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Biopreservation Market Know the diverse technological advancements in the biopreservation – BioSpace

By Stem Cell Clinic

Biopreservation is a process for conserving the tissues, organs and cells along with maintaining their integrity and functionality at different temperatures for a prolonged period of time. The necessary products for biopreservation are cryo bags, tubes, refrigerators, liquid nitrogen tanks, and freezers. These biopreservation equipment have applications in stem cell, DNA, and plasma and tissue research which helps the market to grow steadily. Various researches being carried out in cell therapy and the increasing number of bio banks also encourage market expansion. Currently, the geriatric population is affected with many disorders related to their lifestyle, namely cardiovascular disease, chronic illness, hypertension, and cancer. Biopreservation applications such as drug discovery, regenerative medicines, and bio banking help the consumers or patients during their life span and even at the time of death.

The enormous growth in the global biopreservation market is accelerated by the rising healthcare expenditure, increasing trend of conserving cord blood stem cells of newborns, and the growing investments in research and development pertaining to this field. A considerable healthcare spending is expected to drive the gene banks, bio banks and hospitals to focus on biopreservation. High costs of advanced techniques and stability issues such as tissue injury during thawing and freezing have been considered as some of the primary factors restraining the biopreservation market growth. One of the prominent names in the industry, BioLife Solutions has signed a ten years business supply agreement with Bellicum Pharmaceuticals for manufacturing, marketing of proprietary tissue and cell, and various cellular immunotherapies which target solid tumors and blood cancers. The influential regions for the biopreservation market are North America, Europe and Asia Pacific. Asia Pacific is expected to offer significant growth opportunities to market players, mostly driven by the demand arising from India and China.

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Global Biopreservation Market: Overview

Biopreservation involves maintaining the functionality and integrity of cells, tissues, and organs outside their natural environment for an extended period of storage at different temperatures. For instance, vaccines save 3 million lives every year in the U.S, however, vaccines worth US$ 20 million are wasted each year due to inadequate storage and improper refrigeration.

Biopreservation safeguards the stability, purity, and quality of biospecimens saved in hospitals, biobanks, and gene banks. For instance, preservation of red blood cells (RBCs) is required for the ready availability of safe blood for blood transfusion needs. The biopreservation of RBCs for clinical purposes can be divided on the basis of techniques used to attain biologic stability and safeguard a viable state after extended storage times.

Global Biopreservation Market: Key Trends

The major factors driving the global biopreservation market include increasing R&D expenditure, increasing number of sperm and egg banks, increasing demand for preserving the stem cells of newborns, and rising adoption of regenerative medicine.

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Across the world, the increasing healthcare expenditure for health and well-being will stimulate the growth of the biopreservation market. This is because healthcare expenditure accounts for a significant part of the developmental budget of most countries. According to data from the World Bank, public healthcare spending is expected to rise at a substantially high rate, which along with a substantial healthcare spending will be an important driver for gene banks, hospitals, and biobanks, which are the key end-users of biopreservation market.

A large population afflicted with chronic disorders such as cardiovascular diseases, diabetes, cancer, and hypertension as well as lifestyle diseases will bolster the markets growth. The increasing public and private spending on, medical goods and services, rising disposable income, increasing demand for biobanking services for the preservation of cells, tissues, and organs, and rising disposable income are also expected to further enhance the growth of the global biopreservation market.

Global Biopreservation Market: Market Potential

In a recent development in the biopreservation industry, BioLife Solutions, a leading name in developing, manufacturing, and marketing of proprietary cell and tissue has entered into a ten year business supply agreement with Bellicum Pharmaceuticals. The latter is a leading name in the development of cellular immunotherapies for cancers and inherited blood disorders. On account of this supply agreement, BioLifes CryoStor cell freeze media is incorporated into Bellicums production process for various cellular immunotherapies that targets blood cancers and solid tumors.

In another industry development, BioLife Solutions has entered into a partnership with transportation firm MNX and expects heightened demand for its biologistics services with the entry of more cell therapies into the clinic.

Global Biopreservation Market: Regional Outlook

The global biopreservation market can be analyzed with respect to the regional segments of North America, Europe, Asia Pacific, and Rest of the World. In North America, the U.S. accounts for almost half the revenue of the region. This is due to the increasing demand for detection of chronic diseases, government stipulations for the ethical usage of biological samples, and introduction of newer of biopreservation methodologies.

Asia Pacific biopreservation market, driven by India and China will display a sustainable growth over the next couple of years

Global Biopreservation Market: Competitive Analysis

Some of the key companies operating in the global Biopreservation market include Thermo Fischer Scientific Inc., VWR Corporation, Lifeline Scientific Inc., BioCision LLC, Custom Biogenic Systems Inc., Princeton Cryotech Inc., Sigma-Aldrich Corporation, Biolife Solutions Inc., Cesca Therapeutics Inc., Core Dynamics Ltd., and So-Low Environmental Equipment Co. Inc.

Top companies in the market are focused on mergers and acquisitions, practicing effective services, and develop new products to stay competitive in the biopreservation market. Expanding geographical reach and developing a broad product portfolio with respect to refrigerators, freezers, and consumables is also leading to the increased market share of some of the top players.

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Biopreservation Market Know the diverse technological advancements in the biopreservation - BioSpace

Reawakened immune cells attack cells tied to diseases of aging – STAT – STAT

By Stem Cell Clinic

Scientists have started to test whether natural killer, or NK, cells can be trained to go after hard-to-cure blood cancers in human patients. But making these sentinels of the innate immune system a potential boon to human health spans might be simpler: Rather than needing to be genetically engineered or primed with synthetic antibodies, they just need to be turned on.

