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Category Archives: California Stem Cells

Research at MDI Biological Laboratory explores novel pathways of regeneration and tumorigenesis – Bangor Daily News

Posted: May 28, 2020 at 3:46 am

BAR HARBOR Research by scientists at the MDI Biological Laboratoryis opening up new approaches to promoting tissue regeneration in organs damaged by disease or injury.

In recent years, research in regenerative biology has focused on stem cell therapies that reprogram the bodys own cells to replace damaged tissue, which is a complicated process because it involves turning genes in the cells nucleus on and off.

A recent paper in the journal Genetics by MDI Biological Laboratory scientist Elisabeth Marnik, Ph.D., a postdoctoral fellow in the laboratory of Dustin Updike, Ph.D., offers insight into an alternate pathway to regeneration: by recreating the properties of germ cells.

Germ cells, which are the precursors to the sperm and egg, are considered immortal because they are the only cells in the body with the potential to create an entirely new organism. The stem cell-like ability of germ cells to turn into any type of cell is called totipotency.

By getting a handle on what makes germ cells totipotent, we can promote regeneration by unlocking the stem cell-like properties of other cell types, said Updike. Our research shows that such cells can be reprogrammed by manipulating their cytoplasmic composition and chemistry, which would seem to be safer and easier than changing the DNA within a cells nucleus.

Using the tiny, soil-dwelling nematode worm, C. elegans, as a model, the Updike lab studies organelles called germ granules that reside in the cytoplasm (the contents of the cell outside of the nucleus) of germ cells. These organelles, which are conserved from nematodes to humans, are one of the keys to the remarkable attributes of germ cells, including the ability to differentiate into other types of cells.

In their recent paper entitled Germline Maintenance Through the Multifaceted Activities of GLH/Vasa in Caenorhabditis elegans P Granules, Updike and his team describe the intriguing and elusive role of Vasa proteins within germ granules in determining whether a cell is destined to become a germ cell with totipotent capabilities or a specific type of cell, like those that comprise muscle, nerves or skin.

Because of the role of Vasa proteins in preserving totipotency, an increased understanding of how such proteins work could lead to unprecedented approaches to de-differentiating cell types to promote regeneration; or alternatively, to new methods to turn off totipotency when it is no longer desirable, as in the case of cancer.

The increase in chronic and degenerative diseases caused by the aging of the population is driving demand for new therapies, said MDI Biological Laboratory President Hermann Haller, M.D. Dustins research on germ granules offers another route to repairing damaged tissues and organs in cases where therapeutic options are limited or non-existent, as well as an increased understanding of cancer.

Because of the complexity of the cellular chemistry, research on Vasa and other proteins found in germ granules is often overlooked, but that is rapidly changing especially among pharmaceutical companies as more scientists realize the impact and potential of such research, not only for regenerative medicine but also for an understanding of tumorigenesis, or cancer development, Updike said.

Recent research has found that some cancers are accompanied by the mis-expression of germ granule proteins, which are normally found only in germ cells. The mis-expression of these germ-granule proteins seems to promote the immortal properties of germ cells, and consequently tumorigenesis, with some germ-granule proteins now serving as prognosis markers for different types of cancer, Updike said.

Updike is a former postdoctoral researcher in the laboratory of Susan Strome, Ph.D., at University of California, Santa Cruz. Strome, who was inducted into the National Academy of Sciences last year, first discovered P granules more than 30 years ago. She credits Updike, who has published several seminal papers on the subject, with great imagination, determination and excellent technical skill in the pursuit of his goal of elucidating the function and biochemistry of these tiny organelles.

The lead author of the new study from the Updike laboratory, Elisabeth A. Marnik, Ph.D., will be launching her own laboratory at Husson University in Bangor, Maine, this fall. Other contributors include J. Heath Fuqua, Catherine S. Sharp, Jesse D. Rochester, Emily L. Xu and Sarah E. Holbrook. Their research was conducted at the Kathryn W. Davis Center for Regenerative Biology and Medicine at the MDI Biological Laboratory.

Updikes research is supported by a grant (R01 GM-113933) from the National Institute of General Medical Sciences (NIGMS), an institute of the National Institutes of Health (NIH). The equipment and cores used for part of the study were supported by NIGMS-NIH Centers of Biomedical Research Excellence and IDeA Networks of Biomedical Research Excellence grants P20 GM-104318 and P20 GM-203423, respectively.

We aim to improve human health and healthspan by uncovering basic mechanisms of tissue repair, aging and regeneration, translating our discoveries for the benefit of society and developing the next generation of scientific leaders. For more information, please visitmdibl.org.

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ViaCyte Announces $27 Million Financing to Advance Next Generation Cell Therapies for Diabetes – Yahoo Finance

Posted: May 28, 2020 at 3:46 am

PEC-Direct: Clinical data from ViaCyte's product candidate has shown that implanted cells, when effectively engrafted, are capable of producing circulating C-peptide, a biomarker for insulin, in patients with type 1 diabetes

PEC-Encap: ViaCyte's cell therapy product candidate designed to treat all patients with insulin requiring diabetes is being studied in the clinic utilizing an encapsulated delivery technology developed in collaboration with W.L. Gore & Associates

PEC-QT: ViaCyte, in collaboration with CRISPR Therapeutics, is developing a product candidate for diabetes; based on an immune-evasive stem cell line, this approach has the potential to further broaden the availability of cell therapy for other diseases

The Company also announced board chair succession, naming Ian F. Smith as Executive Chairperson

SAN DIEGO, May 26, 2020 /PRNewswire/ --ViaCyte, Inc., a privately held regenerative medicine company, today announced the close of an approximately $27 million private financing, part of the Series D preferred stock financing entered into in late 2018. Investors included, Bain Capital Life Sciences, TPG Capital, RA Capital Management, Sanderling Ventures, and several individual supporters of the Company. Proceeds from the financing will be used to further advance the Company's multi-product candidate approach to develop medicines that have the potential to transform the way insulin-requiring diabetes is managed, potentially providing a functional cure for patients with type 1 diabetes.

ViaCyte logo. (PRNewsFoto/ViaCyte, Inc.)

Coinciding with the financing, the Company also appointed Ian F. Smithas Executive Chairperson. Mr. Smith was appointed to the Company's Board of Directors in July 2019 and succeeds Fred Middleton, who remains on the board.

Commenting on the financing, Paul Laikind, Ph.D., Chief Executive Officer and President of ViaCyte, said, "During these difficult times we are grateful for the continued support of our investors as well as our clinical trial participants, whose safety and health remains our focus and commitment. We are steadfast in our mission to deliver potentially life sustaining therapies for patients with insulin-requiring diabetes and to continue the significant progress we have made in the past year. ViaCyte is the first company to demonstrate production of C-peptide, a biomarker for insulin, in patients with type 1 diabetes receiving a stem cell-derived islet replacement. Moving forward, we are optimizing the effectiveness of both PEC-Direct and PEC-Encap, the latter of which incorporates novel device material technology created in collaboration with W.L. Gore & Associates. We are also making important progress on our PEC-QT program with our partner, CRISPR Therapeutics, and are now moving into pre-IND activities. This program is designed to eliminate the need for immuno-suppression and could have a transformative impact on a broader population of insulin-dependent patients."

Dr. Laikind continued, "In conjunction with the closure of the financing, we are also pleased to announce the appointment of Ian F. Smith as our Executive Chairperson, succeeding Fred Middleton. Since joining the board last July, Ian and I have worked closely to accelerate ViaCyte's growth and prepare for the future. We are extremely grateful to Fred for his many years of service as Chairperson of ViaCyte's Board of Directors. Throughout his time leading the Board, Fred provided expert guidance as ViaCyte has consistently broken new ground in the field of regenerative medicine and cell replacement therapies."

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Mr. Middleton said, "I am proud to have chaired the Board as ViaCyte developed into a leading company in the regenerative medicine field.I am confident that Ian's unique expertise and executive leadership, specifically with innovative growth-oriented companies, and specifically in corporate strategy and operations, as well as capital markets will help ViaCyte progress its important work and firmly establish itself as a leader in the cell therapy sector."

