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A new psychedelic drug gives psychiatric benefits without causing hallucinations – Massive Science

Following the harassment of Christian Cooper in Central Park in May 2020, Black birders created #BlackBirdersWeek to celebrate Black nature enthusiasts and highlight their belonging in outdoor spaces. Since then, dozens of campaigns have emerged to amplify and appreciate Black academics, scientists, and naturalists.

Next up is #BlackInMarineScienceWeek, running from November 29th to December 5th.Led by founder Dr. Tiara Moore and organizers Amani Webber-Schultz, Dr. Camille Gaynus, Carlee Jackson, Al Troutman, Jasmin Graham, Jeanette Davis, Kris Howard, Leslie Townsell, Kaylee Arnold, and Jaida Elcock, this week represents an opportunity for community building and improved representation.

There are few Black folks in ecology and even fewer in marine ecology, says Arnold, a science communicator and disease ecologist. The network that Ive gained through organizing this week is phenomenal. Meeting other Black marine scientists and showing that to the world, especially young Black folks, is a way to say we exist, were here. We have a full day dedicated to young kids, which is unique and exciting.

The organizers hope that the week will help normalize Black folks doing marine research, inspire younger generations, and remind everyone to check their preconceived notions.

"When I say I study sharks people seem concerned about my swimming or my hair, [and] sometimes respond with 'Oh, thats super interesting'... I dont know if that's because it's unusual for people to study sharks or because Im Black and I study sharks, recalls Elcock, an elasmobranch movement ecologist, science communicator, and co-founder of Minorities in Shark Science. Science is for everybody. People say there isn't diversity because [Black] people arent interested... thats clearly not true theres a whole week dedicated [to it]."

Discussion this week will address the fact that exclusion, not lack of interest, led to todays lack of representation. Centuries of segregation and underinvestment in Black neighborhood pools led to, and are perpetuated by, these incorrect and harmful ideas.

My grandparents and my mom said there were just no pools for her to go to... I had a very different experience. Despite people trying to push us out of the water and science, we persevered, and now we get to break down those stereotypes, notes Arnold.

Black in Marine Science Week is here to do just that, showcasing organizers and participants from every imaginable marine science niche, all shaping how society views the oceans and its inhabitants.

There's more Black folks than even we know and are showcasing. I hope that if the media picks up on the number of us as well, and has better representation. Seminar series are extremely white, and now you have a resource of people you can invite instead, emphasizes Arnold, pointing to the necessity of non-Black marine scientists to step up and ensure representation continues beyond this joyous and educational week.

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A new psychedelic drug gives psychiatric benefits without causing hallucinations - Massive Science

Michigans Catholic bishops say 2 COVID-19 vaccines are OK morally but another is problematic – MLive.com

GRAND RAPIDS, MI Michigans seven Catholic bishops said COVID-19 vaccines by Pfizer and Moderna are morally permissible but raised concerns about AstraZencas vaccine using a cell line that originated from tissue of an aborted fetus.

Pfizer and Moderna have received emergency approval for use by the U.S. Food and Drug Association. Pfizers vaccine has already rolled out across the country while Moderna expects to begin shipping its vaccine on Sunday, Dec. 20.

AstraZencas vaccine along with a vaccine by Johnson & Johnson - is nearing its final trial stage.

The Catholic bishops issued a statement Saturday, Dec., 19, on what they called the morality of COVID-19 vaccines.

It is morally permissible to receive the vaccines developed by Pfizer and Moderna, the bishops said.

Neither of these vaccines have used cell lines originating in tissue taken from aborted babies in their design, development, and production. However, both the Pfizer and the Moderna vaccine did use such a cell line in the confirmatory testing. This connection to the abortion is very remote, however, and it is important to keep in mind that there are varying levels of responsibility. Greater moral responsibility lies with the researchers than with those who receive the vaccine, the bishops wrote.

The vaccine developed by AstraZeneca is more morally problematic, however, the bishops wrote.

It did utilize in the design, production, development, and confirmatory testing a cell line that originated from tissue taken from an aborted baby. This vaccine may be received only if there are no other alternatives. If one does not have a choice of vaccine and a delay in immunization may bring about serious consequences for ones health and the health of others, it would be permissible to accept the AstraZeneca vaccine.

Science Magazine said that at least five COVID-19 vaccine candidates use a fetal kidney cell line from a fetus aborted around 1972 or cells of an 18-week-old fetus that was aborted in 1985.

Dr. Deepak Srivastava, former president of the International Society for Stem Cell Research, told the Associated Press that the fetal cell lines were vital in developing vaccines for a range of viruses.

They are widely used in many aspects in biomedical science because they are so effective, he said. Whats important for the public to know even if they are opposed to the use of fetal cells for therapies, these medicines that are being made and vaccines do not contain any aspect of the cells in them, Srivastava said. The cells are used as factories for production.

In a column for the Heritage Foundation, which promotes conservative public policy, Dr. Melissa Moschella said she strongly opposes abortion but supported using the cell lines derived long ago from the tissue of aborted fetuses - to develop life-saving vaccines.

Cell lines (from one of the fetuses) are far removed from the unborn child from whose tissue they were initially derived. Such cell lines are immortal, meaning that, once developed, they continue to divide and reproduce themselves indefinitely. This means that the use of such lines does not necessarily create additional demand for new fetal tissue, Moschella wrote.

The bishops said the Congregation for the Doctrine of the Faith found vaccinations permissible because of the pandemics serious health risks.

Those who do not receive vaccinations have a moral responsibility to take steps to prevent spread of the virus, they said.

At this same time, we join our voices to call for the development of vaccines that have no connection to abortion. Our consciences must not be dulled, nor may we imply in any way that abortion is acceptable, the bishops said.

The statement was issued by Allen H. Vigneron, archbishop of Detroit, and bishops Paul J. Bradley of Kalamazoo; Earl A. Boyea of Lansing; John F. Doerfler of Marquette; Robert D. Gruss of Saginaw; Walter A. Hurley, apostolic administrator, of Gaylord; and David J. Walkowiak of Grand Rapids.

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Michigans Catholic bishops say 2 COVID-19 vaccines are OK morally but another is problematic - MLive.com

How Researchers Are Making Do in the Time of COVID-19 – The Wire Science

Image: UN/Unsplash.

One of the astonishing aspects of the human response to the COVID-19 pandemic has been how quickly scientists pivoted to studying every facet of the virus in order to mitigate the loss of life and plan for a return to normalcy. At the same time, a lot of non-coronavirus research ground to a near halt.

With research labs and offices shuttered for all but essential workers, many scientists were stuck at home, their fieldwork and meetings canceled and planned experiments kicked down the road as they struggled to figure out how to keep their research programs going. Many took the opportunity to catch up on writing grants and papers; some in between caring for kids came up with strategic workarounds to keep the scientific juices flowing.

To gauge how researchers in different fields are managing,Knowable Magazine spoke with an array of scientists and technical staff among them a specialist keeping alive genetically important strains of fruit flies, the maintenance chief of an astronomical observatory working to keep telescopes safe and on standby during the lockdown, and a paediatrician struggling to manage clinical trials for a rare genetic disease. Here are a few slices of scientific life during the pandemic.

Agnieszka Czechowicz, Stanford University School of Medicine

Czechowicz is a paediatrician in Stanfords division of stem cell transplantation and regenerative medicine, where she manages a research group that develops new therapies and conducts clinical trials on rare genetic diseases.

Agnieszka Czechowiczs father suffers from severe Parkinsons disease. The coronavirus pandemic forced him to remain indoors and away from people, robbing him of the physical conditioning and social interactions he needs to cope with his disease. A recent fall left him in the hospital, bringing the additional worry that he might contract COVID-19 there and isolating him further.

For Czechowicz, his situation brought into sharp relief the challenges the coronavirus has forced upon those carrying out clinical trials, including those she is running, which involve patients traveling to hospitals around the country. Would I have him travel to any clinical site right now for a new Parkinsons treatment? she says. Absolutely not.

The pandemic forced Czechowicz to halt clinical trials she oversees for a rare genetic disease of children called Fanconi anAemia, a condition that impairs the bodys ability to repair damaged DNA and often leads to bone marrow failure and cancer. The treatment Czechowicz and colleagues are testing involves extracting blood-forming stem cells from the patients bone marrow, inserting a healthy copy of a missing or malfunctioning gene and then reinfusing those cells back into the patient.

Every aspect of what I do is massively impacted by the pandemic, Czechowicz says. One of her early-stage clinical trials involves testing the safety of the therapy. But during the initial shutdown which started in mid-March and lasted for two months her patients could not readily travel to Stanford for the necessary follow-up visits, and remote monitoring was difficult.

Theres special blood testing and bone marrow testing that we need to do. In particular, its critical to get the samples to make sure the patients, for example, arent developing leukAemia, she says. Theres no way to know that without really checking the bone marrow. She had to clear large hurdles to get her patients evaluated.

Another early-stage trial, designed to determine the effectiveness of the therapy, also had to stop enrolling new patients. Because speed is important when it comes to treating Fanconi anaemia the children are likely losing stem cells all the time any delay in treatment can be a source of great anxiety for their parents. Czechowicz had to explain to them why the trials were temporarily halted. It was really challenging to have these discussions with the families, she says.

