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This Key Protein Is Essential for Brain Cell Longevity and Growth – SciTechDaily

By Adult Stem Cells

Recent research finds that the insulin receptor protein (INSR) is pivotal for brain stem cell longevity and growth.

Stem cells are the bodys raw materials they are the cells that give rise to all other cells with specialized functions. In the right circumstances, stem cells in the body divide to produce new cells known as daughter cells.

Humans contain neural stem cells in their brains. These brain stem cells may develop into neurons, astrocytes, or oligodendrocytes. Because neural stem cells generate all of the brains cell types, there is a multitude of stem cells in an embryos brain. In fact, the majority of brain cells are born in the embryo stage. These cells persist till adulthood and can be found in particular regions of the brain. Neural stem cells are essential for your brain to properly function.

According to research from Rutgers University, a receptor that was first identified as necessary for insulin action and is also found on neural stem cells found deep in the brains of mice is crucial for brain stem cell longevity, a finding that has important implications for brain health and future therapies for brain disorders.

The research, published in the journal Stem Cell Reports, focuses on a particular protein known as the insulin receptor (INSR), which is prevalent in neural stem cells in the brains subventricular zone. Neural stem cells give rise to the entire nervous system throughout development and persist into adulthood. Over the course of a persons life, these neural stem cells generate new neurons and non-neuronal cells that help the brains infrastructure and function.

Separately, while studying brain tumors, the researchers discovered that INSR plays an important role in the survival and maintenance of a population of specialized brain cancer cells known as glioblastoma (GBM) stem cells. They were able toreducethe growth of those primitive tumor-forming cells by inactivating the INSR in GBM stem cells.

Its important to understand the molecular mechanisms that are critical for the growth and sustenance of the brains stem cells under normal and abnormal growth states, said study author Steven Levison, a professor of neuroscience in the Department of Pharmacology, Physiology, and Neuroscience and director of the Laboratory for Regenerative Neurobiology at Rutgers New Jersey Medical School. Comprehending the signals that regulate these primitive cells could one day lead to new therapeutics for brain disorders.

Many neurodegenerative disorders, such as multiple sclerosis, Parkinsons disease, and Alzheimers disease, are connected with the destruction of brain cells, said co-author Teresa Wood, a Distinguished Professor and Rena Warshow Endowed Chair in Multiple Sclerosis in the Department of Pharmacology, Physiology, and Neuroscience at Rutgers New Jersey Medical School.

If we could influence how brain stem cells function then we can use this knowledge to replace diseased or dead brain cells with living ones, which would advance the treatment of neurological diseases and brain injuries, said Wood, who also teaches and conducts research at the Cancer Institute of New Jersey.

Cell receptors such as INSR are protein molecules that reside on the surfaces of cells. Substances, either natural or human-made, that open the lock of a receptor can spur a cell to divide, differentiate or die. By identifying which receptors perform these functions on specific cell types, and by understanding their structures and functions, scientists can design substances that act as keys to receptors, to turn them on or off.

Previous studies by this research team had shown that a certain key, the signaling protein that is known as the insulin-like growth factor-II (IGF-II), was necessary to maintain the neural stem cells in the two places of the adult brain that harbor these primitive cells. In the current experiment, scientists were looking to identify the receptor. To do so, they used genetic tools that allowed them to both delete the INSR and introduce a fluorescent protein so they could track the neural stem cells and the cells they generate. They found that the numbers of neural stem cells in the subventricular zone in the brains of mice lacking the INSR collapsed.

Adult neurogenesis the idea that new cells are produced in the adult brain has been a burgeoning field of scientific inquiry since the late 1990s, when researchers confirmed what had only been a theory in lab studies of human, primate, and bird brains. Neural stem cells in the adult are stem cells that can self-renew and produce new neurons and the supporting cells of the brain, oligodendrocytes, and astrocytes.

Given the widespread interest in stem cells as well as interest in whether alterations to adult stem cells might contribute to cancer, our research findings should be of interest, Levison said.

Other Rutgers authors included Shravanthi Chidambaram, Fernando J. Velloso, Deborah E. Rothbard, Kaivalya Deshpande, and Yvelande Cajuste of the Department of Pharmacology, Physiology, and Neuroscience at Rutgers New Jersey Medical School. Other participating investigators were at the University of Minnesota, the Albert Einstein College of Medicine, and Brown University.

Reference: Subventricular zone adult mouse neural stem cells require insulin receptor for self-renewal by Shravanthi Chidambaram, Fernando J. Velloso, Deborah E. Rothbard, Kaivalya Deshpande, Yvelande Cajuste, Kristin M. Snyder, Eduardo Fajardo, Andras Fiser, Nikos Tapinos, Steven W. Levison and Teresa L. Wood, 5 May 2022, Stem Cell Reports.DOI: 10.1016/j.stemcr.2022.04.007

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This Key Protein Is Essential for Brain Cell Longevity and Growth - SciTechDaily

The Many Spheres in Which CO2 Chambers Show Their Strengths – MedicalExpo e-Magazine

By Adult Stem Cells

Without CO2 incubators, there would be no coronavirus vaccines today. They are also absolutely essential for cancer research. These multiple uses help save lives and cure many different diseases. We would now like to introduce you to some of the interesting facets of CO2 incubators.

Sponsored by BINDER GmbH.

CO2 incubators are being used to conduct research in laboratories across the globe. The Bioscience Institute Middle East, which is among the worlds leading centers for regenerative medicine, is also using an incubator to process the bodys own cells as well as for plastic surgery applications.

The cellswhich are multiplied in an incubatorare also used in tissue repair as well as for orthopedic and dermatological treatments. The Bioscience Institute only uses skin and fat tissue specimens from adult (mature) cells. Using the bodys owni.e., autologouscells eliminates the risk of rejection while also preventing the complication of graft-versus-host disease (an unwanted reaction of the donors immune cells).

To be even more specific: the CO2 incubators are predominantly used to incubate stem cells from mesenchyme tissue (undifferentiated connective tissue).

Here is how it works: first, cells are extracted from fat tissue. This process is performed by means of enzymatic disaggregation (separation) using various steps of filtration and centrifugation. The crucial stage here is the expansion, i.e., extracting as many stem cells as possible, which is why it is absolutely essential to create the best possible growth conditions.

Dr. Simona Alfano, a biologist at the Bioscience Institute, explained:

When incubating the cells, it is vitally important for the selected parameters to remain exactly constant across all levels.

And this is precisely where the CO2 chambers from BINDER come into their ownwith their reproducible growth conditions, constant climatic conditions, low risk of contamination and high level of safety.

Find out more about why the ph value is a key factor in cell and tissue cultures.

CO2 chambers also played an important role during the coronavirus pandemic: firstly, in the development of coronavirus vaccines and, secondly, to test drugs that may be used to treat COVID-19 on cells.

For this work, the major pharmaceutical companies required huge volumes of cellswhich they were able to acquire with the aid of an incubator. The newly developed active ingredients were then tested using the cells.

The new vaccines used in the fight against the coronavirus were also repeatedly tested on cells in laboratories and evaluated. An incubator proved to be an essential piece of equipment in a laboratoryparticularly during the coronavirus pandemic.

Read more on premium equipment for virus research.

The Institute of Medical Engineering at the Lucerne University of Applied Sciences and Arts has been carrying out research in the field of space biology. The research team, led by Dr. Fabian Ille, is assisted in its work by a CO2 chamber.

Cells from a bovine hoof are being incubated inside the cabinet at regular intervals until they are needed for a specific experiment. Recently, the cells were frozen and taken to the French city of Bordeaux by Dr. Simon West and a team of researchers.

The reason behind this trip was that the research team in Lucerne was selected by the European Space Agency (ESA) to take part in parabolic flights over the Atlantic. Shortly before the parabolic flights, which lasted for a total of three hours, the cells were removed from the incubator and moved to flight hardware that had been prepared specifically for this purpose and was under controlled temperature conditions.