About ViaCyte's Pipeline

The PEC-Direct product candidate, currently being evaluated in the clinic, delivers ViaCyte's PEC-01 cells (pancreatic islet progenitor cells) in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap (also known as VC-01) product candidate, also undergoing clinical evaluation, delivers the same pancreatic islet progenitor cells but in an immunoprotective device. PEC-Encap is being developed for all patients with type 1 diabetes. In collaboration with CRISPR Therapeutics, ViaCyte is developing immune-evasive stem cell lines from its proprietary CyT49 cell line. These immune-evasive stem cell lines, which are being used in the PEC-QT program, have the potential to further broaden the availability of cell therapy for all patients with insulin-requiring diabetes, type 1 and type 2. In addition, a pluripotent, immune evasive cell line has the potential to be used to produce any cell in the body, thus enabling many other potential indications.

About ViaCyte

ViaCyte is a privately held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte's product candidates are based on directed differentiation of pluripotent stem cells into PEC-01 pancreatic islet progenitor cells, which are then implanted in durable and retrievable cell delivery devices. Over a decade ago, ViaCyte scientists were the first to report on the production of pancreatic cells from a stem cell starting point and the first to demonstrate in an animal model of diabetes that, once implanted and matured, these cells secrete insulin and other pancreatic hormones in response to blood glucose levels and can be curative. More recently, ViaCyte demonstrated that when effectively engrafted, PEC-01 cells can mature into glucose-responsive insulin producing cells in patients with type 1 diabetes. To accelerate and expand its efforts, ViaCyte has established collaborative partnerships with leading companies including CRISPR Therapeutics and W.L. Gore & Associates. ViaCyte is headquartered in San Diego, California. The Company also has a robust intellectual property portfolio, which includes hundreds of issued patents and pending applications worldwide. ViaCyte is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit http://www.viacyte.comand connect with ViaCyte on Twitter, Facebook, and LinkedIn.

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SOURCE ViaCyte, Inc.

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Scientists Uncover Ways HIV is Sexually Transmitted in Women – PRNewswire

Posted: May 28, 2020 at 3:46 am

A team of scientists at Gladstone Institutes and UCSF recently uncovered unique properties of immune cells from women's reproductive tissues that, together with HIV molecular tricks, facilitate the virus's spread in a woman's body. Their findings, published in eLIFE, could inform the design of preventive drugs specially tailored for women.

"Our studies reveal intriguing strategies potentially used by HIV to evade the immune system and spread throughout the woman's body," says Nadia Roan, PhD, a visiting scientist at Gladstone who led the study. "Supplementing PrEP or topical microbicides with drugs that target these processes could improve the overall efficacy of prevention approaches."

Remarkably Receptive Hosts

HIV is known to home in on a special type of immune cell called a CD4+ T cell. These cells are found in many tissues, including the lining of the female reproductive tract, and their properties vary depending on their tissue of residence.

"We still lack a fundamental understanding of the features of cells that first become infected upon HIV transmission in women," says Roan, who is also professor of urology at UC San Francisco."This is partly because cells in the female reproductive tract, unlike those circulating in the blood, are difficult to access."

Roan's team obtained cells of the female reproductive tract from biopsy specimens. They exposed the cells to HIV in the lab to identify the likely targets of the virus in this part of the woman's body. In parallel, the scientists conducted the same infections on blood cells and cells from tonsil biopsies.

While T cells from all three sources became infected by the virus, those from the female reproductive tract were up to 100 times more susceptible to infection than the other cells.

"What's intriguing is that T cells in the female reproductive tract seemed naturally primed to become infected by HIV," says Roan. "While T cells from blood require an extra boostcalled activationto become infected by HIV in the lab, those in the female reproductive tract did not."

Remodeled by the Invader

It is difficult to pinpoint HIV's target cellsin the female reproductive tract and elsewherebecause the virus remodels its host cell after infection. For instance, upon entering a CD4+ T cell, HIV removes the CD4 protein from the cell surface, so the cell no longer looks like a CD4+ T cell.

CD4 is just one of a plethora of proteins a T cell puts on its surface. These proteins serve as the cell's identification card; different cell types have different surface protein profiles, and scientists use these profiles to identify the types of cells present in a tissue or a lab culture.

But because of HIV's remodeling, by the time scientists examine an infected cell, they can't tell whether its surface proteins reflect the cells' original identity or a new identity crafted by the virus.

A few years ago, Roan and her team developed a wayto circumvent this problem.

"The virus does not change all the proteins in the cells it infects," says Tongcui Ma, PhD, a postdoctoral researcher in Roan's lab and the first author of the study. "We have a way to monitor a large number of proteins, allowing us to find some that remain unchanged after infection."

These unchanged proteins reveal the identity of the virus's initial targets. By the same token, the scientists also learn what processes the virus remodeled in these cells.

HIV's AgendaSurvive and Spread

Roan's team found that HIV's preferred targets in the female reproductive tract do share some traits with HIV's targets in other tissues. They belong to a class of CD4+ T cells called effector memory cells, which remember previous infections and help fight them off during future encounters.

However, the female reproductive tract cells also display distinctive characteristics compared to blood cells, in particular a high amount of the CCR5 protein on their surface. This protein serves as one of HIV's gateways into cells, and its abundance on the surface of T cells in the female reproductive tractprobably explains their high susceptibility to infection.

In addition, the scientists found that a greater variety of T cells appear susceptible to infection in the female reproductive tract samples than in blood samples, which would further help HIV take hold in this tissue.

"We discovered that after infection, T cells in the female reproductive tractdisplay higher amounts of surface proteins known to guide cells toward lymph nodes, which in turn harbor many of the types of cells HIV can infect," says Ma. "We believe this mechanism may help HIV exit the female reproductive tract and enter the lymphatic system, enabling the eventual systemic spread of the virus throughout the woman's body."

Roan's team uncovered other modifications made by HIV that seem aimed at increasing the virus's ability to persist in the face of an active immune system. Infected cells had lower levels of surface proteins that normally help them respond to pathogens. This would cripple their ability to mount a proper defense against invaders, including HIV.

The virus also increased the cells' production of a protein called BIRC5, which protects cells from untimely death. In fact, not only did the virus increase BIRC5, it also seemed to preferentially target cells with higher than average stores of BIRC5.

"Overall, our study suggests that the female reproductive tract is poised for remarkably efficient HIV infection and dissemination," says Roan. "Our findings mayhelp explain the inconsistent effectiveness of oral PrEP or microbicides in protecting women from sexual transmission of HIV."

Scientists can now use these findings to develop strategies that could stem the ability of sexually transmitted HIV to infect women. Roan and her team have already found that a clinically-tested inhibitor of BIRC5 can block HIV's ability to promote the survival of female reproductive tract cells infected in the lab.

"We hope that complementing current interventions with drugs that target features of T cells in the female reproductive tractthat make them particularly susceptible to HIV will improve the outcome for women," says Roan.

About the Research Project

Other authors include Xiaoyu Luo and Warner C. Greene from Gladstone Institutes, Gourab Mukherjee from University of Southern California, Nandini Sen from Stanford School of Medicine, Trimble Spitzer from Naval Medical Center,and Ashley F. George and Linda C. Giudice from UC San Francisco.

This work was supported by multiple institutes or centers from the National Institutes of Health (R01 AI127219, R01 AI147777, P01 AI131374, P30 DK063720, S10 1S10OD018040, S10 RR028962, and P30 AI027763).

About the Gladstone Institutes

To ensure our work does the greatest good, Gladstone Institutesfocuses on conditions with profound medical, economic, and social impactunsolved diseases. Gladstone is an independent, nonprofit life science research organization that uses visionary science and technology to overcome disease. It has an academic affiliation with the UC San Francisco.

Media Contact: Megan McDevitt | VP Communications | [emailprotected] | 415.734.20191650 Owens Street,San Francisco, CA94158 |gladstone.org|@GladstoneInst

SOURCE Gladstone Institutes

https://gladstone.org

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California Stem Cell Research Institute Bond Initiative (2020)

Posted: May 16, 2020 at 11:47 am

The California Stem Cell Research Institute Bond Initiative (#19-0022) may appear on the ballot in California as an initiated state statute on November 3, 2020.

