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A $50,000 Helmet Can Read User’s Mind. And It’s Ready – NDTV

Posted: June 23, 2021 at 2:01 am

This helmet measures changes in blood oxygenation levels.

Over the next few weeks, a company called Kernel will begin sending dozens of customers across the U.S. a $50,000 helmet that can, crudely speaking, read their mind. Weighing a couple of pounds each, the helmets contain nests of sensors and other electronics that measure and analyze a brain's electrical impulses and blood flow at the speed of thought, providing a window into how the organ responds to the world. The basic technology has been around for years, but it's usually found in room-size machines that can cost millions of dollars and require patients to sit still in a clinical setting.

The promise of a leagues-more-affordable technology that anyone can wear and walk around with is, well, mind-bending. Excited researchers anticipate using the helmets to gain insight into brain aging, mental disorders, concussions, strokes, and the mechanics behind previously metaphysical experiences such as meditation and psychedelic trips. "To make progress on all the fronts that we need to as a society, we have to bring the brain online," says Bryan Johnson, who's spent more than five years and raised about $110 million-half of it his own money-to develop the helmets.

Johnson with one of his helmets in a lab at Kernel's offices.

Johnson is the chief executive officer of Kernel, a startup that's trying to build and sell thousands, or even millions, of lightweight, relatively inexpensive helmets that have the oomph and precision needed for what neuroscientists, computer scientists, and electrical engineers have been trying to do for years: peer through the human skull outside of university or government labs. In what must be some kind of record for rejection, 228 investors passed on Johnson's sales pitch, and the CEO, who made a fortune from his previous company in the payments industry, almost zeroed out his bank account last year to keep Kernel running. "We were two weeks away from missing payroll," he says. Although Kernel's tech still has much to prove, successful demonstrations, conducted shortly before Covid-19 spilled across the globe, convinced some of Johnson's doubters that he has a shot at fulfilling his ambitions.

A core element of Johnson's pitch is "Know thyself," a phrase that harks back to ancient Greece, underscoring how little we've learned about our head since Plato. Scientists have built all manner of tests and machines to measure our heart, blood, and even DNA, but brain tests remain rare and expensive, sharply limiting our data on the organ that most defines us. "If you went to a cardiologist and they asked you how your heart feels, you would think they are crazy," Johnson says. "You would ask them to measure your blood pressure and your cholesterol and all of that."

The first Kernel helmets are headed to brain research institutions and, perhaps less nobly, companies that want to harness insights about how people think to shape their products. (Christof Koch, chief scientist at the Allen Institute for Brain Science in Seattle, calls Kernel's devices "revolutionary.") By 2030, Johnson says, he wants to bring down the price to the smartphone range and put a helmet in every American household-which starts to sound as if he's pitching a panacea. The helmets, he says, will allow people to finally take their mental health seriously, to get along better, to examine the mental effects of the pandemic and even the root causes of American political polarization. If the Biden administration wanted to fund such research, Johnson says, he'd be more than happy to sell the feds a million helmets and get started: "Let's do the largest brain study in history and try to unify ourselves and get back to a steady state."

Johnson is something of a measurement obsessive. He's at the forefront of what's known as the quantified-self movement. Just about every cell in his body has been repeatedly analyzed and attended to by a team of doctors, and their tests now cast him as a full decade younger than his 43 years. Along those lines, he wants to let everyone else analyze, modify, and perfect their minds. No one knows what the results will be, or even if this is a good idea, but Johnson has taken it upon himself to find out.

After selling his payments startup, Johnson radically changed his life.

Unlike many of his tech-millionaire peers, Johnson grew up relatively poor. Born in 1977, he was raised in Springville, Utah, the third of five children. "We had very little and lived a very simple life," says his mother, Ellen Huff. A devout Mormon, she stayed home with the kids as much as possible and earned a modest income from a rental unit on the other side of the family's duplex.

Johnson remembers his mother knitting his clothes and grinding wholesale batches of wheat to make bread. "We were not like my friends," he says. "They would buy things from stores, and we just did not do that." His dad, a trash collector turned lawyer, had a drug problem and an affair, which led to his divorce from Huff. Later, delinquent child support payments, missed pickups on the weekends, and legal troubles contributed to his disbarment. "After some time of challenge, my father successfully overhauled his life 20 years ago," Johnson says. "Throughout his struggles, we remained close and without conflict. He has been a unique source of wisdom, counsel, and stability in my life."

Johnson had little idea what to do with his life until he served a two-year church mission in Ecuador, where he interacted with people living in huts with dirt floors and walls made of mud and hay. "When I came back, the only thing I cared about was how to do the most good for the most people," he says. "Since I didn't have any skills, I decided to become an entrepreneur."

While at Brigham Young University, he started his own business selling cellphones and service plans, making enough money to hire a team of salespeople. After that, he invested in a real estate development company that collapsed and left him $250,000 in debt. To get out of the hole, he took a job selling credit card processing services to small businesses door to door. Soon he was the company's top salesman.

This was the mid-2000s, and Johnson's customers kept complaining about the hassle of setting up and maintaining credit card payment systems on their websites. In 2007 he started Braintree, a software company focused on easing the process with slick interfaces. It succeeded-and had good timing. After signing up a slew of restaurants, retailers, and other small businesses, Braintree became the middleman of choice for a profusion of startups premised on ordering services online, including Airbnb, OpenTable, and Uber. The company also made a great bet on mobile payments, acquiring Venmo for only $26 million in 2012. The next year, EBay bought Braintree for $800 million in cash, a little less than half of which went to Johnson.

Despite his newfound fortune, Johnson felt miserable. He was stressed out and overweight. He'd gotten married and had kids at a young age, but his marriage was falling apart, and he was questioning his life, religion, and identity. He says he entered a deep depressive spiral that included suicidal thoughts.

The decision to sell Braintree well before it peaked in value had been motivated in part by Johnson's need to change those patterns. "Once I had money, it was the first time in my life that I could eliminate all permission structures," he says. "I could do whatever I wanted." He broke with the Mormon church, got divorced, and moved from Chicago, where Braintree was headquartered, to Los Angeles to start over.

Arriving in California, Johnson consulted with all manner of doctors and mental health specialists. His bodily health improved with huge changes to his diet, exercise, and sleep routines. His mind proved a tougher puzzle. He meditated and studied cognitive science, particularly the ways people develop biases, in an effort to train himself to think more rationally. By late 2014 he was convinced his wealth would be best spent advancing humanity's understanding of the brain. He took a large portion of his windfall and started OS Fund, a venture firm that has invested in several artificial intelligence and biotech companies. These include Ginkgo Bioworks, Pivot Bio, Synthego, and Vicarious, some of the most promising startups trying to manipulate DNA and other molecules.

Mostly, though, Johnson staked his fortune on Kernel. When he founded the company, in 2015, his plan was to develop surgical implants that could send information back and forth between humans and computers, the way Keanu Reeves downloads kung fu into his brain in The Matrix. (In the early days, Johnson discussed a potential partnership with Elon Musk, whose company Neuralink Corp. has put implants in pigs and monkeys, but nothing came of it.) The idea was, in part, to transfer thoughts and feelings directly from one consciousness to another, to convey emotions and ideas to other people more richly than human language allows.

Perhaps more important, Johnson reckoned, AI technology was getting so powerful that for human intelligence to remain relevant, the brain's processing power would need to keep pace.

Johnson and I began discussing brains in mid-2018, when I was working on a story about the overlap between neuroscience and AI software. During an initial interview at his company's headquarters in L.A.'s Venice neighborhood, Johnson was cordial but somewhat vague about his aims. But at the end of the visit, I happened to mention the time I underwent a mental healing ritual that involved a Chilean shaman burning holes in my arm and pouring poisonous frog secretions into the wounds. (I do mention this a lot.) Excited, Johnson replied that he had a personal shaman in Mexico and doctors in California who guided him on drug-induced mind journeys. Based on this common ground, he decided to tell me more about Kernel's work and his own adventurous health practices.

