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Head of FDA urged to ensure any COVID vaccine be free of abortion connection – Crux: Covering all things Catholic

Posted: April 24, 2020 at 7:42 pm

WASHINGTON, D.C. The chairmen of four U.S. bishops committees, joined by the leaders of several health care, bioethics and pro-life organizations, urgently and respectfully implored the commissioner of the U.S. Food and Drug Administration to ensure any vaccines developed for the coronavirus are free from any connection to abortion.

To be clear, we strongly support efforts to develop an effective, safe, and widely available vaccine as quickly as possible, the leaders said in an April 17 letter to Dr. Stephen M. Hahn, the FDA commissioner.

However, we also strongly urge our federal government to ensure that fundamental moral principles are followed in the development of such vaccines, most importantly, the principle that human life is sacred and should never be exploited, they said.

Copies of the letter were sent to President Donald Trump, Vice President Mike Pence and Health and Humans Services Secretary Alex M. Azar. The text of the letter was released late April 17 by the U.S. Conference of Catholic Bishops.

The chairman who signed it and their respective USCCB committees were: Archbishop Joseph F. Naumann of Kansas City, Kansas, Committee on Pro-Life Activities; Archbishop Paul S. Coakley of Oklahoma City, Domestic Justice and Human Development; Bishop Kevin C. Rhoades of Fort Wayne-South Bend, Indiana, Committee on Doctrine; and Bishop John F. Doerfler of Marquette, Michigan, the Subcommittee on Health Care Issues, which is a subcommittee of the doctrine committee.

Other signatories were the heads of 20 organizations such as the Catholic Medical Association, National Catholic Bioethics Center, American Association of Pro-Life Obstetricians and Gynecologists, National Association of Catholic Nurses, Southern Baptist Ethics &Religious Liberty Commission, Children of God for Life, March for Life Education & Defense Fund, Family Research Council and Students for Life of America.

We are aware that, among the dozens of vaccines currently in development, some are being produced using old cell lines that were created from the cells of aborted babies, they said.

They noted that, for example, Janssen Pharmaceuticals, Inc. has a substantial contract from HHS and is working on a vaccine that is being produced using one of these ethically problematic cell lines.

Other vaccines such as those being developed by Sanofi Pasteur, Inovio and the John Paul II Medical Research Institute utilize cell lines not connected to unethical procedures and methods.

It is critically important that Americans have access to a vaccine that is produced ethically: No American should be forced to choose between being vaccinated against this potentially deadly virus and violating his or her conscience, the group said.

Fortunately, there is no need to use ethically problematic cell lines to produce a COVID vaccine, or any vaccine, as other cell lines or processes that do not involve cells from abortions are available and are regularly being used to produce other vaccines, they said.

The group told Hahn: We urgently and respectfully implore you to not only ensure that Americans will have access to a COVID vaccine that is free of ethical concerns, but to encourage and incentivize pharmaceutical companies to use only ethical cell lines or processes for producing vaccines.

On April 6, a group of about a dozen Democrats in Congress sent a letter to Azar urging the Trump administration to lift restrictions on research that uses human fetal tissue for potential treatment for COVID-19. They argued that allowing fetal tissue in such studies could lead more quickly to a treatment.

On June 5, 2019, The U.S. Department of Health and Human Services banned the National Institutes of Health from using human fetal stem cells from electively aborted babies for government funded research. The department also issued a $20 million grant for research to develop models that do not rely on human fetal tissue.

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Head of FDA urged to ensure any COVID vaccine be free of abortion connection – My catholic standard

Posted: April 23, 2020 at 12:58 pm

WASHINGTON (CNS) -- The chairmen of four U.S. bishops' committees, joined by the leaders of several health care, bioethics and pro-life organizations, "urgently and respectfully" implored the commissioner of the U.S. Food and Drug Administration to ensure any vaccines developed for the coronavirus "are free from any connection to abortion."

"To be clear, we strongly support efforts to develop an effective, safe, and widely available vaccine as quickly as possible," the leaders said in an April 17 letter to Dr. Stephen M. Hahn, the FDA commissioner.

"However, we also strongly urge our federal government to ensure that fundamental moral principles are followed in the development of such vaccines, most importantly, the principle that human life is sacred and should never be exploited," they said.

"We are aware that, among the dozens of vaccines currently in development, some are being produced using old cell lines that were created from the cells of aborted babies," they said.

They noted that, for example, Janssen Pharmaceuticals, Inc. has a substantial contract from HHS and "is working on a vaccine that is being produced using one of these ethically problematic cell lines."

Other vaccines such as those being developed by Sanofi Pasteur, Inovio and the John Paul II Medical Research Institute "utilize cell lines not connected to unethical procedures and methods."

"It is critically important that Americans have access to a vaccine that is produced ethically: No American should be forced to choose between being vaccinated against this potentially deadly virus and violating his or her conscience," the group said.

"Fortunately, there is no need to use ethically problematic cell lines to produce a COVID vaccine, or any vaccine, as other cell lines or processes that do not involve cells from abortions are available and are regularly being used to produce other vaccines," they said.

The group told Hahn: "We urgently and respectfully implore you to not only ensure that Americans will have access to a COVID vaccine that is free of ethical concerns, but to encourage and incentivize pharmaceutical companies to use only ethical cell lines or processes for producing vaccines."

(The full text of the letter with all the signatories can be found online at http://usccb.org/about/pro-life-activities/index.cfm.)