The ballot initiative would issue $5.5 billion in general obligation bonds for the California Institute for Regenerative Medicine (CIRM), which was created to fund stem cell research. The ballot initiative would require CIRM to spend no more than 7.5 percent of the bond funds on operation costs. The remaining bond funds would be spent on grants to entities that conduct research, trials, and programs related to stem cells, as well as start-up costs for facilities.[1]

The official ballot title is as follows:[2]

Authorizes Bonds to Continue Funding Stem Cell and Other Medical Research. Initiative Statute.[3]

The summary provided for inclusion on signature petition sheets is as follows:[2]

Authorizes $5.5 billion in state general obligation bonds to fund grants from the California Institute of Regenerative Medicine to educational, non-profit, and private entities for: (1) stem cell and other medical research, therapy development, and therapy delivery; (2) medical training; and (3) construction of research facilities. Dedicates $1.5 billion to fund research and therapy for Alzheimers, Parkinsons, stroke, epilepsy, and other brain and central nervous system diseases and conditions. Limits bond issuance to $540 million annually. Appropriates money from General Fund to repay bond debt, but postpones repayment for first five years.[3]

The fiscal impact statement is as follows:[2]

State costs of $7.8 billion to pay off principal ($5.5 billion) and interest ($2.3 billion) on the bonds. Associated average annual debt payments of about $310 million for 25 years. The costs could be higher or lower than these estimates depending on factors such as the interest rate and the period of time over which the bonds are repaid. The state General Fund would pay most of the costs, with a relatively small amount of interest repaid by bond proceeds.[3]

The full text of the ballot measure is available here.

Californians for Stem Cell Research, Treatments & Cures is leading the campaign in support of the ballot initiative.[4]

Ballotpedia has not identified individuals and entities opposing the ballot initiative. If you are aware of published opposition to the ballot initiative, you may send a reference link to editor@ballotpedia.org.

The Californians for Stem Cell Research, Treatments & Cures PAC was registered to support the ballot initiative. The committee had raised $6.06 million. Robert N. Klein II and Klein Financial Corporation provided $4.63 million to the PAC. The committee had expended $8.72 million (expenditures exceeded contributions due to accrued expenses).[6]

There were no PACs registered to oppose the ballot initiative.[6]

The following table includes contribution and expenditure totals for the committee in support of the ballot initiative.[6]

The following was the top donors to the support committee.[6]

In 2004, voters approved Proposition 71, which was a ballot initiative designed to establish a state constitutional right to conduct stem cell research, create the California Institute for Regenerative Medicine (CIRM), and issue $3.00 billion in general obligation bonds to fund CIRM.[7]

As of October 2019, CIRM had spent $2.91 billion of the $3.00 billion bond issue.[8]

In California, the number of signatures required for an initiated state statute is equal to 5 percent of the votes cast in the preceding gubernatorial election. Petitions are allowed to circulate for 180 days from the date the attorney general prepares the petition language. Signatures need to be certified at least 131 days before the general election. As the verification process can take multiple months, the secretary of state provides suggested deadlines for ballot initiatives.

The requirements to get initiated state statutes certified for the 2020 ballot:

Signatures are first filed with local election officials, who determine the total number of signatures submitted. If the total number is equal to at least 100 percent of the required signatures, then local election officials perform a random check of signatures submitted in their counties. If the random sample estimates that more than 110 percent of the required number of signatures are valid, the initiative is eligible for the ballot. If the random sample estimates that between 95 and 110 percent of the required number of signatures are valid, a full check of signatures is done to determine the total number of valid signatures. If less than 95 percent are estimated to be valid, the initiative does not make the ballot.

On October 10, 2019, Robert N. Klein filed the ballot initiative.[1] Attorney General Xavier Becerra (D) released ballot language for the initiative on December 17, 2019, which allowed proponents to begin collecting signatures. The deadline to file signatures is June 15, 2020.

Political responses overviewState reopening plansDocumenting America's Path to RecoveryDaily updatesElection changesChanges to vote-by-mail and absentee voting proceduresFederal responsesState responsesState executive ordersStay-at-home ordersMultistate agreementsNon-governmental reopening plansEvictions and foreclosures policiesTravel restrictionsEnacted state legislationState legislative session changesSchool closuresState court closuresInmate releasesLocal government responsesDiagnosed or quarantined politiciansBallot measure changesArguments about government responsesThe 1918 influenza pandemicPandemic Response Accountability CommitteeUnemployment filingsLawsuitsSubmit

On February 13, 2020, proponents announced that the number of collected signatures surpassed the 25-percent threshold (155,803 signatures) to require legislative hearings on the ballot initiative.[9] In 2014, Senate Bill 1253 was enacted into law, which required the legislature to assign ballot initiatives that meet the 25-percent threshold to committees to hold joint public hearings on the initiatives not later than 131 days before the election.

On March 21, 2020, Sarah Melbostad, a spokeswoman for Californians for Stem Cell Research, Treatments, and Cures, reported that the campaign's signature drive was suspended due to the coronavirus pandemic. Melbostad said, "In keeping with the governors statewide order for non-essential businesses to close and residents to remain at home, weve suspended all signature gathering for the time being. ... Were confident that we still have time to qualify and plan to proceed accordingly."[10]

On May 5, 2020, the campaign reported submitting about 925,000 signatures for the ballot initiative.[11] At least 623,212 of the signatures need to be valid. The recommended deadline to file signatures for the election on November 3, 2020, was April 21, 2020. Counties need to validate the signatures before June 25, 2020, for the ballot initiative to appear on the ballot in 2020. Otherwise, the ballot initiative would appear on the ballot on November 8, 2022.

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BUSINESS: Can lab-grown meat save the planet and dinner? – E&E News

Posted: May 16, 2020 at 11:47 am

The idea is hard to stomach at first: animal meat grown in a lab.

But proponents of "cell-based meat" say the emerging technology has the potential to tackle two global problems at once. Lab-grown beef patties, chicken cutlets and even exotic proteins could help satisfy the world's growing appetite for meat, they argue. And it could be done in a way that cuts down on the tremendous environmental impact of animal agriculture.

Standing in the way is a long list of challenges including regulatory obstacles, sky-high production costs and the ever-present ick factor.

Still, advocates say lab-grown meat could hit store shelves as soon as 2025 if not earlier.

One proponent is Krijn de Nood, the chief executive of Meatable, a Netherlands-based company that is producing animal tissue by mimicking the cellular growth that typically happens inside rather than outside of living organisms. In an interview, de Nood said Meatable is "mission driven" and that it aims to address issues from climate change to animal welfare.

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The company is among dozens of startups worldwide that are racing to scale technology they claim produces "real meat" not plant-based alternatives from companies such as Impossible Foods and Beyond Meat (Climatewire, Oct. 21, 2019).

That's possible, they say, because most cultured protein products originate as stem cells from real animals. Some companies make a point to say that no animals are harmed in the process.

Here's how it typically works. Engineers obtain an animal stem cell sample and isolate "cell lines" with the strongest genetic material. The cells are then placed in an environment like a petri dish or bioreactor that encourages rapid growth, and later differentiation. The resulting fat and muscle tissue is then harvested, structured and processed to create a final product.

De Nood said Meatable already has produced small quantities of meat using this process. And the whole thing took just three weeks a far faster timeline, Meatable notes, than it takes to raise an animal for slaughter. The company plans to host its first public taste testing of a pork prototype in September.

Several other companies already have allowed outsiders to sample their products. Those include Memphis Meats, Peace of Meat and Mosa Meat, which are based in the U.S., Belgium and the Netherlands, respectively.

In fact, one of the first cultured meat tastings dates back to 2013, when Maastricht University physiologist Mark Post presented the world with a beef patty that was produced in a petri dish.

At the time, that single slab of meat cost a whopping 250,000 to produce; Google co-founder Sergey Brin picked up the tab. Several years later, Post co-founded Mosa Meat.

More recently, in March, Peace of Meat hosted an event where attendees sampled a chicken nugget.

Tasting aside, co-founder David Brandes underscored that the startup has a different ambition than many other companies. Rather than producing consumer-facing products, Peace of Meat aims to eventually grow more than 100,000 tons of pure, cultured fat per year. The startup plans to sell the fat to other companies as a key ingredient to enhance the taste and texture of alternative meat products, including those that are plant-based.