By then, Johnson had abandoned neural implants in favor of helmets. The technology needed to make implants work is difficult to perfect-among other things, the human body tends to muddy the devices' signals over time, or to reject them outright-and the surgery seemed unlikely to go mainstream. With the helmets, the basic principle remained the same: put tiny electrodes and sensors as close as possible to someone's neurons, then use the electrodes to detect when neurons fire and relay that information to a computer. Watch enough of these neurons fire in enough people, and we may well begin to solve the mysteries of the brain's fine mechanics and how ideas and memories form.

A wider shot of the Flux helmet's enclosure at Kernel's lab. The booth shields against electromagnetic interference so the instrument can measure very sensitive brain output.

On and off for almost three years, I've watched as Kernel has brought its helmets into reality. During an early visit to the company's two-story headquarters in a residential part of Venice, I saw that Johnson's team had converted the garage into an optics lab full of mirrors and high-end lasers. Near the entryway sat a shed-size metallic cube designed to shield its contents from electromagnetic interference. On the second floor, dozens of the world's top neuroscientists, computer scientists, and materials experts were tinkering with early versions of the helmets alongside piles of other electrical instruments. At that point the helmets looked less like 21st century gadgets and more like something a medieval knight might wear into battle, if he had access to wires and duct tape.

Despite the caliber of his team, Johnson and his odd devices were considered toys by outsiders. "The usual Silicon Valley people and investors would not even talk to us or poke around at all," he says. "It became clear that we would have to spend the time, and I would have to spend the money, to show people something and demonstrate it working."

A hospital or research center will typically employ a range of instruments to analyze brains. The list is a smorgasbord of acronyms: fMRI (functional magnetic resonance imaging), fNIRS (functional near-infrared spectroscopy), EEG (electroencephalography), MEG (magnetoencephalography), PET (positron emission tomography), etc. (et cetera). These machines measure a variety of things, from electrical activity to blood flow, and they do their jobs quite well. They're also enormous, expensive, and not easily condensed into helmet form.

In some cases the machines' size owes in part to components that shield the patient's head from the cacophony of electrical interference present in the world. This allows the sensors to avoid distracting signals and capture only what's happening in the brain. Conversely, signals from the machines need to penetrate the human skull, which happens to be well-evolved to prevent penetration. That's part of the argument for implants: They nestle sensors right up against our neurons, where the signals come in loud and clear.

It's unlikely a helmet will ever gain the level of information an implant can, but Kernel has striven to close the gap by shrinking its sensors and finding artful ways to block electromagnetic interference. Among its breakthroughs, Johnson's team designed lasers and computer chips that were able to see and record more brain activity than any previous technology. Month after month, the helmet became more refined, polished, and lightweight as the team made and remade dozens of prototypes. The only trick was that, to suit the different applications Johnson envisioned for the helmet, Kernel wound up needing to develop two separate devices to mimic all the key functions of more traditional machines.

One of the devices, called Flow, looks like a high-tech bike helmet, with several brushed aluminum panels that wrap around the head and have small gaps between them. Flip it over, and you'll see a ring of sensors inside. A wire at the back can be connected to a computer system.

This helmet measures changes in blood oxygenation levels. As parts of the brain activate and neurons fire, blood rushes in to provide oxygen. The blood also carries proteins in the form of hemoglobin, which absorbs infrared light differently when transporting oxygen. (This is why veins are blue, but we bleed red.) Flow takes advantage of this phenomenon by firing laser pulses into the brain and measuring the reflected photons to identify where a change in blood oxygenation has occurred. Critically, the device also measures how long the pulse takes to come back. The longer the trip, the deeper the photons have gone into the brain. "It's a really nice way to distill out the photons that have gone into the brain vs. ones that only hit the skull or scalp and bounced away," says David Boas, a professor of biomechanical engineering and director of the Neurophotonics Center at Boston University.

The other Kernel helmet, Flux, measures electromagnetic activity. As neurons fire and alter their electrical potential, ions flow in and out of the cells. This process produces a magnetic field, if one that's very weak and changes its behavior in milliseconds, making it extremely difficult to detect. Kernel's technology can discover these fields all across the brain via tiny magnetometers, which gives it another way to see what parts of the organ light up during different activities.

The helmets are not only smaller than the devices they seek to replace, but they also have better bandwidth, meaning researchers will receive more data about the brain's functions. According to the best current research, the Flow device should help quantify tasks related to attention, problem-solving, and emotional states, while Flux should be better suited to evaluating brain performance, learning, and information flow. Perhaps the No.1 thing that has scientists gushing about Kernel's machines is their mobility-patients' ability to move around wearing them in day-to-day settings. "This unlocks a whole new universe of research," Boas says. "What makes us human is how we interact with the world around us." The helmets also give a picture of the whole brain, as opposed to implants, which look solely at particular areas to answer more specific questions, according to Boas.

Once their Kernel helmets arrive, Boas and his colleagues plan to observe the brains of people who've had strokes or suffer from diseases such as Parkinson's. They want to watch what the brain does as individuals try to relearn how to walk and speak and cope with their conditions. The hope is that this type of research could improve therapy techniques. Instead of performing one brain scan before the therapy sessions start and another only after months of work, as is the practice today, researchers could scan the brain each day and see which exercises make the most difference.

Devices are also going out to Harvard Medical School, the University of Texas, and the Institute for Advanced Consciousness Studies (a California lab focused on researching altered states) to study such things as Alzheimer's and the effect of obesity on brain aging, and to refine meditation techniques. Cybin Inc., a startup aiming to develop therapeutic mental health treatments based on psychedelics, will use the helmets to measure what happens when people trip.

All of this thrills Johnson, who continues to harbor the grandest of ambitions for Kernel. He may have given up on computer-interfacing implants, but he still wants his company to help people become something more than human.

A couple years ago, Johnson and I boarded his private jet and flew from California to Golden, Colo. Johnson, who has a pilot's license, handled the takeoffs and landings but left the rest to a pro. We were in Colorado to visit a health and wellness clinic run by physician-guru Terry Grossman and have a few procedures done to improve our bodies and minds.

The Grossman Wellness Center looked like a cross between a medical clinic and the set of Cocoon. Most of the other guests were elderly. In a large central room, about 10 black leather chairs and matching footrests were arranged in a loose circle. Each chair held a couple of fluffy white pillows, with a metal pole on the side for our IV drips. A few of the ceiling tiles had been replaced and fitted with pictures of clouds and palm trees. In rooms off to the side, medical personnel performed consultations and procedures.

Our morning began with an IV infusion of two anti-aging fluids: Myers' Cocktail-a blend of magnesium, calcium, B vitamins, vitamin C, and other good stuff-followed by a helping of nicotinamide adenine dinucleotide. Some of the IV fluids can trigger nausea, but Johnson set the drip to maximum and complemented the IV by having a fiber-optic cable fed into his veins to pepper his blood with red, green, blue, and yellow wavelengths of light for added rejuvenation. "I have to experience pain when I exercise or work," he said, adding that the suffering makes him feel alive.

A few hours later, Johnson went into one of the treatment rooms with Grossman to get a stem cell injection straight into his brain. Earlier he'd provided 5 ounces of his blood, which had then been spun in a centrifuge so Grossman could separate out the plasma and put it through a secret process to "activate the stem cells." Now, Johnson hopped onto a reclined exam table, lying on his back with his head angled toward the floor. Grossman pulled out a liquid-filled syringe. Instead of a needle at the end, it had a 4inchlong, curved plastic tube, which the doctor coated with some lubricating jelly. He pushed the tube into one of Johnson's nostrils, told the patient to take a big sniff, then pinched Johnson's nose shut. They repeated the process for the other nostril. The procedure looked incredibly uncomfortable, but again, Johnson was unfazed, pulling in the stem cells with determination and excitement.

This snorting procedure-designed to improve mood, energy, and memory-was just a small part of Johnson's overall health regimen. Each morning the CEO took 40 pills to boost his glands, cell membranes, and microbiome. He also used protein patches and nasal sprays for other jobs. After all this, he did 30 minutes of cardio and 15 minutes of weights. At lunch he'd have some bone broth and vegetables foraged by his chef from the yards of houses in Venice. He might have a light dinner later, but he never consumed anything after 5 p.m. He went to bed early and measured his sleep performance overnight. Every now and then, a shaman or doctor would juice him up with some drugs such as ketamine or psilocybin. He'd taken strongly enough to these practices to tattoo his arm with "5-MeO-DMT," the molecular formula for the psychoactive compound famously secreted by the Sonoran Desert toad.

