Bruker Corporation to Participate in the Jefferies Virtual London Healthcare Conference – Business Wire

BILLERICA, Mass.--(BUSINESS WIRE)--Bruker Corporation (Nasdaq: BRKR) announced today it will participate in the Jefferies Virtual London Healthcare Conference. Gerald Herman, Chief Financial Officer, will participate in an analyst moderated question and answer session on behalf of the company on Wednesday, November 18, 2020 at 2:05 PM Greenwich Mean Time (9:05 AM Eastern Standard Time).

A live audio webcast of the question and answer session will be available on the Investor Relations section of the Company's website at https://ir.bruker.com . A replay will be posted in the Events & Presentations section of the Bruker Corporation Investor Relations website after the event and will be available for 30 days following the event.

About Bruker Corporation (Nasdaq: BRKR)

Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Brukers high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology. For more information, please visit: http://www.bruker.com.

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Bruker Corporation to Participate in the Jefferies Virtual London Healthcare Conference - Business Wire

McGill researchers awarded $1.5 million in NRC collaborative funding – McGill – McGill Reporter

On November 2, the National Research Council of Canada (NRC) announced the results of its collaborative funding program, with a total of over $44 million awarded to institutions across the country. McGill researchers were among the cohort with more than $1.5 million in project funds awarded. In all, 19 McGill projects were supported through these initiatives. The NRC collaborative funding program is organized into three separate themes:

The support of the NRC through this collaborative funding program partners the creativity and talent of our researchers with those at the NRC, said Martha Crago, Vice-Principal, Research and Innovation. Each of these projects has the potential to make a real impact on peoples lives.

One such example is the work of Bioengineering Professor Amine Kamen, who received support for two projects. The first leverages artificial intelligence (AI) to improve the production of biological agents such as vaccines through the pairing of virtual and physical bioreactors. The second examines at the genomic level the production of Adeno-Associated Virus (AAV) vectors. This could lead to dramatically reduced costs for the targeted delivery of gene therapy treatments.

Funding from the NRC is helping us develop these platform technologies, explained Kamen. They will help ensure our preparedness in the situation of emerging or re-emerging infectious diseases.

Another researcher to have two projects funded was Professor Odile Liboiron-Ladouceur. She has been working on methods to incorporate AI into the design of photonic components, which not only accelerates the design cycles but also pushes the performance of photonic integrated circuits a step further. These circuits have multiple applications, including fiber optic networks, satellite communications, medical diagnostics, and other areas.

Funding from NRC enables a fruitful collaboration with NRC world-class scientists who take part in the training of graduate students as next-generation leaders, said Liboiron-Ladouceur, citing another major benefit of the NRC program.

Professor Amine A. Kamen, Bioengineering, for Digital-twin of bioreactor for accelerated design and optimal operations in production of complex biologics and, Genome-wide CRISPR screen to identify genes that increase the yield and functionality of AAV vectors

Professor Odile Liboiron-Ladouceur, Electrical & Computer Engineering, for AI-assisted miniaturization of integrated photonic components and, Silicon Photonics multiplexer design with machine learning methods

Professor Yelena Simine, Science, for AI-Enabled Design of Aptamers

Professor Lawrence R. Chen, Electrical & Computer Engineering, for Terabit optical networks based on quantum dot lasers and photonic integration

Professor Sylvain Coulombe, Chemical Engineering, for Functionalized BNNTs for Energy Applications

Professor Sasha Omanovic, Chemical Engineering for Development of new composite/ functionalized cathodes for bio-electrochemical conversion of CO2 and CH4

Professor Parisa Ariya, Atmospheric & Oceanic Sciences, for Microcosm studies for improved detection, physicochemical process characterization and modelling of the transport, degradation and fate of microplastics in Canadian waters (COVID-19)

Professor Michael Strauss, Anatomy & Cell Biology, for Tracking the mechanism of antibody trafficking across the blood brain barrier with advanced 3D-structure