"We don't want to make the most fancy-looking piece of food, we don't want to work on exotic species," said Brandes. "You need to produce massive amounts of meat if you really want to have an impact."

Animal agriculture is responsible for a whopping 14.5% of planet-warming emissions, according to the Food and Agriculture Organization of the United Nations. That figure includes greenhouse gases attributable to meat processing, meat-related transportation and manure storage. Then there's the issue of belching cattle which itself is responsible for 65% of the livestock sector's emissions.

Paul Mozdziak, who serves as Peace of Meat's chief scientific officer, was among those who said a central goal of cellular agriculture is to satisfy the world's staggering, and still rising, demand for animal protein but without relying on supply chains that scientists say are environmentally fraught and highly vulnerable to marketplace disruptions.

As an example, Mozdziak pointed to the novel coronavirus crisis, which in recent weeks has temporarily shuttered meat packing plants, forced farmers to cull tens of thousands of animals and spurred fears of a nationwide protein shortage (Greenwire, May 4).

"I absolutely think the pandemic supports the need for this," said Mozdziak, who also directs North Carolina State University's graduate physiology program.

"It's another way to produce food. It's another way to produce protein. It's another way to increase food security," he added. "What if something [else] happens? ... [W]here's the protein going to come from? How are we going to eat?"

But even Mozdziak, who has pondered cultured meat since the early 1990s, acknowledged the obstacles ahead. Despite entrepreneurs' ambitions, he said, the field remains deep in research and development and far from supermarket shelves.

De Nood, of Meatable, highlighted that same issue. "It's all about the scalability of the process," he said, noting that his company is working to drive down costs and move its operations from "small environments" to large bioreactors that would require major processing factories.

Peace of Meat's Brandes agreed. But he said that even if production costs fall, there's the possibility that cultured meat would not meaningfully impact the carbon footprint of the global food system.

"When it comes to greenhouse gas emissions, I think there is a big potential," said Brandes. But producing large quantities of cultured meat would inevitably require substantial amounts of energy, too, "so it really depends where you draw the energy from," Brandes said.

Despite those obstacles and more, some projections have named cultured meat as a key driver of a revolutionary shift away from animal agriculture. Independent think tank RethinkX, for instance, predicts that cell-based meat and plant-based alternatives could render industrial cow farming "obsolete" in the U.S. entirely.

Ermias Kebreab, who is a climate and animal agriculture expert at the University of California, Davis, disagreed with that assessment.

Even as the world becomes more invested in exploring alternatives to conventional protein, Kebreab said, researchers and traditional farmers are actively developing strategies like feeding seaweed to cows to cut the sector's environmental footprint.

In his eyes, sustainable agriculture, rather than cellular agriculture, is what will ultimately enhance food security in developing countries where most future population growth is predicted to occur.

"I'd rather have beef" from cows, said Kebreab, adding that cell-based meat also raises other issues for him, like the products' overall nutritional value. He said he's wary of "highly, highly processed food."

Mozdziak, of Peace of Meat, agreed in part. He doesn't see cellular agriculture putting meat companies out of business.

But "at the same time," he said, "let me vehemently state that I think cultured meat is really important. ... [I]f we're going to have a billion more people on the planet in 30 years, we're going to have to find a way to feed them."

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Sharpless: COVID-19 threatens to reverse long-running trend of decreasing cancer mortality – The Cancer Letter

Posted: May 16, 2020 at 11:47 am

Today I would really like to keep most of the focus on regular NCI business. Im really eager, in fact, to be talking about cancer research and concepts the NCI would like to release. And these will spur interest in cancer research and priority areas. But there is a pandemic going on and we do have some coronavirus items to address as well.

We just had a board meeting on this topic almost entirely devoted to COVID-19. We dont have to do a whole lot on that topic today. But I will just use a few slides to summarize that presentation from the joint board meeting, and remind you of how the NCI has been taking a critical role in an unprecedented response to this pandemic. Also, since things are moving so fast around here right now, there actually have been a few significant developments in the coronavirus spacesince even the joint board meeting just a few weeks ago. Ill briefly summarize that news as well.

In particular, related to those developments, including a new and correct congressional appropriation. There are some COVID items that we do need, and Dinah Singer will direct that discussion at the end of todays meeting.

But let me start out our short COVID discussion by repeating a statement I made last month at the joint board meeting, which is that the primary focus of the National Cancer Institute is, and always will be cancer research and cancer care. Thats a message Ive been delivering in just about every presentation Ive given, in every email and blog post and other materials Ive written during this pandemic response.

And its one that Dinah Singer spoke to at her virtual presentation at AACR two weeks ago on April 28. If you havent seen this, I encourage you to check it out. Dinah also wrote a great post for our Bottom Line blog on the topic, which includes a link to the presentation.

So, this slide summarizes why the NCI is important to the pandemic response. It shows the disproportionate impact of COVID-19 on cancer patients, and patients with cancer whove survived cancer. Additionally, as I illustrated at the joint board meeting, the NCI has unique research expertise and capacity related to Frederick National Lab and our great extramural networks.

Therefore, we have to be involved in the pandemic response. And then, lastly, I think given the nature of this crisis, it has had a tremendous effect on public health. The NCI has a moral obligation to work in this area.

I want to call your attention though to the decrease in care delivery to cancer patients related to the coronavirus pandemic. And this is something, frankly, Ive been worrying about a lot lately, and Ive been hearing from a lot of you and other extramural leaders.

Ive been looking at the statistics about decreases in screening and deferred care, and I am getting very worried about this issue. The data regarding delayed diagnosis and delayed therapy are very clear from cancer research over the decades.

Delayed diagnosis and deferred care leads to worse outcomes for patients with cancer. The things we do to prevent cancer and to diagnose cancer and to treat cancer well, they work, and they cant be put off indefinitely.

And if we do, we will lose ground, and we will give up hard-won progress. And heres a very specific fear I have, in this regard. Every spring, the National Cancer Institute, with the CDC and the ACS and NAACCR, puts out our Annual Report to the Nation on our progress against cancer.

Thanks to advances in screening and prevention and treatment and survivorship, that document has become an annual feel-good story for the NCI. Every year Ive been here, the report has been good news.

Its been a couple of percent drops in cancer mortality each year, and thats been going on, in fact, for decades. But with all this deferred and delayed care and postponed surgeries and later, reduced chemotherapy, and canceled appointments for mammography or a Pap smear or colonoscopy, this is going to have an impact on cancer outcomesan impact that I think well see play out over years to come.

So, Im becoming worried that, because of the pandemic, that in 2021 or 2022 or 2023, we will have the first Annual Report to the Nation since 1993 that shows an increase in cancer mortality. And I know exactly what the statistics will mean for patients. I know that that represents more cancer suffering and more bad outcomes, and more deaths. And lets all agree, we dont want that to happen, and we wont let that happen. I know COVID has caused many changes to how we care for patients.

And we have a legitimate need to be careful during the pandemic in order to protect the public health. But we need to get back to work of caring for our patients. We need our hospitals and our clinics and our infusion centers to start doing what they do best, which is care for our patients who need this. Of course, we have to do this in a manner that is smart, that is careful, that protects patients and staff alike from the coronavirus.

But we need to get back to work. The cost of deferred cancer care will be significant. Neglecting cancer will produce a negative impact on the public health, and one that may trouble our patients for years to come. I plan on talking a lot more about this in the coming weeks. And I havent even spoken about the debilitating impact on cancer science, by having these labs closed and postponedtremendous impact as well.

Just to remind you something that Dinah spoke about, and that is on the blog post as well, is the number of NCI COVID-19 funding opportunities that are somewhat new and recently posted, and still open. This is summarized here. I wont spend a lot of time on them, other than to say were taking both administrative supplements and competitive revisions.

We also had a good discussion at the joint board meeting about allowing a change of scope of certain grants, and we have received a small number of requests to do that, and are working through that. But I think that we are still considering administrative supplements and competitive revisions, and we will be making funding decisions related to these very soon.