In mice, researchers reported on Monday in the journal Med, activating NKT cells can eliminate the senescent cells partly responsible for many diseases of aging. If the results hold up, they could offer a promising alternative to senolytics experimental drugs that destroy these zombified cells that pile up and pollute your tissues as you get older. Although dozens of such drugs have postponed or even reversed diseases of aging in mouse experiments, clinical trials have thus far underwhelmed.

Its an interesting approach that works in experimental animals with two different conditions, said geriatrician James Kirkland of the Mayo Clinic, whose discovery that giving old mice senescent cell-crushing compounds makes the animals live longer, healthier lives, helped take senolytics from backwater to boomtown. Were going to need multiple ways of getting at senescent cells, he said. Any step forward is important, and this is quite a nice step forward. But he cautioned that a single senolytic strategy is unlikely to work for all age-related conditions.

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For decades, scientists had largely ignored senescent cells old and arrested in a permanent state of suspended animation dismissing them as a quirk of evolution, a clever way for the body to keep damaged cells from proliferating into cancer. But more recently, Kirkland and other researchers established that senescence is actually a driver of the decrepitude that comes with old age. As cells stop dividing, they dont exactly go dormant. In their zombie-like state, they start spewing a cocktail of toxic molecules that cause inflammation, damage surrounding tissues, and contribute to diseases like osteoarthritis, atherosclerosis, diabetes, and Alzheimers.

That realization spurred the creation of at least two dozen companies developing ways to systematically purge the body of senescent cells. Senolytics attracted this wave of investment because it promises a scintillating and fundamental shift in medicine away from the one-drug-one-target-one-disease paradigm of the last century, toward correcting a root cause behind many of them with a single treatment.

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One of those researchers is the new studys senior author, Anil Bhushan of the University of California, San Francisco. In 2019, his lab traced the progression of type 1 diabetes in mice and human pancreatic cells. They discovered that signatures of senescence preceded the onset of disease. When his team removed the senescent pancreatic cells in mice, their metabolism stabilized and their diabetes symptoms went away.

What Bhushan took away from that study was that senescence didnt just happen when the bodys biological clocks wound down too far. It occurred in acute diseases too. Thered been talk in the field that an immune surveillance system maintained tissue homeostasis, said Bhushan. We postulated that that system was failing in the disease state and gradually failing in aging, so the only time wed see senescent cells is when this system fails.

To test that hypothesis, his team first went looking for clues as to the identity of their indolent immune cells. By comparing the transcriptional profile which genes were turned on and off in senescent pancreatic cells to healthy ones, they uncovered that the senescent ones boosted production of their antigen-presenting machinery. These are the proteins that, if a cell were infected with a pathogen, would shuttle little bits of the bacteria or virus to its surface, displaying them for immune cells to find. Then they cross-referenced those results with an analysis of senescent stem cells that accumulate in the fat tissues of obese mice who are fed a chronic, high-fat diet. Those cells also upregulated antigen-presenting molecules, and one in particular: CD1d. That was the lock, said Bhushan. And once wed found it, the key was then obvious.

Only one kind of immune cell binds to CD1d invariant natural killer T cells, or iNKTs. Comprising less than 1% of all peripheral blood immune cells, iNKTs are rare but critical components of the bodys surveillance system, scanning for infected and defective cells in need of removal. When they find them, iNKTs expel torrents of cytokines, which signal to other immune cells to do the dirty work. Bhushan figured that something was interfering with that process. And though he wasnt sure what it was, he knew there was a way to fix it.

In the early 1990s, Japanese scientists from Kirin Brewerys pharmaceutical research lab, looking for anticancer treatments in the porous bodies of marine sponges collected in the Okinawan sea, purified a lipid compound called -galactosylceramide. And they discovered that when CD1d grabs onto this -GalCer lipid, it turns on iNKTs like crazy in mice.

So Bhushans team shot up some of their diet-induced obese mice with -GalCer. Within days, the levels of senescent cells in the mouse fat tissues had dropped. So did their fasting glucose. Their insulin sensitivity also improved. Their metabolism started to look normal.

To see how generalizable the effect was, they repeated the experiment with mice whose lung tissues had been damaged by a chemotherapy drug a common model for idiopathic pulmonary fibrosis, a serious and incurable human lung disease, and one of the nastier complications of Covid-19. In those mice, -GalCer successfully activated iNKTs, again resulting in the removal of senescent cells. The treated mice had fewer damaged cells, and they also lived longer than the control group.

Finally, Bhushan and his colleagues looked at how well activated iNKT cells could tell senescent human cells from healthy ones when cultured together. After 18 hours, 100% of the senescent cells had been destroyed; the vast majority of healthy cells went unscathed. That could give the iNKT approach a potential advantage over the senolytics drugs already in development.

Most of them are repackaged cancer drugs that work by flipping on senescent cells self-destruct buttons. But because zombie cells share a lot of molecular features with their fully animated counterparts, those drugs run the risk of creating lots of collateral damage. Clinical trials of one such drug, 17-DMAG, were abandoned due to toxic side effects in the kidney and brain. Other groups are trying to solve this by engineering a different kind of immune cell, the CAR-T cell, to become a better anti-aging treatment. But CAR-Ts come with their own dangerous side effects and are expensive to make.

Bhushan is optimistic that by returning the cells best trained to suss out senescent cells to the ranks of active immune duty, both these safety and cost concerns can be ameliorated. We have this built in specificity of the immune cells part of their job is telling senescent cells apart from healthy ones were just helping them do their job, he said.

Its still an open question. But clinical trials to answer it could be underway by the end of next year. Bhushans initial discoveries are now being developed by a biotech startup called Deciduous Therapeutics, which he co-founded in 2018. Deciduous is backed by 8VC, CRV, and Laura Demings Longevity Fund, and has until now, been operating in stealth. CEO and co-founder Robin Mansukhani told STAT that the company has been focusing on developing compounds that can best stimulate human iNKTs, whose receptors are structurally a bit different from those of a mouse. He expects Deciduous to file its first investigational new drug application to start human testing within the next 18 months, likely for a metabolic disease or fibrotic lung disorder.