To make sure all his efforts were doing some good, Johnson had a lab measure his telomeres. These are the protective bits at the end of DNA strands, which some Nobel Prize-winning science has shown can be good indicators of how your body is aging. The longer the telomeres, the better you're doing. Johnson used to register as 0.4 years older internally than his chronological age, but a couple of years into his regimen under Grossman, when he was in his early 40s, his doctors were telling him he was testing like a man in his late 30s.

During one of our most recent conversations, Johnson tells me he's stopped snorting stem cells and experimenting with hallucinogens. "I got what I wanted from that and don't need to mess with it right now," he says. After many tests and much analysis, he's discovered he operates best if he wakes up at 4 a.m., consumes 2,250 calories of carefully selected food over the course of 90 minutes, and then doesn't eat again for the rest of the day. Every 90 days he goes through another battery of tests and adjusts his diet to counteract any signs of inflammation in his body. He goes to bed each night between 8 and 8:30 p.m. and continues to measure his sleep metrics. "I have done tremendous amounts of trial and error to figure out what works best for my health," he says. "I have worked very hard to figure these algorithms out."

Johnson eats once a day, first thing. Yes, including the wine.

In terms of what our birth certificates say, Johnson and I are the same age. He'll turn 44 in August, a month before I do. To someone like me, who prizes late nights with friends, food, and drink, Johnson's rigid lifestyle doesn't exactly sound romantic. But it does seem to be paying off: When he last got tested, he had the exercise capacity of someone in his late teens or early 20s, and a set of DNA and other health markers pegged his age at somewhere around 30. As for me, I lack the courage to ask science what it makes of my innards and will go on celebrating my dad bod.

As Johnson sees it, had he not changed his lifestyle, he'd have remained depressed and possibly died far too young. Now he does what the data say and nothing else. "I did a lot of damage to myself working 18-hour days and sleeping under a desk," he says. "You might earn the praise of your peers, but I think that sort of lifestyle will very quickly be viewed as primitive." He says he's at war with his brain and its tendencies to lead him astray. "I used to binge-eat at night and could not stop myself," he says. "It filled me with shame and guilt and wrecked my sleep, which crushed my willpower. My mind was a terrible actor for all those years. I wanted to remove my mind from the decision-making process."

The nuance in his perspective can be tricky to navigate. Johnson wants to both master the mind and push it to the side. He maintains, however, that our brain is flawed only because we don't understand how it works. Put enough Kernel devices on enough people, and we'll find out why our brain allows us to pursue addictive, debilitating behaviors-to make reckless decisions and to deceive ourselves. "When you start quantifying the mind, you make thought and emotion an engineering discipline," he says. "These abstract thoughts can be reduced to numbers. As you measure, you move forward in a positive way, and the quantification leads to interventions."

Of course, not everyone will want to make decisions based on what a helmet says their brain activity means. Taking the decisions out of thought patterns-or analyzing them for the purposes of market research and product design-poses its own, perhaps scarier, questions about the future of human agency. And that's if the Kernel devices can fulfill the company's broader ambitions. While the big, expensive machines in hospitals have been teaching us about the brain for decades, our understanding of our most prized organ has remained, in many ways, pretty basic. It's possible Kernel's mountain of fresh data won't be of the kind that translates into major breakthroughs. The brain researchers who are more skeptical of efforts such as Johnson's generally argue that novel insights about how the brain works-and, eventually, major leaps in brain-machine interfaces-will require implants.

Yet scientists who have watched Kernel's journey remark on how the company has evolved alongside Johnson, a complete outsider to the field. "Everybody he's recruited to Kernel is amazing, and he's been able to listen to them and motivate them," says MIT neuroscientist Edward Boyden. "He didn't have scientific training, but he asked really good questions." The test now will be to see how the company's devices perform in the field and if they really can create a whole new market where consumers buy Flow and Flux helmets alongside their Fitbits and Oura rings. "There's a lot of opportunity here," Boyden says. "It's a high-risk, high-payoff situation."

If Johnson's theories are correct and the Kernel devices prove to be as powerful as he hopes, he'll be, in a sense, the first person to spark a broader sort of enlightened data awakening. He recently started a program meant to quantify the performance of his organs to an unprecedented degree. Meanwhile, he's taking part in several experiments with the Kernel helmets and is still looking for ways to merge AI with flesh. "We are the first generation in the history of Homo sapiens who could look out over our lifetimes and imagine evolving into an entirely novel form of conscious existence," Johnson says. "The things I am doing can create a bridge for humans to use where our technology will become part of our self."

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

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Bispecific Antibodies Wage a Two-Pronged Attack on Tumors – Curetoday.com

Posted: June 23, 2021 at 1:59 am

After Michael Herman received a diagnosis of high-risk multiple myeloma in 2013, he started a treatment journey that included several years of chemotherapy and the targeted drug Venclexta (venetoclax tablets), which is investigational for the disease and was designed for patients whose cancers have certain genetic abnormalities. The medicines worked well, but as is often the case with multiple myeloma, Hermans cancer eventually returned.

In July 2019, Herman qualified for a clinical trial of teclistamab, an investigational drug thats part of an emerging class of immunotherapy medicines known as bispecific antibodies. He traveled from his home in Galena, Maryland, to the University of Pennsylvania in Philadelphia to get the treatment: a weekly shot in the abdomen.

After just one dose of teclistamab, Hermans cancer load dropped 99%. His disease is no longer detectable, and the study investigators have told him he can stay on the drug as long as it continues to be effective. In terms of side effects, Herman experiences some aches and pains, but says that it doesnt affect him from getting around.

When I was diagnosed, I was told my life expectancy was four years, says Herman, 59, a retired corporate real estate manager. This drug doubled that. Its a wonderful thing.

Teclistamab is one of several bispecific antibodies being developed to treat a range of cancers. Bispecific antibodies are designed to simultaneously bind two targets a target on immune cells and another on tumor cells pulling them together to unleash an immune attack against the cancerous cells. In the case of teclistamab, the two targets are an antigen called CD3 in the immune systems T cells, and BCMA, which is an antigen thats overexpressed in multiple myeloma.

Several other bispecific antibodies are under development to treat blood cancers and a wide range of solid tumor types, including cervical, gastric, brain and liver.

The idea behind combination immune therapies, which include bispecific antibodies, is to find ways to better target the immune system from the get-go, to minimize the chance of resistance or improve the chance of getting a good response, says Dr. Deborah Wong, an oncologist at UCLA.

The first, and so far only, bispecific antibody on the market, Blincyto (blinatumomab), is approved by the Food and Drug Administration (FDA) to treat some patients with acute lymphoblastic leukemia (ALL). The drug, referred to as a bispecific T-cell engager (also referred to as BiTE), has one arm that attaches to CD3 and a second that binds to the antigen CD19 on the surface of cancerous B cells.

In a trial of patients with relapsed or resistant B-cell precursor ALL, Blincyto increased the rate of complete remissions from 20% among patients on standard-of-care chemotherapy to 42%. In a pediatric study released in March 2021, 69% of children treated with Blincyto were still alive after nearly two years, and 93% showed no sign of disease. In a phase 2 study released in May 2021, there was a 95% response rate among patients with Philadelphia chromosome-positive ALL who received Blincyto plus the targeted drug Iclusig (ponatinib), showing the potential of treating patients without the need for chemotherapy, the researchers said.

Bispecific antibodies can cause side effects, including cytokine release syndrome, a severe inflammatory response marked by high fever, body aches and other symptoms. Although Herman experienced cytokine release after his first shot of teclistamab, he has had minimal side effects since then.

Bispecific antibodies could bring immunotherapy options to patients who arent eligible for treatments like CAR T cells, which are personalized therapies that entail removing immune cells from patients and engineering them to recognize and attack their cancer. Although these T-cell therapies can be lifesaving, they present challenges that could be avoided with bispecific antibodies, says Dr. Joshua Richter, assistant professor of medicine, hematology and medical oncology at the Icahn School of Medicine at Mount Sinai in New York.