With the easing of travel and workplace restrictions, the families began traveling to Stanford in June but with infections back on the rise, many families are becoming hesitant again, says Czechowicz. Fortunately, her trials are small, so she can guide each family through the process of safely resuming the trials and continuing with follow-up. Her own team also has to follow strict safety protocols. For example, even though her lab has 10 members, only two can be in the lab at any one time, and only one parent is allowed into the clinic with the child.

Not all clinical trials can pay such close attention to individual patients. Large trials with hundreds of patients can involve multiple sites and require much more monitoring, so resuming those remains difficult. Also, restrictions on working full bore are slowing the pipeline for new therapies. The impact of that, were not going to see for many years to come, Czechowicz says.

Abolhassan Jawahery, University of Maryland, College Park

Jawahery is a particle physicist and a member of LHCb, one of the main experiments at the Large Hadron Collider (LHC) at CERN, the particle physics laboratory near Geneva.

In December 2018, well before the coronavirus pandemic began, the LHC shut down for upgrades. Housed in a 27-kilometre-long tunnel about 100 meters underground, the LHC accelerates two beams of protons, one clockwise and one counterclockwise, and makes them collide head-on at four locations. There, four gigantic subterranean detectors ATLAS, CMS, LHCb and ALICE sift through the debris of particles created by the collisions, looking for evidence of new physics. (For example, ATLAS and CMS found the Higgs boson, the fundamental particle of the Higgs field, which gives all elementary particles their mass.)

For its next set of experiments, which aim to probe the properties of subatomic particles with greater precision, the LHC needed to increase the intensity of its proton beams. Consequently, the four detectors needed to be upgraded too, to handle the resultant higher temperatures and increased radiation at the sites of the particle collisions. The work was on track for a restart around May 2021 until the pandemic swept all the scientists careful plans away.

The LHC and its four detectors are each run by a separate collaboration. CERN, which manages the LHC, is hopeful it can restart the collider by February 2022. They think that they can get the accelerator going if there are no more major catastrophic events, says physicist Abolhassan Jawahery. But the impact on the four detectors is less clear.

For the LHCb upgrade, Jawaherys team at the University of Maryland had been working on building about 4,000 extremely sensitive electronic circuit boards. These boards have to be burned in before they can be sent to CERN. We put them in an oven, literally cooking the boards and then running extensive tests in order to get them ready so that we can put them in the accelerator and run them for 10 to 20 years, says Jawahery. And none of that could be done during the pandemic shutdown.

The team resumed its work in June, but with restrictions put in place by the state of Maryland. Jawahery runs two labs, and for months was allowed only two people at a time in one lab and three in the other, making progress extremely slow. Still, his team is fortunate that it does not depend on supplies from countries hit hard by the coronavirus. Other labs werent so lucky. Scientists in Milan, for example, built some electronics and detector components for the LHCb, and a lab at Syracuse University in New York built sensors that relied on shipments from Milan. When Milan was completely closed down at the height of the pandemic, Syracuse, too, stopped working on Milan-dependent components.

For Jawahery the lockdown had a silver lining. The LHCs most recent run had produced about 25 gigabytes of data per second but his team had found little time to analyse any of it before the pandemic. We were complaining that we were spending all our time building the new instrument and the data keeps on coming, he says. When he and his team were locked out of their labs, they turned to their data backlog. We could do actual physics, he says. We are already getting ready to publish some papers.

Gordon Gray, Princeton University

Gray is a professionalDrosophila specialist in the department of molecular biology.

Gordon Gray has been called the chef de cuisine of Princetons fly kitchen, where he has been feeding flies for 46 years. He concocts meals for millions of fruit flies, at least 150 litres each week. When the pandemic hit in March and universities around the world shut down, Princeton deemed Grays work an essential service: The Drosophilafruit flies could not be allowed to die off.

Princetons flies include mutant and transgenic strains everything from ones that allow researchers to study the genes that influence normal development of a fly embryos organs, to those that have cancer-causing mutations. If the flies starved, researchers would need months or years to recreate these strains, says Princeton molecular biologist Elizabeth Gavis. And often, as techniques in molecular biology improve, the biologists reexamine flies they had studied earlier to get a more fine-grained understanding, making it worthwhile to preserve the strains.

Normally, if a lab had to shut down, researchers would send their flies to stock centres, such as one at Bowling Green State University in Ohio, that preserve the flies as part of their genetic library. But the stock centres couldnt handle Princetons flies, so Gray found himself on his own. Its basically catch as catch can with regards to the various labs here, just to keep things operational, he says.

For months, university pandemic restrictions have allowed only one person to be in Grays kitchen at a time. This has caused problems. Before the pandemic began, Gray, who is in his late 60s, had started training someone as a backup. But because of the one-person restriction, Gray and his trainee havent been able to work together. Gray envisions doing so soon, while wearing masks, keeping nearly 12 feet apart and communicating using hand signals.

To whip up a batch of fly food, or media, Gray uses a 50-litre steel cauldron, to which is attached a mixer that looks like an outboard motor. Gray fills the cauldron with water and adds agar, sugars, yeasts, salts and cornmeal, then brings it to a boil, all the while stirring watchfully. You dont want it to boil over, because when it does you wind up with a gigantic pancake on the floor, which you have to scoop up immediately because it gels, he says. Once the suspension cools to the right temperature, Gray adds an acid to inhibit mould, then dispenses precise amounts of the media into bottles and vials.

Even before the pandemic, Grays kitchen was isolated, to keep errant fruit flies from contaminating the pristine media. But at least he could work regular hours, because he knew the rhythms of the 10 or so fly labs he cooked for. That has changed. Labs, restricted to two occupants at a time, are now working seven days a week on rotating shifts. Gray comes in to work at all hours, because he cannot predict when each batch of fly food will run out and hell need to cook more.

He tries to work mostly at night to avoid coming into contact with others. But he still worries for his health, given his asthma and age-related risk. The relentless pandemic is taking a toll. Its exhausting, he says. It doesnt help not knowing when we will return to a sense of normalcy.

Celeste Kidd, University of California, Berkeley

Kidd is a child developmental psychologist who uses behavioural tests and computational methods to understand how children acquire knowledge.

When UC Berkeley locked down in March, Celeste Kidd found herself closeted at home, dealing simultaneously with virtual meetings and her three-year-old son. During the early days of the pandemic, Kidd kept a supply of treats handy, and when her toddler came up to her during a meeting shed sneak him some under the desk. But she hadnt accounted for how long the pandemic would last. It turns out thats not a good strategy, long term, she says. I was very literally rewarding him for bad behaviour.

Kidds son soon learned that acting up during her meetings meant more candy. I knew that would happen. I did it anyway because I didnt have the bandwidth to come up with a better solution, she says. But Kidd knew from her own research that children are also extremely flexible and can unlearn behaviours. Eventually, she had a chat with her son. First, she admitted to him that she had made a mistake by giving him candy when he disrupted her meetings, and that was bad of her. Then she brought in new rules: no candy for misbehaving and misbehaviour could even mean no treats for the rest of day. We had some meltdown moments, says Kidd. But he gets it now and he doesnt do those things.

Her son may be the only child Kidd gets to interact with during the pandemic. Thats a huge loss for her research, because the bulk of her work focuses on young children. In normal times, families would bring their children to her lab, where her research team would track their gaze as they watched videos. In one study, for example, infants about seven to nine months old would look away (demonstrating lack of interest) when the events in the video were either too complex or too simple, suggesting that infants use their cognitive resources for stimuli that have just the right amount of information.

Such work, of course, requires the presence of parent, child and researchers, all in the same room. None of that is going to happen anytime soon, she says. Those families are not going to feel comfortable coming in for a while.

Kidd is also concerned about the impact of the pandemic on younger scientists. One of her undergraduate students had spent six months working on a study aimed at exploring the complexity of kids play patterns using physical objects and their relation to working memory and other cognitive resources. The university had approved the protocol, but shelter-in-place orders went into effect the week the first child was to come for the experiment. I feel so bad for her as a young scientist, to have done all this hard work and then right when you get to the fun part, which is collecting the data and finding out if her ideas have lasting merit, she doesnt get to do that part, Kidd says.

The situation might be even worse for grad students and postdocs. All of them are experiencing a big blow to morale in general, because there is so much uncertainty about what the future holds, she says. University budget cuts mean fewer slots for graduate students and fewer jobs for postdocs. Its very hard to stay motivated and get things done when youre not sure if there will be a payoff in the future, says Kidd. Thats literally a study that we ran in the lab so were all acutely aware of it.

Maxime Boccas, ESO Paranal Observatory

Boccas is the head of maintenance, support and engineering at the European Southern Observatorys Paranal Observatory in Chile.

When the massive domes of the Very Large Telescope, a constellation of four 8-meter-class telescopes atop Mount Paranal in Chiles Atacama Desert, open to the night sky each evening and the telescopes get ready for observations, its like a dragon waking up.

When the pandemic hit in March, the dragon on Mount Paranal closed its eyes to the cosmos and slept the first shutdown in its 20-year history, which included a major earthquake in 2010 that paralyzed much of the rest of Chile. For those who had to leave Paranal, it was like being sent away from home. We spend 40% of our life here, says Maxime Boccas, who oversaw the process of ensuring an orderly shutdown of the sites scientific and technical facilities. We work and sleep here, and we stay here eight days in a row. Some of Boccass colleagues have been doing that for 20 to 25 years. Leaving Paranal was like leaving their second home. That was a weird feeling.