Investors pumped the brakes on senolytics after one of the biggest and brightest stars of the nascent sector and another Longevity Fund portfolio company, Unity Biotechnology, announced last August that its lead drug candidate had failed to reduce knee pain in patients with osteoarthritis. The experimental drug was immediately and unceremoniously dumped, along with nearly one-third of Unitys staff.

But despite the recent slowdown, Mansukhani remains optimistic. The issue in the field has always been what is the actual immune system process behind senescence clearing?he said. And I feel like weve uncovered that.

Mayos Kirkland cautions that deciphering one chapter of the immune system users manual isnt likely to be the whole story. Senescence can be caused by lots of things aging, yes, but also obesity, chemotherapy drugs, and radiation. There are about 40 to 50 different things that can push a cell into a death spiral, said Kirkland. That makes it really hard to define what a senescent cell is, because its molecular makeup depends on how its senescence was induced.

But the good news, according to Kirkland, is that all the fundamental aging processes mitochondria powering down, oxygen radicals disfiguring DNA, rampant inflammation, the spiral toward senescence appear to be tightly interlinked. Its looking increasingly like if you hit one part of this network of things going on, you affect all the rest, and usually in a positive way, he said.

Kirkland, together with his team at Mayo, have had some success with a cocktail of dasatinib and quercetin. In 2019, they reported positive results from a Phase 1 pilot study of nine diabetic kidney disease patients senescent cells were reduced. A Phase 2 study is now underway. And his team has several more trials for serious conditions, including osteoporosis and Alzheimers disease, in the pipeline. Kirkland serves as a scientific adviser to a new senolytics company called NRTK Biosciences that has yet to receive funding and anti-aging supplement company Elysium Health.

But the real question for the future, said Kirkland, is which interventions can you combine to get an additive, synergistic effect? Something that actually alleviates not just one disease of aging, but many, or even all of them? Figuring out how immune cells interplay with senescence is going to be the start of looking for those combinations.

Thats whats next for Bhushans lab a painstaking process of deleting different antigen-displaying peptides across dozens of types of immune cells, and mapping out the almost infinitely complex network of interactions brewing in the toxic stew surrounding senescent cells.

We know we only have part of the story, Bhushan said. We know we can fix whatever is going wrong with iNKTs, but we still dont know exactly what that is.

Science Writer

Megan Molteni is a science writer for STAT, covering genomic medicine, neuroscience, and reproductive tech.

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Seattle Cancer Care Alliance is an Authorized Treatment Center for Ide-cel CAR T-Cell Therapy – StreetInsider.com

By Gene Therapy Clinics

News and research before you hear about it on CNBC and others. Claim your 1-week free trial to StreetInsider Premium here.

Cancer center among the first in the nation to offer the first approved CAR T-cell therapy for adults with multiple myeloma

SEATTLE--(BUSINESS WIRE)-- Seattle Cancer Care Alliance (SCCA), the only National Comprehensive Cancer Network designated cancer center in Washington State, today announced that it is an authorized treatment center for the new B-cell maturation antigen (BCMA) targeted chimeric antigen receptor (CAR) T-cell therapy, idecabtagene vicleucel, also known as ide-cel.

Ide-cel was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2021, and is indicated for the treatment of adult patients with relapsed refractory multiple myeloma after four or more prior lines of therapy including a proteasome inhibitor, an immunomodulatory therapy and an anti-CD38 antibody. It is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma and is being marketed under the brand name Abecma.

We are pleased to offer this new advanced therapy to patients who are suffering from relapsed or refractory multiple myeloma, said Nancy Davidson, MD, president and executive director of Seattle Cancer Care Alliance. We are committed to delivering personalized care to our patients and improving patient outcomes and excited to be among the first cancer centers in the nation to offer this treatment to adult patients with multiple myeloma.

Multiple myeloma is a cancer of plasma cells in which abnormal plasma cells build up in bone marrow and limit the bodys ability to make enough healthy blood cells, thus resulting in low blood counts. Multiple myeloma is also associated with bone and kidney damage as well as a weakened immune system. There are over 140,000 people in the United States living with this cancer and according the American Cancer Society approximately 34,920 new cases will be diagnosed in 2021, and 12,410 deaths among those with multiple myeloma will occur.

Ide-cel is a one-time therapy that is created from a patients own white blood cells, which have been modified to recognize and attack myeloma cells. As an anti-BCMA CAR T-cell therapy, ide-cel recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.

In the clinical study that supported its approval, ide-cel was shown to be safe and effective. Approximately 72% of patients partially or completely responded to the treatment with 28% of patients showing complete response. An estimated 65% of this group remained in complete response to ide-cel for at least 12 months.

The FDA approval of this novel therapy is a significant milestone in the advancement of new, innovative therapies for multiple myeloma, said David Maloney, MD, PhD, medical director for cellular immunotherapy at the Bezos Family Immunotherapy Clinic at Seattle Cancer Care Alliance. We are excited about the continued expansion of CAR T-cell treatment options available to our patients, and the potential ide-cel offers to extend the lives of those who have multiple myeloma.

Our clinical trials at the SCCA have provided us with extensive experience using BCMA CAR T-cells for multiple myeloma. The new FDA approval allows our to leverage this knowledge and safely bring a promising therapy to a wider population of adult patients with multiple myeloma, said Damian Green, MD, Seattle Cancer Care Alliance and Associate Professor, and who leads translational myeloma research programs at Seattle Cancer Care Alliance and the Fred Hutchinson Cancer Research Center.

SCCA is home to several of the worlds leading immunotherapy experts whose research has contributed to the foundation of many immunotherapies currently used to treat cancer. SCCAs Bezos Family Immunotherapy Clinic, which opened in 2016, is a state-of-the-art center dedicated to offering the newest cellular immunotherapy clinical trials and FDA approved treatments.