Now with the COVID part of the discussion behind us, at least for the next few hours, lets return to regular NCI business. Frankly, I am really excited, as I said, to be able to spend most of our time today on advancing cancer research and cancer science. Getting these concepts that the BSA will see today is really a lot of work getting these things together.

I think you will be impressed or youll be really shocked by how much the NCI has been able to get done during a period of complete telework. I think this is a testament to the really extreme efforts of the trained professionals in the NCI to get this work done, no matter what the situation.

As always, its good to mention where we are in the appropriations outlook. Theres really not a lot to report. At this stage right now, much of Congresss focus has been on supplemental funding related to the coronavirus pandemic, and the work on the 2021 budget has been a little a bit behind that.

But Congress has been busy and has already passed these supplemental fundings, and as is widely reported, is working on a fifth emergency appropriations bill. At the same time, appropriators are starting to take up their work on the regular FY21 appropriations bill, and I suspect well be hearing more about that soon. So, stay tuned.

Some really wonderful news during the joint board meeting last month, I was able to share some news about Dan Gallahan assuming the permanent role as director of NCIs Division of Cancer Biology. And today Im very pleased to share that Phil Castle will soon take the helm at NCIs Division of Cancer Prevention.

Those of you who know, Phil is replacing Barry Kramer in this role, but DCP has been led for over a year now by Debbie Winn, serving in an acting capacity. Debbie has done a spectacular job in this rolevery hard to be an acting in this roleand I want to thank her for taking this on for the benefit of the NCI. I would like a virtual round of applause for Debbie. Yay Debbie!

Phil is joining us from Albert Einstein College of Medicine in New York, where he served as professor in the Department of Epidemiology and Population Health. He was also the executive director and co-founder of the Global Coalition Against Cervical Cancer.

Phil is no stranger to the NCI. He was a senior tenured investigator and tenure-track investigator in the Division of Cancer Epidemiology and Genetics from 2003 to 2011. While at NCI, he was the lead investigator on several epidemiologic studies, including the Mississippi Delta project, the HPV Persistence and Progression Cohort, and the guidelines cohort and cancer at Kaiser Permanente, Northern California, and the Anal Cancer Screening Study.

Im thrilled Phil is joining the NCI in this key role, and Im really excited to have him join and provide vision for the DCP mission regarding cancer prevention, screening and early detection. So, welcome, Phil.

Id like to give a brief update on the Childhood Cancer Data Initiative. We are anxiously anticipating an upcoming working group report for the joint board meeting in June. As some of you know, Jaime Guidry Auvil kicked off the BSA working group on March 27 and provided an overview of its activities, as well as its relationship with ongoing NCI pediatric initiatives.

While we await the report, its important to note that we are using the FY20 CCDI funding to support foundational aspects of childhood cancer research and data related to those efforts, from which to build CCDI in years FY21 to FY30. So, we are working on this at a good speed with the already appropriated funds and are eagerly awaiting more advice from the working group on the shape of this initiative.

Ill just mention that the cell-based therapy and vector production efforts at Frederick National Lab are proceeding apace. As I mentioned though at the joint board meeting, we have actually had our first trial, using a CAR T-cells prepared at Frederick, open. The virus production facility will soon come online. And well evaluate potential viral production projects proposed by the extramural community.

So, we envision Frederick will have capacity to make viral vectors as needed for extramural searchers. This will include both developmental and clinical trial proposals.

Needless to say, Im thrilled with the progress and ramping up of this facility. In fact, this summer we will begin accepting applications. Weve dedicated space to produce viral projects, so those of you who will need help producing virus for, say, a CAR T trial or some other related efforts, stay tuned for the announcement about the acceptance of applications.

I think many on this board are aware of the interesting pattern of prostate cancer statistics over the last few years, regarding incidence and mortality, with changing recommendations related to PSA screening. The NCI has been following this area carefully. We had a very large internal NCI meeting, spanning the gamut from basic researchers to clinical trialists, to population health science researchers, to discuss where our prostate cancer research portfolio ought to be, in light of these changing statistics, and we decided a good way to go forward would be to have a lot of advice from the extramural community.

And for that reason, were working towards a workshop next spring to bring in extramural perspective to convene the best folks to try and understand where the NCI should be focusing its research mission related to prostate cancer now. Bill Dahut and others are leading this effort at the NCI.

I thought Id mentioned a few quick research updates that we found exciting. I always like to try and at least note some of the great science that NCI has done, either intramurally, or funded extramurally, and always try and bring up a few recent items.

This is work from the DeNardo lab at Washington University, published recently in Cancer Cell, related to dendritic cells in tumor immunotherapy. It proposes that the number of dendritic cells in a tumor may explain why immunotherapy works for some cancers, but not others, and work in miceboosting dendritic cell number triggered an immune response in pancreatic cancer, which has been traditionally difficult in terms of immunotherapy. So exciting research proposals to follow.

Work from the Richard Kitsis lab at Albert Einstein tries to better understand the relationship between daunorubicin and doxorubicin and cardiomyopathy, and developed an experimental drug to prevent this chemotherapy-induced heart toxicity. It does so without interfering with the chemotherapys therapeutic ability to kill cancer cells in mice. So, interesting work for a long-standing problem related to the use of these agents at extended doses for patients.

In some microbiome research from Marcel van den Brink at Memorial Sloan Kettering in people with blood, hematologic malignancies, the health of their gut microbiome appears to affect the risk of dying after receiving allogeneic stem cell transplant, according to this NCI-funded study, published in the New England Journal of Medicine that got tremendous attention in the press. An exciting development to help improve outcomes for patients who need allogeneic transplantation.

Finally, in addition to our grantee blog, Bottom Line, which is now widely read, and our research enterprise blog, which is Cancer Currents, I also also want to remind everyone about an important resource on our cancer.gov site. This site is specifically designed for researchers with questions. And it is updated frequently with new information as it becomes available.

To date, weve tracked over 20,000 visits to these blogs and other researcher-focused web content. I wanted to stress that we know all too well that the extramural community, as is the case in nearly every sector of the nation, things are really hurting out there.

And regardless of how the back-to-business plan does roll out at various institutions, it will really take some time to bounce back. We know, for instance, that universities and institutions have begun furloughing staff and laying off researchers. We know clinical trials accrual is down, especially for non-treatment trials.

All of this will slow the pace of research, but beyond that and equally important, the public health crisis represents a real hardship for our families, our communities, and patients with cancer. NCI has not lost sight of this. Well do all we can help to recover from these significant setbacks.

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Federal inmates to be confined to cells for two weeks amid coronavirus outbreak | TheHill – The Hill

Posted: April 2, 2020 at 6:45 am

Federal prison inmates will be confined to their cell or quarters for the next two weeks as a part of efforts to stem the spread of the coronavirus, the Federal Bureau of Prisons (BOP)announced on Tuesday.

Theagency said in a press release that the decision came in response to a "growing number of quarantine and isolation cases in our facilities." The confinement period will begin on Wednesday, though inmates will still have access to programs and services offered in federal prisons, including mental health treatment and education.

BOP said it's also working with the United States Marshals Service to "significantly decrease" incoming movement.A decision on whether to extend the confinement period or return to modified operations will be made on April 15.

At least 28 inmates in federal custody and 24 agency employees have reportedly tested positive for COVID-19. The Federal Bureau of Prisons announced last Saturday that an inmate in federal custody in Louisiana died from the virus.

The agency noted that the inmate,Patrick Jones, 49, "had long-term, pre-existing medical conditions whichthe CDC lists as risk factors for developing more severe COVID-19 disease."

The outbreak of the novel coronavirus has led to increasing calls for state and federal prisons to reduce populations to prevent overcrowding and stem the spread of the disease.

California announced on Tuesday that it would release up to 3,500 nonviolent inmatesand suspend intake from county jails. New York City Mayor Bill de BlasioBill de BlasioSchumer calls for military official to act as medical equipment czar De Blasio: NYC needs 400 ventilators, 3.3 million N95 masks by Sunday Federal inmates to be confined to cells for two weeks amid coronavirus outbreak MORE (D) also said this week that nearly 1,000 nonviolent offenders had been releasedfrom its city jail system.