CAR-Ts are not off-the-shelf products, so they take time for manufacturing, whereas bispecifics are off the shelf, Richter says. And even though there is a risk of side effects with bispecific antibodies, they are titratable, meaning they can be given in small doses to start and then in larger doses after the immune system is given a chance to adapt. We are concerned about giving CAR-Ts to older people because some can get quite sick (from cytokine release), Richter says. Its nice to have a more titratable alternative.

Several bispecific antibodies aimed at multiple myeloma are in clinical trials now, some of which are showing early promise. In a phase 1 dose-ranging study of an intravenous formulation of teclistamab, for example, 58% of patients on the recommended dose for phase 2 trials showed a partial response and 30% had a complete response. Although 70% of participants experienced cytokine release, none had symptoms severe enough to prompt them to pull out of the trial. Other side effects included anemia, a drop in white blood cells and fatigue. A phase 2 study of the drug in multiple myeloma is ongoing and recruiting patients.

Another trial of a BCMA-CD3-targeted bispecific antibody, elranatamab, was paused in May because of cases of peripheral neuropathy reported by some patients. The drugs developer, Pfizer, was asked to investigate the cases and report what it finds to the FDA. Patients in the trial who were benefiting from the drug were able to stay on it, but no new patients will be accepted until the investigation is complete.

There are other promising approaches to multiple myeloma in early-stage testing, Richter says, including a bispecific antibody called cevostamab, which targets CD3 and FcRH5, an antigen expressed on the surface of almost all multiple myeloma cells. Interim results from an ongoing phase 1 study that were reported in December showed an overall response rate of 53%. Responses were even seen in patients who had failed five previous treatments.

Another prospect in multiple myeloma is a bispecific antibody called GBR1342, which targets CD3 and CD38, an antigen implicated in the disease and other blood cancers. The drug, now in phase 1 testing, received orphan drug designation from the FDA in 2019, which could expedite its development path.

There are several bispecific antibodies in development to treat other blood cancers, including acute myeloid leukemia (AML). For example, a drug called flotetuzumab targets CD3 and CD123, a molecule called an interleukin-3 receptor thats prevalent on malignant cells in AML. In a trial of the drug in patients who had relapsed after other therapies, 32% of participants achieved a response, and more than half of those were able to go on to receive stem cell transplants, which put them in remission.

The flotetuzumab trial results highlighted another potential advantage of bispecific antibodies, which is that they may offer patients a bridge to other treatments that could result in more durable remissions, such as stem cell transplants. The ALL treatment Blincyto has also been shown to offer some patients a good lead-in to stem cell transplants. In a trial comparing the drug to standard-of-care chemotherapy, the overall response rate to Blincyto was 44%, and 24% of the patients receiving the drug went on to have stem cell transplants.

Oncologists at The University of Texas MD Anderson Cancer Center in Houston are now testing Blincyto in patients with newly diagnosed ALL, and there are encouraging early results. Last year, researchers reported results from a small trial in which patients with ALL started with four cycles of chemotherapy and then were placed on maintenance treatments that included Blincyto. There was a 100% response rate, and 79% of patients stayed in remission for two years.

Historically, we can cure about 40% to 50% of elderly patients with ALL, so if this response rate holds over time, it will be a tremendous improvement, essentially doubling survival rates, said Dr. Marina Konopleva, a professor and physician-scientist in the department of leukemia and stem cell transplantation at MD Anderson.

Phil Briggs, who received a diagnosis of ALL in January 2018, was treated with Blincyto in the fall of 2020, after his cancer stopped responding to standard-of-care chemotherapy. He found the drug to be far more tolerable than chemotherapy, which had caused him to lose his appetite and drop more than 50 pounds, in addition to developing peripheral nerve damage. Aside from a slight skin irritation, I felt fantastic, says Briggs, 62, who is being treated at MD Anderson.

Briggs courses of Blincyto came in a portable pump, allowing him to receive the agent on an outpatient basis without having to go to the hospital. After four months on the drug, he was able to undergo a stem cell transplant and is now in remission. I felt so much better that I was able to go straight from (Blincyto) to the stem cell trans- plant without any side effects, says Briggs, who is now planning to go back to work as an insurance salesman.

Targeting solid tumors with immunotherapy has been difficult because they lack a single target for immune cells to latch on to, and the environment that surrounds them may not be conducible for immune cells to readily attack the cancer cells. The two-pronged design of bispecific antibodies could help overcome those hurdles.

Several bispecific antibodies being developed to treat solid tumors include one treatment group that targets an immune checkpoint like PD-L1 or CTLA-4, inhibiting it so the immune system can launch an attack.

For example, a bispecific antibody called FS118, which is now being tested in a phase 1 trial in solid tumors, has one treatment group that inhibits PD-L1 and another that blocks another immune checkpoint called LAG-3. Initial results from a trial released last year showed that patients who had been treated with PD-1 or PD-L1 blockers and became resistant to them had durable stabilization of their disease on FS118.

A bispecific antibody called XmAb20717 blocks PD-1 and CTLA-4 and is being tested in patients with a number of solid tumor types. The response rate in a trial reported last November was 19% and included a complete remission in one patient with melanoma. Partial responses were seen in patients with ovarian cancer, non-small cell lung cancer (NSCLC) and castration-resistant prostate cancer.

Other bispecific antibodies in development to treat solid tumors target disease-promoting genetic mutations. One of these agents was recently approved by the FDA. Called Rybrevant (amivantamab-vmjw), it targets EGFR and MET in NSCLC with abnormalities in those genes. It is the first fully human, bispecific antibody approved in lung cancer. The approval was based on results from the phase 1 study, where the response rate to the drug was 40% in patients who had previously been treated with platinum chemotherapy, and 74% of patients saw their disease stabilize.

With so many bispecific antibodies in development across a range of cancer types, many patients could benefit from enrolling in clinical trials of these new therapies, says Wong. Clinical trials are a good option to consider, especially if youve already been on standard therapies, she says. It may be that patients who responded well to their initial therapy and then developed resistance could be good candidates for bispecific antibodies.

And because bispecifics target the immune system, they could improve the prognosis for many patients, Wong says: The beauty of immunotherapy is that the immune system has a long memory, so theres a potential for patients to have long-lasting responses to these drugs.

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Mississippi INBRE Research Efforts Aided by Technology Upgrade – Southern Miss Now

Posted: June 23, 2021 at 1:58 am

Fri, 06/18/2021 - 16:14pm | By: David Tisdale

An enhancement of the cutting edge technology employed by the Mississippi INBREs (IDeA Network of Biomedical Research Excellence) Imaging Facility, headquartered at The University of Southern Mississippi (USM), will keep its affiliate faculty and student researchers at the forefront in STEM (Science, Technology Engineering and Mathematics) research.

The Mississippi INBRE Imaging Core has upgraded its existing Leica SP8 confocal microscope to the STELLARIS STED super resolution platform, one of the most complete imaging systems in the region. The instrument was acquired through funding from the NIH-supported Mississippi INBRE Imaging Core Facility, as well as an NSF Major Research Instrumentation Program grant whose Principal Investigator (PI) is Dr. Alex Flynt, an associate professor in USMs Center for Molecular and Cellular Biosciences.

The Mississippi INBRE Imaging Facility, directed by Dr. Jonathan Lindner, provides imaging and microscopy expertise to researchers throughout the state, offering access to and training on biomedical research equipment at no cost to users. The facility houses several types of microscopes, as well as a variety of large-scale instruments. The imaging facility also offers computational services and expertise to Mississippi researchers.

The addition of the STELLARIS STED super resolution microscope will enhance the quality and scope of biomedical research in the state of Mississippi, accommodating the varied needs of the INBRE Imaging Core user base. This cutting-edge technology is now accessible to faculty and students at USM and across the state who otherwise would not have access to super-resolution confocal microscopy.

According to Dr. Flynt, while light-based microscopes are indispensable to the advancement of many scientific fields. Unfortunately, he says, there is a lower limit to the size of objects that can be observed due to the physics of light itself, a barrier that impedes investigation of minuscule objects. Fortunately, recent advances have vaulted over this hurdle, yielding super-resolution microscopes such as the STELLARIS STED.