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What Explains The COVID-19 Race Gap? : Shots – Health News – NPR

Posted: April 23, 2020 at 12:58 pm

An EMT wearing protective equipment moves a patient into Elmhurst Hospital Center in the Queens borough of New York. Preliminary data suggest COVID-19 is having a disproportionate impact on communities of color. Bloomberg via Getty Images hide caption

As data emerges on the spectrum of symptoms caused by COVID-19, it's clear that people with chronic health conditions are being hit harder.

While many people experience mild illness, 89% of people with COVID-19 who were sick enough to be hospitalized had at least one chronic condition. About half had high blood pressure and obesity, according to data from the Centers for Disease Control and Prevention. And about a third had diabetes and a third had cardiovascular disease. So, what explains this?

"Obesity is a marker for a number of other problems," explains Dr. Aaron Carroll, a public health researcher at the Indiana University School of Medicine. It's increasingly common for those who develop obesity to develop diabetes and other conditions, as well. So, one reason COVID-19 is taking its toll on people who have obesity is that their overall health is often compromised.

But does obesity specifically affect the immune system? Perhaps.

Prior research has shown that people with obesity are less protected by the flu vaccine. They tend to get sicker from the respiratory disease even if they've been immunized. In fact, researchers have found that as people gain excess weight, their metabolism changes and this shift can make the immune system less effective at fighting off viruses.

"What we see with obesity is that these [immune] cells don't function as well,' says Melinda Beck, a health researcher at University of North Carolina, Chapel Hill. Basically, she explains, obesity throws off the fuel sources that immune cells need to function. "The [immune cells] are not using the right kinds of fuels," Beck says. And, as a result, the condition of obesity seems to "impair that critical immune response [needed] to deal with either the virus infection or [the ability] to make a robust response to a vaccine."

So this is one explanation as to why people with obesity seem more vulnerable to serious infection. But, there are many more questions about why some people are hit harder, including whether race is a factor.

The CDC found that 33% of people who've been hospitalized with COVID-19 are African American, yet only 13% of the U.S. population is African American. Some local communities have found a similar pattern in their data. Among the many (26) states reporting racial data on COVID-19, blacks account for 34% of COVID deaths, according to research from Johns Hopkins University.

This disproportionate toll can be partially explained by the fact that there's a higher prevalence of obesity, high blood pressure and diabetes among African Americans compared with whites.

And as Dr. Anthony Fauci of the National Institutes of Health said last week at a White House coronavirus task force briefing, this crisis "is shining a bright light on how unacceptable that is, because yet again, when you have a situation like the coronavirus, [African Americans] are suffering disproportionately."

There are several factors, including some genetic ones, that may make African Americans more vulnerable to COVID-19. "There have been a few studies that have pointed to African Americans potentially having genetic risk factors that make them more salt-sensitive," says Ren Robinson, a professor of chemistry who researches chronic disease at Vanderbilt University. This may increase the likelihood of high blood pressure, which, in turn, is linked to more serious forms of COVID-19. "It could be a contributing factor," she says, but there are likely multiple causes at play.

Another issue to consider, she says, may be high stress levels. She says when a person experiences racial discrimination, it can contribute to chronic stress. She points to several studies that link discrimination and stress to higher levels of inflammation among black adults. "And chronic stress can make one more vulnerable to infection because it can lower your body's ability to fight off an infection," she says.

Chronic stress is linked to poverty so this could be a risk factor for low-income communities. In fact, research has shown that people who report higher levels of stress are more likely to catch a cold, when exposed to a virus, compared with people who are not stressed.

According to a new survey from Pew Research Center, health concerns about COVID-19 are much higher among Hispanics and blacks in the U.S. While 18% of white adults say they're "very concerned" that they will get COVID-19 and require hospitalization, 43% of Hispanic respondents and 31% of black adults say they're "very concerned" about that happening.

And other aspects of structural racism could contribute to the elevated risk for black Americans.

"Every major crisis or catastrophe hits the most vulnerable communities the hardest," say Marc Morial, president and CEO of the National Urban League. And he points to several factors that help to explain the racial divide.

"Black workers are more likely to hold the kinds of jobs that cannot be done from home," Morial says. So, they may be more likely to be exposed to the virus, if they are working in places where it's difficult to maintain social distancing. In addition, he points to longstanding inequities in access to quality care.

"There also is bias among health care workers, institutions and systems that results in black patients ... receiving fewer medical procedures and poorer-quality medical care than white individuals," he says. He says an expansion of Medicaid into those states that still haven't expanded would be one effective policy to address these inequities.

The characteristics of the communities where people live could affect risk, too especially for those who live in low-income neighborhoods. The roots of chronic illness stem from the way people live and the choices that may or may not be available to them. People who develop the chronic illnesses that put them at higher risk of COVID-19 often lack access to affordable and healthy foods or live in neighborhoods where it's not safe to play or exercise outside.

"Let's take a patient with diabetes for example. They are already at high risk for COVID-19 by having a chronic condition," says Joseph Valenti, a physician in Denton, Texas, who promotes awareness of the social determinants of health through his work with the Physicians Foundation.

"If they also live in a food desert, they have to put themselves in greater risk if they want access to healthy food. They may need to take a bus, with people that have COVID-19 but aren't showing symptoms, to get access to nutritious food or even their insulin prescription," he says.

Poor nutrition, and the obesity linked to it, is a leading cause of premature death around the globe. And, this pandemic brings into focus the vulnerability of the millions of people living with lifestyle-related, chronic disease.