Professor Sylvain Coulombe, Chemical Engineering, for developing a scalable solvent-free process for functionalization of Boron Nitride Nanotubes

Professor Audrey Helene Moores-Franois, Chemistry, for functionalized chitosan nanocrystals as catalysts for organic transformation reactions

Professor Mark Driscoll, Mechanical Engineering, for full body medical image segmentation for simulation-ready finite element models

Professor Abdolhamid Shafaroud Akbarzadeh, Bioresource Engineering, for bio-inspired Architected Ceramics for High Temperature Applications

Professor Victoria Kaspi, Physics, for a time-domain digital signal processing backend for fast radio burst follow up

Professor Maryam Tabrizian, Biomedical Engineering, for one step multiplex aptamer selection and validation using magnetic nanoparticle aptamer library (aptaMAG) coupled to microfluidic surface plasmon resonance imaging biosensor

Professor Lyle Whyte, Natural Resources Sciences, for an improved bio-inorganic system to couple solar energy to microbial carbon dioxide fixation

Professor Donald Smith, Plant Science, for Core microbes for field pea farming

Professor Jeffrey Bergthorson, Mechanical Engineering, for Optimized configuration of metal energy carrier for renewable energy sources

Read the NRC press release

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McGill researchers awarded $1.5 million in NRC collaborative funding - McGill - McGill Reporter

Can We Recreate Every Human Cell Type In The Body? This UK Startup Thinks So. – Forbes

Bit Bio, a UK synthetic biology startup backed by Silicon Valley investors, has partnered with the ... [+] London Institute for Mathematical Sciences, marking a milestone in the fusion of biology and mathematics for coding human cells.

Theres a fundamental difference between Bit Bio and most other biotechnology startups. If you just need something to work once, you can find what you need with massive amounts of screening and testing think drug development, or finding a single bacterial cell with the desired qualities.

But, when we make the leap and turn biology into an engineering discipline we can predict, reproduce, and scale, things fall apart. Our understanding of life is too weak.

Thats the fundamental challenge Bit Bio, a UK-based startup, is taking on through a commercial partnership with a non-profit research institution, the London Institute of Mathematical Sciences (LIMS).

Together, they will take on a shared moonshot goal: recreating every human cell type in the body. Not only would this be a monumental scientific milestone, but access to human cells would also accelerate the development of cell therapies, which have always been limited to testing in mice.

Cellular reprogramming is as much of a mathematical problem as it is a biological one. What we've learned about cell types is that the boundaries between cell states and sub cell states sort of blur. If you stop trying to classify them in the traditional way, and just try to map the transcriptional state that is necessary to achieve such a state - then you suddenly have a completely different view on identity, explains Dr. Mark Kotter, the founder and CEO of Bit Bio.

Mark Kotter is a stem cell biologist and neurosurgeon at the University of Cambridge, and ... [+] Founder/CEO of Bit Bio.

Bit Bios cell reprogramming platform allows them to turn on gene expression at will, and flipping the right switches could transition one cell type to another. Thats why their computational team is using neural networks to map recorded gene transcription to cell states. However, it hasnt been the one-size-fits-all toolkit that it often seems to be.

Neural networks is a common buzzword tossed around the tech space. By imitating the circuitry in our brains, neural nets have learned to do tasks ranging from voice recognition and weather forecasting to identifying dementia from EEG recordings.

However, a problem that Kotter soon identified was that the moment you go into complex [biological] data, there's some off the shelf tools that everyone uses, but there isn't really that much math that's, you know, usable. It's not that that kind of maths doesn't exist or people haven't thought about it, it's just that it hasn't crossed the boundary.

How do you discover new biology in massive amounts of data? First, you need new math, and this collision of fields has already proved fruitful for both collaborators.

The interaction with people that come from a different planet, so to speak, is extremely useful, Kotter reflects. The main reason why I'm very excited about working with LIMS is that they are really some of the smartest people in this particular field.