About Seattle Cancer Care Alliance

Seattle Cancer Care Alliance brings together the leading research teams and cancer specialists from Fred Hutch, Seattle Childrens and UW Medicine one extraordinary group whose sole purpose is the pursuit of better, longer, richer lives for our patients. Based in Seattles South Lake Union neighborhood, Seattle Cancer Care Alliance has nine clinical care sites in the region, including a medical oncology clinic at EvergreenHealth in Kirkland; hematology/medical oncology and infusion services at Overlake Medical Center in Bellevue, medical and radiation oncology clinics at UW Medical Center - Northwest Seattle and medical oncology services at SCCA Issaquah, as well as Network affiliations with hospitals in five states. For more information about SCCA, visit seattlecca.org.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210513005357/en/

Karina San Juan, ksanjuangu@seattlecca.org or (206) 606-1926 Heather Platisha, hplatisha@seattlecca.org or (206) 606-7239

Source: Seattle Cancer Care Alliance

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Seattle Cancer Care Alliance is an Authorized Treatment Center for Ide-cel CAR T-Cell Therapy - StreetInsider.com

Discovery of a new genetic cause of hearing loss illuminates how inner ear works – India Education Diary

By Gene Therapy Clinics

A gene calledGAS2plays a key role in normal hearing, and its absence causes severe hearing loss, according to a study led by researchers in the Perelman School of Medicine at the University of Pennsylvania.

The researchers, whose findings arepublished online today inDevelopmental Cell, discovered that the protein encoded byGAS2is crucial for maintaining the structural stiffness of support cells in the inner ear that normally help amplify incoming sound waves. They showed that inner ear support cells lacking functionalGAS2lose their amplifier abilities, causing severe hearing impairment in mice. The researchers also identified people who haveGAS2mutations and severe hearing loss.

Anatomists 150 years ago took pains to draw these support cells with the details of their unique internal structures, but its only now, with this discovery aboutGAS2, that we understand the importance of those structures for normal hearing, said study senior authorDouglas J. Epstein, PhD, professor of genetics at Penn Medicine.

Two to three of every 1,000 children in the United States are born with hearing loss in one or both ears. About half of these cases are genetic. Although hearing aids and cochlear implants often can help, these devices seldom restore hearing to normal.

One of the main focuses of the Epstein laboratory at Penn Medicine is the study of genes that control the development and function of the inner eargenes that are often implicated in congenital hearing loss. The inner ear contains a complex, snail-shaped structure, the cochlea, that amplifies the vibrations from sound waves, transduces them into nerve signals, and sends those signals toward the auditory cortex of the brain.

Unraveling the role ofGas2in hearing

A few years ago, Epsteins team discovered thatGas2, the mouse version of humanGAS2, is switched on in embryos by another gene known to be critical for inner ear development. To determineGas2s role in that development, the team developed a line of mice in which the gene had been knocked out of the genome and called themGas2-knockout mice.

Alex Rohacek, PhD, a former graduate student in the Epstein lab, was puzzled to observe that theGas2-knockout mice had inner ears with cells and structures that seemed quite normal. However, the animals, when tested, turned out to be severely hearing-impaired, with deficits at high sound frequencies of up to 50 decibelsequivalent to a loss of 99.999 percent of the normal acoustic energy.

Tingfang Chen, PhD, a postdoctoral fellow and co-first author on the study, determined thatGas2is normally active within inner-ear support cells called pillar cells and Deiters cells. In these cells, the protein encoded by the gene binds to flexible, tube-like structures called microtubules in a way that bundles and stabilizes them, effectively stiffening the cells.

With help from the collaborating team ofBenjamin L. Prosser, PhD, assistant professor of Physiology at Penn Medicine and an expert on microtubules, the researchers discovered that when pillar cells and Deiters cells lackGas2, their microtubule bundles tend to come apart, dramatically reducing the stiffness of the cells.

That turns out to have dire implications for hearing. Within the inner ear, pillar cells and Dieters cells help form the basic structure of the cochlea and serve as physical supports for cells called outer hair cells. The outer hair cells move in response to incoming acoustical vibrationsessentially to provide a crucial amplification of that sound energy. The experiments revealed that the pillar and Deiters cells loss of stiffness, due to the absence ofGas2, severely degrades the sound-amplifying properties of the outer hair cells they support.

We observed that some of Deiters cells in theGas2-knockout mice even buckled under the tension of the rapid movements of the outer hair cells, Epstein said.

The experiments included sophisticated imaging of propagating sound waves in the inner ears of liveGas2-knockout and normal mice, conducted by collaboratorJohn Oghalai, MD, chair and professor of otolaryngology-head and neck surgery at the Keck School of Medicine of USC, and his team.

GAS2also causes human hearing loss

Curiously, the researchers could find no reports ofGAS2-associated congenital hearing loss in the medical literature. Even when they canvassed colleagues around the world who run hearing-loss clinics, they came up empty-handed.

Then one day,Hannie Kremer, PhD, professor and chair of molecular otogenetics at Radboud University Medical Center in the Netherlands, emailed Epstein. She and her team had been studying a Somalian family in which four of the siblings had severe hearing loss from early life. The affected family members had no mutations in known hearing-loss genesbut each carried two mutant copies ofGAS2.

The study therefore establishesGAS2as a very probable new hearing loss gene in humansthe first one known to affect the mechanical properties of inner ear support cells.

The prevalence of hearing loss in people due toGAS2mutations remains to be determined, but Epstein noted that this type of congenital hearing loss is nevertheless an attractive target for a future gene therapy.

In many genetic hearing loss conditions, the affected cells are permanently damaged or die, but in this one, the affected cells are intact and conceivably could be restored to normal or near-normal by restoringGAS2function, he said.