"We're seeing the convergence of chronic disease with an infection," says UNC's Beck. And the data suggest that the combination of these two can lead to more serious illness. "We're seeing that obesity can have a great influence on infection," she says.

So, will this shine a spotlight on the need to address these issues? "Hopefully," Beck says. "I think paying attention to these chronic diseases like obesity is in everybody's best interest."

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Reversing diabetes with CRISPR and patient-derived stem cells – FierceBiotech

Posted: April 23, 2020 at 12:56 pm

Insulin injections cancontrol diabetes, but patients still experience serious complications such as kidney disease and skin infections. Transplanting pancreatic tissues containing functional insulin-producing beta cells is of limited use, because donors are scarce and patients must take immunosuppressant drugs afterward.

Now, scientists atWashington University in St. Louis havedeveloped a way to use gene editing system CRISPR-Cas9 to edit a mutation in human-induced pluripotent stem cells (iPSCs) and then turnthem into beta cells. When transplanted into mice, the cells reversed preexisting diabetes in a lasting way, according to results published in the journal Science Translational Medicine.

While the researchers used cells from patients with Wolfram syndromea rare childhood diabetes caused by mutations in the WFS1 genethey argue that the combination of a gene therapy with stem cells could potentially treat other forms of diabetes as well.

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This virtual event will bring together industry experts to discuss the increasing pace of pharmaceutical innovation, the need to maintain data quality and integrity as new technologies are implemented and understand regulatory challenges to ensure compliance.

One of the biggest challenges we faced was differentiating our patient cells into beta cells. Previous approaches do not allow for this robust differentiation. We use our new differentiation protocol targeting different development and signaling pathways to generate our cells, the studys lead author, Kristina Maxwell, explained in a video statement.

Making pancreatic beta cells from patient-derived stem cells requires precise activation and repression of specific pathways, and atthe right times, to guide the development process. In a recent Nature Biotechnology study, the team described a successful method that leverages the link between a complex known as actin cytoskeleton and the expression of transcription factors that drive pancreatic cell differentiation.

This time, the researchers applied the technology to iPSCs from two patients with Wolfram syndrome. They used CRISPR to correct the mutated WFS1 gene in the cells and differentiated the edited iPSCs into fully functional beta cells.

After transplanting the corrected beta cells into diabetic mice, the animals saw their blood glucose drop quickly, suggesting the disease had been reversed. The effect lasted for the entire six-month observation period, the scientists reported. By comparison, those receiving unedited cells from patients were unable to achieve glycemic control.

RELATED:CRISPR Therapeutics, ViaCyte team up on gene-edited diabetes treatment

The idea of editing stem cells with CRISPR has already attracted interest in the biopharma industry. Back in 2018, CRISPR Therapeutics penned a deal with ViaCyte to develop off-the-shelf, gene-editing stem cell therapies for diabetes. Rather than editing iPSCs from particular patients themselves to correct a faulty gene, the pairs lead project used CRISPR to edit healthy cells so that they lackedthe B2M gene and expressed PD-L1 to protect against immune attack. The two companies unveiled positive preclinical data inSeptember.

Other research groups working on gene therapy or stem cells for diabetes include a Harvard University scientist and his startup Semma Therapeutics, whichdeveloped a method for selecting beta cells out of a mixture of cells developed from PSCs. Scientists at the University of Wisconsin-Madison recently proposed that removing the IRE1-alpha gene in beta cells could prevent immune T cells from attacking them in mice with Type 1 diabetes.

The Washington University team hopes its technology may help Type 1 diabetes patients whose disease is caused by multiple genetic and environmental factors as well as the Type 2 form linked to obesity and insulin resistance.

We can generate a virtually unlimited number of beta cells from patients with diabetes to test and discover new drugs to hopefully stop or even reverse this disease, Jeffrey Millman, the studys co-senior author, said in the video statement. Perhaps most importantly, this technology now allows for the potential use of gene therapy in combination with the patients own cells to treat their own diabetes by transplantation of lab-grown beta cells.

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Induced pluripotent stem cells and CRISPR reversed diabetes in mice – Drug Target Review

Posted: April 23, 2020 at 12:56 pm

Induced pluripotent stem cells made to produce insulin and CRISPR, used to correct a genetic defect, cured Wolfram syndrome in mice.

Using induced pluripotent stem cells (iPSCs) produced from the skin of a patient with a rare, genetic form of insulin-dependent diabetes called Wolfram syndrome, researchers transformed the human stem cells into insulin-producing cells and used CRISPR-Cas9 to correct a genetic defect that had caused the syndrome. They then implanted the cells into lab mice and cured the unrelenting diabetes in those models.

The findings, from researchers at Washington University School of Medicine in St. Louis, US, suggest this CRISPR-Cas9 technique may hold promise as a treatment for diabetes, particularly the forms caused by a single gene mutation and it also may be useful one day in some patients with the more common forms of diabetes, such as type 1 and type 2.

This is the first time CRISPR has been used to fix a patients diabetes-causing genetic defect and successfully reverse diabetes, said co-senior investigator Dr Jeffrey Millman, an assistant professor of medicine and of biomedical engineering at Washington University. For this study, we used cells from a patient with Wolfram syndrome because, conceptually, we knew it would be easier to correct a defect caused by a single gene. But we see this as a stepping stone toward applying gene therapy to a broader population of patients with diabetes.