The scientists from Lucerne wanted to use the parabolic flights to investigate how the cells respond and adapt to mechanical forces. These findings will help them in future attempts to cultivate cartilage that is of a stronger and better consistency, for example. In other words, it might be possible to remove cells from a patient, reproduce them with this innovative new method, and then use them again in the treatment of human patients.

Weightless conditions are helping us to make significant progress, said Dr. Ille, reflecting on the research project so far.

In laboratory tests that have already been carried out, West and Ille have been able to demonstrate in very broad terms that this process could work in the future.In these tests, weightless conditions were simulated using a random position machine. Here again, a CO2 chamber from BINDER was used.

Safety is the absolute top priority here.180C sterilization ensures, for example, that every trial series begins with a clean and fully sterile incubator. Whats more, the fanless design means that germs are not stirred up.

The result is optimal cell growth and absolutely no contamination from airborne germs. A deep-drawn inner chamber without corners or edges also enables the incubator to be cleaned thoroughly with ease. It is therefore no surprise that major pharmaceutical manufacturers choose specifically to put their trust in CO2 incubators from BINDER.

BINDER CO2 incubators are the perfect combination of a range of solutions180C hot air sterilization, rapid control, fixture-free interiors and absolutely zero consumables. For optimal cell growthsafe, reliable, smart, economicallook no further than BINDER.

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The Many Spheres in Which CO2 Chambers Show Their Strengths - MedicalExpo e-Magazine

‘Ghost heart’: Built from the scaffolding of a pig and the patient’s cells, this cardiac breakthrough may soon be ready for transplant into humans -…

By Adult Stem Cells

"It actually changed my life," said Taylor, who directed regenerative medicine research at Texas Heart Institute in Houston until 2020. "I said to myself, 'Oh my gosh, that's life.' I wanted to figure out the how and why, and re-create that to save lives."

That goal has become reality. On Wednesday at the Life Itself conference, a health and wellness event presented in partnership with CNN, Taylor showed the audience the scaffolding of a pig's heart infused with human stem cells -- creating a viable, beating human heart the body will not reject. Why? Because it's made from that person's own tissues.

"Now we can truly imagine building a personalized human heart, taking heart transplants from an emergency procedure where you're so sick, to a planned procedure," Taylor told the audience.

"That reduces your risk by eliminating the need for (antirejection) drugs, by using your own cells to build that heart it reduces the cost ... and you aren't in the hospital as often so it improves your quality of life," she said.

Debuting on stage with her was BAB, a robot Taylor painstakingly taught to inject stem cells into the chambers of ghost hearts inside a sterile environment. As the audience at Life Itself watched BAB functioning in a sterile environment, Taylor showed videos of the pearly white mass called a "ghost heart" begin to pinken.

"It's the first shot at truly curing the number one killer of men, women and children worldwide -- heart disease. And then I want to make it available to everyone," said Taylor to audience applause.

"She never gave up," said Michael Golway, lead inventor of BAB and president and CEO of Advanced Solutions, which designs and creates platforms for building human tissues.

"At any point, Dr. Taylor could have easily said 'I'm done, this just isn't going to work. But she persisted for years, fighting setbacks to find the right type of cells in the right quantities and right conditions to enable those cells to be happy and grow."

"We were putting cells into damaged or scarred regions of the heart and hoping that would overcome the existing damage," she told CNN. "I started thinking: What if we could get rid of that bad environment and rebuild the house?"

Soon, she graduated to using pig's hearts, due to their anatomical similarity to human hearts.

"We took a pig's heart, and we washed out all the cells with a gentle baby shampoo," she said. "What was left was an extracellular matrix, a transparent framework we called the 'ghost heart.'

"Then we infused blood vessel cells and let them grow on the matrix for a couple of weeks," Taylor said. "That built a way to feed the cells we were going to add because we'd reestablished the blood vessels to the heart."

The next step was to begin injecting the immature stem cells into the different regions of the scaffold, "and then we had to teach the cells how to grow up."

"We must electrically stimulate them, like a pacemaker, but very gently at first, until they get stronger and stronger. First, cells in one spot will twitch, then cells in another spot twitch, but they aren't together," Taylor said. "Over time they start connecting to each other in the matrix and by about a month, they start beating together as a heart. And let me tell you, it's a 'wow' moment!"

But that's not the end of the "mothering" Taylor and her team had to do. Now she must nurture the emerging heart by giving it a blood pressure and teaching it to pump.

"We fill the heart chambers with artificial blood and let the heart cells squeeze against it. But we must help them with electrical pumps, or they will die," she explained.

The cells are also fed oxygen from artificial lungs. In the early days all of these steps had to be monitored and coordinated by hand 24 hours a day, 7 days a week, Taylor said.

"The heart has to eat every day, and until we built the pieces that made it possible to electronically monitor the hearts someone had to do it person -- and it didn't matter if it was Christmas or New Year's Day or your birthday," she said. "It's taken extraordinary groups of people who have worked with me over the years to make this happen."

But once Taylor and her team saw the results of their parenting, any sacrifices they made became insignificant, "because then the beauty happens, the magic," she said.

"We've injected the same type of cells everywhere in the heart, so they all started off alike," Taylor said. "But now when we look in the left ventricle, we find left ventricle heart cells. If we look in the atrium, they look like atrial heart cells, and if we look in the right ventricle, they are right ventricle heart cells," she said.

"So over time they've developed based on where they find themselves and grown up to work together and become a heart. Nature is amazing, isn't she?"

As her creation came to life, Taylor began to dream about a day when her prototypical hearts could be mass produced for the thousands of people on transplant lists, many of whom die while waiting. But how do you scale a heart?

"I realized that for every gram of heart tissue we built, we needed a billion heart cells," Taylor said. "That meant for an adult-sized human heart we would need up to 400 billion individual cells. Now, most labs work with a million or so cells, and heart cells don't divide, which left us with the dilemma: Where will these cells come from?"

"Now for the first time we could take blood, bone marrow or skin from a person and grow cells from that individual that could turn into heart cells," Taylor said. "But the scale was still huge: We needed tens of billions of cells. It took us another 10 years to develop the techniques to do that."

The solution? A bee-like honeycomb of fiber, with thousands of microscopic holes where the cells could attach and be nourished.

"The fiber soaks up the nutrients just like a coffee filter, the cells have access to food all around them and that lets them grow in much larger numbers. We can go from about 50 million cells to a billion cells in a week," Taylor said. "But we need 40 billion or 50 billion or 100 billion, so part of our science over the last few years has been scaling up the number of cells we can grow."

Another issue: Each heart needed a pristine environment free of contaminants for each step of the process. Every time an intervention had to be done, she and her team ran the risk of opening the heart up to infection -- and death.

"Do you know how long it takes to inject 350 billion cells by hand?" Taylor asked the Life Itself audience. "What if you touch something? You just contaminated the whole heart."

Once her lab suffered an electrical malfunction and all of the hearts died. Taylor and her team were nearly inconsolable.

"When something happens to one of these hearts, it's devastating to all of us," Taylor said. "And this is going to sound weird coming from a scientist, but I had to learn to bolster my own heart emotionally, mentally, spiritually and physically to get through this process."

Enter BAB, short for BioAssemblyBot, and an "uber-sterile" cradle created by Advance Solutions that could hold the heart and transport it between each step of the process while preserving a germ-free environment. Taylor has now taught BAB the specific process of injecting the cells she has painstakingly developed over the last decade.

"When Dr. Taylor is injecting cells, it has taken her years to figure out where to inject, how much pressure to put on the syringe, and the best speed and pace to add the cells," said BAB's creator Golway.

