotter. If you look at these cell therapies at the moment you get mixed bags of cells. There are some that work and some that have dangerous side effects. We think we can be precise [and] safety is the biggest thing at this point.

The company claims that it can produce cell lines in less than a week with 100 percent purity, versus the mixed bags from other companies cell cultures.

Our moonshot goal is to develop a platform capable of producing every human cell type. This is possible once we understand the genes governing human cell behaviour, which ultimately form the operating system of life, Kotter said in a statement. This will unlock a new generation of cell and tissue therapies for tackling cancer, neurodegenerative disorders and autoimmune diseases and accelerate the development of effective drugs for a range of conditions. The support of leading deep tech and biotech investors will catalyse this unique convergence of biology and engineering.

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Bit Bios enter button for the keyboard to the software of life nabs the company $41.5 million - TechCrunch

Could pressure for COVID-19 drugs lead the FDA to lower its standards? – The Conversation US

By Stem Cell Treatment

Given the death, suffering, social disruption and economic devastation caused by COVID-19, there is an urgent need to quickly develop therapies to treat this disease and prevent the spread of the virus.

But the Food and Drug Administration, charged with the task of evaluating and deciding whether to approve new drugs and other products, has a problem. The FDAs standards appear to be dropping at a time when rigorous regulatory review and robust oversight are crucial.

For example, on March 28, the FDA granted emergency use authorization (EUA) for chloroquine phosphate and hydroxychloroquine sulfate, despite the drugs having known safety concerns and negligible evidence of efficacy in treating COVID-19.

As a specialist in bioethics and public health, I see troubling signs that suggest the FDAs new program for expediting reviews of potential therapies for COVID-19 is not working as it should. Instead, its regulatory oversight has been weakened. In its place, I see signs of political interference, inappropriate pressure to authorize products for emergency use, and an overwhelming surge of clinical studies that challenges the FDAs capacity to carefully scrutinize them before deciding whether they should proceed.

Even with numerous special approval programs in existence, it typically takes about eight years for new drugs to proceed from initial authorization of clinical trials to FDA approval. Because the process of testing drugs and other potential therapies can be so lengthy, the pandemic poses a challenge to the FDAs usual review and approval processes.

In response to COVID-19, the FDA established the Coronavirus Treatment Acceleration Program (CTAP) to expedite the regulatory review process and help facilitate the speedy development of treatments and preventive measures.

The FDA has redeployed many staff members to serve on CTAP review teams. In public statements about CTAP, the FDA has not disclosed how many staff members serve on these teams. And its not certain if all reassigned staff members have the background and training required to review COVID-19 studies and individual patient requests for expanded access to investigational new drugs. There is little publicly available information concerning how CTAP is staffed, how review teams have been organized, and what kinds of expertise particular teams of reviewers possess.

If FDA employees are being assigned unfamiliar responsibilities, or are reviewing applications for products beyond their expertise, theres a risk those reviews will not be sufficiently thorough.

CTAP is essentially an opaque regulatory initiative. Decisions emerge from CTAP but we dont know who made them, why they were made, or what information was provided to FDA. While some details have been shared, I believe that, in general, CTAP would benefit from greater transparency.

The FDA, claiming to cut red tape, says its now reviewing many clinical study protocols for COVID-19 within 24 hours. But what specific bureaucratic impediments did the FDA eliminate to fast-track the process? That we dont know. In public statements about CTAP, the FDA hasnt identified what bureaucratic impediments it removed. The agency has yet to disclose this important information.

What we do know: The FDA has enabled COVID-19 studies to proceed at a far more rapid pace than trials that are testing interventions for other diseases. By doing so, the FDA needs to respond to scientists, physicians, bioethicists, regulatory specialists and other critics concerned that the FDA is failing to maintain its regulatory standards.

Mounting evidence indicates CTAPs oversight may be inadequate. One example: The FDA has cleared an application for a clinical study to test a stem cell product to see if its safe and if it works. The stem cells, researchers hope, will provide enough immune support to reduce symptoms and hospitals stays for COVID-19. But the study has no control group that can be used to compare the stem cell intervention against a placebo or sham procedure.

Without such a control group, the study will not generate usable data concerning whether or not the administered stem cells are effective.

Because of how little information has been disclosed about CTAPs operation, the inner workings of CTAP seem beyond public scrutiny. No information is available on why some trials were cleared to proceed despite what many researchers would consider glaring shortcomings. This includes poor study design, small sample size, substantial overlap with other studies, or as in case of the stem cell study, a lack of a control group.