Wolfram syndrome is caused by mutations to a single gene, providing the researchers an opportunity to determine whether combining stem cell technology with CRISPR to correct the genetic error also might correct the diabetes caused by the mutation.

Researchers at Washington University School of Medicine in St. Louis have transformed stem cells into insulin-producing cells. They used the CRISPR gene-editing tool to correct a defect that caused a form of diabetes, and implanted the cells into mice to reverse diabetes in the animals. Shown is a microscopic image of insulin-secreting beta cells (insulin is green) that were made from stem cells produced from the skin of a patient with Wolfram syndrome [credit: Millman lab Washington University].

Millman and his colleagues had previously discovered how to convert human stem cells into pancreatic beta cells. When such cells encounter blood sugar, they secrete insulin. Recently, these researchers developed a new technique to more efficiently convert human stem cells into beta cells that are considerably better at controlling blood sugar.

In this study, they took the additional steps of deriving these cells from patients and using the CRISPR-Cas9 gene-editing tool on those cells to correct a mutation to the gene that causes Wolfram syndrome (WFS1). Then, the researchers compared the gene-edited cells to insulin-secreting beta cells from the same batch of stem cells that had not undergone editing with CRISPR.

In the test tube and in mice with a severe form of diabetes, the newly grown beta cells that were edited with CRISPR more efficiently secreted insulin in response to glucose. Diabetes disappeared in mice with the CRISPR-edited cells implanted beneath the skin and the animals blood sugar levels remained in normal range for the entire six months they were monitored. Animals receiving unedited beta cells remained diabetic. Although their newly implanted beta cells could produce insulin, it was not enough to reverse their diabetes.

We basically were able to use these cells to cure the problem, making normal beta cells by correcting this mutation, said co-senior investigator Dr Fumihiko Urano, the Samuel E. Schechter Professor of Medicine and a professor of pathology and immunology. Its a proof of concept demonstrating that correcting gene defects that cause or contribute to diabetes in this case, in the Wolfram syndrome gene we can make beta cells that more effectively control blood sugar. Its also possible that by correcting the genetic defects in these cells, we may correct other problems Wolfram syndrome patients experience, such as visual impairment and neurodegeneration.

Were excited about the fact that we were able to combine these two technologies growing beta cells from induced pluripotent stem cells and using CRISPR to correct genetic defects, Millman said. In fact, we found that corrected beta cells were indistinguishable from beta cells made from the stem cells of healthy people without diabetes.

Moving forward, the process of making beta cells from stem cells should get easier, the researchers said. For example, the scientists have developed less intrusive methods, making iPSCs from blood and they are working on developing stem cells from urine samples.

The study is published in Science Translational Medicine.

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Planned Clinical Trial of Allogeneic Stem Cell Therapy Remestemcel-L in Patients with COVID-19 – Cancer Network

Posted: April 23, 2020 at 12:56 pm

Mount Sinai Health System announced that they will be using remestemcel-L (Ryoncil), an innovative allogeneic stem cell therapy, in patients with coronavirus disease 2019 (COVID-19).

Additionally, Mount Sinai indicated that they will play a central role in a clinical trial for patients with severe acute respiratory distress syndrome, which affects individuals with severe cases of COVID-19.

Remestemcel-L has previously been tested in patients who have had a bone marrow transplant, who can experience an overactive immune response similar to that observed in severe cases of COVID-19.

Mount Sinai began administering remestemcel-L to patients in late March under the FDAs compassionate use program. The therapy was given to 10 patients with moderate to severe cases of COVID-19-related acute respiratory distress syndrome (ARDS), most of whom were on ventilators, and the doctors saw encouraging results.

We are encouraged by what we have seen so far and look forward to participating in the randomized controlled trial starting soon that would better indicate whether this is an effective therapy for patients in severe respiratory distress from COVID-19, Keren Osman, MD, medical director of the Cellular Therapy Service in the Bone Marrow and Stem Cell Transplantation Program at The Tisch Cancer Institute at Mount Sinai and associate professor of Hematology and Medical Oncology at the Icahn School of Medicine at Mount Sinai, said in a press release.

The randomized clinical trial evaluating the therapeutic benefit and safety of remestemcel-L will be conducted at Mount Sinai, which will serve as the clinical and data coordinating center. The stem cell therapy will be evaluated in 240 patients with COVID-19-related ARDS in the US and Canada. Moreover, the trial will be conducted as a public-private partnership between the Cardiothoracic Surgical Trials Network.

The coronavirus pandemic has caused exponential increases of people suffering with acute respiratory distress syndrome, requiring intubation and mechanical ventilation with many dying, Annetine Gelijns, PhD, the Edmond A. Guggenheim Professor of Health Policy at the Icahn School of Medicine at Mount Sinai, said in a press release. We have designed a clinical trial that will expeditiously determine whether the stem cell therapy will offer a life-saving therapy for a group of patients with a dismal prognosis.

Remestemcel-L consists of mesenchymal stem cells. The therapy was previously assessed in a phase III trial in children who had graft-versus-host disease (GVHD), which can occur after bone marrow transplants. Further, the inflammation that occurs in GVHD is the result of a cytokine storm. A similar cytokine storm has been found to take place in patients with COVID-19 who develop acute respiratory distress syndrome.

These stem cells have shown excellent response rates in severe graft-versus-host disease in children, John Levine, MD, professor of Hematology, Medical Oncology, and Pediatrics at the Icahn School of Medicine at Mount Sinai, who is also the co-director of the Mount Sinai Acute GVHD International Consortium (MAGIC), said in a press release. Mesenchymal stem cells have a natural property that dampens excessive immune responses.