"A robot can do that quickly and precisely. And as we know, no two hearts are the same, so BAB can use ultrasound to see inside the vascular pathway of that specific heart, where Dr. Taylor is working blind, so to speak," Golway added. "It's exhilarating to watch -- there are times where the hair on the back of my neck literally stands up."

Taylor left academia in 2020 and is currently working with private investors to bring her creation to the masses. If transplants into humans in upcoming clinical trials are successful, Taylor's personalized hybrid hearts could be used to save thousands of lives around the world.

In the US alone, some 3,500 people were on the heart transplant waiting list in 2021.

"That's not counting the people who never make it on the list, due to their age or heath," Taylor said. "If you're a small woman, if you're an underrepresented minority, if you're a child, the chances of getting an organ that matches your body are low.

If you do get a heart, many people get sick or otherwise lose their new heart within a decade. We can reduce cost, we can increase access, and we can decrease side effects. It's a win-win-win."

Taylor can even envision a day when people bank their own stem cells at a young age, taking them out of storage when needed to grow a heart -- and one day even a lung, liver or kidney.

"Say they have heart disease in their family," she said. "We can plan ahead: Grow their cells to the numbers we need and freeze them, then when they are diagnosed with heart failure pull a scaffold off the shelf and build the heart within two months.

"I'm just humbled and privileged to do this work, and proud of where we are," she added. "The technology is ready. I hope everyone is going to be along with us for the ride because this is game-changing."

The rest is here:
'Ghost heart': Built from the scaffolding of a pig and the patient's cells, this cardiac breakthrough may soon be ready for transplant into humans -...

Global Live Cell Imaging Market to be Driven by Growing Stem Cell Research Market in the Forecast Period of 2022-2027 mbu timeline – mbu timeline

By Stell Cell Research

The new report by Expert Market Research titled, Global Live Cell Imaging Market Report and Forecast 2022-2027, gives an in-depth analysis of the global live cell imaging market, assessing the market based on its segments like product type, application, technology, and major regions. The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analysing the market based on the SWOT and Porters Five Forces models.

Request a free sample copy in PDF or view the report [emailprotected] https://bit.ly/3mtMGEU

The key highlights of the report include:

Market Overview (2017-2027)

As the number of stem cell research projects grows, so does the use of live cell imaging tools to analyse the location, purity, and amount of cells and their components, boosting market growth. The use of live cell imaging tools to precisely detect protein levels for optimal medication therapy is rising, as it is critical to determine the interaction between stem cells and tissues during stem cell research. The introduction of numerous government initiatives to support research and development (R&D) activities is fueling the live cell imaging industrys expansion. For example, in March 2020, the Canadian government announced a $6.9 million investment to promote stem cell research efforts in the country through the Stem Cell Networks research financing programme.

Furthermore, the increasing use of live cell imaging in the discovery of new medications is propelling the market forward. The development of new technologies that allow for the precise analysis of RNA, nucleic acid, proteins, and DNA, among other things, is driving demand for many diagnostic methods, moving the market forward. Furthermore, the rise in the prevalence of chronic diseases like cancer is driving up demand for live cell imaging in both diagnosis and treatment. The expanding research and development (R&D) activities to detect cancer cells in bone marrow while also allowing for the identification of specific cancer cells are likely to boost market growth.

Industry Definition and Major Segments

The study of living cells using microscope technology to obtain images of live cells and tissues is known as live cell imaging. It is essential in a variety of laboratory operations in biological and biomedical research because it gives real-time and reliable information on cells and tissues, making it suitable for stem cell research and regenerative medicine development.

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By technology, the market can be divided into:

The market can be categorised based on its applications into:

The major product types of live cell imaging are:

The regional markets include:

Market Trends

Artificial intelligence (AI), deep learning, and 3D printing are progressively being integrated into live cell imaging techniques, as technology improvements are a key antecedent of scientific research and development efforts. The expanding use of artificial intelligence (AI) allows for more precise, simpler, and time-efficient cell imaging. Furthermore, AI-based microscopy can recognise and analyse minor cell components like nuclei, allowing researchers to analyse data more quickly and effectively. AI-based microscopes also automate and optimise many functions for quantifying live cells, resulting in increased cell viability and faster image capture. This is fueling the expansion of the live cell imaging sector by increasing demand for such microscopes in research centres.

Furthermore, the increasing use of 3D printing in a variety of medical and biological applications is fueling market expansion. Because air bubbles are a common problem in perfusion chambers used in live cell imaging, the demand for fluidic devices made with 3D printing technology is increasing dramatically. Furthermore, the cost-effectiveness of 3D printing is increasing the affordability of live cell imaging research operations, which is propelling the market forward. In the forecast future, the development of portable and low-profile devices that can be directly installed on optical microscopes to improve cell imaging precision is expected to drive market expansion for live cell imaging.

Latest News on Global Live Cell Imaging [emailprotected] https://bit.ly/3HaaQ0z

Key Market Players

The major players in the market are Carl Zeiss AG, Leica Microsystems GmbH, Nikon Instruments Inc., Becton, Dickinson and Company, GE Healthcare and Others.

About Us:

Expert Market Research is a leading business intelligence firm, providing custom and syndicated market reports along with consultancy services for our clients. We serve a wide client base ranging from Fortune 1000 companies to small and medium enterprises. Our reports cover over 100 industries across established and emerging markets researched by our skilled analysts who track the latest economic, demographic, trade and market data globally.

At Expert Market Research, we tailor our approach according to our clients needs and preferences, providing them with valuable, actionable and up-to-date insights into the market, thus, helping them realize their optimum growth potential. We offer market intelligence across a range of industry verticals which include Pharmaceuticals, Food and Beverage, Technology, Retail, Chemical and Materials, Energy and Mining, Packaging and Agriculture.

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Global Live Cell Imaging Market to be Driven by Growing Stem Cell Research Market in the Forecast Period of 2022-2027 mbu timeline - mbu timeline

Stem Cells Market to Cross US$ 25.68 Bn by 2028, Increasing Demand for Stem Cells in Regenerative Medicines Accelerates Market Growth – BioSpace

By Stell Cell Research

Wilmington, Delaware, United States:

According to the report, the global stem cells market was valued at US$ 11.73 Bn in 2020 and is projected to expand at a CAGR of 10.4% from 2021 to 2028. Stem cells are defined as specialized cells of the human body that can develop into various different kinds of cells. Stem cells can form muscle cells, brain cells and all other cells in the body. Stem cells are used to treat various illnesses in the body.

North America was the largest market for stem cells in 2020. The region dominated the global market due to substantial investments in the field, impressive economic growth, increase in incidence of target chronic diseases, and technological progress. Moreover, technological advancements, increase in access to healthcare services, and entry of new manufacturers are the other factors likely to fuel the growth of the market in North America during the forecast period.

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Asia Pacific is projected to be a highly lucrative market for stem cells during the forecast period. The market in the region is anticipated to expand at a high CAGR during the forecast period. High per capita income has increased the consumption of diagnostic and therapy products in the region. Rapid expansion of the market in the region can be attributed to numerous government initiatives undertaken to improve the health care infrastructure. The market in Asia Pacific is estimated to expand rapidly compared to other regions due to shift in base of pharmaceutical companies and clinical research industries from developed to developing regions such as China and India. Moreover, changing lifestyles and increase in urbanization in these countries have led to a gradual escalation in the incidence of lifestyle-related diseases such as cancer, diabetes, and heart diseases.

Technological Advancements to Drive Market

Several companies are developing new approaches to culturing or utilizing stem cells for various applications. Stem cell technology is a rapidly developing field that combines the efforts of cell biologists, geneticists, and clinicians, and offers hope of effective treatment for various malignant and non-malignant diseases. The stem cell technology is progressing as a result of multidisciplinary effort, and advances in this technology have stimulated a rapid growth in the understanding of embryonic and postnatal neural development.