This specific super-resolution technology is well-suited for imaging dynamic objects like those in cells, as well as nanoparticles created in the laboratory, Dr. Flynt said. Areas of research that will be investigated with this microscope include material scientists studying assembly of plastic-like materials, cell biologists, and biochemists investigating cell components important in Alzheimers and genetic tools, and microbiologists who examine bacterial community structures involved in infection and plant-soil interactions.

Dr. Lindner concurs, noting also that researchers from a broad base of biological, chemical, and material science fields, including cellular and developmental biology, virology, biochemistry, high performance materials, and nanoparticle development, can greatly benefit from the instruments unique and powerful capabilities.

Microscopes are essential tools for the investigation of biological and molecular systems, Dr. Lindner said. Access to cutting-edge instruments is vital for cell biology, embryology, biochemistry, and imaging advanced materials.

Further, the addition of the advanced microscope will provide important training opportunities for students, also enhancing Mississippi STEM education.

The Leica STELLARIS STED Super-Resolution Confocal Microscope upgrades the previous confocal microscope to a fully automated platform with a 3D STimulated Emission Depletion (STED) super resolution module. The STED technology enables fluorescence microscopy approaches for visualizing objects smaller than the diffraction limit of light, increasing resolution up to 10 times more than traditional microscopes. For reference, the diameter of a nucleus of an average human cell is approximately 10 micrometers. STED super-resolution imaging is capable of resolution below 50 nanometers, over 200 times smaller than a nucleus. This enables the real-time study of sub-cellular molecular interactions and mechanisms on the nanoscale.

The system is capable of both conventional confocal scanning and resonant scanning for rapid low-light illumination imaging, which is ideal for live specimens. It is equipped with an automated motorized stage with upgraded software for expanded view image stitching options, 3D modeling, FRAP, and co-localization. Additionally, the instrument is outfitted with an Okolab CO2chamber for long term mammalian tissue culture imaging, and a Hamamatsu Flash camera for ultrafast acquisition.

Mississippi INBRE, directed by USM Professor Dr. Mohamed Elasri, is a statewide program supported by an award from the National Institutes of General Medical Sciences. Its mission is to enhance the biomedical foundation in Mississippi and engage talented researchers and students in biomedical research projects that will increase the state's research competitiveness, as well as positively impact the health of the states citizens.

For more information about Mississippi INBRE, visit msinbre.org.

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We Can’t Cheat Aging and Death, Claims New Study – Reason

Posted: June 23, 2021 at 1:57 am

Human beings and other primates all inevitably age at fixed rates, according to a new study in Nature Communications. "Human death is inevitable," one of the researchers concludes gloomily in the accompanying press release. "No matter how many vitamins we take, how healthy our environment is or how much we exercise, we will eventually age and die."

The study aims to test the "invariant rate of aging" hypothesis, which posits that the rate of aging is relatively fixed within species. Bodies break down as their tissue and genetic repair mechanisms fail at species-typical rates, leading inevitably to death. The researchers explore this hypothesis by comparing patterns of births and deaths in nine human populations and 30 non-human primate populations, including gorillas, chimpanzees, and baboons living in the wild and in zoos. Their results, they report, imply the existence of "biological constraints on how much the human rate of ageing can be slowed."

To reach this conclusion, Fernando Colchero of the University of Southern Denmark and his team looked at the relationship between life expectancythat is, the average age at which individuals die in a populationand lifespan equality, which measures how concentrated deaths are around older ages.

If deaths are evenly distributed across age groups, the researchers explain, "the result is high lifespan variation and low lifespan equality. If however, deaths are concentrated at the tail-end of the lifespan distribution (as in most developed nations), the result is low lifespan variance and high lifespan equality."

Human life expectancy has been increasing at the rate of about three months per year since the 19th century. The researchers report that most of that increase has been "driven largely by changes in pre-adult mortality." In the accompanying press release, Colchero notes that "not only humans, but also other primate species exposed to different environments, succeed in living longer by reducing infant and juvenile mortality. However, this relationship only holds if we reduce early mortality, and not by reducing the rate of ageing."

Historically, about 1 in 4 children died before their first birthdays and nearly half died before reaching adulthood. Globally, only 1 out 35 children today don't make it to their first birthday. The reduction of early adult deaths from accidents, natural disasters, and infectious diseases has also contributed to longer life expectancies. Consequently, global average life expectancy has more than doubled from just 31 years in 1900 to around73 years now. Since more people are now dying at older ages, global lifespan equality has been increasing.

In the United States, average life expectancy at birth was 47 years in 1900; back then, only 12 percent of people could expect to live past age 65. Over the past 12 decades, life expectancy at birth in the U.S. has increased by 30 years; life expectancy at age 60 has risen by only 7 years. In 2014, U.S. life expectancy reached a high of 78.9 yearsbefore stalling out due to the rising deaths from despair among middle-aged whites and then from the COVID-19 pandemic. Nearly 88 percent of Americans can expect to reach 65 years of age.

Why do all animals, including human beings, age? One popular theory for how species-typical rates of aging emerge is that individuals are selected by nature so that they can keep their health long enough to reproduce and get the next generation up to reproductive snuff. If a body invests a lot of energy in repairing itself, it will reduce the amount of energy it can devote to reproduction. Thus, natural selection favors reproduction over individual longevity.

"Understanding the nature and extent of biological constraints on the rate of ageing and other aspects of age-specific mortality patterns is critical for identifying possible targets of intervention to extend human lifespans," the researchers note. Colchero optimistically adds: "Not all is lost. Medical science has advanced at an unprecedented pace, so maybe science might succeed in achieving what evolution could not: to reduce the rate of ageing."

The good news is that a lot of promising research on anti-aging and age-reversal interventions is advancing rapidly. In December, researchers at the University of San Francisco reported that a small molecule drug achieved rapid restoration of youthful cognitive abilities in aged mice, accompanied by a rejuvenation of brain and immune cells. Another December study found that dosing aged mice with amolecule called prostaglandin E2 can activate muscle stem cells to repair damaged muscle fibers, making the mice 20 percent stronger after one month of treatment. As we age, senescent cells accumulate and secrete molecules that cause various age-related diseases. Researchers are working on senolytic compounds that would help restore youthful vigor by clearing out these senescent cells.

The transhumanist biogerontologist Aubrey de Grey, co-founder of the SENS Research Foundation, argues that anti-aging research is on the trajectory to achieve that he calls "longevity escape velocity." That's when the annual rate of increase in life expectancy exceeds 12 months for every year that passes. De Grey recently tweeted that he thinks that there is a 50 percent chance that humanity will reach longevity escape velocity by 2036. If so, our species may finally be able to cheat aging and death.

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Lineage’s OPC1 Cell Therapy for the Treatment of Spinal Cord Injury to Return to Clinical Testing – Business Wire

Posted: June 23, 2021 at 1:55 am

CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided an update on the clinical advancement of OPC1, its investigational allogeneic oligodendrocyte progenitor cell (OPC) transplant therapy for the treatment of spinal cord injury (SCI). Following feedback received from an interaction held with the U.S. Food and Drug Administration (FDA) last week under the FDAs Regenerative Medicine Advanced Therapy (RMAT) program, Lineage intends to submit an amendment to its Investigational New Drug application (IND) for OPC1 to support a Phase 1 clinical study to evaluate the safety and performance of Neurgain Technologies Inc.s Parenchymal Spinal Delivery System (Neurgain PSD system) to deliver OPC1 cells to the spinal cord. In February, the Company entered into an exclusive option and license agreement with Neurgain to evaluate its novel PSD system in both preclinical and clinical settings. The IND amendment is expected to be submitted to the FDA in the fourth quarter of 2021. The data from the Phase 1 clinical study is intended to validate the Neurgain PSD system for use in a late-stage clinical study, expected to begin in 2022 following the completion of the Phase 1 study.