Some institutions have also begun testing anti-IL-6 agents, such as tocilizumab (Actemra), for the treatment of cytokine release syndrome in patients with COVID-19 who develop acute respiratory distress syndrome.

Reference:

Mount Sinai Leading the Way in Innovative Stem Cell Therapy for COVID-19 Patients [news release]. New York, NY. Published April 9, 2020. newswise.com/coronavirus/mount-sinai-leading-the-way-in-innovative-stem-cell-therapy-for-covid-19-patients/?article_id=729684&sc=dwhr&xy=10019792. Accessed April 15, 2020.

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Coronavirus Q&A: Dr. Camillo Ricordi Gives Update On Trials Of Stem Cell Treatment For Most Severe COVID-19 Cases – CBS Miami

Posted: April 23, 2020 at 12:56 pm

MIAMI (CBSMiami) A team of doctors at the University of Miami is working on what could be groundbreaking therapy for treating some COVID-19 patients.

With a focus on those suffering with severe lung inflammation, theyre using the umbilical system cells to treat patients.

For an update on how its progressing, Dr. Camillo Ricordi, a University of Miami professor and stem cell therapy researcher, joined Eliott Rodriguez and Rudabeh Shahbazi via Skype.

Q: This therapy is building off a 10-patient study in China and the results of that study are limited. So what information gave you hope that this would work on a broad scale?

A: Well, the information from this initial study have been incredibly encouraging. The editor in chief of the journal that did editorial on the paper presented commented as extraordinary results, but that need to be validated by law by lots of clinical trials. So were happy that FDA approved us to do such clinical trial at the University of Miami. And the nice thing is that well have the results in a very short time because these cells is like injecting anatomy of cells, 200 million cells, into those that will be fighting the complication of the infection and will know within weeks the there is a positive effect.

Q: How many patients are in the trial? When did you start? Have you seen any results so far?

A: We did. We have 24 patients in this initial trials. We didnt start the first patient, there have been only patients that are on compassionate release so far. And the initial results are coming from China and Israel. But we are ready to go. We have the terms the six doses already ready to be delivered and other 25 doses are ready to follow. So we have over as far as cell supply for the entire clinical trial, and we hope to have results very soon.

Q: So for the layman like us, can you explain how, why the stem cells infused in a vein end up in a lung?

A: Yeah, actually, this is a nice feature because when we do these trials, I directed Diabetes Research Institute at the University of Miami, so, traditionally, we did this trial for type 1 diabetes or for kidney disease. But in this case, when you inject the cells IV, intravenously, the first filter that is the lungs. So naturally the cells are trapped by the lungs as much as 95%. So in the case of targeting the pancreas or the kidney, you have to do an interventional radiology procedure to put a catheter in there that goes to these organs. But when you target the lung, this is a natural way of delivery and these cells form naturally to the lung. In addition, the cells sense inflammation and tissue injury, and hone, they go targeting specifically the site of tissue injury and inflammation. So in this case is even more relevant that in a simple intravenous, like a blood transfusion, will exactly target the lung, that is the organ that we want to treat

Q: How long do you expect to have to wait before you know if this was working?

A: Well, we know from the radiologic examination of the lungs from the studies in China, for example, that within days a resolution of the lung pathology.

Q: What is the typical recovery rate for COVID patients who have been put on a ventilator and is that meant to treat patients before they get to that critical stage?

A: Well, the typical recovery rate that we expect with this treatment is within a week we should know. So this is not a trial that we are required, like months or years of follow up to see if there is a beneficial effect or not. We are confident that within days or a week you will know if this is working or not as soon as we start.

Q: Is this is therapy meant to complement other forms of therapy?

A: I think it will definitely be used as a combination therapy. We dont exclude any other therapy as part of the combination therapy. With another agent that may help fight this is immune reaction, this pro-inflammatory reaction and also the problem that you see in micro-thromboembolism and the coagulation problem that you see in these patients. So I think is in a way is a unique therapy because its not just for COVID-19, but its for any virus targeting the lung with this massive reaction. So it will be something that we are planning in the future to create the repository for rapid intervention and integrated response to any pandemic or a situation in which you have an emergency that you need to treat an injury to the lung of such dimension. But in the meantime, when there is not a pandemic situation, you can use these cells. We have trials ongoing that has been authorized by the FDA for type 1 diabetes, Alzheimer, for kidney disease. So its a cell type that can be used in many other situations to start normal organ function, not just COVID-19.

Q: If this succeeds, how big of a deal is it?

A: If this succeeds, it will be a way to treat the severe cases of COVID-19 while we wait for a vaccine. But also to have a repository of cells that will be able to treat any other possible pandemic or epidemic where the lung will be a target of the viral attack. In this case, you have an army of cells that are ready to be used and fight this viral infection and all the consequences that can induce in the lungs.

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Sangamo taps Mogrify for off-the-shelf CAR-Treg project – FierceBiotech

Posted: April 23, 2020 at 12:56 pm

Sangamo Therapeutics has struck a deal with Mogrify to gain access to a source of cells for use in its allogeneic CAR-Treg therapies. The agreement sees Sangamo pay an upfront fee to get Mogrify to apply its direct cell conversion technology to the generation of regulatory T cells.