That specific problematic trials are being allowed to proceed within a wider climate of disrespect for evidence-based clinical research adds to the concern. Many scientists fear that President Trumps boosterism for drugs he believes prevent or treat COVID-19 has helped to undermine the independence and integrity of FDA decision-making. The FDAs emergency use authorization for hydroxychloroquine sulfate and chloroquine phosphate only heightened the concern. The independence of the FDA is also in question amid efforts to develop safe and effective vaccines for COVID-19.

The agency has indicated that summary statistics about CTAP will be forthcoming. So far, however, the FDA has only disclosed limited information about the programs operations. Meanwhile, the number of trials allowed to proceed and need for oversight has grown.

When the creation of CTAP was announced on March 31, the FDA said clinical trials had begun for 10 therapeutic agents to treat COVID-19, with 15 more in planning stages. The FDA now reports that by mid-April, it had received 950 inquiries and proposals concerning COVID-19 related drug development. By May 11, 144 active trials of therapeutic agents were in progress, or cleared to proceed. Another 457 development programs for therapeutic agents were in planning stages.

It is good to have such information in the public domain. However, I believe the public deserves to know much more about how CTAP is functioning. Along with providing regular updates on the number of COVID-19 applications it has received, and the number cleared to proceed, the FDA needs to report the number of proposed studies it has declined to review; the number of times the FDA has not cleared studies to proceed and has instead imposed holds due to safety issues; and the duration between when investigational new drug applications were submitted and when the studies were allowed to proceed or placed on hold.

Most importantly, the public needs to know more about how decisions are being made within CTAP. Public understanding of CTAP would increase if the FDA identified the clinical studies it reviews and clears, and provided links to listings on ClinicalTrials.gov.

The FDAs commissioner has defended the agencys practices during the pandemic, including the use of less robust datasets. But the FDAs review process needs to result in the development of safe and effective COVID-19 treatments. Speed of product development, while crucial in a pandemic, must never be prioritized over all other considerations. Political pressure cannot influence regulatory decision-making; the agency must release more information about CTAPs review standards and decision-making processes. First and foremost, the FDAs rigorous oversight rather than a race to satisfy an aggressive and perhaps political agenda is imperative during this pandemic.

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Could pressure for COVID-19 drugs lead the FDA to lower its standards? - The Conversation US

Vancouver Island father dies of leukemia after battle to find mixed-race stem cell donor – Lake Country Calendar

By Stem Cell Treatment

A Saanich father who fought to grow the data bank of mixed-race stem cell donors has died of leukemia.

Jeremy Chow was diagnosed with acute myeloid leukemia in November 2018. While chemotherapy treatment worked and Jeremy entered remission, doctors advised that stem cell therapy would be the best possible treatment to eradicate the risk of returning cancer cells.

But when Jeremy and his wife Evelyn Chow began their quest to find a match, they learned there were virtually no donors in the national or worldwide registry who matched Jeremys genetic makeup a requirement for a successful stem cell transplant.

READ ALSO: In a fight against cancer, Victoria mans only stem cell match was his own donation

Ironically, Jeremy had applied to become a stem cell donor years earlier. When doctors searched the database they found one unusable match: his own donation. Shocked and saddened by the lack of options, the family spearheaded the Match4Jeremy campaign, organizing stem cell drives and raising awareness of the dire need for mixed race and Asian donors.

On Aug. 8, 2019, the family learned that Jeremys cancer had returned. But the Chows battle to find a match didnt slow down. They worked with the Otherhalf-Chinese Stem Cell Initiative to host an emergency stem cell drive in Vancouver that month.

Despite their tireless efforts, Jeremy did not recover from the second round of cancer. The father of two died on May 30 with his wife at his side.

On a GoFundMe page aimed at raising money for his daughters educations, family friend Jenny Leung says Jeremy fought hard and did it with grace, humour and a positive attitude.

READ ALSO: Stem cell donor with rare genetic makeup needed to save Saanich man after cancer returns

Jeremys priority was always being able to provide and take care of his family, Leung writes. He was so involved with his girls lives, from driving them to their extracurricular activities to attending school fairs, to braiding their hair and explaining to them the importance of a good education.