The skeleton staff just 20 of the normal 150 or so people remained on site kept the observatory safe, ensuring that essential systems continued working: computers that astronomers were accessing remotely, the fire detection system and the earthquake protection system essential for protecting the 8-meter-wide primary mirrors from Chiles frequent quakes. The mirrors will likely never be made again, says Boccas. All the factories that cast and polished them are dismantled. If we lost a mirror, it would take between 5 and 10 years to build up the factory again and fabricate it. So each mirror has an airbag a tube that inflates around it when the system detects tremors and other protections.

During the shutdown, astronomers kept their fingers crossed. They were anxious that no big thing, like a supernova in our galaxy, would explode, Boccas says. The heavens have been quiet, but the six-month shutdown harmed research that involves continuously monitoring the same patch of the sky for transient phenomena such as gamma ray bursts. It creates a hole in their science program, says Boccas.

The observatory began a slow return to normalcy on September 9. Boccas is overseeing the reawakening of each telescope, one at a time. The staff still less than full strength is now working in shifts that have doubled from 8 to 15 days to limit the amount of travel to and from the site. The four large telescopes are now up and running again, and Boccas hopes they will be back to working together as one by the end of January.

Boccas, his crew and a few lucky astronomers are glad to be back at Paranal. It really feels like a family and I think everyone has noticed that, he says. Even in the kitchen, they have to cook for 30 people instead of 150, so the quality of the food is different, its slightly better.

But even as people return to the observatory, Boccas worries about long-term effects of the shutdown. Given the reduced staff, he has had to cut down on the frequency of preventive maintenance tasks, such as changing belts and lubricating motors, potentially shortening the lifetime of some components. We will not know until six months, a year or three years from now, he says.

This article is part ofReset: The Science of Crisis & Recovery, an ongoing series exploring how the world is navigating the coronavirus pandemic, its consequences and the way forward. Reset is supported by a grant from the Alfred P. Sloan Foundation.

Anil Ananthaswamy is a science journalist who enjoys writing about cosmology, consciousness and climate change. Hes a 2019-20 MIT Knight Science Journalism fellow. His latest book is Through Two Doors at Once. http://www.anilananthaswamy.com.

This article originally appeared in Knowable Magazine, an independent journalistic endeavour from Annual Reviews.

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How Researchers Are Making Do in the Time of COVID-19 - The Wire Science

Real-time observation helpful in Stem cell for vascular diseases: Study – Hindustan Times

A study has found out that Stem cell treatment for vascular diseases can be predicted through real time observation.(ANI)

A recent study has found out that Stem cell treatment for vascular diseases can be predicted through real-time observation.

In the study which was published in the journal Biomaterials, therapeutic efficacy prediction was done using initial distribution images of stem cells that differentiate to endothelial cells. It can be applied to research in the field of stem cell treatments for blood vessel regeneration.

In recent years, the number of high-risk groups for ischemic diseases such as critical limb ischemia where tissues of the toe may decay is increasing due to an increase in the number of people with obesity, diabetes, and hypertension which are triggered by changes in dietary habits, smoking and consumption of alcohol. A number of studies are actively conducted on endothelial progenitor cells (hEPCs), which are stem cells that contribute to the blood vessel regeneration in the ischemic tissues, to treat such ischemia diseases.

Vascular hEPCs migrate to regions requiring angiogenesis, such as ischemic regions, and then differentiate into endothelial cells of blood vessels or release growth factors that help the formation of blood vessels to induce regeneration of the damaged blood vessels. Hence, these cells can be developed into stem cell therapy for diseases related to blood vessels including ischemic diseases.

However, when the hEPCs with outstanding blood vessel regeneration capability are used as stem cell therapy in ischemic diseases, the therapeutic treatment efficacy may differ depending on various variables such as survival of the transplanted cells and migration to the treatment region. Accordingly, treatments for ischemic diseases are remaining in the clinical stage without being commercialized due to the limitations in accurately observing and predicting the therapeutic efficacy.

The Korea Institute of Science and Technology (KIST) recently announced that the collaborative research team led by Dr. Kwangmeyung Kim from Center for Theragnosis and Sung-Hwan Moon from Stem Cell Research Institute, T&R Biofab Co. Ltd developed a method that can predict the therapeutic efficacy based on the distribution of the initial transplantation of hEPCs by tracking the initial distribution and migration of the transplanted cells using fluorescence romographic images.

The KIST research team first enabled observing fluorescence signals through fluorescence molecular tomography by binding fluorescent dyes to the surface of hEPCs. Subsequently, the team transplanted the cells into the hind limb of mouse with severe limb ischemia and tracked them through images for 28 days to evaluate the cell movement in the body; then, tracked and observed the regeneration process of the blood flow through laser scanning microscope (Laser Doppler imaging). As a result, it was revealed that the hEPCs migrate to the damaged tissues where the ischemic disease is found.

Additionally, the shapes of cell clusters were observed to be injected into two different shapes as a result of analyzing the images of hEPCs during the initial transplantation of cell therapy treatment. The two shapes were condensed round shape and spread shape. When the therapeutic efficacy was observed by classifying the experimental groups into these two shapes, it was found that the initial condensed round shape cells migrated better and showed superior therapeutic efficacy in the experimental groups. Based on these findings, the research team predicted that the treatment efficacy will be superior when the treatment cells are formed into a condensed round shape during the initial treatment.

Our developed technology, which can quickly and accurately monitor the initial transplantation forms and changes of stem cell therapy, will enable predicting the efficacy of the transplanted hEPCs in the early stages of ischemic disease treatments, and we expect it to be used in the development of stem cell therapy treatments for ischemic diseases in the future, said Dr. Kwangmeyung Kim at KIST, who led the research.

(This story has been published from a wire agency feed without modifications to the text. Only the headline has been changed.)

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Real-time observation helpful in Stem cell for vascular diseases: Study - Hindustan Times

NurOwn May Be Given to Early ALS Patients in US Who Finished Phase… – ALS News Today

BrainStorm Cell Therapeutics has opened an expanded access program (EAP) in the U.S. to allow certain amyotrophic lateral sclerosis (ALS) patients to gain access to its investigational cell-based therapy NurOwn.

EAPs, also known as compassionate use programs, are intended to make investigational therapies available outside of a clinical trial to people whose serious or life-threatening conditions have few or no adequate treatments, when the therapys benefits are thought to outweigh potential risks.

Developed in partnership with the U.S. Food and Drug Administration (FDA), the program will allow clinicians to prescribe NurOwn, at no cost, to ALS patients who completed the therapys pivotal, placebo-controlled Phase 3 trial (NCT03280056) and who meet specific eligibility criteria.

Those with less advanced disease as measured by the ALS Functional Rating Scale(ALSFRS-R) will be the first to receive the treatment. This decision was based on the trials top-line data, which showed a superior treatment response in people in earlier stages of ALS.

Detailed, full data are expected to be presented at upcoming scientific conferences, and published in a peer-reviewed scientific journal.

We are pleased to have the opportunity to treat additional patients with NurOwn through this Expanded Access Program, which was strongly advocated for by members of the ALS advocacy community, Chaim Lebovits, BrainStorms CEO, said in a press release.

We recognize the urgency with which people with ALS want and need access to new potential treatments. This EAP is an important next step to providing an immediate option for some patients, Lebovits added.

Fred Fisher, president and CEO of The ALS Associations Golden West Chapter, said that enabling early access, while the data review continues, is an extraordinary gesture of support and compassion for those living with ALS, and reflects an understanding of the ALS communitys urgent need for an effective therapy. The Golden West Chapter represents the largest ALS community in the U.S.

I applaud Brainstorm for taking this important step, and I look forward to learning the results of their full data analysis, Fisher added.

Lebovits emphasized that BrainStorm remains committed to rapidly advancing NurOwn through clinical development and regulatory review in the hope that the greatest number of people living with ALS may benefit. The EAP will not interfere with data or regulatory timelines.

NurOwn involves collecting mesenchymal stem cells(MSCs) from a patientsown bone marrow, and expanding and maturating them into cells that produce high levels of neurotrophic factors molecules that promote nervous tissue growth and survival. MSCs are stem cells that can generate a variety of other cell types.

The mature cells called MSC-NTF cells are then injected into the patients spinal canal to promote and support nerve cell repair. Using a patients own cells minimizes the risk of an immune reaction, as might occur with cells from a donor.

NurOwn has been designated an orphan drug in both the U.S. and European Union, and given to fast track designation in the U.S.; all help to speed its clinical development and review.

Afterpromising Phase 2 resultsin people with fast-progressing ALS, BrainStorm launched a Phase 3 trial to confirm NurOwns benefits in a larger patient population.

The Phase 3 study evaluated the therapys safety and effectiveness in 189 people with rapidly progressing ALS, who wererandomly assigned to a total of three injections of either NurOwn or a placebo, given directly into the spinal canal, every other month.

Patients were recruited at six clinical sites in the U.S.: three in California, two in Massachusetts, and one in Minnesota. NurOwn will be available under the EAP at these six centers.

Top-line data showed that a greater proportion of NurOwn-treated patients (34.7%) had a slower disease progression as assessed with the ALSFRS-R compared with those given a placebo (27.7%).