Kotter met Thomas Fink, the founder of LIMS during his PhD in Cambridge, but never imagined they would one day be actively collaborators. Coincidentally, LIMS had a cell identity project on the back burner since 2012 the same year that Kotter began working on the problem.

This convergence embodies the merging of two fields that were not quite as far apart as they seemed. And in this interdisciplinary world, you see the human cell after us at the moment taking shape.

Im the founder of SynBioBeta, and some of the companies that I write about are sponsors of the SynBioBeta conference andweekly digest. Thank you toDesiree Hofor additional research and reporting in this article.

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Can We Recreate Every Human Cell Type In The Body? This UK Startup Thinks So. - Forbes

UNC researchers believe a mutation may make COVID-19 more vulnerable to a vaccine – WRAL Tech Wire

CHAPEL HILL A new study published inScienceconfirms that SARS-CoV-2 has mutated in a way thats enabled it to spread quickly around the world, but the spike mutation may also make the virus more susceptible to a vaccine.

The new strain of coronavirus, called D614G, emerged in Europe and has become the most common in the world. Research at theUniversity of North Carolina at Chapel Hilland theUniversity of Wisconsin-Madisonshows the D614G strain replicates faster and is more transmissible than the virus, originating in China, that spread in the beginning of the pandemic.

There were bright spots in the study findings: While the D614G strain spreads faster, in animal studies it was not associated with more severe disease, and the strain is slightly more sensitive to neutralization by antibody drugs.

The study provides some of the first concrete findings about how SARS-CoV-2 is evolving.

The D614G virus outcompetes and outgrows the ancestral strain by about 10-fold and replicates extremely efficiently in primary nasal epithelial cells, which are a potentially important site for person-to-person transmission, saidRalph Baric, PhD, professor of epidemiology at the UNC-Chapel HillGillings School of Global Public Healthand professor of microbiology and immunology at theUNC School of Medicine.

PPD lands praise from partner Moderna which reports strong results for COVID-19 vaccine

Baric has studied coronaviruses for more than three decades and was integral in the development ofremdesivir, the first FDA-approved treatment for COVID-19.

Researchers believe the D614G strain of coronavirus dominates because it increases the spike proteins ability to open cells for the virus to enter. These crown-like spikes give the coronavirus its name.

The D614G mutation causes a flap on the tip of one spike to pop open, allowing the virus to infect cells more efficiently but also creating a pathway to the virus vulnerable core.

With one flap open, its easier for antibodies like the ones in the vaccines currently being tested to infiltrate and disable the virus.

For the recent study, Baric Lab researchers including first author Yixuan J. Hou, PhD worked in collaboration withYoshihiro Kawaoka, PhD, and Peter Halfmann, PhD, both virologists at the University of Wisconsin-Madison. UNC School of Medicine authors are Richard Boucher, MD, director of the UNC Marsico Lung Institute; Rhianna E. Lee, a graduate student in the UNC Department of Cell Biology and Physiology; Teresa M. Mascenik, a research specialist; and Scott Randell, PhD, associate professor of cell biology and physiology and Marsico member.

The original spike protein had a D at this position, and it was replaced by a G, Kawaoka said. Several papers had already described that this mutation makes the protein more functional and more efficient at getting into cells.

That earlier work, however, relied on a pseudotyped virus that included the receptor-binding protein but was not authentic. Using reverse genetics, Barics team replicated a matched pair of mutant SARS-CoV-2 viruses that encoded D or G at position 614 and compared basic property analysis using cell lines, primary human respiratory cells, and mouse and hamster cells.

Kawaoka and Halfmann contributed their unique coronavirus study model, which uses hamsters. The University of Wisconsin-Madison team including Shiho Chiba, who ran the hamster experiments performed replication and airborne transmission studies with both the original virus and the mutated version created by Baric and Hou.