Ready access to sources of cells has emerged as a key area of focus for developers of off-the-shelf cell therapies, leading to deals such as Allogenes alliance with Notch Therapeutics. That deal, like other moves by allogeneic cell therapy players, reflected a desire to replace the finite donated T cells used in early off-the-shelf prospects with renewable, more scalable sources of starting materials.

Sangamo has identified Mogrify as a provider of such materials. Mogrify put itself on the map early last year when Darrin Disley, the former leader of Horizon Discovery, joined the startup as CEO and invested in its seed round. Months later, Mogrify raised a $16 million series A round.

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Mogrify attracted the interest of Disley, Sangamo and an investor syndicate led by Ahren Innovation Capital on the strength of its technology for converting one human cell type into another human cell type. In the case of the Sangamo deal, Mogrify will use the platform to convert induced pluripotent stem cells and embryonic stem cells into regulatory T cells.

RELATED:Bristol Myers' Juno unit enlists Oxford BioMedica for CAR-T work

The agreement with Sangamo tasks Mogrify with handling the discovery and optimization of the cell conversion technology. Sangamo will have exclusive rights to use the technology to generate Tregs. By applying its ZFP gene engineering technology to the Tregs, Sangamo plans to develop allogeneic cell therapies for use in the treatment of inflammatory and autoimmune diseases.

Sangamo is paying an upfront fee of undisclosed size to work with Mogrify. As programs based on the Tregs advance, Mogrify is in line to receive development and regulatory milestones, plus payments linked to product sales.

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News of the deal comes months after Sangamo got authorization in the U.K. to run a phase 1/2 trial of an autologous CAR-Treg cell therapy, TX200, in kidney transplant patients. Partnering with Mogrify will support Sangamos efforts to get allogeneic cell therapies into the clinic, building on its work with Kite Pharma to apply its technology to off-the-shelf cancer treatments such as CD19 CAR-T prospect KITE-037.

Having formed the pact with Sangamo, Mogrify now has two commercial deals with U.S. biopharma companies. The deals will provide Mogrify with a source of money as it works on internal cell therapy candidates in disease areas including musculoskeletal, autoimmune and cancer.

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Pregnant and positive | Scientists look for COVID-19 immunity in the womb – WHAS11.com

Posted: April 23, 2020 at 12:55 pm

PENNSYLVANIA, USA Brianna Boriosi, 30, and her husband Marc both are considered essential employees because they work in inpatient drug and alcohol treatment services. They are now self-quarantining at home because they both tested positive for COVID-19.

What makes their case more complicated and worrisome is that Brianna is 7-and-a-half months pregnant, due June 24. Of course she immediately called her doctors.

They told me I was their first positive pregnancy case with COVID-19 in their practice, Brianna said.

Almost immediately after she found out she was positive she was getting calls from the Pennsylvania Department of Health.They wanted to know what the circumstances were leading up to getting infected, but also they hoped Brianna would give consent for test samples.

Once the babys born, they talked about maybe taking some of the umbilical cord or the blood in there, Brianna said. As well as the placenta, and if Im willing, looking into possibly donating stem cells.

It didnt take long for her to say yes.

There was a possibility that the baby will either be immune or have some of these antibodies.

While doctors believe the virus will not get passed onto her unborn child, scientists hope what they find through tests can help them to get to a vaccine and the cure.

Anything I can do to help or donate or whatever, Im definitely all about it.

Her positive test could lead to keeping everyone negative for the virus in the future. Brianna wants that for their baby as well as their two-year-old son.

Because both Brianna and Marc are positive, doctors presume their son is as well. The couple is thankful that he hasnt shown any symptoms, and they hope and pray it stays that way.

RELATED: Feds to track, publicly share info on nursing home COVID-19 outbreaks

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RELATED: Reports suggest many may have had coronavirus with no symptoms

Contact reporter John Charlton atjcharlton@whas11.com. Follow him onTwitter (@JCharltonNews) andFacebook.

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Pregnant and positive | Scientists look for COVID-19 immunity in the womb - WHAS11.com

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AVITA Medical Announces Intention to Redomicile to the United States of America – Yahoo Finance

Posted: April 23, 2020 at 12:53 pm

Intention to establish primary listing on NASDAQ with continued (secondary) listing on ASX

AVITA Medical Limited (Company) (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, announced today its intention to redomicile the Company and its subsidiaries (Avita Group) from Australia to the United States of America by way of a scheme of arrangement under Part 5.1 of the Corporations Act 2001 (Cth) (Redomiciliation).

To implement the Redomiciliation, the Company has entered into a Scheme Implementation Agreement dated 20 April 2020 with AVITA Therapeutics, Inc. (Avita US), a newly-formed company incorporated in Delaware in the United States. A copy of the Scheme Implementation Agreement is attached and will be available on the Companys website.

The Redomiciliation is subject to regulatory and court approvals, as well as approval by the Companys shareholders at an extraordinary general meeting which will be convened to address the Redomiciliation (Scheme Meeting).

After carefully considering the advantages, disadvantages and risks of the Redomiciliation, the directors of the Company (Board) are of the unanimous view that the advantages of the Redomiciliation materially outweigh its disadvantages and risks. In particular, the Board believes that the Redomiciliation will:

The Board unanimously recommends that shareholders vote in favour of the resolution to approve the Redomiciliation at the Scheme Meeting. Each member of the Board intends to vote the shares in the Company which they hold (or which are held on their behalf) in favour of that resolution.