However, this difference did not reach statistical significance. This was mainly due to unexpectedly good placebo group responses, exceeding those reported in other ALS trials, the company reported.

Also, no significant group differences were observed in ALSFRS-R score mean changes over the seven months of treatment (-5.52 in the NurOwn group vs. -5.88 in the placebo group), meaning that the trial failed to meet both its main and secondary effectiveness goals.

However, greater treatment responses were seen in a pre-specified group of participants with less advanced disease.

In this group, 34.6% of those given NurOwn showed a slower disease progression, compared with 15.6% of those in the placebo group. In addition, the mean decline in the ALSFRS-R total score was 1.77 with NurOwn and 3.78 with a placebo reflecting a 2.01-point improvement with the cell-based therapy.

Differences between these groups were also not statistically significant, but they were considered clinically meaningful. Based on these positive findings, BrainStorm is actively working with the FDA to identify regulatory pathways that may support NurOwn approval as an ALS treatment.

Biomarker analyses also confirmed that NurOwn was driving its intended biological effects. Its use significantly increased the levels of neurotrophic factors, and dropped those of neurodegenerative and neuroinflammatory biomarkers, in patients cerebrospinal fluid a finding not observed among placebo patients. (The cerebrospinal fluid is the liquid that surrounds the brain and spinal cord.)

This expanded access program is an appropriate and welcome next step in following up the exciting results of the Phase 3 study; it is widely anticipated and deeply appreciated by our ALS patients, said Robert Brown, MD, PhD, one of the trials principal investigators.

Brown is also the Leo P. and Theresa M. LaChance chair in medical research, and chair of the neurology department atUniversity of Massachusetts Medical Schooland UMass Memorial Medical Center.

NurOwn will initially be manufactured by the Dana Farber Cancer Institute, assisted by on-site BrainStorm personnel.

BrainStorm also is evaluating NurOwn as a potential therapy for other neurodegenerative diseases, such as multiple sclerosis, Parkinsons disease, Huntingtons disease, as well as for autism spectrum disorder.

Marta Figueiredo holds a BSc in Biology and a MSc in Evolutionary and Developmental Biology from the University of Lisbon, Portugal. She is currently finishing her PhD in Biomedical Sciences at the University of Lisbon, where she focused her research on the role of several signalling pathways in thymus and parathyroid glands embryonic development.

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Ins holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Cincias e Tecnologias and Instituto Gulbenkian de Cincia. Ins currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.

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NurOwn May Be Given to Early ALS Patients in US Who Finished Phase... - ALS News Today

Follow the Money: Spatial Omics, CAR-NK Cells, AI-Powered Biology – Bio-IT World

December 21, 2020 | Funding updates around the life sciences including cash for a handheld mass spec device, Series D for oncolytic immunotherapy, a new company launch in allogenic CAR-NK cells, AI-powered cell classification, a 3-D sequencing platform, and more.

$170M: Israeli Digital Health First VC Firm

OTV (formerly Olive Tree Ventures), Israels digital health first venture capital firm, today announced the closing of a fund with a total value of $170M. OTV also announced their new name and the appointment of a new Head of Asia Pacific to spearhead the funds expansion into the regions market. OTV is the only venture capital fund in Israel whose primary focus is digital health, specializing in supporting their portfolio companies reach maturity, refine execution, tackle regulatory hurdles and ensure a global imprint on validated products. Over the course of the past five years, OTV has prioritized investment in digital health companies that develop cutting-edge solutions to todays most pressing healthcare problems. OTVs portfolio includes some of the worlds highest-profile digital health leaders, including TytoCare, Lemonaid Health, Emedgene, Scopio and Donisi Health.

$116M: Handheld, Desktop Mass Spec

908 Devices, which provides mass spectrometry devices for forensic and scientific research, raised the proposed deal size for its upcoming IPO. The Boston, MA-based company now plans to raise $116 million by offering 6.3 million shares at a price range of $18 to $19. The company had previously filed to offer the same number of shares at a range of $15 to $17. At the midpoint of the revised range, 908 Devices will raise 16% more in proceeds than previously anticipated. 908 Devices provides handheld and desktop mass spectrometry devices that are used to interrogate unknown and invisible materials, providing actionable answers to directly address critical problems in life sciences research, bioprocessing, industrial biotech, forensics and adjacent markets. Since its inception, the company has sold more than 1,200 handheld and desktop devices to over 300 customers in 32 countries, including 18 of the top 20 pharmaceutical companies by 2019 revenue, as well as numerous domestic and foreign government agencies and leading academic institutions.

$91M: Series C for Digital, Decentralized Trials

Medable has announced $91 million in Series C funding to accelerate the life sciences industrys shift to digital and decentralized clinical trials. The round was led by Sapphire Ventures, with follow-on investment from existing investors GSR Ventures, PPD, and Streamlined Ventures. The funding brings Medables total capital raised to more than $136 million. Medables flexible and modular software platform enables clinical leaders to shift from clinic-centric to patient-centric research strategies. The platform provides a unified experience for patients and clinicians, enabling recruitment, remote screening, electronic consent, clinical outcomes assessment (eCOA), eSource, telemedicine, and connected devices. Medable has seen rapid eCOA adoption, driving the field forward with enhancements including connected devices and telemedicine. The COVID-19 pandemic has driven demand for remote clinical trial technologies and Medable is enabling complex research protocols to be conducted remotely through its platform. By minimizing the need for in-person site visits, Medable customers have achieved unprecedented results including 3X faster enrollment and over 90% retention rates.

$58M: Series B for Healthcare Ecosystem Platform

H1, a global platform for the healthcare ecosystem, announced today that it has closed a $58 million Series B round of funding. The round was co-led by IVP and Menlo Ventures, which led the Series A round in April 2020. Transformation Capital, Lux Capital, Lead Edge Capital, Novartis dRx and YC also participated. H1 has created the largest healthcare platform to forge connections in the healthcare ecosystem. The H1 team has taken a unique approach to building the platform that combines AI, human powered engineering, third-party data sources, and government partnerships, to create the largest platform of healthcare professionals, currently spanning over 9 million healthcare professions around the globe.

$50M: Series C for Somatic Cancer, Wellness Platform

Congenica has announced the completion of its Series C funding round, raising $50 million. The round was co-led by Tencent and Legal & General and included other new investors Xeraya, Puhua Capital and IDO Investments. Existing investors Parkwalk, Cambridge Innovation Capital and Downing also participated. The funding is aimed at accelerating international market development and driving further expansion of Congenicas product platform into somatic cancer, wellness and through partnerships with pharmaceutical companies. Furthermore, the company will deliver capabilities including the ability to integrate with existing electronic health systems and deliver automated interpretation.

$47M: Series D for Novel Oncolytic Immunotherapies

CG Oncology has closed a $47 million Series D preferred stock financing led by new investor Kissei Pharmaceutical Co., Ltd., with participation from existing investors ORI Healthcare Fund, Camford Capital and Perseverance Capital Management. The financing will support the advancement of CG Oncologys late-stage clinical programs for its lead oncolytic immunotherapy, CG0070, including an ongoing global Phase 3 trial (BOND3) with CG0070 as a monotherapy for the treatment of BCG-unresponsive, Non-Muscle Invasive Bladder Cancer (NMIBC), and a combination Phase 2 study (CORE1) of CG0070 with KEYTRUDA (pembrolizumab) in the same indication. In addition, a Phase 1b study (CORE2) is currently ongoing with CG0070 in combination with OPDIVO (nivolumab) as a neoadjuvant immunotherapy for Muscle-Invasive Bladder Cancer (MIBC) in cisplatin-ineligible patients.

$42M: Series A for Allogeneic CAR-NK Cell Therapies

Catamaran Bio has launched with $42 million in financing. Sofinnova Partners and Lightstone Ventures co-led the Series A round that is part of the launch financing, with participation by founding investor SV Health Investors, as well as Takeda Ventures and Astellas Venture Management. Proceeds will be used to advance the companys two lead chimeric antigen receptor (CAR)-NK cell therapy programs. In addition, funding will expand the companys TAILWIND Platform, an integrated and proprietary suite of technologies for designing, genetically engineering, and manufacturing allogeneic CAR-NK cell therapies.

$34M: Series B for glycoproteomic powered ovarian cancer diagnostic

InterVenn Biosciences has raised $34M in a Series B fundraising. The latest round was led by Anzu Partners with full participation of Genoa Ventures, Amplify Partners, and True Ventures; Xeraya Capital and the Ojjeh Family joined the syndicate as well. Funds will be used to commercialize the companys High-Throughput-Glycoproteomic powered diagnostic for ovarian cancer; to service increasing partnership platform demand; and to accelerate development efforts for the immuno-oncology treatment response and colorectal cancer indications. InterVenn has demonstrated that analysis of protein glycosylation, the most common and most complex form of post-translational protein modification, is a highly effective way of discovering uniquely informative biomarkers. This breakthrough was made possible given the companys development of its AI neural network for high throughput analysis (PiP) and enabling software that powers the proprietary Vista research product for over a dozen different oncology indications.