He added that such a gene therapy might be useful not only in more obvious cases of hearing loss in early childhood, but also in casesperhaps more numerousin which inherited mutations lead to a slower development of hearing loss in adulthood.

Funding was provided by the National Institutes of Health (R01 DC006254, R01 DC014450, R01 DC013774, R01 DC017741, R01 HL133080), the Boucai Innovation Fund in Auditory Genomics, the National Science Foundation (15-48571), and the Heinsius Houbolt Foundation.

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Discovery of a new genetic cause of hearing loss illuminates how inner ear works - India Education Diary

Castle Biosciences Announces Pipeline Initiative to Develop Genomic Test Targeting Systemic Therapy Response in Patients with Psoriasis, Atopic…

By Gene Therapy Clinics

FRIENDSWOOD, Texas--(BUSINESS WIRE)--Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced its innovative pipeline initiative to develop a genomic test aimed at predicting systemic therapy response in patients with moderate to severe psoriasis, atopic dermatitis and related conditions.

Castle Biosciences has designed, developed and validated multiple genomic tests, including three dermatologic genomic tests, all of which are currently commercially available. These tests are designed to provide information for clinicians and patients to make personalized treatment decisions along the patient care continuum, including pre-diagnosis and following diagnosis, based on the biology of each patients disease. With the Companys pipeline test for psoriasis, atopic dermatitis and related conditions, Castle expands its dermatology focus from cancer to include inflammatory skin disease. This pipeline initiative is expected to produce a genomic test that predicts systemic therapy response to guide therapy selection in patients with moderate to severe psoriasis, atopic dermatitis and related conditions.

We are in an industry-leading position, as the only diagnostic company with a suite of dermatologic gene expression profile tests, said Derek Maetzold, president and chief executive officer of Castle Biosciences. We have demonstrated our ability to successfully develop, validate and bring to market clinically actionable, innovative tests. We start by identifying dermatologic diseases with high unmet clinical need. We then use the gene expression profile of an individual patients biology in an effort to develop gene expression profile tests designed to assist clinicians and their patients by better informing treatment to optimize health outcomes and reduce health care costs.

We are excited to expand our pipeline beyond cancer to other dermatologic diseases that significantly impact patients lives and have unanswered clinical questions. We are working with several leading experts in inflammatory skin diseases to develop a test that can predict a patients response to therapy for patients with moderate to severe psoriasis, atopic dermatitis and related conditions. Our goal is to shift systemic therapy selection such that the appropriate therapy is selected the first time. This goal is clinically and economically important, as the burden of cost for todays therapies are front loaded, and a significant amount is incurred within the first three months of treatment. If our test is able to guide therapy selection, based on the patients own disease biology, we believe we can help direct therapy selection decisions to start patients on potentially the most effective treatment sooner, while reducing the likelihood of a patient discontinuing or switching therapies, possibly resulting in a better utilization of healthcare resources.

Based upon our development and validation timelines, we believe that we can launch this pipeline test by the end of 2025, utilizing our well-established dermatologic sales channels, adding approximately $1.9 billion to our current estimated U.S. total addressable market.

Castle has initiated a 4,800 patient, prospective, multi-center clinical study to develop and validate this pipeline test. We expect to recruit approximately 50 participating centers from across the U.S.

About Psoriasis, Atopic Dermatitis and Related Conditions

Inflammatory skin disease accounts for a significant number of patient visits to both primary care and dermatology clinics across the U.S. every year. Psoriasis and atopic dermatitis are among the most common inflammatory skin conditions, and patient quality of life is severely impacted by these chronic diseases. Fortunately, systemic medications developed over the past 15 years have demonstrated a significant improvement in patients lives. In the U.S. alone, there are about 18 million patients diagnosed with psoriasis and atopic dermatitis, and approximately 450,000 patients annually are eligible for these systemic therapies. While there are now many effective treatments options available for those with moderate to severe disease, current clinical practice relies on a trial-and-error approach for therapy selection. To answer this unmet clinical need, Castle Biosciences is developing a gene expression profile test to predict response to systemic therapies for patients with moderate to severe psoriasis, atopic dermatitis and other related diseases. Personalized guidance for therapy selection and anticipated efficacy has the potential to improve patient health outcomes by enabling clinicians to select the best medication for their patients specific skin disease.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a commercial-stage dermatologic diagnostics company focused on providing physicians and their patients with personalized, clinically actionable genomic information to make more accurate treatment decisions. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx-Melanoma, DecisionDx-CMSeq), cutaneous squamous cell carcinoma (DecisionDx-SCC), suspicious pigmented lesions (DecisionDx DiffDx-Melanoma) and uveal melanoma (DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq). For more information about Castles gene expression profile tests, visit http://www.CastleTestInfo.com. Castle also has active research and development programs for tests in other dermatologic diseases with high clinical need, including its test in development to predict systemic therapy response in patients with moderate to severe psoriasis, atopic dermatitis and related conditions. Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix, Arizona. For more information, visit http://www.CastleBiosciences.com.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, DecisionDx DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements

The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the safe harbor created by those sections. These forward-looking statements include, but are not limited to, statements concerning the potential success of our pipeline initiative; potential improvements in patient treatment, optimized health outcomes and reduced healthcare costs attributable to any test developed by our pipeline initiative; anticipated timing for launch of our pipeline test; and the potential increase in our estimated U.S. total addressable market. The words anticipates, believes, estimates, expects, intends, may, plans, projects, will, would and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, changes in need and market opportunity for any tests developed through this pipeline initiative may impact our estimated total U.S. market opportunity, delays in clinical studies may delay our ability to launch our pipeline test, our pipeline test may not be as effective as anticipated, the effects of the COVID-19 pandemic on our business and our efforts to address its impact on our business, changes in the competitive landscape and introduction of competitive products, subsequent study results and findings that contradict earlier study results and findings, the level and availability of reimbursement for our products, our ability to manage our anticipated growth and the risks set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

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Castle Biosciences Announces Pipeline Initiative to Develop Genomic Test Targeting Systemic Therapy Response in Patients with Psoriasis, Atopic...