The Company has engaged BDO Corporate Finance Limited (Independent Expert) to report on whether the Redomiciliation is in the best interests of shareholders as a whole. The scheme booklet in connection with the Redomiciliation (Scheme Booklet) will include the report of the Independent Expert.

- shareholders in eligible jurisdictions who hold Shares (other than the ADS Depositary) will receive 5 CHESS depositary interests (CDIs) in Avita US (Avita US CDIs) for every 100 Shares held by them on the record date for the Redomiciliation (Record Date); and

- the ADS Depositary (who holds Shares for the benefit of holders of the Companys ADSs) will receive one Avita US Share for every 100 Shares held by it on the Record Date and will distribute to ADS holders one Avita US Share for every 5 ADSs held by them on the Record Date (upon surrender by them of their ADSs and payment of the ADS Depositarys fee for that surrender).

Therefore, shareholders in eligible jurisdictions and ADS holders (on the Record Date), upon receiving Avita US CDIs or Avita US Shares, will hold an equivalent proportional interest in Avita US as they held in the Company prior to implementation of the Redomiciliation.

Shareholders (on the Record Date) in certain ineligible jurisdictions (which are listed under the definition of "Ineligible Shareholder" in the Scheme Implementation Agreement) will have their entitlements sold pursuant to a sale facility, and those holders will receive the relevant net proceeds of that sale. In addition, shareholders (on the Record Date) who have a fractional entitlement to an Avita US Share or an entitlement to Avita US CDIs that is not sufficient to equate to a whole Avita US Share, will have those fractional interests sold pursuant to the same sale facility and those holders will receive the relevant net proceeds of that sale.

Implementation of the Redomiciliation is conditional upon the satisfaction of certain conditions, which are set out in the Implementation Agreement, including:

For the Redomiciliation to be implemented, a requisite majority of shareholders must vote to approve the Redomiciliation at the Scheme Meeting, which is intended to be held in June 2020.

Due to the COVID-19 pandemic and the restrictions imposed by Australian governments in response to it, the Company will be making an application to the Federal Court of Australia for orders to permit the Scheme Meeting to be conducted exclusively as a virtual meeting. Accordingly, it is proposed that the Scheme Meeting will be conducted by way of a live webcast only.

Further details on how to participate in the Scheme Meeting by way of live webcast and on how to vote (including by way of proxy, attorney or corporate representative) will be provided in the Scheme Booklet.

Any changes to the proposal that the Scheme Meeting be conducted exclusively as a virtual meeting will be outlined in the Scheme Booklet and thereafter on the ASX, NASDAQ and via news release, and will also be notified on the Companys website (https://www.avitamedical.com/).

ADS holders will be entitled to vote and participate in the Scheme Meeting through the Bank of New York Mellon, the ADS depositary.

Indicative timetable and next steps

Shareholders do not need to take any action at this time.

The Scheme Booklet is intended to be sent to shareholders in May 2020. The Scheme Booklet will contain, amongst other things, further information relating to the Redomiciliation, reasons for the Boards unanimous recommendation, information on the Scheme Meeting and on how to vote and the report of the Independent Expert.

If approved by the requisite majorities of shareholders (and subject to regulatory and court approvals), the Avita Group is targeting to implement the Redomiciliation by 30 June 2020, following which Avita US Shares and Avita US CDIs will be issued and can be traded on NASDAQ and the ASX respectively.

These dates are indicative only and subject to, amongst other things, court availability (particularly in the current environment) and the conditions precedent to completion of the Redomiciliation (as set out in the Scheme Implementation Agreement) being satisfied or waived.

Authorized for release by the Chief Financial Officer of AVITA Medical Limited.

###

ABOUT AVITA MEDICAL LIMITED

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a RES REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

To learn more, visit http://www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "intend," "could," "may," "will," "believe," "estimate," "look forward," "forecast," "goal," "target," "project," "continue," "outlook," "guidance," "future," other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

SCHEME IMPLEMENTATION AGREEMENT

AVITA Medical Limited

AVITA Therapeutics, Inc.

KPMG Law

KPMGInternational Towers Sydney 3300 Barangaroo AvenueSydney NSW 2000ABN 78 399 289 481 | DX1056 Sydney

Liability limited by a scheme approved under Professional Standards Legislation

CONTENTS

1. DEFINITIONS AND INTERPRETATION2. SCHEME3. OPTIONS, RSUS AND WARRANTS IN AVITA AUSTRALIA4. CONDITIONS5. GENERAL OBLIGATIONS OF PARTIES6. AVITA AUSTRALIA OBLIGATIONS7. AVITA US OBLIGATIONS8. ANNOUNCEMENT9. TERMINATION10. REPRESENTATIONS AND WARRANTIES11. RELEASE12. COSTS AND STAMP DUTY13. GST14. NOTICES15. AMENDMENT AND ASSIGNMENT16. GENERAL

DATED 20 April 2020

PARTIES

AVITA Medical Limited ACN 058 466 523 of Level 7, 330 Collins Street, Melbourne, 3000, Victoria, Australia (Avita Australia)

AVITA Therapeutics, Inc., a company incorporated in the State of Delaware in the United States of America, with a principal business address of 28159 Avenue Stanford, Suite 220, Valencia, California 91355 (Avita US)

RECITALS

Avita Australia is an Australian public company listed on the ASX (as its primary listing) and on NASDAQ (as its secondary listing).

The Avita Australia securities quoted for trading on the ASX are Avita Australia Shares, and the Avita Australia securities quoted for trading on NASDAQ are Avita Australia ADSs.