$24M: Series A for Molecular Cartography

Resolve Biosciences has completed a $24 million Series A financing round and appointed Co-founder Jason T. Gammack as Chief Executive Officer. The Series A financing round was led by PS Capital Management and MasterMind Advisory Services and included participation from Alafi Capital, John Shoffner, and High Tech Grnderfonds. The company will use the proceeds to accelerate product development and drive industry adoption of its Molecular Cartography technology. The company's Molecular Cartography platform is a groundbreaking multi-analyte and highly multiplex spatial analysis technology that enables scientists to resolve the most daunting biological challenges in areas such as oncology, neuroscience, and infectious disease. It produces deep contextual datasets that illuminate molecular interactions at subcellular resolution, while preserving the sample tissue. The initial applications of Resolve's Molecular Cartography platform deliver the highest-resolution view of transcriptomic activity and provide the ability to interrogate hundreds of genes in a single run. Future solutions will add DNA, protein, and metabolomic data layers. Unlike current approaches, Resolve's technology provides the required sensitivity, specificity, and workflow convenience to elucidate the cell's complex transcriptional landscape.

$23M: Series A for Traumatic Brain Injury Test

BRAINBox Solutions announced the initial closing on a $23 million Series A financing to support the clinical development of the company's BRAINBox TBI (Traumatic Brain Injury) Test to aid both in the diagnosis and prognosis of mild TBI (concussion). BioVentures Investors led the financing round and was joined by the Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon Holdings LLC, Astia Angels and additional qualified investors, including Kevin Love, professional basketball player and mental health advocate. BRAINBox TBI is the first test designed to assist in both the diagnosis and prognosis of concussion. The multi-marker and multi-modality test, which can be used in either point-of-care or clinical laboratory settings, includes a panel of blood biomarkers as well as advanced digital neurocognitive testing in partnership with BrainCheck, Inc. Using proprietary AI algorithms, BRAINBox TBI combines the results of the test components and patient reported outcomes to generate a single, objective score for diagnosis up to 96 hours from the time of injury and a prognosis report for likely injury-related symptoms up to three months post-event.

$23M: Series B for Digital, Computational Pathology Solutions

Proscia has secured $23 million in Series B funding led by Scale Venture Partners, with participation from Hitachi Ventures, the strategic corporate venture capital arm of Hitachi, Ltd., bringing its funding total to $35 million. The company will use the investment to accelerate its global growth and strengthen its position of leadership in transforming cancer research and diagnosis at a time when demand for modernizing pathology is higher than ever. With its Concentriq software platform, Proscia is accelerating the transformation to digital pathology, which centers around high-resolution images of tissue biopsies, as the new standard of care. Concentriq combines enterprise scalability with powerful AI applications to help laboratories, health systems, and life sciences companies unlock new insights, accelerate breakthroughs, and improve patient outcomes.

$21.5M: Series B for Software, Data Products for Biomarker Discovery

Ovation.io has raised $21.5 million in Series B funding led by SignalFire with participation from Madrona Venture Group, Borealis Ventures, StageDotO Ventures and industry veteran David Shaw. Ovations suite of software and data products make it easier for molecular diagnostic labs to bring innovative tests to the patients that need them. Developed by scientists to help laboratories accelerate adoption of molecular diagnostics, Ovation is a turn-key, cloud-based platform with configurable, out-of-the-box workflows for molecular tests and seamless integrations to support the needs of a rapidly growing lab. With this latest round of funding, Ovation will work with its network of participating labs to develop insights that can help life-science companies reduce the time and cost associated with biomarker discovery.

$20M: Series A for AI-Powered Cell Classification

Deepcell has closed its Series A round of financing with $20 million, led by Bow Capital and joined by Andreessen Horowitz, which led its $5 million seed round. The new funding will allow Deepcell to develop its microfluidics-based technology, continue building a cell morphology atlas of more than 400 million cells, and drive a hypothesis-free approach to cell classification and sorting. Spun out of Stanford University in 2017, Deepcell is using deep learning and big data to classify and isolate individual cells from a sample. The technology combines advances in AI, cell capture, and single-cell analysis to sort cells based on detailed visual features, delivering novel insights through an unprecedented view of cell biology. The Deepcell platform maintains cell viability for downstream single-cell analysis and can be used to isolate virtually any type of cell even those occurring at frequencies as low as one in a billion to offer access to rare cells and atypical cell states that will help advance precision medicine research.

$20M: Series B for Spatial Omics

Rebus Biosystems has closed a $20 million Series B financing round, led by Illumina Ventures and joined by Lifecore Partners, Ncore Ventures, Xolon Invest, CTK Investments, Ray Co., Ltd., Seegene Medical Foundation, LabGenomics Co., Ltd., and Timefolio Asset Management. At the heart of the Rebus Biosystems spatial omics solution is the companys patented Synthetic Aperture Optics (SAO) system, which provides the resolution and sensitivity of a 100X oil lens, but with the breadth and depth of a 20X air lens. Data is captured 100 times faster than with other imaging based spatial omics methods that rely on 100x lenses and z-stacking. Speed and ease of use of the system is further improved by integration with custom microfluidics and image processing.

$14.8M: Scaled Up Production of Portable PCR Diagnostic Device

QuantuMDx Group Limited, a UK-based life sciences company, is investing over 11 million to scale up production to mass manufacture its flagship diagnostic device, Q-POC and disposable test cassette. QuantuMDx accelerated development, scale-up and manufacture of Q-POCits rapid point-of-care testing systemearlier this year in response to the COVID-19 pandemic.Q-POC is a portable, PCR device offering rapid, sample-to-answer, molecular diagnostic testing at the point of care, with results in approximately 30 minutes. The Q-POC system comprises a sample collection kit, single-use test cassette and analyzer. The companys first commercial assay for Q-POC will detect SARS-CoV-2, the virus causing COVID- 19, and Flu A & B, providing a powerful rapid PCR diagnostics and surveillance tool for clinicians and public health officials.QuantuMDx has worked with British development partner Cambridge Design Partnership to undertake pilot manufacturing of Q-POCTM, and is now working with Cogent Technology, as the company scales for volume manufacturing.

$14M: Novel Treatment for Ischemic Stroke

BrainsGate has secured $14 million in a new investment round at a pre-money valuation of $147 million. New investor, BNP Joint Capital Fund, and the Impact investment and consulting firm SPERO led the round alongside existing investors, Elron, Medtronic, Agate, Pitango, and Cipio. The new investment is expected to fund BrainsGate through its pre-market approval (PMA) and enable it to achieve volume production readiness and apply for coverage from the Centers for Medicare & Medicaid Services (CMS) for its Ischemic Stroke System (ISS). BrainsGates therapy involves a less than 5 minutes procedure in which a neurostimulator implant is injected into an existing canal. The implant stimulates a nerve center that augments collateral blood flow to improve stroke patients outcomes in a 24-hour window. In May 2020, BrainsGate received marketing approval in Europe (CE marking) of its ISS product. BrainsGates PMA application was filed with the US FDA in February 2020. The company plans to initiate commercialization activities subject to the PMA being approved.

$10.6M: UK Investment Firm for Life Sciences

Intuitive Investments Group, a closed-end investment company focused on the life sciences sector, has raised 7.85 million (before expenses) in its AIM float by placing 39,250,000 new Ordinary Shares at 20p. The net proceeds of the Placing will be used by the Company to invest in fast growing and/or high potential Life Sciences businesses, based predominantly in the UK, wider Europe and the US, chosen from an identified pipeline of investment opportunities. Investments will be focused on diagnostics and healthcare, medical devices, tools and technologies and bio-therapeutics and pharmaceuticals

$7.4M: BARDA Extension For Point-of-Care Infection Diagnostics

Inflammatix has announced a contract extension of $7.4 million from the Biomedical Advanced Research and Development Authority (BARDA) to further develop its point-of-care test and system to diagnose infection by reading the immune system. The contract is part of a BARDA contract worth up to $72 million, if all options are exercised. The new funding will support continued development and commercialization of Inflammatixs sample-to-answer, point-of-care Myrna test system, which is designed to read RNA using machine learning and produce results in under 30 minutes, as well as continued development of the ViraBac EZ test (formerly known as HostDx Fever), which reads gene expression patterns in the immune system to identify whether a suspected infection is bacterial or viral, enabling physicians to quickly and accurately determine when to prescribe antibiotics. The test will use a fingerstick collection and capillary blood sample, and is designed for use in primary care, urgent care and other outpatient clinical settings.

$6.6M: Series A for Robotics, Machine Learning in Biology

Trailhead Biosystems announced its $6.6 million Series A financing. The company has developed a proprietary platform to perform systems-level interrogation of complex biological problems, ranging from the generation of industrially-scalable manufacturing conditions for specialized human cells to combinatorial drug discovery in cancer and anti-viral therapies. Trailhead robotically conducts the largest dimensioned experiments in biology, using machine learning to discover critical process parameters and combinatorial inputs that explain biological responses. Trailhead aims to rapidly develop the capability of creating specialized human cell types at high purity for regenerative medicine and therapeutic purposes at an industrial scale, addressing current industry needs for highly specialized cells used in drug discovery and modeling of human diseases. Through strategic partnerships, the cells provided by the company will be used to address multiple areas of clinical need. The company currently develops products that target type I diabetes, Parkinson's disease, Multiple Sclerosis, Alzheimer's disease, and blood disorders, among others.