Accelerated Biosciences’ Immune-Privileged Human Trophoblast Stem Cells (hTSCs) Offer Breakthrough Opportunities in Cancer-Targeting Therapeutics and…

By Induced Pluripotent Stem Cells

CARLSBAD, Calif.--(BUSINESS WIRE)--Accelerated Biosciences, a regenerative medicine innovator, announced today new data that further demonstrates statistically significant cytolysis with induced pluripotent stem cell (iPSC)-derived natural killer (NK) cells programmed from its ethically sourced human trophoblast stem cells (hTSCs). Pluristyx, a Seattle-based firm supporting drug development, regenerative medicine, and cell and gene therapies, further confirmed Accelerated Biosciences hTSC line offers before-unrealized opportunities in cell-specific therapeutics. Along with this recent data on successful iPSC differentiation, Accelerated Biosciences has already demonstrated efficient differentiation of its pluripotent stem cells with remarkable doubling times and growth characteristics to programmed NK, cartilage, bone, fat, neuron, pancreas, liver, and secretome cells.

This new data validates our findings, explains Yuta Lee, President and Founder of Accelerated Biosciences. We know the properties of our trophoblast stem cells have been long-sought by the medical science community because of the potential to speed and amplify the development of life-saving therapeutics; theyre immune privileged, chromosomally stable (not tumorigenic), pathogen free, pluripotent, easy to scale and manufacturer, and of special interest, they are ethically sourced from the chorionic villi (pre-placental tissue) of non-viable and often life-threatening tubal ectopic pregnancies. Mr. Lees father, Professor Jau-Nan Lee, MB, MD, PhD, an obstetrics and gynecologic physician and researcher in Taiwan, first isolated hTSC in 2003. Mr. Lee created Accelerated Biosciences to elevate the visibility of this pluripotent human trophoblast stem cell platform to those engaged in developing allogeneic cell therapeutics and has been instrumental in the filing and prosecution of intellectual property to protect the companys hTSC platform to date holding 34 patents.

Benjamin Fryer, PhD, Co-founder and CEO of Pluristyx, worked closely with Accelerated Biosciences to prepare much of its key hTSC data. Dr. Fryer, a trophoblast expert who was previously a research scientist at Janssen Research & Development of Johnson & Johnson, now serves on Accelerated Biosciences Scientific Advisory Board. Initially I was skeptical these cells were what they said they were. If we hadnt grown and characterized them in our lab, I might have remained skeptical. These are indeed trophoblast stem cells, explained Dr. Fryer. The potential of these cells is enormous. One of the industrys largest challenges is that its almost impossible to scale primary cells. These cells are scalable. With these cells you can make the amount required for millions of patients and theyre sourced compliant to regulatory requirements. Weve made IPS cells (induced pluripotent stem cells) and NK (natural killer) cells from them, which is the next wave of cells for cell therapies. For therapeutic developers, because these cells are not sourced from a person or viable embryo, these cells deliver the trifecta of legal, ethical, and IP advantages.

As the biotechnology industry works toward developing therapies that target only diseased cells without harming healthy cells and tissues, cell-based therapies draw increasing interest, explains industry expert, Martina Molsbergen, CEO of C14 Consulting, who has partnered with Accelerated Biosciences in a business development role. With all the promise that cell therapies hold, the biotechnology industry also remains concerned that the therapeutics are derived in a socially and ethically responsible manner. Accelerated Biosciences has discovered and is now offering what scientists see as the holy grail of stem cell sources.

Prominent biosciences experts have been drawn to Accelerated Biosciences cell breakthrough. Protein chemist and molecular biologist Igor Fisch, PhD, former President and CEO of Selexis, Geneva, Switzerland, recognizes the impact that Accelerated Biosciences hTSCs will have on human health: Not only are these cells politically correct, but they can also differentiate. Because they are sourced from pre-placenta material, theyre immune privileged, which means that are not seen as foreign by the human body. With these cells, we can create a cell bank a single source for a wide range of patients.

Peter Hudson, FTSE, BSc Hons, PhD, Chief Scientist and a senior advisor to Avipep P/L in Melbourne, Australia, and an adjunct professor at the University of Queensland, led a large oncology consortium to complete the first Phase 1 clinical trial of a novel engineered antibody targeting prostate and ovarian cancer. Hudsons interest in Accelerated Biosciences hTSCs has evolved into a role on its Scientific Advisory Board. Trophoblast stem cells are likely to be the next wave of cancer-targeting therapeutics, explains Dr. Hudson. The ability to ethically source trophoblast stem cells and program them to target only diseased, cancerous cells is very powerful technology.

Why are scientists so interested in stem cell-based therapies?

The human body constantly produces specialized cells from its own stem cells (undifferentiated cells) to renew and repair itself. Current therapies harness this power in autologous cell therapies in which the patients own cells are removed, differentiated into disease-fighting cells, and reinserted.

What makes the human trophoblast stem cell so important to medical science?

The human trophoblast stem cell (hTSC) comes from placental tissue and has special properties that make it extremely desirable to therapeutic developers. The hTSC is such an early stem cell that it has much more capacity for growth than a stem cell taken from an adult, for example. This means that one cell can become millions. The hTSC also carries with it the same immune-privilege that a growing embryo has inside its mother: its not seen as foreign although its genetically different than its mother. Unlike other foreign materials, the hTSC is not rejected by the human body, which means that it can be used with many different patients (allogeneic cell therapy). With these benefits, the scientific community holds a high regard for hTSCs, but it also faces socio-ethical concerns about how those stem cells are typically sourced.