Criminal justice reform advocates criticized the Federal Bureau of Prisons's move to confine inmates for an extended period. Scott Hechinger, a public defender in Brooklyn, tweeted that "solitary confinement is not a solution. Solitary confinement is torture."

Solitary confinement is not a solution. Solitary confinement is torture. https://t.co/Wv8J8Bdo80

"Essentially solitary confinement for AT LEAST two weeks for EVERYONE. Can't make this up," Ed Chung, the vice president of criminal justice reform at the Center for American Progress, tweeted.

So the Bureau of Prisons just announced how they will fight #COVID19: "For 14 days, inmates in every institution will be secured in their assigned cells/quarters"

Essentially solitary confinement for AT LEAST two weeks for EVERYONE. Can't make this up...https://t.co/eULNTOcBVN pic.twitter.com/lvYzj6yjAX

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Fate Therapeutics: Potential Catalysts Ahead – Seeking Alpha

Posted: March 17, 2020 at 6:45 pm

Today, we will see why Fate Therapeutics (FATE) is an attractive pick in March 2020.

Fate Therapeutics is a clinical-stage biopharmaceutical company focused on the development of next-generation cellular immunotherapies for cancer and immune disorders. The company has pioneered proprietary iPSC (induced pluripotent stem cell) platform technology to develop off-the-shelf cell-based cancer immunotherapy products. Current patient-derived autologous and allogeneic cell therapies suffer from drawbacks such as high costs, manufacturing complexity, product heterogeneity, and high turnaround time. These methods, including patient and donor-derived approaches to cell therapy, also require batch-to-batch sourcing and engineering of millions of primary cells.

Fate Therapeutics aims to be the game-changer in cell-based cancer immunotherapy space by enabling the development of off-the-shelf cell products derived from master cell lines. The company aims to develop less costly, homogenous, and multi-dose or multi-cycle cell therapies with small turnaround time. The resultant cell therapy products are expected to be well-defined and uniform in the composition and can be mass-produced at a significant scale in a cost-effective manner and can be delivered off-the-shelf for broad patient accessibility.

The company's cell therapy pipeline comprises immune-oncology programs including off-the-shelf NK- and T-cell product candidates derived from master iPSC lines, and immuno-regulatory programs, including product candidates to prevent life-threatening complications in patients undergoing hematopoietic cell transplantation and to promote immune tolerance in patients with autoimmune disease.

Human-induced Pluripotent Stem cells are generated by reprogramming adult somatic cells to a pluripotent state. Fibroblasts are the most commonly used primary somatic cell type for the generation of induced pluripotent stem cells. They are reprogrammed using retroviruses. Pluripotent cells are capable of differentiating in all cell types that make up the body.

A single human iPSC can potentially differentiate into more than 200 cell types and provides a renewable source for making cells.

NK (natural killer) cells are the body's first line of defense against tumors and various pathogens. Fate Therapeutics is leveraging its iPSC platform to produce off-the-shelf NK cell therapy products.

FT500 is Fate Therapeutics' first off-the-shelf iPSC-derived NK-cell product candidate. The FT500 study is an open-label, multi-dose Phase 1 clinical trial designed to evaluate FT500 for the treatment of advanced solid tumors.

The dose-escalation stage of the study was originally designed to assess the safety and tolerability of three once-weekly doses of FT500, without IL-2 cytokine support, as a monotherapy and in combination with one of three FDA-approved ICI (immune checkpoint inhibitor) therapies in patients that have failed prior ICI therapy.

Data for the first 12 patients in the Phase 1 study has demonstrated clean safety for the iPSC platform. The cutoff date considered was November 28, 2019. It was seen that there were no reported dose-limiting toxicities, no FT500 related Grade 3 or greater adverse events or serious adverse events, and no incidents of cytokine release syndrome, neurotoxicity, or graft-versus-host disease.

Further, the trial also involved the evaluation of a multi-dose treatment course consisting of outpatient lympho-conditioning followed by three once-weekly doses of FT500 over up to two 30-day treatment cycles. Here, based on patients' T-cell and antibody repertoire, no anti-product immune responses against FT500 were evident over the multi-dose treatment course.

A total of 62 doses of FT500 were administered to these 12 patients in a safe and well-tolerated manner. Initial clinical data thus provides strong evidence that multiple doses of iPSC-derived NK-cells can be delivered off-the-shelf without patient matching.

In December 2019, the company disclosed plans to amend the trial protocol by including IL-2 cytokine support with each dose of FT500 after completion of 300 million cells per dose cohort in the ICI combination arm. The company has commenced dose-expansion part of Phase 1 trial with 300 million cells per dose and is focusing on enrolling NSCLC patients who are refractory to or have relapsed following CBT. This tumor type is highly susceptible to NK-cell recognition and killing. The study is enrolling at three clinical sites in the U.S. Fate Therapeutics expects expansion data readout from the trial in the second half of 2020.

Fate Therapeutics is studying the second product candidate from iPSC product platform and off-the-shelf NK-cell cancer immunotherapy, FT516, in an open-label, multi-dose Phase 1 trial. This product has been engineered to augment antibody-dependent cellular cytotoxicity.

In December 2019, the company announced results for two patients dosed with FT516. FT516 was administered as a monotherapy to the first patient who was suffering from relapsed/refractory AML (acute myeloid leukemia). The company dosed FT516 in combination with rituximab to the second patient who was suffering from high-risk DLBCL (diffuse large B-cell lymphoma) and had relapsed after multiple rituximab combination regimens, autologous hematopoietic stem cell transplant, and CAR (chimeric antigen receptor) T-cell therapy. The patients had received a first treatment cycle consisting of outpatient lympho-conditioning, three once-weekly doses of FT516 and IL-2 to better promote NK-cell activity.

Initial clinical data based on bone marrow biopsy at day 42 demonstrated no morphologic evidence of leukemia. There was even evidence of hematopoietic recovery following the completion of the first FT516 treatment cycle in the AML patient. There was also no circulating leukemia cells in the patient's peripheral blood. The patient even reported the recovery of neutrophils without growth factor support. The data did not demonstrate dose-limiting toxicities, although serious adverse events were seen. Initial dose escalation data may be read out in the second half of 2020.

This initial clinical evidence highlights the high probability of engineered iPSC-derived NK-cells demonstrating anti-tumor activity in AML indication. Besides, there is a body of data that has demonstrated clinical proof-of-concept for donor-derived NK-cell therapy in relapsed refractory AML and relapsed refractory DLBCL.

In December 2019, FDA accepted FT516's second IND application for studying the product in combination with PDL1, PD1, EGFR and HER2-targeting monoclonal antibody therapies in solid tumor indications. Initially, the company plans to prioritize the combination of FT516 and avelumab in patients with advanced solid tumors who are refractory to or have relapsed following, at least one line of anti-PDL1 monoclonal antibody therapy. The company plans to initiate enrollment in a clinical trial for FT516 and avelumab in mid-2020.

Fate Therapeutics is studying off-the-shelf multi-antigen targeted CAR NK-cell product candidate, FT596, in solid tumor indications.

In December 2019, Fate Therapeutics reported favorable in vivo preclinical data for FT596.

Here, in humanized mouse models of lymphoma and leukemia, FT596's efficacy was comparable to that of primary CAR T-cells in promoting tumor clearance and extending survival. FT596 combined with rituximab also showed the enhanced killing of lymphoma cells in vivo as compared to rituximab alone. FT596 can thus emerge to be best-in-class off-the-shelf treatment in B-cell malignancies. Fate Therapeutics has started enrolling patients in the open-label Phase I study. Initial dose escalation data readout on FT596 is expected in the second half of 2020.

Fate Therapeutics has high hopes for FT596, considering that initial clinical data from a donor-derived CAR19 NK-cell program at MD Anderson, demonstrated a 73% overall response rate in patients with relapsed refractory non-Hodgkin's lymphoma and chronic lymphocytic leukemia with no major toxicities. Hence, while the efficacy seemed similar to CAR T therapy, the safety profile was differentiated in favor of CAR NK-cell therapies.