$6.1M: 3-D Sequencing Platform

DNA sequencing instigator Single Technologies announced the completion of a heavily oversubscribed 5 million share issue to existing and new shareholders. Among the new investors are Jens von Bahr, Rothesay Ltd, Carl-Henric Svanberg funded Cygnus Montanus Trust, Professor Ulf Landegren and Andreas Ehn. The funds will be used to accelerate development of the companys 3-D sequencing platform. Stockholm Corporate Finance acted as financial advisor. The new funding will enable the company to finalize automating its 3-D sequencing process, make it more robust and improve quality for both Whole Genome Sequencing (WGS) and transcriptomics applications. The ambition is to open the first data sequencing production site in Stockholm by 2022.

$5M: Gates Grant for At-Home COVID-19 Test

Sherlock Biosciences has received a $5 million grant from the Bill & Melinda Gates Foundation to continue to advance INSPECTR, its instrument-free, synthetic biology-based molecular diagnostics platform. In addition to advancing the INSPECTR platform development to be as sensitive as gold-standard PCR tests, the funding will support the development of an over-the-counter disposable product, similar to an at-home pregnancy test, that can be used to detect SARS-CoV-2, the virus that causes COVID-19. Pending approval, the company says they will launch this product in mid-2021. INSPECTR, which stands for Internal Splint-Pairing Expression Cassette Translation Reaction, uses synthetic biology to enable the creation of instrument-free diagnostic tests that can be conducted at home, at room temperature. INSPECTR can be adapted to work on a simple paper strip test or to provide an electrochemical readout that can be read with a mobile phone. It can also be adapted for use in laboratory or point-of-care settings.

$4M: Prostate Health Center at Mount Sinai

Mount Sinai has received a $4 million donation from Lizzie and Jonathan Tisch to support prostate health and the Milton and Carroll Petrie Department of Urology at Mount Sinai. The prostate program will be named The Lizzie and Jonathan Tisch Center for Prostate Health. The medical services provided at the Lizzie and Jonathan Tisch Center for Prostate Center include state-of-the-art prostate cancer screening and imaging technologies, precision urology, focal therapy, targeted biopsies, robotics for prostate cancer surgery, prostate cancer fusion biopsy, and active surveillance. Additionally, prostate cancer experts such as Dr. Tewari; Avinash Reddy, MD; Sujit Nair, PhD; Robert Valenzuela; MD; Michael Palese, MD; and Steven Kaplan, MD, are available to see patients at the newly named Center.

$2.9M: NIH Grant for Human Placental Stem Cells

Human placental stem cells may have the potential to regenerate heart tissue after a heart attack, according to Mount Sinai researchers who have received a $2.9 million grant from the National Institutes of Health to study them. Their findings could lead to new therapies for repairing the heart and other organs. Hina W. Chaudhry, MD, Director of Cardiovascular Regenerative Medicine at the Icahn School of Medicine at Mount Sinai, is the Principal Investigator for this four-year award. Dr. Chaudhry and a team of investigators previously discovered that mouse placental stem cells can help the hearts of mice recover from injury that could otherwise lead to heart failure. They identified a specific type of placental stem cells, called Cdx2 cells, as the most effective in making heart cells regenerate.

$2M: Cryo Solutions for Cell, Gene Therapy

GlycoNet has secured a $2-million USD equity investment for PanTHERA CryoSolutions (PanTHERA), a Canadian biotechnology start-up. The investment came from US-based investor Casdin Capital and bioproduction tools supplier BioLife Solutions Inc. In addition to an up-front investment, subject to closing conditions, BioLife will provide an additional $2 million to support product development over the next 24 months in exchange for exclusive, worldwide marketing and distribution rights to the technology for use in cell and gene therapy applications. The core technology from PanTHERA was created out of an academic research collaboration between the University of Ottawa and the University of Alberta. During cryopreservation of biological materials, the uncontrolled growth of ice causes cell injury and death. PanTHERA's solution is to develop ice recrystallization inhibitors (IRIs) to control the growth of ice and prevent this damage from occurring, ultimately resulting in superior cellular products after thawing.

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Follow the Money: Spatial Omics, CAR-NK Cells, AI-Powered Biology - Bio-IT World

Stem cells in drug development – Nordic Life Science

The high cost and uncertain outcomes of developing new drugs has taken a toll on research over the past several years. Few companies can take the hit of investing hundreds of thousands of dollars in research and testing, only to see dangerous side effects emerge during the final stages, human clinical trials.

The pursuit of more accurate, less costly testing methods has led many companies to stem cells, which can be coaxed into developing into cells of human organs such as the heart and liver and provide a more accurate, less expensive process for testing. Researchers have been able to generate cells in the laboratory that reach the gold standard required by the pharmaceutical industry to test drug safety. Now, drug companies are increasingly adopting stem cells for research, for testing the toxicity of drugs and identifying potential new therapies.

Id say there have been a lot of advances in past five years, but its still in its early days, said Dr. Steven Minger, chief scientist for cellular sciences, GE Healthcare Life Sciences. There is still a concern about how good the cells are and how they will react. Weve gone a long way and have a lot of high-quality data, but pharmaceutical companies still have to decide if this is superior to the method they have been using for 40-50 years.

Standard procedure for decades has been to test new drugs on the organs of animals, such as rabbits. But in many cases, there were no adverse reactions in the animals, so companies proceeded to clinical trials, only to discover then the drug caused side effects on human organs, forcing the company to abandon the drug or launch costly research to find a solution.

Now some new medications are being tested for safety on differentiated cells generated from humanpluripotent cell lines, which are stem cells capable of developingintoanytypeofcellortissueexcept thosethatformaplacentaorembryo. Not only is there an endless supply of them, but they provide a more consistent basis for testing. Human cells are much more predictable and predictable certainly lowers risks, Minger noted. Not to mention saving money; developing a new compound can cost as much as $27 million, he added.

Companies were spending millions of dollars to fail, Minger continued, This [stem cell testing] will make for safer, cheaper, better drugs. The sooner companies are aware of problems with a drug, the easier it is to address them. They can bail fast, bail early or get rid of the toxic compounds as quickly as possible, he said. And just because a drug comes up bad, doesnt mean the drug is bad. It gives you more options early. The fact that you have data early means you have time to do something with it. Later on, you dont what to spend billions to find out the problem.

Cells currently available for use in testing are heart muscle and liver, which are the organs where 80 percent of drug failures occur, Minger added. Drug companies get the cells from firms such as Swedens Takara Bio Europe AB, which produces heart muscle cells and liver cells for drug and biotechnology companies as well as universities. They allow for early testing on human material; you have quality controlled material from the same source, said Kristina Runeberg, site head/senior director, business development, for Takara Bio Europe AB. Heart and liver cells were considered most important and developed first, but she expects neural cells to come next, and researchers also are working on beta cells, which are in the pancreas.

The results from stem cell testing so far are convincing companies and regulatory agencies that this is the new best practice. The U.S. Federal Drug Administration (FDA) is expected to require at least some drugs to undergo stem cell testing as part of the approval process in the not so distant future.

We have huge amounts of data and believe they are superior to animal cells; now through a number of organizations working together with the FDA, there is starting to be a consensus built that stem cells have a huge potential and should be the new standard for how pharmaceutical compounds are assessed on a safety basis, according to Minger.

Future developments include using stem cells to test for long-term chronic toxicity in certain drugs, which requires keeping the same culture for longer periods of time, Runeberg said. Researchers also are working on new ways to identify hazards and test toxicity, added Minger.

There are 220 different cell types, and it is theoretically possible to make them all, Runeberg added. The field has started with the most important ones. In the future, more and more will be developed and more companies will be commercially involved.

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Stem cells in drug development - Nordic Life Science

Global Cell Culture Market by Product, Application, End-user and Region – Forecast to 2025 – PRNewswire

DUBLIN, Dec. 18, 2020 /PRNewswire/ -- The "Global Cell Culture Market by Product (Consumables [Media, Serum, Vessels], Equipment [Bioreactor, Centrifuge, Incubator, Autoclave]), Application (Therapeutic Proteins, Vaccines, Diagnostics, Stem Cells), End-user (Pharma, Biotech) and Region - Forecast to 2025" report has been added to ResearchAndMarkets.com's offering.

The global cell culture market is projected to reach USD 33.1 billion by 2025 from USD 19 billion in 2020, at a CAGR of 11.8% during the forecast period.

The growth of this market is majorly driven by the growing awareness about the benefits of cell culture-based vaccines, increasing demand for monoclonal antibodies (mAbs), funding for cell-based research, growing preference for single-use technologies, and the launch of advanced cell culture products. On the other hand, the high cost of cell biology research and the lack of proper infrastructure for cell-based research activities are the major factors restraining this market's growth.

Based on product, the consumables segment holds the largest market share during the forecast period

Based on product, the cell culture market is segmented into equipment and consumables. The consumables segment accounted for the largest market share in 2019 and is expected to register the highest CAGR during the forecast period. The dominant share and high growth of the consumables segment can be attributed to the repeated purchase of consumables and increased funding for cell-based research.

Based on application, the biopharmaceutical production segment is expected to register the highest CAGR during the forecast period

Based on application, the cell culture market is categorized into biopharmaceutical production, stem cell research, diagnostics, drug screening & development, tissue engineering and regenerative medicine, and other applications. The biopharmaceutical production application segment is expected to register the highest CAGR during the forecast period.The high growth of this segment is attributed to the commercial expansion of major pharmaceutical companies, growing regulatory approvals for the production of cell culture-based vaccines, and the increasing demand for monoclonal antibodies (mAbs).