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Adult Stem Cells Segment to Dominate Global Market

In terms of product type, the global stem cells market has been classified into adult stem cells, human embryonic stem cells, and induced pluripotent stem cells. The adult stem cells segment accounted for leading share of the global market in 2020. The capability of adult stem cells to generate a large number of specialized cells lowers the risk of rejection and enables repair of damaged tissues.

Autologous Segment to Lead Market

Based on source, the global stem cells market has been bifurcated into autologous and allogenic. The autologous segment accounted for leading share of the global market in 2020. Autologous stem cells are used from ones own body to replace damaged bone marrow and hence it is safer and is commonly being practiced.

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Regenerative Medicines to be Highly Lucrative

In terms of application, the global stem cells market has been categorized into regenerative medicines (neurology, oncology, cardiology, and others) and drug discovery & development. The regenerative medicines segment accounted for major share of the global market in 2020, as regenerative medicine is a stem cell therapy and the medicines are made using stem cells in order to repair an injured tissue. Increase in the number of cardiac diseases and other health conditions drive the segment.

Therapeutics Companies Emerge as Major End-users

Based on end-user, the global stem cells market has been divided into therapeutics companies, cell & tissue banks, tools & reagents companies, and service companies. The therapeutics companies segment dominated the global stem cells market in 2020. The segment is driven by increase in usage of stem cells to treat various illnesses in the body. Therapeutic companies are increasing the utilization of stem cells for providing various therapies. However, the cell & tissue banks segment is projected to expand at a high CAGR during the forecast period. Increase in number of banks that carry out research on stem cells required for tissue & cell growth and elaborative use of stem cells to grow various cells & tissues can be attributed to the growth of the segment.

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Regional Analysis

In terms of region, the global stem cells market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global stem cells market in 2020, followed by Europe. Emerging markets in Asia Pacific hold immense growth potential due to increase in income levels in emerging markets such as India and China leading to a rise in healthcare spending.

Competition Landscape

The global stem cells market is fragmented in terms of number of players. Key players in the global market include STEMCELL Technologies, Inc., Astellas Pharma, Inc., Cellular Engineering Technologies, Inc., BioTime, Inc., Takara Bio, Inc., U.S. Stem Cell, Inc., BrainStorm Cell Therapeutics, Inc., Cytori Therapeutics, Inc., Osiris Therapeutics, Inc., and Caladrius Biosciences, Inc.

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Stem Cells Market to Cross US$ 25.68 Bn by 2028, Increasing Demand for Stem Cells in Regenerative Medicines Accelerates Market Growth - BioSpace

3D Cell Culture Market to reach 6.47 billion in 2030 with a CAGR of around 16.3% – GlobeNewswire

By Stell Cell Research

New York, United States, June 07, 2022 (GLOBE NEWSWIRE) -- 3D cell culture is regarded as an artificially created environment where the biological cells are allowed to grow or interact with their respective surroundings in all three dimensions. In terms of technology,scaffold-based technologyhad thelargest revenue share of more than about 68.96 % in 2020 and it is estimated to maintain its dominance all over the forecasted period of 2020-2030. Moreover, on a regional basis, North America dominated the total 3D Cell Culture Market in 2020, possessing a revenue share of more than 43 %. However, the APAC region is prevised to witness the fastest CAGR within the regional market from 2020 to 2030.

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The segmentation outlook of the latest report published by Strategic Market Research on3D Cell Culture Market is as follows:

Based on Technology

Based on Application

Based on End-User

Regions

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The 3D Cell Culture Market is poised to reach a market value of USD 6.47 billion by 2030 from USD 1.43 billion in 2020, at a CAGR of 16.3 % during the forecasted period. Growth in this 3D Cell Culture market is primarily driven by the rise in the focus on new upcoming alternatives for animal testing, increase in the focus on personalized medicine, growing occurence of chronic diseases, and the wide availability of funding for the research purposes. The high utility of 3D models for research purposes about Covid-19 as well as respiratory diseases is prevised to provide massive growth opportunities to the 3D Cell Culture market. Several other vital parameters amplifying the market growth include the introduction of new products and the broad applications of 3D protocols in the field of biological researches.

By Technology, the scaffold-based technologysegment held the largest share of the 3D Cell Culture Market.

In terms of technology,scaffold-based technologyhad thelargest revenue share of more than 68.96 % in 2020.Furthermore, surge in the demand for scaffold-based technology and the rise in the awareness of nanotechnology in the field of biomedical research and its vast applications is prevised to provide ample opportunities for the growth of the segment. The National Institutes of Health declared an investment of around USD 445 Million in nanomedicine in the year 2020. In addition, the National Nanotechnology Initiative got more than USD 1.7 Billionin funding in the year 2021, which in turn will foster the expansion of the 3D cell culture scaffold market.

By Application, the Cancer segment possessed the highest share of the 3D Cell Culture Market.

In terms of Application, the Cancer market segment possessed the maximum portion of the total 3D Cell Culture Market share, accounting for about 24.56 % of the total market revenue, and is previse to expand at a CAGR of 15.4 % in 2020. Growing R&D activities by utilizing spheroids as model systems to create anti-cancer treatments and the rise in the usage of 3-dimensional cellular models are the key drivers that are amplifying the growth of this market segment. As per The National Cancer Institute, it is reported that there were 16.9 million cancer survivors in USA in the year 2020, and by the end of the year 2030, the total number of cancer survivors is projected to reach a landmark of 22.2 million. Furthermore, from 2021 to 2030, the stem cell research market segment is prevised to expand at the fastest CAGR throughout the forecasted timeframe.

By End-User, the Biotechnology and Pharmaceutical industries dominated the entire 3D Cell Culture Market.

In terms of End-user, the entire market is segregated into Biotechnology & Pharmaceutical Industries, Research Laboratories and Institutes, Hospitals and Diagnostic Centers, and Others. Among these segments, the biotechnology and pharmaceutical industries category held the largest revenue share of more than 46% in the year 2020. In comparison to 2D cell culture, the 3D cell culture possesses a wide variety of benefits and advantages in terms of supplying appropriate oxygen content and nutritional gradients and helps to better understand various cell functions like adhesion, proliferation, morphology, viability, microenvironment, and response to drugs. These are some of the key factors that are driving the segments growth.

North America held a significant portion of the 3D Cell Culture Market share.

By Region, North America dominated the total 3D Cell Culture Market in 2020, possessing a revenue share of more than 43 %. It is also anticipated that the North American region will maintain its dominance throughout the projected period due to the factors like rise in the private and state financial support for building advanced 3D cell culture models, rise in the healthcare expenditures, and the growing number of research institutes and universities. For example, Inventia Life Science, a global leader in advanced 3D cell culture for clinical and research purposes, has declared the closure of a USD 25 Million Series B funding round which was led by Blackbird Ventures. On the other hand, the APAC/Asia- Pacific region is prevised to witness the fastest CAGR within the regional market from 2021 to 2030. It is primarily due to the rising investments by various multinational corporations in the entire region.

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3D Cell Culture Market to reach 6.47 billion in 2030 with a CAGR of around 16.3% - GlobeNewswire

Zernicka-Goetz Receives Honors from the NOMIS Foundation – Caltech

By Stell Cell Research

Magdalena Zernicka-Goetz, Bren Professor of Biology and Biological Engineering and affiliated faculty member with Caltech'sTianqiao and Chrissy Chen Institute for Neuroscience, has been awarded the 2022 NOMIS Distinguished Scientist and Scholar Award. Established in 2016, the award is presented to "pioneering scientists and scholars who, through their innovative, groundbreaking research, have made a significant contribution to their respective fields and who inspire the world around them," according to the NOMIS Foundation.