Although early, this data has highlighted CAR NK-cells' capacity to confer a high level of efficacy without the CAR-T cell therapy-related toxicities. Fate Therapeutics expects FT596 to effectively replace patient-specific and allogeneic CAR19 T-cell immunotherapies. The latter single-antigen specific and hence pose a risk of disease relapse due to antigen escape as well as cause significant toxicities due to off-target activity. FT596, on the other hand, has been engineered with three active anti-tumoral functional components.

Fate Therapeutics aims to be the first company to introduce off-the-shelf iPSC-derived CAR T-cell therapy to patients, FT819, by submitting IND in the second quarter of 2020. The company expects to file an IND application for off-the-shelf CRISPR-edited, iPSC-derived NK-cell product candidate, FT538, by early May 2020. The company has also planned IND submission for FT576 in the second half of 2020.

Although Fate Therapeutics is pioneering a revolutionary approach for mass production of off-shelf cell therapy products, its pipeline is very early stage. There has not been sufficient data from its clinical programs to make an informed estimate about the success probability of these programs. In this backdrop, the company is exposed to significant R&D failure risks. In case data readouts from FT500 and FT596 clinical programs do not match expectations, the company may witness increased share price volatility.

At the end of 2019, the company had cash worth $261 million on its balance sheet. The company spent cash worth $83.2 million on operating activities in 2019. This is a proxy for the 2019 cash burn rate. We assume that the annual cash burn rate in 2020 will be around $120 million, considering that three assets have entered in-human trials. Hence, the company seems to have cash that can sustain operations until the end of 2021. However, if cash is needed at a faster pace, the company may land up requiring more funds. This can lead to equity dilution.

According to finviz, the 12-month consensus target price of Fate Therapeutics is $37.94. On March 4, Citi analyst Yigal Nochomovitz reiterated the "Buy" rating and increased target price from $26 to $41. On March 4, Barclays analyst Peter Lawson also initiated coverage of Fate Therapeutics with an Overweight rating and $40 price target.

On March 3, BMO Capital analyst Do Kim raised the firm's price target on Fate Therapeutics to $28 from $22 and reiterated the "Market Perform" rating. On March 3, Guggenheim analyst Michael Schmidt reiterated the "Buy" rating and increased target price from $25 to $41. On March 3, Roth Capital analyst Tony Butler reiterated the "Neutral" rating but increased the target price from $20 to $30. On March 3, BTIG analyst Amanda Murphy reiterated the "Buy" rating and increased target price from $27 to $42. The analyst has also raised the estimated value of the company's iPSC platform from $740 million to $2.0 billion.

On March 3, Oppenheimer analyst Matthew Biegler reiterated the "Outperform" rating and increased the target price from $27 to $36. Piper Sandler analyst, Edward Tenthoff also reiterated the "Overweight" rating and raised the target price from $28 to $57.

In September 2019, Fate Therapeutics launched in-house GMP (Good Manufacturing Practices) manufacturing facility at headquarters in San Diego, California. This is custom designed to use clonal master iPSC lines as a renewable cell source for the consistent and scaled manufacture of off-the-shelf NK-cell and CAR T-cell products. The company has already produced hundreds of cryopreserved, infusion-ready doses of FT500, FT516, and FT596 at a low cost per dose. Currently stored in inventory, these doses are immediately available for use in the clinical settings.

The full control of cGMP production and the technical expertise to genetically engineer iPSCs and create qualified clonal master lines for clinical use implies that the company has operational expertise and redundancies required for the consistent cost-effective manufacturing and clinical supply of off-the-shelf cell products.

I believe that the 12-month target price of $30 fairly reflects the growth potential as well as risks associated with early-stage Fate Therapeutics. I consider this company to be a good pick for aggressive biotech investors with an investment horizon of at least one year.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Confocal microscopy: Seeing what does not meet the eye – Ophthalmology Times

Posted: March 17, 2020 at 6:45 pm

Limbal stem cell deficiency (LSCD) is an ocular surface disorder that results from decreases in the number and function of corneal epithelial stem and progenitor cells that results in the inability to maintain the normal homeostasis of the corneal epithelium.

LSCD signs include conjunctivalization and persistent epithelial defects with or without neovascularization, ocular surface inflammation, and scarring. The disease can be acquired non-immune-mediated, acquired primary immune-mediated, idiopathic, or inherited.

Related: Ocular surface inflammation: Vicious cycle of ocular surface disruption

Diagnosis can be tricky because the disease presentation varies greatly with the degrees of severity of the stem cell deficiency, according to Sophie X. Deng, MD, PhD. This can range from stippling staining in the very early stage to a vortex configuration in the late stage with loss of the palisades of Vogt and vortex keratopathy.

A problem with LSCD is the difficulty in differentiating it from severe dry eye disease, according to Dr. Deng, professor, Stein Eye Institute, University of California, Los Angeles. LSCD can present with staining patterns not generally associated with the disease.

Physicians have used impression cytology to detect corneal goblet cells in LSCD, but the sensitivity of the technique is too low to establish a definitive diagnosis and the degree of the stem cell deficiency cannot be quantified.

Related: Doing justice to corneal irregularities

Confocal microscopyConfocal microscopy using the Heidelberg Retina Tomograph III (HRT) is a more reliable and rapid way to diagnose LSCD that visualizes all of the corneal microstructures from the epithelium to the endothelium, Dr. Deng explained.

In vivo imaging using the HRT III has very high resolution, which facilitates visualization of individual cells, the nerve plexus, the conjunctiva/cornea junction, and the palisades of Vogt, she said.

The goal of microscopy is detection of the changes in the cell morphology that are evident even in early-stage disease. Dr. Deng demonstrated that the corneal cells appear to enlarge with disease progression and become more metaplastic followed subsequently by the absence of stem cells altogether in the corneal epithelium. In the limbus, some eyes exhibit an influx of inflammatory cells.

Related: Stem cell treatment: What could possibly go wrong with procedure?

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A Tale Of Two States: California Shifts Towards Mitigation Over Containment While New York Sends In National Guard – Kaiser Health News

Posted: March 17, 2020 at 6:45 pm

California and New York are two of the states that have seen the most cases. Officials in California say the "cat is out of the bag" when it comes to community spread, and it is focusing on mitigation strategies like canceling large events. In New York, Gov. Andrew Cuomo has created a one-mile containment zone to try to stop the spread in a community that was particularly hard hit.

Los Angeles Times:California Retreats From Containment, New York Sends In National GuardIn New York, Gov. Andrew Cuomo sent the National Guard to a suburban enclave northeast of New York City to prevent COVID-19 from infecting more people there, after 108 residents tested positive in recent days. In Santa Clara, where California is experiencing its largest outbreak of the virus with 45 positive cases confirmed, health officials continued to direct residents not to congregate, following a ban on large events earlier this week. (Chabria, Gutierrez, Baumgaertner and Karlamangla, 3/11)

The Washington Post:Coronavirus: Schools Close, National Guard Deployed To Help New York Suburb Stem Spread Of DiseaseNew York Gov. Andrew M. Cuomo took the country's most drastic steps to curb the spread of the coronavirus Tuesday, ordering the closure of schools and other gathering places within a one-mile radius in this New York suburb. The creation of what he called a "containment zone" for two weeks will keep about half the city's 10,500 students at home and will allow the National Guard to sanitize public spaces. (Guarino, Bailey, Meckler and Zezima, 3/10)

The New York Times:Coronavirus In N.Y.: Containment Area Is Ordered For New RochelleThe National Guard will move in. Schools, churches and synagogues will be shut down. Large indoor gatherings will be officially banned. The sights and rituals of life in this New York City suburb, which had already been altered, took an eerie turn on Tuesday when Gov. Andrew M. Cuomo announced a drastic new step to try to control the spread of the coronavirus in the largest cluster in the United States. (Nir and McKinley, 3/10)

Associated Press:National Guard Sent Into New York Suburb To Help Control VirusNew Yorks governor announced Tuesday he is sending the National Guard into a New York City suburb to help fight what is believed to be the nations biggest cluster of coronavirus cases one of the most dramatic actions yet to control the outbreak in the United States. The move came as health authorities contended with alarming bunches of infections on both sides of the country and scattered cases in between. (Villeneuve and Rodriguez, 3/10)