They found that the mutated virus not only replicates about 10 times faster its also much more infectious.

Hamsters were inoculated with one virus or the other. The next day, eight uninfected hamsters were placed into cages next to infected hamsters. There was a divider between them so they could not touch, but air could pass between the cages.

Researchers began looking for replication of the virus in the uninfected animals on day two. Both viruses passed between animals via airborne transmission, but the timing was different.

With the mutant virus, the researchers saw transmission to six out of eight hamsters within two days, and to all the hamsters by day four. With the original virus, they saw no transmission on day two, though all of the exposed animals were infected by day four.

We saw that the mutant virus transmits better airborne than the [original] virus, which may explain why this virus dominated in humans, Kawaoka said.

The researchers also examined the pathology of the two coronavirus strains. Once hamsters were infected, they presented essentially the same viral load and symptoms. (The hamsters with the mutated strain lost slightly more weight while sick.) This suggests that while the mutant virus is much better at infecting hosts, it doesnt cause significantly worse illness.

Researchers caution that the pathology results may not hold true in human studies.

SARS-CoV-2 is an entirely new human pathogen and its evolution in human populations is hard to predict, Baric said. New variants are continually emerging, like the recently discovered mink SARS-CoV-2 cluster 5 variant in Denmark that also encodes D614G.

To maximally protect public health, we must continue to track and understand the consequences of these new mutations on disease severity, transmission, host range and vulnerability to vaccine-induced immunity.

(C) UNC

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UNC researchers believe a mutation may make COVID-19 more vulnerable to a vaccine - WRAL Tech Wire

I want to give my child the best: the race to grow human breast milk in a lab – The Guardian

Dr Leila Strickland became a mother when she was a few months away from completing her postdoctorate fellowship in cell biology at Stanford University. She spent the first three months of her sons life at home on maternity leave, relentlessly struggling to breastfeed. I was having a hard time producing enough milk. She never expected to find feeding her baby a greater challenge than advanced cytology.

My mom breastfed me and my sister until we were over two years old. All my life, Id fully embraced the proposition that breast milk is the best nutrition for a baby, and that this is what I would feed my baby. Lactation consultants, paediatricians and well-meaning friends told her to just keep trying. Because I was so unprepared for it, I found it really isolating. I felt like there was something wrong with me.

Eventually reluctantly Strickland decided to bottle-feed her baby with formula. It was convenient and practical, and made it possible for me to get more sleep, and for my husband to participate. In some ways I was able to be a better mom, and I was a lot happier, but I knew I was making a trade-off. I knew the product my child was getting was optimal for raising cows, that it didnt have the ideal nutrient composition. It was good enough but what mom is happy with good enough?

Eleven years later, Strickland has combined her experiences as both a stressed mother and a cell biologist in a way that could change how we feed our babies for ever: she has worked out how to make human breast milk without the human breast. Her startup, Biomilq, cultures breast cells in a lab farming them outside the body and collects the milk they secrete. The company calls it the mother of all patented technology and it has caught the eye of Bill Gates, who bought a $3.5m (2.7m) stake in Biomilq in June. Potentially, it could end the infant formula industry as we know it.

While the science shows breast is best helping cement the emotional connection between mother and child; providing optimal nutrition, antibodies and bacteria; reducing the risk of obesity and diabetes in adulthood breastfeeding can be a lottery. Many women find it straightforward and rewarding, but for others it is painful and demoralising. Sometimes babies have tongue-tie and wont latch on, or the mother has mastitis, or doesnt produce enough milk for the baby to put on the weight required to satisfy ever-watchful midwives and health visitors. Sometimes the baby is premature, or ill, and needs to be fed through a tube, or the mother is embarrassed about feeding in public, or needs to go back to work. Faced with these challenges, the most determined mothers might express milk with a pump; but pumping can be a time-consuming and often wretched experience.