Zernicka-Goetz's research addresses fundamental questions about how life begins, such as: What drives a fertilized egg to divide and grow until it becomes 40 trillion cells, and how do these cells know how to make a person? To address these questions, she has developed methods for tracking living embryos to determine how stem cells are first created, establish their fates, and work together to shape the body. She also pioneered methods to grow embryos beyond implantation, techniques that won the "People's Choice Scientific Breakthrough of the Year" in 2016 inSciencemagazine. Her team used these methods to createthe first complete embryo models from stem cells that develop like natural embryos.

In 2021, the team determined the molecular signals involved in how an embryo becomesasymmetrical and polarizedand how the embryo forms itshead-to-tail body axis.

Zernicka-Goetz received her PhD from Warsaw University and joined the Caltech faculty in 2019. Prior to Caltech, she was professor of mammalian development and stem cell biology at the University of Cambridge, England. She is a fellow of the British Academy of Medical Science, the Polish Academy of Sciences, and a recipient of anNIH Director's Pioneer Award and the 2022 Edwin G. Conklin Medal from the Society for Developmental Biology.

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Zernicka-Goetz Receives Honors from the NOMIS Foundation - Caltech

Lokken to retire as vice chancellor for government and community relations – The Source – Washington University in St. Louis

By Stell Cell Research

Pamela Lokken, vice chancellor for government and community relations at Washington University in St. Louis, will retire from the university this fall after more than 30 years of service.

We celebrate Pam for her substantial contributions to the Washington University community, both measurable and immeasurable, Chancellor Andrew D. Martin said. She has been instrumental in positioning the university to advance its mission at the national, state and local levels. She has served in this role during several critical junctures in the universitys history collaborating closely with Chancellors Danforth, Wrighton and myself and has done so with her characteristic humility, warmth, humor and common sense. I join with countless others across the university in stating, simply, that we will miss Pam and that we deeply appreciate all she has done to make Washington University a leader in higher education.

Lokken joined Washington University in 1991 and has served in senior leadership roles for over three decades. As vice chancellor, she has led a team that oversees the universitys federal, state and local governmental and community affairs initiatives. Her experience includes extensive engagement at all levels of government and associated legislative bodies, executive branch departments and regulatory agencies. Among her specific areas of public policy expertise are scientific research, health care, higher education and tax policy.

Earlier this year, Lokken was honored by the Association of American Universities (AAU) whose membership is composed of Americas leading research universities with the 2022 Legacy Award, which recognizes career excellence, distinguished contributions to the community and national leadership in the higher education community. An excerpt from the award citation states: By all measures Pam is one of the great leaders in higher education in building trust and alliances with the federal government as well as taking it on, when needed. Pam knows that our work is not about who is in or out in D.C., but about students, teaching, research and patient care and promoting, protecting and providing for Washington University and the St. Louis region.

As a trusted leader, Lokken developed critical relationships to advance meaningful change.Her accomplishments include establishing the National Institute for Food and Agricultural Research at the U.S. Department of Agriculture; transferring federal property to make Washington University the sole owner of the Tyson Research Center; preserving the universitys ROTC program from elimination; protecting stem cell research; and expanding the Missouri Medicaid program. She also was instrumental in the vision and early development of the Danforth Plant Science Center, the expansion of St. Louis public transit system and university-supported development in surrounding communities.

Lokken helped spearhead the creation of several national and statewide advocacy coalitions to protect and advance research being conducted at Washington University and other institutions, including The Science Coalition, the Coalition for the Advancement of Medical Research, Supporters of Agricultural Research, United for Medical Research, Missouri Biotechnology Association and Missouri Cures. She has chaired key committees for the AAU, the American Association of Medical Colleges and the Consortium on Financing Higher Education and has served as a board member of the National Association of Independent Colleges and Universities, Tuition Plan Consortium and the Stowers Institute for Medical Research.

Im immensely proud of the progress the university has made as an engaged partner in community and government affairs over the past three decades. Weve elevated our research profile, expanded our student financial aid, and enhanced our economic and community impact in the St. Louis region, Lokken said. Im honored to have been part of these efforts and I credit so much of the progress to the talented and dedicated team in the Office of Government & Community Relations, with whom Ive had the enormous privilege to work.

Lokkens last day at the university will be Sept. 2. A search for her successor will be announced in coming weeks.

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Lokken to retire as vice chancellor for government and community relations - The Source - Washington University in St. Louis

Updated Data for Janssen’s Bispecific Teclistamab Suggest Continued Deep and Durable Responses in the Treatment of Patients with Relapsed or…

By Stell Cell Research

New teclistamab data presented at the 2022 ASCO Annual Meeting report longer follow-up from Phase 1/2 MajesTEC-1 study evaluating the BCMAxCD3 bispecific antibody, including progression-free survival and subgroup analyses

Data from MajesTEC-1 study published in The New England Journal of Medicine

June 5, 2022, CHICAGO /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated efficacy and safety results from the teclistamab Phase 1/2 MajesTEC-1 study. Teclistamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting B-cell maturation antigen (BCMA), which is being studied in patients with relapsed or refractory multiple myeloma (RRMM) who have received three or more prior lines of therapy.1The data were featured as part of an oral session during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Additional poster presentations featured data on teclistamab as a monotherapy, as well as in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj). Applications seeking approval of teclistamab are currently under health authority review in the U.S. and Europe.

The multicohort, open-label, Phase 1/2 MajesTEC-1 study is investigating the safety and efficacy of teclistamab in patients with RRMM who received at least three prior lines of therapy. As of March 2022, 165 patients were treated with teclistamab at the recommended subcutaneous (SC) Phase 2 dose (RP2D) of 1.5 mg/kg preceded by step-up doses of 0.06 and 0.3 mg/kg across both Phase 1 (NCT03145181) and Phase 2 (NCT04557098)of the study.

Longer Follow-up from MajesTEC-1 Study in Patients with Triple Class Exposed Multiple Myeloma (Abstract #8007)

At a median follow-up of 14.1 months (0.2624.4), an overall response rate (ORR) of 63 percent (95 percent Confidence Interval [CI], range, 55.270.4) was observed in patients with triple class exposed multiple myeloma, with a complete response (CR) or better achieved in 39.4 percent of patients.1 Study participants had three or more prior lines of therapy, with a median of five prior lines, including a prior proteasome inhibitor, immunomodulatory drug and anti-CD38 antibody.1 The majority of patients were triple-class refractory and/or refractory to their last line of treatment.1Although response duration data are not mature, the median duration of response at this time is 18.4 months and has not been reached in patients who achieved a CR or better (95 percent CI, 14.9 not estimable).1 This suggests responses to teclistamab were durable and deepened over time.1 The medium progression-free survival (PFS) was 11.3 months (95 percent CI, 8.817.1).1 Adverse events (AEs) were low-grade for the most part and manageable with no new safety signals seen.1

These results from the MajesTEC-1 study were also simultaneously published online in The New England Journal of Medicine.2

"The MajesTEC-1 study update suggests patients with relapsed or refractory multiple myelomareceiving teclistamab achieved a deep response that was also durable," said Ajay K. Nooka, M.D., MPH, FACP, Associate Professor of Hematology and Medical Oncology at Emory School of Medicine and principal study investigator. "These longer-term data, notably the overall response rate and progression-free survival, are encouraging in this heavily pretreated patient population."