It is a privilege to report that our novel OPC1 program will be returning to clinical testing earlier than anticipated. There currently are few opportunities for SCI patients to participate in clinical trials, so we are excited to re-engage with these patients and their advocacy community as part of our efforts to improve outcomes for individuals with this debilitating condition, for which there are no FDA-approved treatments, stated Brian M. Culley, Lineages CEO. In the past 18 months, we have significantly increased the purity and production scale of the OPC1 cells utilized in a prior clinical study. This improved production process has been transferred to our in-house Current Good Manufacturing Practice (cGMP) suite and will support production of clinical study material for later-stage clinical work. In parallel, we are finalizing plans to test the safety of the Neurgain PSD system to deliver OPC1 in SCI patients. We believe this device can improve the ease and precision of delivering our cells to the spinal parenchyma. As an added benefit, based on feedback from the FDA, in addition to patients with subacute SCI, we anticipate that patients with chronic SCI also will be eligible for enrollment in this study. Gaining additional OPC1 safety and device performance data across a broader range of patients and injury types will be more informative to the program and support further product and device development. Our recent accomplishments in areas of production and delivery contributed real-world feasibility to the promising clinical results previously reported with this program, in which OPC1 demonstrated improvements to quality of life and motor function for certain SCI patients. Importantly, we are working to be in a position to initiate a late-stage clinical study in SCI next year.

The Neurgain PSD system has been designed to allow for the administration of cells to the spinal cord without stopping the patients ventilator during the procedure. Elimination of the need to stop respiration during surgery is expected to reduce the complexity, risk, and variability of administering cells to the area of injury. The Neurgain PSD system has been designed to provide delivery of cells with accurate anatomical positioning and dosing, is more compact than existing devices and is attached directly to the patient during the procedure. This innovative delivery system is expected to provide a significant improvement in usability and provide more flexibility to the surgeon when compared to the methods and tools utilized to deliver OPC1 cells in the completed Phase 1/2a SCiStar study of OPC1 for the treatment of cervical SCI. Neurgain Technologies, Inc. is a medical device company that is developing technologies developed by neurosurgeons at the University of California San Diego.

Lineage plans to evaluate the safety and performance of the Neurgain PSD system to deliver OPC1 to the spinal cord in both the preclinical and clinical setting. If results of these studies are positive, Lineage may exercise its option to enter into a pre-negotiated license and commercialization agreement with Neurgain. Pursuant to that agreement, Lineage may integrate the Neurgain PSD system into a late-stage clinical trial and, if approved, commercial use of OPC1 for the treatment of patients with spinal cord injury. There currently are no FDA approved treatments for spinal cord injury.

About Spinal Cord InjuriesA spinal cord injury occurs when the spinal cord is subjected to a severe crush or contusion and frequently results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. The cost of a lifetime of care for a severe spinal cord injury can be as high as $5 million.

About OPC1OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements in motor recovery in individuals with subacute spinal cord injuries. OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. While variability exists for the precise duration of each phase, subacute SCI generally refers to the phase that is three to six weeks post-injury and chronic SCI refers to the phase beginning after the subacute phase. The OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine (CIRM). OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation for its use in subacute cervical SCI and Orphan Drug designation from the FDA.

About Lineage Cell Therapeutics, Inc.Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical programs are in markets with billion dollar opportunities and include three allogeneic (off-the-shelf) product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of subacute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineages VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking StatementsLineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, may, will, estimate, continue, anticipate, design, intend, expect, could, can, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to advancement of the clinical development of OPC1 to treat SCI, OPC1s potential to improve quality of life and/or motor function for patients with SCI, the potential benefits of using the Neurgain PSD system to deliver OPC1 for the treatment of SCI, OPC1s regulatory approval pathway, and Lineages potential exclusive license and commercialization agreement with Neurgain. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineages business and other risks in Lineages filings with the Securities and Exchange Commission (SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading Risk Factors in Lineages periodic reports with the SEC, including Lineages most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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NanoString Launches nCounter Stem Cell Characterization Panel to Advance the Development of Stem Cell Therapy – Business Wire

Posted: June 23, 2021 at 1:55 am

SEATTLE--(BUSINESS WIRE)--NanoString Technologies, Inc. (NASDAQ: NSTG), a leading provider of life science tools for discovery and translational research, today announced the launch of the nCounter Stem Cell Characterization Panel for the analysis and optimization of stem cell lines used in the development of potential novel therapeutics.

Recent breakthroughs in stem cell therapy, regenerative medicine, and CRISPR engineering have advanced the development of promising new treatments for debilitating diseases across a broad range of research areas, including neurological and cardiovascular disease, vision loss, and certain types of cancers. However, one of the biggest challenges with stem cell research is the high variability found within the development and manufacturing process that impacts the ability of the stem cells to differentiate and function. The new nCounter Stem Cell Characterization panel measures the eight essential components of stem cell biology and provides a novel, standardized assay for evaluating factors that influence and determine viability, functionality, and pluripotency.

"The simple, automated workflow and highly reproducible, digital results make the nCounter system an excellent fit for all types of stem cell applications," said Chad Brown, senior vice president of Sales and Marketing at NanoString. "With this panel, researchers have a powerful new tool that can quickly assess stem cell health to advance development efforts and optimize stem cell production, achieving robust results in less than 24 hours."

"The Process Development team at ARMI-BioFabUSA is very excited to use the nCounter Stem Cell Characterization panel across a number of our projects where we are developing human tissues composed of mature cells differentiated from stem cells. The Stem Cell Characterization Panel will give us greater insight into the differentiation status of our cells and the success of our current process development and manufacturing runs," said Damian Hile, senior process development scientist at Advanced Regenerative Manufacturing Institute-BioFabUSA (ARMI-BioFabUSA).

The novel 770 gene panel is available for humans and mice and was designed at NanoString with input from leading stem cell experts. To learn more about the nCounter Stem Cell Characterization Panel, visit NanoString at the virtual 2021 ISSCR Conference June 21-26. In addition, NanoString is sponsoring the Cellular Identity: Pluripotency Dynamics session, with Joseph Beechem, Ph.D., chief scientific officer at NanoString.

To learn more about the panel and how the development of the panel can expedite stem cell research, visit the Brief nCounters stem cell experience.

About ARMI-BioFabUSA

The Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, NH, is an organization funded by the United States Department of Defense. ARMI's mission is to make practical the large-scale manufacturing of engineered tissues and tissue-related technologies to benefit existing industries and grow new ones. ARMI brings together a consortium of over 150 partners from across the industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs. For more information on ARMI-BioFabUSA, please visit http://www.ARMIUSA.org.

About NanoString Technologies, Inc.

NanoString Technologies is a leading provider of life science tools for discovery and translational research. The company's nCounter Analysis System is used in life sciences research and has been cited in more than 4,300 peer-reviewed publications. The nCounter Analysis System offers a cost-effective way to easily profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision, facilitating a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The company's GeoMx Digital Spatial Profiler enables highly-multiplexed spatial profiling of RNA and protein targets in a variety of sample types, including FFPE tissue sections.

For more information, please visit http://www.nanostring.com.

NanoString, NanoString Technologies, the NanoString logo, GeoMx, and nCounter are trademarks or registered trademarks of NanoString Technologies, Inc. in various jurisdictions.

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Tessa Therapeutics Announces Collaboration with A*STAR’s – GlobeNewswire

Posted: June 23, 2021 at 1:55 am

BEDMINSTER, N.J. and SINGAPORE, June 23, 2021 (GLOBE NEWSWIRE) -- Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, today announced a collaboration agreement with the Agency for Science Technology and Researchs (A*STAR) Institute of Molecular and Cell Biology (IMCB)in Singapore to form a research laboratory. Jointly operated by Tessa and IMCB, the facility will harness new preclinical technologies and provide capabilities to accelerate the discovery and development of the next generation of cell therapies.

The collaboration is focused on IMCBs research expertise, including new humanized patient-derived-xenograft (PDX) and patient-derived-organoid (PDO) models. These models will be used to screen Tessas novel cell therapies and accelerate clinical development as well as enable the discovery of potential new therapeutic targets against cancer.

In addition, the laboratory will contribute other preclinical and clinical work, including product characterization studies and compiling data required for Investigational New Drug (IND) applications with the U.S. Food and Drug Administration (FDA) and other regulatory submissions.