The other alternative is formula. But, as Strickland says, it is a trade-off. Although their composition has improved, infant formulas are generally made from cows milk and therefore have sugars, proteins and fats best suited to calves. Human milk contains hormones, antibodies and friendly bacteria, as well as unique proteins and sugars. Formula also has a substantial carbon footprint; it is made from products that depend on dairy farming, or the cultivation of palm oil or soy. Theres also the shame many mothers feel after they turn to the bottle: women who use formula after struggling with breastfeeding have been shown to experience greater levels of guilt than mothers who chose not to breastfeed from the start.

Founded in January 2020, Biomilq boasts that it is women-owned, science-led and mother-centred. Strickland is juggling running the lab with homeschooling her two children through lockdown; in our video call from her house in North Carolina, she is casually dressed in a sweatshirt, and I can hear the sound of plates being knocked off tables in far-off rooms as we speak.

Growing food in a lab is called cellular agriculture and Strickland describes her work as if it were a kind of farming. We start with these amazing cells that line a womans mammary gland, she explains. Using the same techniques that weve used for decades to grow cells outside the body, were able to reproduce the behaviour these cells have evolved over millions of years, to produce components in quantities that match the babys needs.

Scientists have long been culturing cells for biomedical research, but it was in 2013, when Maastricht Universitys Mark Post served up a lab-grown hamburger to food critics on live TV, that the idea of making food from cells entered the public consciousness. Since then, dozens of startups worldwide have begun to make meat in the same way. No animal has to suffer and there are seemingly endless possibilities, from cruelty-free foie gras to kosher bacon.

Seeing Posts burger consumed live was a pivotal moment for Strickland. It was obvious to her that milk had to be next, though it poses a different technical challenge. Those guys have to harvest every single cell they grow and turn it into a product, she says. Her product is the secretion rather than the cell. Just as dairy farmers have different priorities to beef farmers, Stricklands product demands that she keeps her cells alive and producing for as long as possible, instead of selling them off as soon as they mature.

She started to do homespun experiments with her husband, who has a background in chemistry and engineering: he designed the scaffold on which the cells are grown and kept separate from their secretions. They rented a small lab space and spent about $5,000 (3,827) on used equipment from eBay, but the experiments were expensive. We were choosing between feeding cells and feeding our children. We had to choose our children, Strickland laughs. They used the cheapest source of mammary cells they could find: cow udders bought for $20 (15) a piece from the bewildered manager of the nearest slaughterhouse, taken to the lab and minced up.

Strickland monitored their growth in different conditions, and when she thought shed come up with the optimal technique, started experimenting with human breast cells, bought from commercial suppliers who normally provide them for breast cancer research. But she had no budget to test if her cells were actually producing human milk. For the most part, between 2013 and 2016, I just had a really expensive science hobby that most people in my life thought was extremely weird.

Burnt out, she gave up her lab in 2016. But no one else seemed to be pursuing her idea and it nagged away. In 2019, Strickland decided to make one more serious stab at this experiment. A mutual friend introduced her to Michelle Egger, who would eventually become Biomilqs CEO. Egger has a background in food science and had been working at the Bill and Melinda Gates Foundation. I know how to grow cells but I dont know anything about how to grow a company, so Michelle brought that crucial expertise, Strickland says.

Egger and Strickland got a commercial lab to run a proof-of-concept experiment, growing cells for a month and collecting samples every day. In February 2020, the results were in: the cells were producing the unique proteins and sugars found in human breast milk. The breakthrough led to the $3.5m investment from Gates, which will allow them to scale up the process, and which has changed Stricklands life. Im really doing my dream, she says. I get emotional in our meetings, because its really personal for me.

The breast milk Strickland produces in her lab is different from the milk that comes out of a human breast. It cant change in response to a babys needs, as milk from a breast can (for example, being diluted on hotter days when the baby needs more fluids); it contains no hormones or bacteria from the mothers biome. Most significantly, it has no antibodies, because these are imported into the milk from the mothers blood, which disembodied cells cant do. Thats a part of breast milk we wont be able to replicate, Strickland says, matter-of-factly.