No new safety signals were observed with longer follow-up.1 In 14.1 month follow-up data presented at ASCO 2022, the most common grade 3/4 hematologic AEs were neutropenia (64.2 percent); anemia (37 percent); lymphopenia (32.7 percent) and thrombocytopenia (21.2 percent). Infections occurred in 76.4 percent of patients (44.8 percent grade 3/4).1 The most common nonhematologic AE was cytokine release syndrome (CRS), all of which were grade 1/2 except for 1 transient grade 3 CRS (72.1 percent all grade).1The median time to CRS onset was two days (range, 16) and median duration was two days (range, 19).1 There were five treatment-related deaths, and dose reductions and discontinuations due to AEs were infrequent.1

First Results from Cohort C of the MajesTEC-1 Study of Teclistamab in Patients with RRMM with Prior Exposure to BCMA Targeted Treatment (Abstract #8013)

Initial results were also presented from Cohort C of the MajesTEC-1 study evaluating teclistamab in the treatment of patients with RRMM who had previously been exposed to an anti-BCMA treatment.3 These patients had received a median of six prior lines of therapy, most (85 percent) were triple-class refractory and 35 percent were penta-drug refractory.3The use of teclistamab following prior treatment with chimeric antigen receptor T cell (CAR-T) therapy and/or an antibody drug conjugate (ADC) (e.g., belantamab mafodotin) targeting BCMA resulted in a promising response rate in patients with heavily pretreated RRMM.3At a median follow-up of 12.5 months (0.7-14.4), the ORR was 52.5 percent (95 percent CI, 36.168.5) among 40 patients who received teclistamab in Cohort C.3 Responses to teclistamab occurred early and deepened over time, with comparable response rates in patients previously treated with an ADC and/or CAR-T.3

A tolerable side-effect profile was observed in patients previously treated with anti-BCMA treatment, with no dose reductions or discontinuations due to AEs.3 The safety profile for Cohort C was comparable with that observed in BCMA treatment-naive patients, with no new safety signals.3 In 12.5 month follow-up data, 26 patients (65 percent; 30 percent grade 3/4) had infections.3 The most common AEs (n=40) were CRS (65 percent any grade), with a median time to CRS onset and duration of two days (range, 2-6) and two days (range, 1-4) respectively.3 Cytopenias (grade 3/4) were noted as follows; neutropenia (62.5 percent); thrombocytopenia (30 percent); anemia (35 percent); and lymphopenia (42.5 percent).3

Initial Patient-Reported Health-Related Quality of Life (HRQoL) Outcomes in Patients with RRMM Treated with Teclistamab (Abstract #8033)

Initial results from an analysis of patient-reported health-related quality of life (HRQoL) outcomes following treatment with teclistamab were also shared in a poster session.4 The study analyzed patient-reported assessments of quality of life metrics among patients in the MajesTEC-1 trial who had received their first treatment dose by March 18, 2021.4The metrics analyzed include function (physical, role, emotional, cognitive, social); symptoms (fatigue, nausea/vomiting, pain, appetite loss, constipation, diarrhea); and generic health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).4 Over 80 percent of the 110 patients included in the patient-reported outcomes (PRO) analysis noted meaningful improvement (percentages of patients with clinically meaningful change from baseline [EORTC QLQ-C30 scales: 10 points]) in at least one of the symptom scales.4 Reduction in pain scores occurred as early as cycle two.4 At the moment, no meaningful improvement was observed in the scales for physical functioning and fatigue.4 These initial PRO results complement recent clinical data and support teclistamab as a potential off-the-shelf, T-cell redirecting therapy for patients with RRMM.4

As of September 7, 2021, median duration of treatment was 5.7 months and median follow-up was 7.8 months.4 Global healthstatus scores significantly improved from baseline (95 percent CIs for least squares mean change did not cross 0) at cycles four, six, and eight; emotional functioning significantly improved at all time points.4 PRO assessments included European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 item (EORTC QLQ-C30).4 PROs were assessed on day one of each treatment cycle (28 days per cycle).4Additional follow-up is needed to assess the full benefit of meaningful improvement in functional outcomes.4

Two Studies Investigate the Safety and Efficacy of Teclistamab and DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in Combination for the Treatment of Patients with RRMM

Updated results from the Phase 1 TRIMM-2 study (NCT04108195) were featuredduring a poster session (Abstract #8032) at ASCO 2022, evaluating teclistamab in combination with DARZALEX FASPRO, a CD38-directed monoclonal antibody approved to be given subcutaneously for the treatment of patients with multiple myeloma.5 In the study, patients received a median of five prior lines of therapy; 75.4 percent had prior exposure to anti-CD38 therapies, and 63.1 percent were refractory to anti-CD38 treatment.5 Evaluable patients achieved an ORR of 76.5 percent at a median follow-up of 8.6 months (0.319.6).5

A poster presentation for the ongoing multicenter, open-label, randomized Phase 3 MajesTEC-3 (NCT05083169) study comparing the efficacy of teclistamab in combination with daratumumab versus investigator's choice of daratumumab in combination with pomalidomide and dexamethasone (DPd) or bortezomib and dexamethasone (DVd) (Poster TPS8072)in patients with RRMMwas also presented at ASCO.6

Additional data from both the teclistamab (Abstract #S188) and talquetamab (Abstract #S183) cohorts of the TRIMM-2 study will be featured as oral presentations at the European Hematology Association (EHA) 2022 Congress taking place in Vienna, Austria, June 9-12.7,8

"The updated data presented at ASCO support the ongoing evaluation of teclistamab as a monotherapy and in combination with standard of care treatments," said Yusri Elsayed, M.D., M.HSc., Ph.D., Vice President, Disease Area Leader, Hematologic Malignancies, Janssen Research & Development, LLC. "These resultsunderscore our ongoing commitment to address the unmet need for new therapeutic options and our effort to bring forward novel treatments for multiple myeloma patients in the near future."

About Teclistamab

Teclistamab is an investigational, fully humanized IgG4, T-cell redirecting, bispecific antibody targeting both BCMA (B-cell maturation antigen) and CD3, the T-cell receptor. BCMA is expressed at high levels on multiple myeloma cells.9,10,11,12,13Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce killing of tumor cells.8

Teclistamab is currently being evaluated in several monotherapy and combination studies. In2020, the European Commission and the U.S. Food and Drug Administration (FDA) each granted teclistamab Orphan Drug Designation for the treatment of multiple myeloma. In January 2021 and June 2021, teclistamab receiveda PRIority MEdicines (PRIME) designation by the European Medicines Agency (EMA) and Breakthrough Therapy Designation (BTD) by the U.S. FDA, respectively. PRIME offers enhanced interaction and early dialogue to optimize drug development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.14 The U.S. FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.15 In December 2021, Janssen submitted a Biologics License Application (BLA) to the FDA seeking approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma; a marketing authorization application (MAA) was submitted to the EMA for teclistamab approval in January 2022.

About DARZALEX FASPRO

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered into a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. DARZALEX FASPRO is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma and now light chain (AL) amyloidosis. DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology.

DARZALEX FASPRO is indicated for the treatment of adult patients with multiple myeloma:

DARZALEX FASPRO in combination with bortezomib, cyclophosphamide, and dexamethasone is indicated for the treatment of adult patients with newly diagnosed AL amyloidosis. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Limitations of Use

DARZALEX FASPRO is not indicated and is not recommended for the treatment of patients with AL amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

Full prescribing information for DARZALEX FASPRO is available here.

DARZALEX FASPROIMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

DARZALEX FASPROis contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase or any of the components of the formulation.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Other Administration Reactions

Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO.

Systemic Reactions

In a pooled safety population of 898 patients with multiple myeloma (N=705) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPROas monotherapy or in combination, 9% of patients experienced a systemic administration-related reaction (Grade 2: 3.2%, Grade 3: 1%). Systemic administration-related reactions occurred in 8% of patients with the first injection, 0.3% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 3.2 hours (range: 4 minutes to 3.5 days). Of the 140 systemic administration-related reactions that occurred in 77 patients, 121 (86%) occurred on the day of DARZALEX FASPRO administration. Delayed systemic administration-related reactions have occurred in 1% of the patients.

Severe reactions included hypoxia, dyspnea, hypertension and tachycardia. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritis, chills, vomiting, nausea, and hypotension.

Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPROdepending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions.

Local Reactions

In this pooled safety population, injection-site reactions occurred in 8% of patients, including Grade 2 reactions in 0.7%. The most frequent (>1%) injection-site reaction was injection site erythema. These local reactions occurred a median of 5 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO. Monitor for local reactions and consider symptomatic management.

Cardiac Toxicity in Patients with Light Chain (AL) Amyloidosis

Serious or fatal cardiac adverse reactions occurred in patients with light chain (AL) amyloidosis who received DARZALEX FASPROin combination with bortezomib, cyclophosphamide and dexamethasone. Serious cardiac disorders occurred in 16% and fatal cardiac disorders occurred in 10% of patients. Patients with NYHA Class IIIA or Mayo Stage IIIA disease may be at greater risk. Patients with NYHA Class IIIB or IV disease were not studied. Monitor patients with cardiac involvement of light chain (AL) amyloidosis more frequently for cardiac adverse reactions and administer supportive care as appropriate.

Neutropenia

Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPROuntil recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO, higher rates of Grade 3-4 neutropenia were observed.

Thrombocytopenia

Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX FASPRO until recovery of platelets.

Embryo-Fetal Toxicity

Based on the mechanism of action, DARZALEX FASPROcan cause fetal harm when administered to a pregnant woman. DARZALEX FASPROmay cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPROand for 3 months after the last dose.

The combination of DARZALEX FASPROwith lenalidomide is contraindicated in pregnant women, because lenalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide prescribing information on use during pregnancy.

Interference with Serological Testing

Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted.

Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO. Type and screen patients prior to starting DARZALEX FASPRO.

Interference with Determination of Complete Response

Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO-treated patients with IgG kappa myeloma protein.

ADVERSE REACTIONS

The most common adverse reaction (20%) with DARZALEX FASPRO monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, pyrexia, cough, muscle spasms, back pain, vomiting, upper respiratory tract infection, peripheral sensory neuropathy, constipation, pneumonia, and peripheral edema.

The most common adverse reactions (20%) in patients with light chain (AL) amyloidosis who received DARZALEX FASPRO are upper respiratory tract infection, diarrhea, peripheral edema, constipation, fatigue, peripheral sensory neuropathy, nausea, insomnia, dyspnea, and cough.

The most common hematology laboratory abnormalities (40%) with DARZALEX FASPRO are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.

Please see full Prescribing Information for DARZALEX FASPRO.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow.16 When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow with tumors. In 2020, worldwide an estimated 176,000 people were diagnosed with multiple myeloma.17 In 2022, it is estimated that more than 34,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.18 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.19

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism, & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.

Learn more at http://www.janssen.com. Follow us at http://www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Dr. Nooka has served as a paid consultant to Janssen; he has not been paid for any media work.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamaband DARZALEX FASPRO. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC or any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 2, 2022, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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1 Nooka A et al. Teclistamab, a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM): Updated efficacy and safety results from MajesTEC-1. 2022 ASCO Annual Meeting American Society of Clinical Oncology. June 2022. 2 Moreau P et al. Teclistamab, a BCMAxCD3 antibody, in triple class exposed multiple myeloma. The New England Journal of Medicine, June 2022. 3 Touzeau C et al. Efficacy and safety of teclistamab (tec), a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in patients (pts) with relapsed/refractory multiple myeloma (RRMM) after exposure to other BCMA-targeted agents. 2022 ASCO Annual Meeting American Society of Clinical Oncology. June 2022. 4 Martin T et al. Health-related quality of life in patients with relapsed/refractory multiple myeloma (RRMM) treated with teclistamab, a B-cell maturation antigen (BCMA) x CD3 bispecific antibody: patient-reported outcomes in MajesTEC-1. 2022 ASCO Annual Meeting American Society of Clinical Oncology. June 2022. 5 Rodriguez-Otero P et al. A novel, immunotherapy-based approach for the treatment of relapsed/refractory multiple myeloma (RRMM): Updated phase 1b results for daratumumab in combination with teclistamab (a BCMA x CD3 bispecific antibody). 2022 ASCO Annual Meeting American Society of Clinical Oncology. June 2022. 6 Mateos M et al. Randomized, phase 3 study of teclistamab plus daratumumab versus investigator's choice of daratumumab, pomalidomide, and dexamethasone or daratumumab, bortezomib, and dexamethasone in patients with relapsed/refractory multiple myeloma. 2022 ASCO Annual Meeting American Society of Clinical Oncology. June 2022. 7 Rodriguez-Otero P et al. A novel, immunotherapy-based approach for the treatment of relapsed/refractory multiple myeloma (RRMM): Updated phase 1b results for daratumumab in combination with teclistamab (a BCMA x CD3 bispecific antibody). EHA 2022 Congress European Hematology Association. June 2022. 8 WJC van de Donk N et al. Novel Combination Immunotherapy for the Treatment of Relapsed/Refractory Multiple Myeloma: Update Phase 1B Results for Talquetamab (A GPRC5D x CD3 Bispecific Antibody) in Combination with Daratumumab. EHA 2022 Congress European Hematology Association. June 2022. 9 Labrijn AF et al. Proc Natl Acad Sci USA. 2013;110:5145. 10 Frerichs KA et al.Clin Cancer Res. 2020; doi: 10.1158/1078-0432.CCR-19-2299. 11 Cancer Research Institute. "Adoptive Cell Therapy: TIL, TCR, CAR T, AND NK CELL THERAPIES." Available at:https://www.cancerresearch.org/immunotherapy/treatment-types/adoptive-cell-therapy. 12 Cho SF et al. Frontiers in Immunology. 2018; 9: 1821. 13 Benonisson H et al. Molecular Cancer Therapeutics. 2019 (18) (2) 312-322. 14 European Medicines Agency. PRIME Factsheet. Available at: https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines. Accessed December 2021. 15 The U.S. Food and Drug Administration. "Expedited Programs for Serious Conditions." Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf. Accessed December 2021. 16 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol.2020;95(5):548-5672020;95(5):548-567. http://www.ncbi.nlm.nih.gov/pubmed/32212178 17 Cancer.Net. "Multiple Myeloma: Statistics." Available at:https://www.cancer.net/cancer-types/multiple-myeloma/statistics#:~:text=Worldwide%2C%20an%20estimated%20176%2C404%20people,worldwide%20died%20from%20multiple%20myeloma. Accessed June 3, 2022. 18 American Cancer Society. "Key Statistics About Multiple Myeloma." Available at: https://cancerstatisticscenter.cancer.org/?_ga=2.84250769.967379196.1642100198-1705811479.1642100198#!/. Accessed April 2022. 19 American Cancer Society. "What Is Multiple Myeloma?" Available at: https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed January 2022.

Media Contact:Satu Glawe +49 172-294-6264

Bernadette King +1 215-778-3027

Investor Relations:Raychel Kruper +1 732-524-6164

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Updated Data for Janssen's Bispecific Teclistamab Suggest Continued Deep and Durable Responses in the Treatment of Patients with Relapsed or...

IPSCs For Democratized Cell Therapy – BioProcess Online

By Induced Pluripotent Stem Cells

By Matthew Pillar, Editor, BioProcess Online

Differentiated Focus On Harnessing The Innate Immune System

Cytovia Therapeutics was launched in 2019 on the premise that allogeneic, innate immune cells held the best promise for next-generation cell therapy development in oncology. The co-founders of Cytovia, CEO Dr. Daniel Teper and Board Director Dr. Laurent Audoly, built the company on two complementary technologies: (1) natural killer cells differentiated from stem cells (iNK cells), that could potentially be edited, and (2) multifunctional tetravalent cell engager antibodies that boost the activity of natural killer cells (dubbed FLEX-NK cell engagers). Both technologies, says Dr. Teper, generate so-called off the shelf therapeutics that can be suited to all patients.