We at Tessa are excited to have this opportunity to work with A*STAR and IMCB in advancing our efforts to bring much-needed novel treatments to cancer patients globally, stated Ivan D. Horak, M.D., Chief Medical Officer and Chief Scientific Officer of Tessa Therapeutics. This collaboration will allow Tessa to leverage IMCBs considerable expertise in developing and harnessing new research tools, as well as A*STARs state-of-the art facilities, to enhance our preclinical pipeline development and discovery efforts, and by doing so, further strengthen our research and development pipeline.

The agreement marks Tessas second collaboration with IMCB, a research institute within A*STAR, Singapores lead government agency spearheading scientific discovery and innovation in the region.

Cell therapies are rapidly evolving to treat several cancers. However, the screening and validation of these approaches via successful preclinical models is key to ensuring that these novel therapeutics are swiftly moved along from bench to bedside for better patient outcomes, stated Chen Qingfeng, Ph.D., Co-Principal Investigator for the laboratory and Senior Principal Investigator, IMCB, A*STAR. We look forward to working with Tessa to accelerate their clinical development and find novel therapeutic targets against cancer.

Wanjin Hong, Ph.D., Executive Director of IMCB, A*STAR, commented, This agreement underscores the value of academia and industry partnerships that play an essential role in translating novel scientific discoveries into important new therapeutics for improved health outcomes. It further demonstrates A*STARs role in adding vibrancy to the local biotech ecosystem.

About Tessa Therapeutics

Tessa Therapeutics is a clinical-stage biotechnology company developing next-generation cell therapies for the treatment of hematological cancers and solid tumors. Tessas lead clinical asset, TT11, is an autologous CD30 targeting CAR-T therapy currently being investigated as a potential treatment for relapsed or refractory classical Hodgkin lymphoma (Phase 2) and CD30-positive non-Hodgkin lymphoma (Phase 1). TT11 has been granted RMAT designation by the FDA and PRIME designation by European Medicine Agency. Tessa is also advancing an allogeneic off-the shelf cell therapy platform targeting a broad range of cancers in which Epstein Barr Virus Specific T Cells (EBVSTs) are augmented with CD30-CAR technology to prevent graft rejection. A therapy using this platform is currently the subject of a Phase 1 clinical trial in CD30-positive lymphoma. A third clinical asset evaluates novel combination therapy of HER2-CAR-T cells and binary oncolytic virus in an ongoing Phase 1 study targeting HER2 positive solid tumors. Tessa has its global headquarters in Singapore, where the company has built a state of the art, commercial cell therapy manufacturing facility. Tessas United States headquarters are in New Jersey. For more information on Tessa, visit http://www.tessacell.com.

Cautionary Note on Forward Looking Statements

This press release contains forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, to the fullest extent applicable) including, without limitation, with respect to various regulatory filings or clinical study developments of the Company. You can identify these statements by the fact that they use words such as anticipate, estimate, expect, project, intend, plan, believe, target, may, assume or similar expressions. Any forward-looking statements in this press release are based on managements current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the Companys financial results, the ability to raise capital, dependence on strategic partnerships and licensees, the applicability of patents and proprietary technology, the timing for completion of the clinical trials of its product candidates, whether and when, if at all, the Companys product candidates will receive marketing approval, and competition from other biopharmaceutical companies. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made, and disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Companys views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The Companys products are expressly for investigational use pursuant to a relevant investigational device exemption granted by the U.S. Food & Drug Administration, or equivalent competent body.

Tessa Therapeutics Media ContactTiberend Strategic Advisors, Inc.Johanna Bennett+1-212-375-2686jbennett@tiberend.com

Dave Schemelia+1-609-468-9325dschemelia@tiberend.com

Ingrid Mezo+1-646-604-5150imezo@tiberend.com

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Caladrius Biosciences to Assess its CLBS201 CD34+ Cell Therapy in Diabetic Kidney Disease – GlobeNewswire

Posted: June 23, 2021 at 1:55 am

BASKING RIDGE, N.J., June 22, 2021 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (Nasdaq: CLBS) (Caladrius or the Company), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, today announced that the U.S. Food and Drug Administration (FDA) has authorized its investigational new drug (IND) application for the study of CLBS201, a CD34+ cell therapy for the treatment of diabetic kidney disease (DKD).

Our latest development program, CLBS201, is designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic patients with reduced kidney function. Specifically, we will be targeting patients with later stage chronic kidney disease. Based on a wealth of published preclinical and early clinical data, it appears that the innate ability of CD34+ cells to promote the growth of new microvasculature could be a means to attenuate the progression, or even reverse the course, of DKD, stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. We plan to initiate a phase 1/2 proof-of-concept study of CLBS201 within the next several months. Kidney disease remains a largely unmet medical need, especially as the general population ages and the incidence of diabetes and hypertension increases.

About Caladrius Biosciences

Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease. We are developing first-in-class cell therapy products based on the finely tuned mechanisms for self-repair that exist in the human body. Our technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication.

The Companys current product candidates include: CLBS16, the subject of both a recently completed positive Phase 2a study and a newly initiated Phase 2b study (www.freedom-trial.com) in the U.S. for the treatment of coronary microvascular dysfunction (CMD); HONEDRA (CLBS12), recipient of orphan designation for Buergers Disease in the U.S. as well as SAKIGAKE designation and eligible for early conditional approval in Japan for the treatment of critical limb ischemia (CLI) and Buergers Disease based on the results of an ongoing clinical trial; CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic kidney disease (DKD); and OLOGO (CLBS14), a Regenerative Medicine Advanced Therapy (RMAT) designated therapy for which the Company is in discussion with the FDA to finalize a Phase 3 protocol of reduced size and scope for a confirmatory trial in subjects with no-option refractory disabling angina (NORDA). For more information on the Company, please visitwww.caladrius.com.

Safe Harbor for Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect managements current expectations, as of the date of this press release, and involve certain risks and uncertainties. All statements other than statements of historical fact contained in this press release are forward-looking statements including, without limitation, all statements related to the completion of the private placement, the satisfaction of customary closing conditions related to the private placement and the intended use of net proceeds from the private placement as well as any expectations of revenues, expenses, cash flows, earnings or losses from operations, cash required to maintain current and planned operations, capital or other financial items; any statements of the plans, strategies and objectives of management for future operations; market and other conditions; any plans or expectations with respect to product research, development and commercialization, including regulatory approvals; any other statements of expectations, plans, intentions or beliefs; and any statements of assumptions underlying any of the foregoing. Without limiting the foregoing, the words plan, project, forecast, outlook, intend, may, will, expect, likely, believe, could, anticipate, estimate, continue or similar expressions or other variations or comparable terminology are intended to identify such forward-looking statements, although some forward-looking statements are expressed differently. Factors that could cause future results to differ materially from the recent results or those projected in forward-looking statements include the Risk Factors described in the Companys Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 25, 2021 and in the Companys other periodic filings with the SEC. The Companys further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this Press Release. Caladrius does not intend, and disclaims any obligation, to update or revise any forward-looking information contained in this Press Release or with respect to the matters described herein, except as required by law.

Contact:

Investors:Caladrius Biosciences, Inc.John MendittoVice President, Investor Relations and Corporate CommunicationsPhone:908-842-0084Email:jmenditto@caladrius.com

Media: Real ChemistryRachel GirardReal ChemistryPhone: 401-477-4030Email: rgirard@realchemistry.com

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Caladrius Biosciences to Assess its CLBS201 CD34+ Cell Therapy in Diabetic Kidney Disease - GlobeNewswire

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John Pawelek, Who Explored the Causes of Metastasis, Dies at 79 – The Scientist

Posted: June 23, 2021 at 1:55 am

John Pawalek

yale school of medicine

John Mason Pawelek, a dermatology and cancer researcher at the Yale School of Medicine, died on May 31 at age 79 of an apparent heart attack. Pawelek, a past president of the Pan American Society for Pigment Cell Research, had a longstanding interest in the biological factors that regulate skin pigmentation. In recent years, he became interested in understanding what causes the skin cancer melanoma to metastasize.