She can afford to be relaxed about this, because Biomilqs market research suggests babies who drink their product will be getting breastfed anyway, and given Biomilq as a supplement. Those babies will be getting the antibodies from their own mother, then they will be getting a breast milk with a very similar composition when shes not able to breastfeed if she wants to go back to work, say, or sleep through the night. Their mission statement says their product is for women who need a little boost. Their target consumer is someone who is determined to breastfeed, but cant. Just like Strickland was.

But how liberating will lab-produced breast milk be? Its easy to imagine a scenario in which employers might be less willing to give women the space and time to breastfeed if a product like this exists. I do think we want to be careful and conscientious about things like that, Strickland says. We certainly wouldnt want to compromise any womans ability to breastfeed. She pauses. Any women who are at work and still trying to feed their babies breast milk are spending a good part of their day pumping. Thats what wed be targeting the pumping. Saving you from having to do that.

For Strickland, its about addressing the gulf between the expectations put on mothers and the reality. We want to celebrate breastfeeding, and encourage women to do it. Theres just not a great conversation going on about the challenges, she says. Most babies are not exclusively breastfed for six months [as recommended by the World Health Organization] and its not because women dont know or care about the benefits. Its because modern life really offers women no solution to achieve it.

***

The pressure not to accept the good enough provided by infant formula weighs heavily on mothers who want to breastfeed but are prevented from doing so by biology or circumstance. Its enough to have fuelled the growth of the underground online breast milk market. The invention of formula should have put an end to the practice of wet nursing; rather, the stigma attached to it has given rise to a new digital wet-nursing economy.

Services such as onlythebreast.com link up breast milk sellers with buyers, leaving it up to buyers to do their own screening. Searches can be narrowed down according to location, the age of the baby the milk has been produced for and whether the seller is following a specific diet: vegan, gluten-free or even paleo. The website advises that frozen expressed milk should be doubled bagged, wrapped in newspaper and put in a cooler with dry ice before being couriered to the recipient. It would set you back around 36 a day to feed the average month-old baby with milk bought here, priced at 1-1.50 an ounce, not including postage and packaging.

Of course, many women are happy to give their breast milk away for free. There are 15 hospital milk banks in the UK, providing screened, pasteurised donor milk, but it is destined for sick and premature babies in neonatal units. Mothers of healthy babies in search of breast milk often join one of Facebooks dozens of milk-sharing networks in hope of finding a nearby donor. The Human Milk 4 Human Babies UK Facebook group has more than 27,000 members. A new request for milk is posted every hour or so, often accompanied by photographs of tiny babies, wide-eyed with hunger.

The women posting on these forums have turned to social media out of desperation. One mother, who asked for donor milk to tide her four-week-old over while she works on topping up her supply, told me her failure to produce enough milk for him was an extremely painful experience. Everybody agrees that breast milk is a better option than formula.

Another mother began the search for breast milk a month before her second child was born. It was, she said, the best decision. She had tried everything to breastfeed her first baby, from renting a hospital-grade breast pump to taking drugs that might help boost lactation, but nothing worked. She now drives for at least an hour and a half every other week to collect frozen donor milk for her five-month-old son.

Human breast milk has nutritional ingredients formula simply doesnt, she said. I think of it as eating quality organic foods versus taking a synthetic supplement. It is the best thing I can give my child. When I sent a link to the Biomilq site, she replied, Wow. Finally. Shame [its] not available yet as I struggle to keep up with my sons demand. Will be forced to move on to formula.

Breast milk has become a symbol of optimal nutrition and optimal motherhood. But Joan Wolf, associate professor of womens and gender studies at Texas A&M University and author of Is Breast Best?, says women have been grossly misled about the extent of the advantages, because its impossible to disentangle the benefits of breast milk from the benefits of having a mother who wants to breastfeed.