The unmet needs Cytovia seeks to address represent some very large patient populations. Worldwide, there are close to 800,000 hepatocellular carcinoma patients, and about 100,000 suffering from myeloma. Myeloma, while representing a smaller patient population, is a more mature market. In recent years, pharmaceutical treatments for myeloma grew from a few billion in worldwide sales to more than 20 billion, and sales are expected to approach 30 billion by 2026, says Dr. Teper. The largest product in that category is the CD38 antibody DARZALEX (daratumumab) from J&J, which alone tallied $6 billion in sales in 2021.

Daniel Teper, Co-Founder, Chairman & CEO, Cytovia Therapeutics, IncHepatocellular carcinoma, on the other hand, represents a new frontier. Less than 30 percent of the patients with advanced disease responds to current treatment, with an average of just 6.8 months of progression-free survival, says Teper.

That technology has given rise to a preclinical pipeline that company co-founder, chairman, and CEO Dr. Daniel Teper repeatedly characterizes as differentiated. We noticed that a number of cell therapy companies have migrated toward targets that are well-validated, but very crowded, such as CD19 or BCMA, he says. Noting that theres nothing wrong with that and hes right, because competition yields innovation in drug development he acknowledges that the business risk of joining the well-validated masses gets real at the clinical stage. Once you validate the technology and order clinical trials, if youre number seven of 25 CD19 or BCMA therapies, youve got a big challenge ahead of you, he surmises.

Regarding Cytovias differentiation strategy, its programs display different indications and treatment modalities, including a FLEX-NK cell engager targeting GPC3 for the treatment of solid tumors including hepatocellular carcinoma, another FLEX-NK cell engager targeting CD38 for multiple myeloma, and even a CAR-iNK cell candidate targeting epidermal growth factor receptor (EGFR) for glioblastoma. Its a balanced portfolio of relatively novel targets, he says.

Fast Moving R&D Efforts And A Compelling Strategy

In April, Cytovia Chief Medical Officer Stanley R. Frankel, MD and Chief Scientific Officer Wei Li, Ph.D. presented at the annual meeting of the American Association for Cancer Research (AACR). Dr. Teper calls it a milestone for two reasons. First, this marked the initial presentation of our own data at one of the most relevant scientific meetings, which is an important achievement for a young company. Second, consistently with our mission to differentiate, were the only company thats developed both an IPSC-derived NK cell platform and an NK engager antibody platform. At the AACR meeting, we presented in vivo proof-of-concept data combining our iNK cells together with our GPC3-targeting NK engagers, demonstrating that we could reduce the tumor burden and the relevant biomarker protein in hepatocellular carcinoma, he says.

The combination of antibodies and cells is unique and important, says Dr. Teper, because as the disease becomes more severe, the patients functional NK cell count is depleted. The capability of an antibody that redirects NK cells to kill tumor cells is limited if those NK cells arent functional when theyre engaged.

The ability to add billions of NK cells, off the shelf, to reestablish the patients immune pool, leads to very significant efficacy, says Dr. Teper. He says the approach might be an alternative to CAR-NK therapy, or it might be complimentary, but it will definitely improve accessibility. He anticipates the therapy being administered on an outpatient basis due to the limited risk of cytokine release syndrome and GVHD.

If clinical trials confirm that the combination of the two is safe and effective, we're essentially opening up the opportunity for many more patients to benefit from cell therapy.

Included among those patients, he says, are those suffering from solid tumors, which have presented cell therapy developers with a particularly vexing challenge. The differentiator in Cytovias NK cell engagers, says Dr. Teper, is that they target NKp46, an activating receptor on the NK cell. Unlike some other activating receptors, NKp46 is very stable in its expression in infiltrating NK cells and we believe this is a potential advantage in targeting solid tumor., he says. Gene editing techonology will allow the company to consider edits to further reduce the inhibition of the tumor microenvironment and perhaps, he says, increase the persistence of NK cells.

Locking Down Best-In-Class Allogeneic Cell Therapy Manufacturing

Dr. Teper says that while the currently marketed autologous products are working for many patients, their production process is complex, the cost to produce them is too high, and the risk of side effects including cytokine release syndrome (CRS) and graft-versus-host disease (GVHD) limit their use. Allogeneic CAR T-cell products have initially demonstrated some promising data, but not to the level of autologous products, he says. In contrast, allogeneic NK and CAR NK approaches have shown initial efficacy, have very good safety profiles, and are more reasonably manufactured. While most of those approaches to-date have been produced from donor-derived cells, Dr. Teper believes induced pluripotent stem cells (IPSCs) are the way of the future due to the consistency and scalability they lend to the manufacturing process. In addition to batch-to-batch consistency challenges in donor-derived cells, which limit their scalability, their lack of homogeneity makes gene editing more difficult, he says. IPSCs, on the other hand, offer excellent product characterization, better scalability, a lower cost of goods, and easier gene editing opportunity. Thats because they originate from a highly controlled master cell bank that enables engineers to differentiate, expand, and cryopreserve trillions of highly characterized cells. There are inherent process development, manufacturing, and cost advantages to IPSCs, and we think the FDA and other global regulatory agencies will increasingly request that cell therapy products be perfectly characterized. That's much easier to do when you have a monoclonal cell bank and you're able to characterize the product at every step of development.

For its part, Cytovia is manufacturing its current supply internally. The CDMOs are catching up with new cell therapy manufacturing technologies, and IPSC technologies in particular, says Dr. Teper. That requires a sometimes-inefficient transfer of knowledge and processes. We believe that internal control of manufacturing allows us to control the quality and availability of the product for clinical trials, and these are both extremely important for a young company.

Rather than wholly outsource to a CDMO, Cytovia partners on R&D and GMP manufacturing with organizations including Cellectis, CytoImmune, the Hebrew University of Jerusalem, INSERM, the New York Stem Cell Foundation, STC Biologics, and the University of California San Francisco. In partnership with BioSciencesCorp, the company maintains a dedicated 100,000 square-foot facility in Puerto Rico comprised of six clean rooms and a process development lab, staffed entirely by Cytovia, which is currently producing clinical CGMP batches in anticipation of filing INDs late this year in preparation for clinical trials in early 2023.

Tracking To Plan On Securing Capital To Enable R&D And Clinical Trials

Pending the closings, proceeds from private placements, funds in Isleworth's trust account (net of redemptions), and proceeds from other prospective financings in the aggregate of up to $100 million, Cytovia forecasts up to two years of operating capital for further development of its gene-edited iNK and FLEX-NK cell engager technologies. The company plans to focus on multiple milestones, the most near-term being the filing of the companys first INDs in 2022 and early 2023 for its GPC3 FLEX-NK cell engager antibody (CYT-303) and its non-edited iNK cell (CYT-100) in hepatocellular carcinoma and its CD38 FLEX-NK cell engager antibody (CYT-338) for multiple myeloma. In clinical trials, the company plans to study the antibodies and the cells alone and in combination. By the end of 2023, it intends to bring two additional productsCYT -150, a gene-edited iNK cell and CYT -503, a GPC3-targeted CAR iNK productto the clinic. Its a franchise of multiple modalities, and our phase 1/2 trial will interrogate the safety and clinical response of each of them in one therapy or in combination, and then determine which well move forward for pivotal trials, says Dr. Teper.

By the end of 2023, it intends to bring two additional productsfor hepatocellular carcinomaCYT -150, a gene edited iNK cell and CYT -503, a GPC3-targeted CAR iNK productto the clinic. Its a franchise of multiple modalities that can be used alone or in combination, and our phase 1/2 trial will interrogate the safety and clinical response of each of them in one therapy or in combination, and then determine which well move forward for pivotal trials, says Dr. Teper.

Learn more about Cytovia Therapeutics at http://www.cytoviatx.com

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