Even though he was in his late 70s, John thought like a 19-year-old in that he was always open to new ideas that cut against the grain, and was in no way beholden to current medical orthodoxies, says Greggory LaBerge, a medical geneticist at the University of Colorado School of Medicine who also directs the Denver Police Departments Forensics and Evidence Division.

LaBerge collaborated frequently with Pawelek to test the provocative idea that many solid tumors spread throughout the body after immune cells and cancer cells have fused. LaBerge says Pawelek believed that such fusion could explain metastasis for many cancers, not just melanoma, and that stopping such cell fusion is a promising new treatment target. Other experts in oncology, as The Scientistrecently reported, believe that more evidence is needed to make such sweeping claims.

Pawelek was born in Baltimore, Maryland, on April 15, 1942. He graduated in 1963 from Gettysburg College, where he met his future wife Linda through singing in the college choir. Pawelek went on to earn a doctorate in biology from Brown University in 1967, after which he began an affiliation with Yale University that lasted more than 50 years.

In the 1990s, Pawelek helped develop a synthetic melanin product known as Melasyn, which he initially intended as a skin cancer preventive. Dermatologists have long known that insufficient melanin production is linked to a higher risk of wrinkling and various skin cancers, and Pawaleks research using mice showed that Melasyn protected against UV exposure. The product, which can adjust to the complexion of the person wearing it, blending into the varying skin tones of different people, was eventually marketed and sold as a cosmetic product.

According to an obituary, in his free time Pawelek was a bon vivantwho participated in piano jam sessions at pigment cell conferences and performed in church plays and musicals at the Unitarian Society of New Haven, Connecticut. He once played piano with Fats Domino and was among the activists who marched from Selma to Montgomery, Alabama, with Martin Luther King Jr. in 1965.

He was one of a kind. He was very passionate about everything he did, says Anjela Galan, a skin cancer pathologist at Yale who collaborated with Pawelek to study the causes of metastasis. I was shocked about his loss because he was so lively.

LaBerge concurs. He was a great guy who was so much fun to be around.

In a career that produced nearly 200 peer-reviewed publications, Pawelek was perhaps most excited by the paper/manuscript that turned out to be the final one of his lifetime, Galan notes. In a May 28 study in Cancer Genetics,Pawelek, LaBerge, Galan, and colleagues demonstrated a complete metastatic journey of fused immune-cancer cells from a primary melanoma site to a lymph node and then to the brain. This followed earlier work by Pawelek and colleagues hinting at such a trajectory.

Pawelek is survived by his wife Linda; sons Aaron, Josh, and Nathan; daughters-in-law Susan, Stephany, and Karen; and grandchildren Oliver, Mason, Aidan, Zachary, and Max.

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John Pawelek, Who Explored the Causes of Metastasis, Dies at 79 - The Scientist

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Precision Medicine: Improving Health With Personalized Solutions – BioSpace

Posted: June 23, 2021 at 1:55 am

Cancer treatments are improving as scientists are finding ways to develop new techniques and treatments. One of which is precision medicine, where they have focused on improving patients health using personalized solutions.

RELATED: Oxfords Genomics Pushing the Boundaries of Personalized Medicine

Precision medicine, in the simplest definition, is the way a patient is treated, diagnosed, or prevent disease by checking his/her genetics, environment, or lifestyle.

This type of treatment is related to pharmacogenomics. Where pharmacogenomics is the study of how a persons gene affects his/her response to a drug, it is used to treat a person through effective and safe medication tailored to their genes.

Precision medicine is now commonly used on patients treated with pancreatic cancer, lung cancer, melanoma/skin cancer, and colon cancer. It is also used to detect and treat HIV and cystic fibrosis.

Slowly, it is also seen in treatments for heart diseases, Alzheimers disease, rheumatoid arthritis, and multiple sclerosis.

In cancer patients, most medical facilities treat every patient the same way. However, studies suggest that not everyone responds to treatments the same way. One persons body may react differently with medicines as compared to another person.

Genetics plays a role in treating tumors, and precision medicine promise to tailor treatments based on a persons genes. It is seeing how a tumor would react to certain treatments that may work for other people.

Precision medicine can be used in the prevention and prediction of disease and management and treatment. Here are some examples of how it is used to treat, prevent, or treat people in a practical setting.

Checking your familys history of diseases and illnesses can somehow determine what you are capable of acquiring. If a family member has a history of cancer, heart diseases, diabetes, high blood pressure, or other chronic diseases, there is a high chance of you getting it.

With this data and information, a doctor can create treatment plans to prevent these from happening to you.

For example, when the doctor finds out that any of your family members had breast cancer, then the chances of you having it is likely. The doctor will then decide for you to have regular mammograms to check for any signs.

Newborns (usually right after theyre conceived) are screened where blood samples are taken. This test will check if they have any pre-existing conditions acquired from their parents, check hearing capabilities or heart defects, among others.

This way, the baby will be treated accordingly if any crucial or life-threatening conditions are seen.

For example, the newborn screening shows Baby Mary has severe combined immunodeficiency (SCID), she will receive a bone marrow transplant immediately to battle her condition. SCID is life-threatening to babies since its responsible for fighting off infections.

Personal trackers such as smartwatches or other mobile devices that check on your health can be lifesavers and be tools for precision medicine.

For example, a person is notified by his smart device that he is experiencing abnormal heart rates even if he has no family history of any heart condition. He then goes to see a doctor because of this and has been diagnosed with atrial fibrillation. This device could have saved his life because that condition can lead to a stroke. Now, he can treat his condition before it worsens.

Genomic sequencing can be used to control and track-out infectious diseases. Similar to whats been used to track COVID-19, this approach shows a DNA of a germ or virus where scientists have the opportunity to learn more about it and find a treatment a cure for it.

An example of this is the COVID-19, where scientists were able to extract samples from those infected with the virus and learn about it and find vaccines and cures for it, which is now slowly happening to us.

As a treatment, tumor profiling is genetic testing of a tumor. It is a way for doctors to choose which kind of treatment they would use for a condition. They would know from this process if cancer will return or would need radiation or chemotherapy.

For example, Jennys breast cancer returned and is diagnosed again. But her tumor profiling reveals she has triple-negative breast cancer. Her approach to this, along with her doctors, is a more aggressive one, including chemotherapy, radiation, and mastectomy.

RELATED: FDA Approves GSKs Checkpoint Inhibitor Jemperli for Endometrial Cancer

As mentioned above, pharmacogenomics studies how a person reacts to a certain treatment based on their genes. Doctors using this treatment can gauge if a certain medicine can be effective or not based on a patients history. They can also determine if the patient will experience any serious side effects.

For example, John needs to undergo Fluorouracil (5-FU), which is a type of chemotherapy. But if John has a low level of an enzyme called dihydropyrimidine dehydrogenase (DPD), which helps metabolize fluorouracil in the body, the doctors would need to check on him using pharmacogenomics. If he has a low dose of fluorouracil, an oncologist will decrease the dosage in the chemotherapy to prevent any serious side effects.

With these examples revealed, some facilities and companies provide precision medicine to improve the living conditions of patients treated with different diseases.

ExactCure is a French start-up that combines artificial intelligence with precision medicine to create flawless software for the use of drugs to be used by patients depending on their kidney status, genotype, gender, or age.

Patients use this service by inputting their data, and ExactCure will give the necessary medications based on the information provided.

Tepthera is a Swiss start-up that focuses on cancer immunotherapy, infectious and auto-immune diseases.

Their focus concerning precision medicine is on identifying T cell antigens for better and personalized therapies and treatment.

Caris Life Sciences is a molecular science company that focuses on precision medicine in oncology. They are working on the development of innovative therapeutics and advance potential treatments for cancer in the clinic.

They develop profiling assays for oncology that scan DNA, RNA and proteins to reveal a molecular blueprint to help physicians determine the best course of treatment for cancer patients.

Precigen is a Maryland-based company that is advancing its UltraCAR-T cell therapy approach to treating cancer.

They are now developing next-generation gene and cell therapies that can change the treatment paradigm in immuno-oncology, autoimmune disorders and infectious diseases.

There are numerous ways to treat diseases and medical conditions with the use of precision medicine. Scientists are continually finding out ways to improve patients lives by using their traits.

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