The Wall Street Journal:Containment Area Planned For New York Suburb To Stem Coronavirus SpreadNow this Westchester County suburb has become ground zero for one of the largest efforts in the country to contain the spread of the novel coronavirus. Many residents are in quarantine. Businesses are struggling to get customers in the door. And on Thursday, New York state plans to close schools for two weeks in a roughly three-square-mile area of New Rochelle and limit large public gatherings, officials said. People would be able to enter and exit the zone and move about within it. Restaurants and businesses would remain open, officials said, but facilities such as houses of worship and schools would be closed. (Vielkind, Brody and Paris, 3/10)

CBS News:New York Has 173 Cases Of Coronavirus Among The Highest In The U.S.As the total number of cases of coronavirus in the U.S. continues to rise, New York Governor Andrew Cuomo said New York now has at least 173 cases making it among one of the states with the largest number of confirmed cases in the country. In New York, 108 cases are in Westchester County, with New York City and Nassau County following with 36 and 19 cases, respectively, according to officials. Rockland county has six cases, Saratoga has two, Suffolk and Ulster each have one. (Lewis, 3/10)

The Wall Street Journal:New York City Eyes Measures To Stop Virus Spread To JailsNew York City correctional officials said Tuesday they were preparing measures to stop the coronavirus from infecting staff and prisoners at jails that experts said could become incubators for the rapidly-spreading disease. The Department of Correction is focused on keeping its jail cells and shared space clean, screening visitors for symptoms, raising awareness with posters about avoiding the disease and encouraging inmates to keep a physical distance from each other, officials said. (Paul, 3/10)

The Wall Street Journal:Coronavirus Could Sap New Yorks Tax Revenue, Cuomo SaysNew York lawmakers, facing a $6 billion budget deficit, began the month with an optimistic projection. Stock markets were doing well, Wall Street bonuses were coming in strong, and lawmakers could plug some of the gap by assuming another $700 million in revenue was coming. Also at the beginning of the month, the state confirmed its first case of novel coronavirus. (Vielkind, 3/10)

San Francisco Chronicle:Bay Area Counties Shift Coronavirus Stance: It Can Be Slowed, But Not ContainedCoronavirus cases have blown up across Northern California in the past week, and counties increasingly are refocusing from aggressive containment of the disease to acceptance that its in the community and their limited resources are better spent on slowing down its spread. On Tuesday, Sacramento County reported its first death, and the third in the state. The victim in their 90s with underlying health problems was a resident of an assisted living facility. The same day, the county announced it would no longer conduct extensive investigations on every new case of COVID-19 the disease caused by coronavirus and that people who have contact with a known case will no longer be asked to quarantine for two weeks. (Allday, 3/10)

Los Angeles Times:Why Bay Area Coronavirus Warnings Are Stricter Than L.A. Area'sUp to now, some Bay Area public health agencies have been more aggressive than those in Los Angeles and some other counties in issuing coronavirus-related restrictions. But that could be about to change. With the first case of the coronavirus believed to be transmitted within the community now reported in Los Angeles County, the experiences in the San Francisco Bay Area may offer a glimpse for what Southern California is in for. (Lin and Shalby, 3/10)

NPR:Coronavirus: Sacramento County Gives Up On Automatic 14-Day QuarantinesCalifornia's Sacramento County is calling off automatic 14-day quarantines that have been implemented for the coronavirus, saying it will focus instead on mitigating the impact of COVID-19. The change is an acknowledgement that the county cannot effectively manage the quarantines while its health system copes with coronavirus cases. It also reflects problems with the U.S. government's coronavirus testing program issues that slowed efforts to identify people with the deadly virus and to contain COVID-19. (Chappell, 3/10)

Los Angeles Times:Northern California Woman Dies Of Coronavirus In Senior FacilityAn elderly patient in a northern California assisted living facility has died of the novel coronavirus, sparking fears of an outbreak among other residents of the facility and renewing concerns about statewide availability of testing kits to detect the virus. Sacramento County health officials announced Tuesday that a patient in her 90s was the countys first fatality from COVID-19. The Sacramento Bee identified the facility as Carlton Senior Living. (Chabria, 3/10)

KQED:Coronavirus: As Cases In California Climb, Newsom Addresses Testing ConcernsIn a wide-ranging press conference, Gov. Gavin Newsom said that 157 people in California have now tested positive for the new coronavirus. The governor also detailed the latest steps California is taking to ramp up testing, implement social distancing guidance, and prepare for school closures, while processing passengers from the Grand Princess cruise 21 of whom are confirmed to have COVID-19. (Stark, 3/10)

Los Angeles Times:L.A. School Board Weighs Emergency Declaration For CoronavirusThe Los Angeles Board of Education on Tuesday declared a state of emergency, giving Supt. Austin Beutner the authority to take actions needed to close schools if necessary in response to the coronavirus outbreak. The action is seen as a precaution that would allow Beutner to act quickly as the need arises in the nations second-largest school district. As of Tuesday night, there were no plans to close schools and no individual diagnosed with COVID-19 had a connection to an L.A. Unified school, according to the district. (Blume and Kohli, 3/10)

Los Angeles Times:California Coronavirus: Silicon Valley Bans Gatherings Of 1,000 Or MoreWith Silicon Valley reporting a rapidly rising number of confirmed coronavirus cases, the health officer for Santa Clara County issued a rare legal order banning mass gatherings of 1,000 or more people. Santa Clara County, with 43 confirmed coronavirus cases and one death, has Californias largest number of confirmed infections. After declining an earlier recommendation to halt mass gatherings late last week, the San Jose Sharks said the team would abide by the countys new order at SAP Center in downtown San Jose, which is enforceable by the county sheriff and city police agencies. (Lin, 3/10)

The Hill:Three TSA Employees In California Test Positive For CoronavirusThree employees with the Transportation Security Administration (TSA) in California tested positive for the coronavirus, the agency confirmed Tuesday.The employees, who work at Mineta San Jose International Airport in Santa Clara County, and all other workers they came in contact with over the past two weeks are quarantined at home. (Axelrod, 3/11)

The New York Times:Coachella, Influential Music Festival, Is Postponed Amid Virus FearsCoachella is postponed. Organizers of the Coachella Valley Music and Arts Festival, the giant pop festival in the picturesque desert of Southern California, have delayed next months event to October over concerns about the coronavirus, the festival announced on Tuesday after days of speculation. (Sisario, 3/10)

Reuters:Passengers Plod Off Coronavirus-Stricken Cruise Ship In Face Masks In CaliforniaHundreds of travelers who boarded a cruise liner for Hawaii last month in sandals and sunglasses trudged off the coronavirus-stricken ship in face masks at the Port of Oakland, California, on Tuesday, headed to quarantine sites around the country. The tightly controlled disembarkation began on Monday, hours after the cruise ship Grand Princess arrived at a specially secured terminal across San Francisco Bay from its home port amid cheers from weary passengers who had spent days at sea confined to their staterooms. (3/10)

San Francisco Chronicle:SF Archdiocese Shutters 90 Schools After Student Tests Positive For The CoronavirusThe Archdiocese of San Francisco announced the closure of all its schools after a student tested positive for the coronavirus.The 90 schools in San Francisco, San Mateo and Marin counties will shut down Mar. 12 through Mar. 25, said Pamela Lyons, superintendent of schools in a letter to families Tuesday. The announcement did not identify the school the student attends, but the principal of Riordan High School in San Francisco confirmed that a student there tested positive for the virus Sunday. (Tucker, 3/10)

San Francisco Chronicle:Ro Khannas Bay Area District Is Being Hit By Coronavirus. He Says Congress Must Do MoreFremont Rep. Ro Khannas district has been one of the hardest hit in the country by the novel coronavirus.Santa Clara County, which covers much of Khannas 17th Congressional District, reported 43 cases as of Tuesday, the most in California. There are at least 153 cases across the state.Khanna says Congress isnt doing enough to stop the virus from spreading. The Chronicle spoke with him Monday about his push to increase emergency funding and quell racist sentiments during the outbreak. Here are highlights from the interview, which has been condensed for space purposes and clarity. (Gardiner, 3/10)

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A Tale Of Two States: California Shifts Towards Mitigation Over Containment While New York Sends In National Guard - Kaiser Health News

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