Pharmaceutical & Biotechnology companies end-user segment is expected to grow at the highest CAGR in the cell culture market during the forecast period

Based on end-users, the cell culture market is segmented into pharmaceutical & biotechnology companies, academic & research institutes, hospitals and diagnostic centers, and cell banks. The pharmaceutical & biotechnology companies segment is expected to witness the highest growth during the forecast period. The growing use of single-use technologies, the increasing number of regulatory approvals for cell culture-based vaccines, and the presence of a large number of pharmaceutical players in this market are some of the factors driving the cell culture market for this end-user segment.

North America is expected to account for the largest share of the cell culture market in 2019

In 2019, North America accounted for the largest share of the cell culture market, followed by Europe, the Asia-Pacific, Latin America, and the Middle East & Africa. The large share of this market segment can be attributed to the growing regulatory approvals for cell culture-based vaccines, technological advancements, and growth in the biotechnology & pharmaceutical industries in the region are the key factors driving the growth of the cell culture market in North America.

Key Topics Covered:

1 Introduction

2 Research Methodology 3 Executive Summary

4 Premium Insights 4.1 Cell Culture: Market Overview 4.2 Asia-Pacific: Cell Culture Market Share, by End-user and Country (2019) 4.3 Cell Culture Market: Geographic Growth Opportunities 4.4 Regional Mix: Cell Culture Market 4.5 Cell Culture Market: Developed Vs. Developing Markets

5 Market Overview 5.1 Introduction 5.2 Market Dynamics 5.2.1 Market Drivers 5.2.1.1 Growing Awareness About the Benefits of Cell Culture-Based Vaccines 5.2.1.2 Increasing Demand for Monoclonal Antibodies 5.2.1.3 Funding for Cell-Based Research 5.2.1.4 Growing Preference for Single-Use Technologies 5.2.1.5 Launch of Advanced Cell Culture Products 5.2.1.6 Growing Focus on Personalized Medicine 5.2.2 Market Restraints 5.2.2.1 High Cost of Cell Biology Research 5.2.2.2 Lack of Infrastructure for Cell-Based Research in Emerging Economies 5.2.3 Market Opportunities 5.2.3.1 Growing Demand for 3D Cell Culture 5.2.3.2 The Growing Risk of Pandemics and Communicable Diseases 5.2.3.3 Emerging Economies 5.3 COVID-19 Impact on the Cell Culture Market 5.4 Value Chain Analysis 5.5 Supply Chain Analysis 5.6 Ecosystem Analysis 5.7 Regulatory Analysis

6 Cell Culture Market, by Product 6.1 Introduction 6.2 Impact of the COVID-19 on the Cell Culture Market 6.3 Consumables 6.3.1 Sera, Media, and Reagents 6.3.1.1 Media 6.3.1.1.1 Serum-Free Media 6.3.1.1.1.1 Lack of Sera Eliminates the Risk of Contamination by Viruses 6.3.1.1.2 Classical Media & Salts 6.3.1.1.2.1 Classical Media is Commonly Used in Virology, Vaccine Production, and Primary Tissue Explant Culture 6.3.1.1.3 Stem Cell Culture Media 6.3.1.1.3.1 Stem Cell Culture Media to Witness the Highest Growth in the APAC Market During the Forecast Period 6.3.1.1.4 Specialty Media 6.3.1.1.4.1 Specialty Media is Suitable for the Growth of Selective Cell Types 6.3.1.2 Reagents 6.3.1.2.1 Growth Factors 6.3.1.2.1.1 Growth Factors are Unique Cell Signaling Molecules That Help in Cell Proliferation & Development 6.3.1.2.2 Supplements 6.3.1.2.2.1 Supplements Such as Amino Acids Play a Key Role in Inducing Cell Growth 6.3.1.2.3 Buffers & Chemicals 6.3.1.2.3.1 Chemical Buffers are Widely Used, But It Can be Toxic at Higher Concentrations 6.3.1.2.4 Cell Dissociation Reagents 6.3.1.2.4.1 Dissociation Reagents Can be Enzymatic or Non-Enzymatic 6.3.1.2.5 Balanced Salt Solutions 6.3.1.2.5.1 Balanced Salt Solutions Find Wide Applications in Life Sciences 6.3.1.2.6 Attachment & Matrix Factors 6.3.1.2.6.1 The Development of Cells is Dependent on Attachment Factors 6.3.1.2.7 Antibiotics/Antimycotics 6.3.1.2.7.1 The Possibility of Contamination Risks Make the Long-Term Use of Antibiotics/Antimycotics Conditional 6.3.1.2.8 Contamination Detection Kits 6.3.1.2.8.1 Contamination Detection Kits Provide Rapid Results 6.3.1.2.9 Cryoprotective Reagents 6.3.1.2.9.1 Cryoprotective Reagents Protect Tissues/Cells from Damage due to Freezing 6.3.1.2.10 Other Cell Culture Reagents 6.3.1.3 Sera 6.3.1.3.1 Fetal Bovine Sera (FBS) 6.3.1.3.1.1 Use of FBS is Now Restricted due to Regulatory Guidelines 6.3.1.3.2 Adult Bovine Sera (ABS) 6.3.1.3.2.1 ABS is a Cost-Effective Alternative to FBS and is Used as a Biochemical Reagent in IVD 6.3.1.3.3 Other Animal Sera 6.3.2 Vessels 6.3.2.1 Roller/Roux Bottles 6.3.2.1.1 Roller Bottles Offer an Economical Means of Cultivating Large Cell Volumes 6.3.2.2 Cell Factory Systems/Cell Stacks 6.3.2.2.1 Cell Stacks Require Special Handling Equipment and Skilled Expertise 6.3.2.3 Multiwell Plates 6.3.2.3.1 Larger Well Formats Allow for Greater Culture Volumes 6.3.2.4 Flasks 6.3.2.4.1 Disposable Flasks are in Greater Demand Among End-users 6.3.2.5 Petri Dishes 6.3.2.5.1 The Wide Usage of Petri Dishes is Attributed to Ease of Use 6.3.3 Bioreactor Accessories 6.4 Equipment 6.4.1 Supporting Equipment 6.4.2 Bioreactors 6.4.3 Storage Equipment

7 Cell Culture Market, by Application 7.1 Introduction 7.2 Impact of the COVID-19 on the Cell Culture Market 7.3 Biopharmaceutical Production 7.3.1 Therapeutic Proteins 7.3.1.1 Growing Applications of Recombinant Proteins to Drive the Growth of this Segment 7.3.2.1 Rising Incidence of Disease Outbreaks to Drive the Market Growth for Vaccine Production 7.4 Diagnostics 7.4.1 The Growing Risk of Viral Infections Drives the Uptake of Cell Culture Products for Diagnostics 7.5 Drug Screening & Development 7.5.1 Increasing Adoption of Cell-Based Assays in R&D Activities to Drive Segment Growth 7.6 Stem Cell Research 7.6.1 Increasing Stem Cell Research Activities & Investments Drive Segment Growth 7.7 Tissue Engineering and Regenerative Medicine 7.7.1 Increasing Funding for Regenerative Medicine Boosts Segment Growth 7.8 Other Applications

8 Cell Culture Market, by End-user 8.1 Introduction 8.2 Impact of the COVID-19 on the Cell Culture End-User Market 8.3 Pharmaceutical & Biotechnology Companies 8.3.1 Growing Regulatory Approvals for Cell-Culture Based Vaccines Drives Segment Growth 8.4 Hospitals and Diagnostic Laboratories 8.4.1 Increasing Applications of Cell Culture for the Diagnosis of Various Diseases to Drive Segment Growth 8.5 Research & Academic Institutes 8.5.1 Increasing Government Funding for Research Projects and the High Prevalence of Cancer to Drive Growth for this End-User Segment 8.6 Cell Banks 8.6.1 Increasing Awareness of Preserving Stem Cells to Drive Segment Growth

9 Cell Culture Market, by Region 9.1 Introduction 9.2 COVID-19 Impact on the Cell Culture Market 9.3 North America 9.5 Asia-Pacific 9.6 Latin America 9.7 Middle East and Africa

10 Competitive Landscape 10.1 Overview 10.2 Competitive Scenario 10.2.1 Partnerships, Agreements, and Collaborations (2020) 10.2.2 Product Launches & Upgrades (2020) 10.2.3 Expansions (2020) 10.2.4 Acquisitions (2019-2020)

11 Company Evaluation Matrix and Company Profiles 11.1 Company Evaluation Matrix Definition & Methodology 11.2 Competitive Leadership Mapping (2019) 11.2.1 Stars 11.2.2 Emerging Leaders 11.2.3 Pervasive Companies 11.2.4 Emerging Companies 11.3 Market Share Analysis, 2019 11.4 Company Profiles 11.4.1 Thermo Fisher Scientific Inc. 11.4.2 Merck KGaA 11.4.3 Becton, Dickinson & Company 11.4.4 Corning Incorporated 11.4.5 Danaher Corporation 11.4.6 Eppendorf AG 11.4.7 Fujifilm Irvine Scientific, Inc. (Acquired by Fujifilm Corporation) 11.4.8 Lonza Group AG 11.4.9 Sartorius AG 11.4.10 Cellgenix GmbH 11.4.11 Miltenyi Biotec 11.4.12 Stemcell Technologies, Inc. 11.4.13 Himedia Laboratories 11.4.14 Invivogen 11.4.15 Infors AG 11.4.16 Promocell 11.4.17 Pan Biotech GmbH 11.4.18 Seracare Life Sciences Incorporation 11.4.19 Caisson Labs 11.4.20 Solida Biotech GmbH