Avita US is a company incorporated in Delaware in the United States, which has been established for the purpose of effecting a redomiciliation of the Avita Group to the United States.

The Avita Group wishes to effect a redomiciliation from Australia to the United States by Avita US acquiring all of the Avita Australia Shares by way of a scheme of arrangement between Avita Australia and the Avita Australia Shareholders under Part 5.1 of the Corporations Act.

Avita Australia and Avita US propose to implement the Scheme on the terms and conditions of this agreement.

OPERATIVE PROVISIONS

1. DEFINITIONS AND INTERPRETATION

1.1. Definitions

The following definitions apply in this agreement, unless the context requires otherwise:

ADS means an American Depositary Share.

ADS Depositary means The Bank of New York Mellon.

ADS Holder means a holder of Avita Australia ADSs.

Announcement means an announcement, press release or other public statement (other than a draft explanatory statement, an explanatory statement or a supplementary explanatory statement as required under Part 5.1 of the Corporations Act).

ASIC means the Australian Securities and Investments Commission.

ASIC Policy means the regulatory policies (including regulatory guides) issued by ASIC as at the date of this agreement setting out its policy in relation to (among other things) the interpretation and enforcement of relevant sections of the Corporations Act.

ASX means ASX Limited (ABN 98 008 624 691) or the securities market which it operates, as the context requires.

ASX Settlement means ASX Settlement Pty Limited (ABN 49 008 504 532) as the holder of a licence to operate a clearing and settlement facility.

ASX Settlement Operating Rules means the operating rules of the clearing and settlement facility operated by ASX Settlement for the time being and from time to time, as modified by any express written exemption or waiver given by ASX or ASX Settlement.

ATO means the Australian Taxation Office.

ATO Class Ruling means the class ruling which Avita Australia will seek from the ATO to the effect that Australian resident Scheme Participants who hold their Avita Australia Shares (or Australian resident ADS Holders who hold their Avita Australia ADSs) on capital account and who make a capital gain from the exchange of their Avita Australia Shares (or Avita Australia ADSs) for Avita US Shares or Avita US CDIs under the Scheme will be eligible for scrip-for-scrip roll-over relief under the relevant Australian tax laws.

Authorisation means:

(a)

an approval, authorisation, consent, declaration, exemption, licence, notarisation, permit or waiver (however it is described), including any amendment or renewal and any condition attaching to it by or from a Government Authority; and

(b)

in relation to anything that could be prohibited or restricted by law if a Government Authority acts in any way within a specified period, the expiry of that period without that action being taken.

Authorised Nominee means CHESS Depositary Nominees Pty Limited (ACN 071 346 503, Australian Financial Services Licence number 254514), an approved general participant of ASX Settlement and a wholly-owned subsidiary of ASX.

Avita Australia means AVITA Medical Limited ACN 058 466 523.

Avita Australia ADS means an ADS representing 20 Avita Australia Shares, which trade on NASDAQ under the ticker code "RCEL".

Avita Australia Share means an issued fully paid ordinary share in the capital of Avita Australia.

Avita Australia Shareholder means a person entered in the Register as the holder of one or more Avita Australia Shares.

Avita Australia Shareholder Approval means the Scheme Resolution being passed by the majorities of Avita Australia Shareholders required under section 411(4)(a)(ii) of the Corporations Act.

Avita Group means Avita Australia and its Subsidiaries and, after implementation of the Scheme, Avita US and its Subsidiaries.

Avita US means AVITA Therapeutics, Inc..

Avita US CDI means a CDI representing a beneficial interest in 1/5 of an Avita US Share.

Avita US Share means a fully paid share of voting common stock in the capital of Avita US.

Business Day means a day that is not a Saturday, Sunday or a public holiday or bank holiday in Melbourne, Australia.

CDI means a CHESS Depositary Interest, being a unit of beneficial ownership in a share that is registered in the name of the Authorised Nominee in accordance with the ASX Settlement Operating Rules for the purpose of enabling that share to be recorded and transferred in accordance with those operating rules.

Condition means a condition precedent set out in clause 4.1.

Corporations Act means the Australian Corporations Act 2001 (Cth).

Court means the Federal Court of Australia or any other court of competent jurisdiction under the Corporations Act agreed in writing by Avita Australia and Avita US.

Deed Poll means the deed poll to be executed by Avita US substantially in the form of Schedule 3, pursuant to which Avita US covenants in favour of Scheme Participants to perform certain of its obligations under this agreement and certain steps attributed to it under the Scheme, with such amendments as are approved in accordance with its terms.

Effective means, in relation to the Scheme, the coming into effect, under section 411(10) of the Corporations Act, of the order of the Court made under section 411(4)(b) of the Corporations Act in relation to the Scheme, but in any event at no time before an office copy of the order of the Court is lodged with ASIC.

Effective Date means the date on which the Scheme becomes Effective.

FATA means the Foreign Acquisitions and Takeovers Act 1975 (Cth).

FIRB means the Australian Foreign Investment Review Board.

First Court Hearing Date means the first day of the hearing of the Court of an application for an order under section 411(1) of the Corporations Act convening the Scheme Meeting.

Fractional Avita US Share has the meaning given in clause 2.7.

Government Authority means:

(a)

a government, whether foreign, federal, state, territorial or local;

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AVITA Medical Announces Intention to Redomicile to the United States of America - Yahoo Finance

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