You look at the sociology of breastfeeding, and the beliefs of women who breastfeed: they are determined to do everything they possibly can for their baby, she says. They are middle class; they feel theyve got to keep up with each other. Wolf argues that we increasingly feel we have a duty to reduce risk to ourselves or our families. Mothers must reduce any risk to an infant, no matter how small, and no matter the cost to the mother herself. Breast milk gets fetishised because of the risk element because its natural, and because it gives women a feeling of absolute power over their babies.

The availability of lab-grown milk wont assuage that desire to minimise all risks to your baby, Wolf says. One day we will have 15 different breast milks to pick from, each with different qualities. [Mothers] wont know which to pick. Theyll say, If I take this one the baby will get a gastrointestinal infection, or if I pick this one will they get cancer later. And this lab-grown breast milk could be very dangerous, because it could reinforce the idea that it really matters to breastfeed.

***

Stricklands work in the US may be groundbreaking, but she is not alone. She has an equally well-funded rival across the Pacific Ocean, backed by investors as diverse as British vegan private equity titan Jeremy Coller and Prince Khaled bin Alwaleed bin Talal Al Saud of Saudi Arabia.

We are the first biotech company in the world that is using cell-based methods to create milk, says Fengru Lin, founder and CEO of Singapores TurtleTree Labs, with the steely confidence of someone who is sure her company is not only first, but will be the best.

I speak to Lin and TurtleTrees chief strategist, Max Rye, in a video call to their respective homes in Lins native Singapore (Rye moved here from the US when they launched the company). Shes in an emerald blouse, her hair scraped back into a neat ponytail. He is every inch the relaxed American, leaning back on his sofa in a blue polo shirt. Before I even ask my first question, Rye tells me they want mothers to breastfeed. I always like to say, right at the beginning, we think its wonderful. We dont ever want that to stop. Theres nothing else like it, he says. Even though we can make human breast milk as a product, we are still far from the real thing.

Breast milk was an afterthought for TurtleTree Labs. The company began by culturing cows milk without the cow, and can now produce everything from sheeps and goats to camels milk, taking stem cells from freshly expressed milk and culturing them, instead of farming mammary cells as Biomilq does.

It started a few years ago when I was learning to make cheese as a hobby, Lin explains. It was difficult to find milk in Asia. There arent many cows in Singapore. She travelled around Indonesia and Thailand, and saw the problems of intensive dairy farming first-hand. Hormones and antibiotics are being pumped into the cows. As a result, the milk quality really suffers. They are impregnating the cow just to get her milk, again and again, every year. And the amount of methane cows create 37% of global emissions.

Lin was working as an account manager at Google at the time, and Rye, a tech executive, came to give a talk on new sustainable technologies. When he mentioned the startups growing meat from cells in a lab, Lins mind turned immediately to milk. Afterwards Fengru came up to me asking about milk, Rye says. And I thought, theres got to be someone working on this. There has to be. He holds his palms up in disbelief. But no, nobody was doing this.

They founded the company together in early 2019, and say it was feedback from dairy companies that prompted them to branch out into breast milk. The folks who provide milk in the stores are the same people who provide the raw ingredients for infant formula, Rye says. They approached us and said, Listen, youve got something really interesting: if you can make human milk, you can transform the way infant formula is done. We realised, this is where the demand is. Its also where the big money is: customers are used to paying a lot more for infant formula than they are for cows milk.

Instead of producing and bottling its own breast milk, TurtleTree Labs plans to licence its technology to existing formula companies. Rye wont tell me the names, only that they are four of the five biggest in the world.

There are huge regulatory hurdles to be crossed before lab-grown breast milk can go on sale, but Rye and Lin say getting approval for its individual components will be more straightforward. And they are thinking very broadly about possible consumers: elderly people and cancer patients may one day drink their breast milk or parts of it.