12 Appendix 12.1 Insights from Industry Experts 12.2 Discussion Guide 12.3 Knowledge Store: The Subscription Portal 12.4 Available Customizations

For more information about this report visit https://www.researchandmarkets.com/r/ea1loc

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Global Cell Culture Market by Product, Application, End-user and Region - Forecast to 2025 - PRNewswire

Glycostem and Ghent University sign license agreement on NK cell therapy technology | DNA RNA and Cells | News Channels – PipelineReview.com

Details Category: DNA RNA and Cells Published on Friday, 18 December 2020 13:05 Hits: 509

- New opportunities for the development of NK-antibody combination therapies

- Significant positive effect on production time of Glycostem's lead product oNKord, and future CAR-NK and TCR-NK therapies

OSS, The Netherlands I Dec. 17, 2020 I Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic off-the-shelf Natural Killer (NK) cells, and Ghent University (UGent) have signed a license agreement for an innovative NK cell production technology. Ultimately, this agreement will bring significant benefit to targeted treatment of patients suffering from cancer. The agreement not only opens up new opportunities for development of NK-antibody combination therapies but also has significant positive impact on the production time of Glycostem's lead product oNKord and its second (CAR-NK) and third (TCR-NK) generation therapies viveNKTM.

"This license agreement offers new opportunities for more targeted treatment of cancer patients. By using UGent's technology we are able to increase the expression of CD16 receptors resulting in an increase of the NK-cell's activity and its antibody binding properties. When a patient's immunity is weak, administering NK-cells will boost the patient's immune system and increase the antibody's therapeutic effectiveness," explains Troels Jordansen, CEO at Glycostem.

Glycostem's NK-cell based therapies are manufactured in its in-house GMP licensed facility. "Ghent University's technology has the potential to almost halve the time needed for NK cell progenitor cells to differentiate into fully functional NK-cells. By incorporating this in our processes both our manufacturing time and cost-effectiveness will be affected very positively without negative effect on the potency of the NK cells. This is an important part of paving the way for further upscaling the production of our NK-cells," says Troels Jordansen.

"We are glad to see our research translated to a clinical setting as it is based on many years of fundamental research into NK cell biology," tells Prof. Georges Leclercq, head of the UGent research team and group leader in the Cancer Research Institute Ghent (CRIG). "We hope that with this collaboration, we can positively impact the lives of many patient's affected by difficult to treat cancers."

Dr. Dominic De Groote (UGent Business Development) further explains: "This partnership is the result of continuing efforts by Ghent University and Ghent University Hospital to become a leading academic and clinical center for cell-based therapies. This technology is part of our growing portfolio of oncology and Advanced Therapy Medicinal Products (ATMP) related assets that we are actively developing from the bench to the bedside through our translational platforms."

Taking cellular immunotherapy to the next level

Glycostem is focused on developing first, second and third generation cancer treatments based on NK-cells. This licensing deal will affect Glycostem's full portfolio. After a successful phase I study Glycostem initiated a first-of-its-kind pivotal trial in acute myeloid leukemia (AML) with in-house manufactured nonmodified NK cells (oNKord). Over the coming months, AML patients will receive this form of treatment as part of a phase I-IIa trial. A pivotal phase IIa trial for Multiple Myeloma (MM) patients is expected to start second half of 2021. This makes Glycostem one of the frontrunners in this promising field of cellular immunotherapy.

About Glycostem

Netherlands-based Glycostem Therapeutics BV, a clinical stage biotech company, develops allogeneic cellular immunotherapy to treat several types of cancer. By harnessing the power of stem cell-derived Natural Killer (NK) cells, Glycostem's products are a safe alternative to CAR-T-cells. Glycostem's lead product, oNKord, is manufactured from allogeneic raw material and is available off-the shelf. Thanks to its nine patent families, longstanding technical expertise and resources, as well as 'Orphan Drug Designation', Glycostem has secured a leadership position in the global NK-cell market.

oNKord is produced in a closed system (uNiKTM) in Glycostem's state-of-the-art and GMP (Good Manufacturing Practice) licensed production facility in the Netherlands, from which it can be distributed globally. The production technology includes ex vivo generation of high numbers of NK-cells with a high degree of purity for clinical applications. oNKord successfully passed phase I clinical trial (elderly and frail AML - Acute Myeloid Leukemia - patients), providing solid safety data and strong indication of clinical activity, including response on MRD (Minimal Residual Disease). Results indicate that oNKord may be safely infused in AML patients.

Glycostem is furthermore developing a range of CAR-NK and TCR-NK products in-house and in cooperation with global partners.

Glycostem Therapeutics BV http://www.glycostem.com

Foot note: "oNKord" is a registered trademark of Glycostem in the US and in Europe. Trademark registrations of "viveNK" and "uNiK" are pending.

About Ghent University

Ghent University (UGent) is a major Belgian university located in the heart of Europe. Our organization is dedicated to research and innovation with over 5,500 researchers active in a wide area of life, physical and social sciences. Strong partnerships with the Ghent University Hospital (1000+ beds), VIB, IMEC and global leaders in academia and pharma/biotech industry thrive life science innovation at our university and is part of the thriving Belgian biotech region. Our translational platforms such as CRIG (focus on cancer) and GATE (focus on advanced therapy medicinal products) facilitate to bring science to the patient.

Prof. Georges Leclercq has a longstanding and internationally recognized expertise in differentiation and function of NK cells. The recent focus of his research group is to reveal the role of several transcription factors in the differentiation of human hematopoietic stem cells into mature NK cells, and in the maintenance and function of these mature NK cells. The ultimate aim is to attribute to improved NK-based cancer immunotherapy.

Cancer Research Institute Ghent http://www.crig.ugent.be

SOURCE: Glycostem

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Glycostem and Ghent University sign license agreement on NK cell therapy technology | DNA RNA and Cells | News Channels - PipelineReview.com

EdiGene Expands Management Team by Appointment of Head of US Subsidiary Dr. Bo Zhang and Head of Business Development Dr. Kehua Fan – BioSpace

Dec. 14, 2020 10:00 UTC

BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- EdiGene, Inc., which develops genome editing technologies to accelerate drug discovery and develop novel therapeutics for a broad range of diseases, today announced the appointment of Bo Zhang, Ph.D., as Head of the US Subsidiary, and Kehua Fan, M.D., as Head of Business Development. Both will report to Dr. Dong Wei, CEO of EdiGene.

Our company and R&D portfolio are entering into an exciting phase, as evidenced by the recent close of Series B financing and submission of the first gene editing product IND in China, said Dong Wei, Ph.D.CEO of EdiGene, Translating cutting-edge gene editing technologies into innovative solutions for patients requires deep internal R&D expertise as well as strong external partnerships. We are delighted to have Dr. Zhang and Dr. Fan join us at this significant stage of growth. Their extensive experience and proven track record in advancing innovative therapies, in addition to strong leadership skills, will help us to strengthen our portfolio and accelerate technology translation to help patients in need.

Dr. Zhang has around 20 years of experience in research and drug development in both industry and academia in the US. Prior to joining EdiGene, he was Vice President of KLUS Pharma and focused on cell therapy and new technologies. Before that, he was Director of Development at Cobalt Biomedicine leading CAR-T and other cell/gene therapy programs, and R&D Director at OvaScience developing stem cell-based products. Prior to that, he held various oncology research and development positions at Merrimack Pharmaceuticals and Archemix. Dr. Zhang completed his postdoctoral fellowship at Harvard Medical School/Boston Childrens Hospital. He received his B.S. degree from Henan Normal University, M.S. degree from Chinese Academy of Sciences and Ph.D. from University of New Hampshire.

Dr. Kehua Fan has over 15 years of Business Development, Clinical Development of innovative drugs and other healthcare industry experience with MNCs and biotech companies. Before EdiGene, she served as Head of Strategy and Partnership at Junshi Biosciences, in charge of pipeline development strategy focus on oncology, autoimmune and metabolic diseases along with external partnership. Before that, she held positions in business development, clinical development strategy and operation on various therapeutic areas at Quintiles, GSK, Sanofi and Pfizer. She started her career as a General Surgeon at Zhongshan Hospital of Chongqing. She received a masters degree in Cardiovascular Pharmacology from West China Medical Center of Sichuan University and a bachelors degree in Clinical Medicine from Soochow University.

About EdiGene, Inc EdiGene is a biotechnology company focused on leveraging the cutting-edge genome editing technologies to accelerate drug discovery and develop novel therapeutics for a broad range of genetic diseases and cancer. The company has established its proprietary ex vivo genome-editing platforms for hematopoietic stem cells and T cells, in vivo therapeutic platform based on RNA base editing, and high-throughput genome-editing screening to discover novel targeted therapies. Founded in 2015, EdiGene is headquartered in Beijing, with subsidiaries in Guangzhou, China and Cambridge, Massachusetts, USA. More information can be found at http://www.edigene.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201214005267/en/

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EdiGene Expands Management Team by Appointment of Head of US Subsidiary Dr. Bo Zhang and Head of Business Development Dr. Kehua Fan - BioSpace