Accelerated Biosciences sidesteps hTSC sourcing concerns in a profoundly elegant way. Dr. Jau-Nan Lee, an OB-GYN in Taiwan, found inspiration in what was considered medical waste. When surgical intervention was necessary to remove an ectopic pregnancy that would otherwise risk the womans life, the non-viable embryo and pre-placental tissue lodged in the fallopian tube was removed, sent to pathology, and discarded. Gaining permission from institutional colleagues and sampling the pre-placental tissue, Dr. Lee isolated hTSC that offered all the benefits of hTSC pluripotency, immune privilege, and scalability without pathogens and without ethical compromises.

About Accelerated Biosciences

Founded in 2013, Accelerated Biosciences is a private company focused on regenerative medicine and built around the hTSC discoveries of obstetrics and gynecology physician and researcher, Professor Jau-Nan Lee, MB, MD, PhD. Accelerated Biosciences holds a large and robust patent portfolio and an encumbrance-free intellectual property (IP) estate. Accelerated Biosciences mission is to leverage its renewable, immune-privileged human cell source to fuel breakthrough cell therapies that effectively target the most challenging diseases of the human body. For more information about Accelerated Biosciences, visit acceleratedbio.com or email mmolsbergen@c14consultinggroup.com.

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Accelerated Biosciences' Immune-Privileged Human Trophoblast Stem Cells (hTSCs) Offer Breakthrough Opportunities in Cancer-Targeting Therapeutics and...

Study Models the Effect of Herpes Infection on Fetal Brain Development – Pharmacy Times

By Induced Pluripotent Stem Cells

HSV-1 can spread to the fetal brain during pregnancy and cause lifelong neurological problems, such as cognitive dysfunction, learning disabilities, and dementia.

Three cell-based models shed light on how herpes simplex virus type 1 (HSV-1) infection may contribute to various neurodevelopmental disabilities and long-term neurological problems into adulthood, according to a study published in PLOS Pathogens. HSV-1 can spread to the fetal brain during pregnancy and cause lifelong neurological problems, such as cognitive dysfunction, learning disabilities, and dementia.

Progress in understanding the role of HSV-1 in human fetal brain development has been hampered by restricted access to fetal human brain tissue. Additionally, existing animal models are limited in their applicability to humans. To address the knowledge gap, the investigators generated 3 cell-based neurodevelopmental disorder models, including a 2D layer of cells and a 3D brain-like structure. These models are based on human-induced pluripotent stem cells (hiPSCs), which are immature, embryonic stem cell-like cells. These hiPSCs are generated by genetically reprogramming specialized adult cells.

According to the investigators, HSV-1 infection in neural stem cells derived from hiPSCs resulted in activation of the caspase-3 apoptotic pathway, which initiates programmed cell death. HSV-1 infection also impaired the production of new neurons and hindered the ability of hiPSC-derived neural stem cells to convert into mature neurons through a process called neuronal differentiation.

The study also found that the HSV-1-infected brain organoids mimicked the pathological features of neurodevelopmental disorders in the human fetal brain, including impaired neuronal differentiation and abnormalities in brain structure. In addition, the 3D model showed that HSV-1 infection promotes the abnormal proliferation and activation of non-neuronal cells called microglia, accompanied by the activation of inflammatory molecules, such as TNF-alpha, IL-6, IL-10, and IL-4.

According to the authors, the findings open new therapeutic avenues for targeting viral reservoirs relevant to neurodevelopmental disorders. They added that the study provides novel evidence that HSV-1 infection impaired human brain development and contributes to the neurodevelopmental disorder pathogen hypothesis.

REFERENCE

How herpes infection may impair human fetal brain development [news release]. EurekAlert; October 22, 2020. Accessed May 7, 2021. https://www.eurekalert.org/pub_releases/2020-10/p-hhi101520.php

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Study Models the Effect of Herpes Infection on Fetal Brain Development - Pharmacy Times

Induced Pluripotent Stem Cells Market is set for Lucrative Growth | Top Companies Thermo Fisher Scientific Inc., FUJIFILM Corporation, KSU | The…

By Induced Pluripotent Stem Cells

The Induced Pluripotent Stem Cells market is expected to grow at a CAGR of 9.7% and is poised to reach $XX Billion by 2027 as compared to $XX Billion in 2020. The factors leading to this extraordinary growth is attributed to various market dynamics discussed in the report. Our experts have examined the market from a 360 degree perspective thereby producing a report which is definitely going to impact your business decisions. In order to make a pre-order inquiry, kindly click on the link below:- https://decisivemarketsinsights.com/induced-pluripotent-stem-cells-market/93040505/pre-order-enquiry

The Induced Pluripotent Stem Cells market research industry analysis report by Decisive Markets Insights gives the examination and estimation about the crucial reasons or the drivers that are liable for the development of the market related to the industry. Decisive Markets Insights provides the market research industry report in several various domains and sectors such as BFSI, IT & Telecom, Healthcare, Manufacturing, Retail, Transportation, Energy & Utilities, and Others as well.Moreover, some vital reasons are given in the market research report that can affect and hamper the development of the market during the estimation of the time frame. Based on the size of the endeavor, the end clients of the worldwide market can be sorted easily. Thus, the open doors for the players of the global market are presented in the market research report.

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Key Companies Operating in this Market

Thermo Fisher Scientific Inc., FUJIFILM Corporation, Horizon Discovery Ltd., Takara Bio Inc, Cell Applications, Inc., Lonza Group AG, Evotec A.G., ViaCyte, Inc., CELGENE CORPORATION, Fate Therapeutics, Astellas Pharma Inc.,

Market by Type (Hepatocytes, Fibroblasts, Keratinocytes, Amniotic Cells, Neuronal Cells, Cardiac Cells, Vascular Cells, Immune Cells, Renal Cells, Liver Cells, Others

Market by Application Academic Research, Drug Development & Discovery, Toxicity Screening, Regenerative Medicine

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Additionally, some of the tools such as the SWOT analysis and the PESTEL analysis arevastly used to measure some of the vital aspects of the Induced Pluripotent Stem Cells market that are likely to affect the global market for the estimated forecast period.Based on figures by different segments, divisions, past and the current information of the market, the development estimation of the market is well offered in the market research industry report. Besides this, the market research industry report can assist the customers in taking vital decisions for their growth and development in the business in the current as well as the expected future conditions as well.