He was always looking for a way to care for those around him whether it meant sharing knowledge, offering a helping hand, or just being there in any way he could, she added. Jeremy was truly someone to look up to and although he was always supporting others, he rarely asked for anything in return.

While the Chow family fought for a match for Jeremy, their crusade for stem cell donors gained momentum when they realized just how dire the situation was for mixed-race and Asian Canadians. Only three per cent of the Canadian Blood Services stem cell registry is mixed race.

In March 2019, Jeremy spoke with Black Press Media.

If all of this goes well [and] I stay in remission, and the awareness is out there and other people sign up to be donors and other people are getting the help they need, then thats a win, he said.

Donations are being accepted via GoFundMe to support Jeremys family and his daughters future education.

READ ALSO: Victoria couple continues fight for increased diversity in Canadian stem cell registry

Do you have something to add to this story, or something else we should report on? Email:nina.grossman@blackpress.ca

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Vancouver Island father dies of leukemia after battle to find mixed-race stem cell donor - Lake Country Calendar

Royalty Pharma Acquires Partial Royalty Interest on Prevymis From AiCuris Anti-Infective Cures GmbH – Citybizlist Real Estate

By Stem Cell Treatment

NEW YORK and WUPPERTAL, Germany, (GLOBE NEWSWIRE) -- Royalty Pharma and AiCuris Anti-infective Cures GmbH, a leading company in the discovery and development of drugs against infectious diseases, announced today that they have entered into an agreement whereby Royalty Pharma has acquired a partial royalty interest on Prevymis (letermovir) from AiCuris for a one-time payment of $220 million. Prevymis is licensed by MSD, the tradename of Merck & Co. Inc., Kenilworth, NJ, USA.

The product was approved by the US Food & Drug Administration (FDA) in 2017 and by the European Medicines Agency (EMA) and Japans Pharmaceuticals and Medical Devices Agency (PMDA) in 2018 for prophylaxis (prevention) of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) who are at high risk for CMV reactivation. CMV infection is a complication in these patients, and early CMV reactivation after transplant is associated with increased mortality.

The agreement with Royalty Pharma reflects the major medical need for innovative anti-infective drugs and their commercial potential, and enables us to further advance our proprietary pipeline of novel treatments against infectious diseases without losing the possibility to participate on future revenues from Prevymis, said Dr. Holger Zimmermann, CEO of AiCuris Anti-infective Cures GmbH.

We are excited to add a royalty interest in this important therapy to our portfolio, said Pablo Legorreta, Founder and CEO of Royalty Pharma.

About Royalty PharmaFounded in 1996, Royalty Pharma is the industry leader in acquiring pharmaceutical royalties. Royalty Pharma funds innovation in life sciences both directly and indirectly: directly when it partners with life sciences companies to co-develop and co-fund products in late-stage clinical trials, and indirectly when it acquires existing royalty interests from the original innovators (academic institutions, research hospitals, foundations and inventors). The companys portfolio includes royalty interests in over 45 products including AbbVie and J&Js Imbruvica, Astellas and Pfizers Xtandi, Biogens Tysabri, Gileads HIV franchise, Mercks Januvia, Novartis Promacta, and Vertexs Kalydeco, Symdeko and Trikafta. Royalty Pharma is also a leading investor in pre-approval royalties, having since 2011 invested over $5.6 billion in royalties on pre-approval products and committed over $1.2 billion to direct R&D funding in exchange for royalties. For more information, visitwww.royaltypharma.com

About AiCuris Anti-infective Cures GmbH

AiCuris was founded in 2006 as a spin-off from Bayer and focuses on the discovery and development of drugs targeting infectious diseases. SANTO Holding is the Companys majority investor. PREVYMIS (Letermovir), a first-in-class non-nucleoside cytomegalovirus (CMV) inhibitor acting via a novel mechanism of action, was licensed to MSD in 2012 and is approved in the EU, the USA, Japan and other parts of the world for use in bone marrow transplants for the prevention of HCMV infections in adults who receive an allogeneic hematopoietic stem cell transplant. The Company is developing drugs for the treatment of viruses such as human CMV, herpes simplex virus (HSV), hepatitis B virus (HBV), and adenoviruses. In the field of antibacterials, AiCuris seeks to develop innovative treatment options for life-threatening, multidrug-resistant, hospital-treated pathogens.

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Royalty Pharma Acquires Partial Royalty Interest on Prevymis From AiCuris Anti-Infective Cures GmbH - Citybizlist Real Estate

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