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Induced Pluripotent Stem Cells Market is set for Lucrative Growth | Top Companies Thermo Fisher Scientific Inc., FUJIFILM Corporation, KSU | The...

Stem Cell Therapy Market by Type, Therapeutic Application and Cell Source – Global Forecasts to 2026 – ResearchAndMarkets.com – Business Wire

By Induced Pluripotent Stem Cells

DUBLIN--(BUSINESS WIRE)--The "Global Stem Cell Therapy Market by Type (Allogeneic, Autologous), Therapeutic Application (Musculoskeletal, Wound & Injury, CVD, Autoimmune & Inflammatory), Cell Source (Adipose tissue, Bone Marrow, Placenta/Umbilical Cord) - Forecasts to 2026" report has been added to ResearchAndMarkets.com's offering.

The global stem cell therapy market is projected to reach USD 401 million by 2026 from USD 187 million in 2021, at a CAGR of 16.5% during the forecast period.

Growth in this market is majorly driven by the increasing investment in stem cell research and the rising number of GMP-certified stem cell manufacturing plants. However, factors such as ethical concerns and the high cost of stem cell research and manufacturing process likely to hinder the growth of this market.

The allogeneic stem cell therapy segment accounted for the highest growth rate in the stem cell therapy market, by type, during the forecast period

The stem cell therapy market is segmented into allogeneic and autologous stem cell therapy. Allogeneic stem therapy segment accounted for the largest share of the stem cell therapy market. The large share of this segment can be attributed to the lesser complexities involved in manufacturing allogeneic-based therapies.

This segment is also expected to grow at the highest growth rate due to the increasing number of clinical trials in manufacturing allogeneic-based products.

Bone Marrow-derived MSCs segment accounted for the highest CAGR

Based on the cell source from which stem cells are obtained, the global stem cell therapy market is segmented into four sources. These include adipose tissue-derived MSCs (mesenchymal stem cells), bone marrow-derived MSCs, placenta/umbilical cord-derived MSCs, and other cell sources (which include human corneal epithelium stem cells, peripheral arterial-derived stem cells, and induced pluripotent stem cell lines).

The bone marrow-derived MSCs segment is expected to witness the highest growth rate during the forecast period, owing to an increasing number of clinical trials focused on bone marrow-derived cell therapies and the rising demand for these cells in blood-related disorders.

Asia Pacific: The fastest-growing country in the stem cell therapy market

The stem cell therapy market is segmented into North America, Europe, Asia Pacific, RoW. The stem cell therapy market in the Asia Pacific region is expected to grow at the highest CAGR during the forecast period.

Factors such as the growing adoption of stem cell-based treatment in the region and the growing approval & commercialization of stem cell-based products for degenerative disorders drive the growth of the stem cell therapy market in the region.

Market Dynamics

Drivers

Restraints

Opportunities

Challenges

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/qiagh1

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Stem Cell Therapy Market by Type, Therapeutic Application and Cell Source - Global Forecasts to 2026 - ResearchAndMarkets.com - Business Wire

Global Induced Pluripotent Market Showing Impressive Growth by 2027||Thermo Fisher Scientific; Cell Applications, Inc.; Axol Bioscience Ltd.;…

By Induced Pluripotent Stem Cells

A complete Induced Pluripotent market analysis report is created by thoroughly understanding business environment which best suits the requirements of the client. With this market research document it becomes easy to develop a successful marketing strategy for the business. This market research report is a complete overview of the market that takes into account various aspects of product definition, market segmentation based on various parameters, and the established merchant landscape. Estimations about the rise or fall of the CAGR value for specific forecast period are also mentioned in the report. A credible Induced Pluripotent market report not only gives an advantage to develop the business but also helps to outshine the competition.

The induced pluripotent market is expected to gain market growth at a potential rate of 9.2% in the forecast period of 2020 to 2027. Increase in the expenditure incurred by various private and government sources on R&D is the vital factor escalating the induced pluripotent market growth.

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Few of the major competitors currently working in the induced pluripotent market areBristol-Myers Squibb Company; CELGENE CORPORATION; Astellas Pharma Inc.; Thermo Fisher Scientific; Cell Applications, Inc.; Axol Bioscience Ltd.; Organogenesis Holdings; Merck KGaA; FUJIFILM Holdings Corporation; Fate Therapeutics; KCI Licensing, Inc.; Japan Tissue Engineering Co., Ltd.; Vericel; ViaCyte, Inc.; STEMCELL Technologies Inc.; Horizon Discovery Group plc; Lonza; Takara Bio Inc.; Promega Corporation and QIAGEN.

The report provides insights on the following points:

Induced Pluripotent Market Scope and Market Size

The induced pluripotent market is segmented on the basis of product, cell type, application and end-user. The growth among segments helps you analyse niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

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Market Drivers

Market Restraints

Table of Contents:

1 Introduction

2 Research Methodologies

3 Executive Summary

4 Premium Insights

5 Market Overview

6 Industry Trends

7 Compliance in Induced Pluripotent Market

8 Induced Pluripotent Market, By Service

9 Induced Pluripotent Market, By Deployment Type

10 Induced Pluripotent Market, By Organization Size

11 Induced Pluripotent Market Analyses, By Vertical

12 Geographic Analyses

13 Competitive Landscapes

14 Detailed Company Profiles

15 Related Reports

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