Early indications show certain bioactive proteins or complex sugars in human milk could be good for senior care and adult health, Lin says. Geriatric patients can have similar issues with their digestive system as infants, and early studies have shown certain compounds in breast milk may impede the growth of some cancers. But the benefits are under-researched: there isnt enough spare human milk to be giving it to adults on a clinically significant scale, and convincing them to try it is a challenge.

As soon as those sugars and proteins get regulatory approval, though, they can be added to existing infant formulas bringing them closer to breast milk than ever. TurtleTree expect that to happen as early as next year.

***

Strickland balks at the idea of working with the formula industry. Theres already distrust of these companies, the Nestls and Abbotts of the world, she says. We think its important to bring this product to market with as much credibility and authenticity as possible, as women and mothers and scientists ourselves. Our customers will appreciate seeing it come from us, rather than them.

Biomilqs initial plan is as eye-catching as the product itself: they are going to produce customised breast milk for early adopters, grown from the customers own cells. Moms would go through a fine needle biopsy procedure during their pregnancy, Strickland explains. That cell sample would be sent to us so we could start growing it up and producing milk. And then when shes ready, we can start shipping it to her.

I wasnt expecting to hear this: taking cells from pregnant women suggests that Biomilq is not solely for women who are having trouble breastfeeding but is also geared to those who assume they will need help before their baby even arrives. And its going to be very expensive, Strickland says: That would go at a pretty high price point, as a custom service.

But the initiative is more about demonstrating the potential of the product than the beginning of a business model, she says. We aim to generate an evangelised group of moms, parents and caregivers, who are excited enough to make that initial level of commitment.

It is difficult to envisage a way that breast milk grown in a lab can be anything other than an elite product. TurtleTree Labs estimates their milk costs $30 (23) a litre to produce, and even if that figure comes down dramatically (as they expect it to), the technology involved will always be more expensive than dairy-based formula. While breastfeeding is free, it is rarely compatible with full-time employment. A product like this will give those who can afford it either a nutritional edge, or a professional one.

Isnt this just going to be for very wealthy women? And wont it give them even greater advantages than they already enjoy?

We do not want this to be a product that perpetuates inequalities, Strickland replies, firmly. Thats something we think a lot about. Making this widely accessible is very much a part of our long-term plan. For instance, Biomilq is exploring ways employers might be able to subsidise the product for their staff although this raises further concerns that employers might expect nursing mothers to return to work earlier. Its a bit like a game of whack-a-mole: you push down on one problem and something pops up on the other side, Strickland concedes.

It may be many years before we can go to the supermarket and buy a bottle of breast milk. But the existence of companies such as TurtleTree Labs and Biomilq could well be a symptom of a problem, rather than a solution. In the wrong circumstances, their products could be used to stop women from breastfeeding in public, or to make formula feeding even more taboo. If women were more supported in breastfeeding, less ashamed of using the good enough dairy-based formula and less judged in general, then breast milk grown in a lab might not be necessary.

Strickland thinks once her product is on the market, it will be less easy to judge women for how they feed their babies. A mom sitting there feeding a bottle of our milk will look the same as a mother with a bottle of formula or her pumped milk. It would be indistinguishable, she says. Plus lab-grown milk is already provoking much-needed discussions about what we think is natural. If nothing else, I consider Biomilq already a success because we get to participate in these conversations.

Its hard to argue with that. But whether lab-grown breast milk changes the conversation for the better depends on who is making it, and who gets to use it. This invention may be Stricklands baby, but she cant control what it will grow into.

Jenny Kleeman is the author of Sex Robots & Vegan Meat: Adventures At The Frontier Of Birth, Food, Sex & Death (Picador).

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I want to give my child the best: the race to grow human breast milk in a lab - The Guardian

Insights on the Glycobiology Global Market to 2025 – Featuring Shimadzu, Takara Bio & Waters Among Others – ResearchAndMarkets.com – Business Wire

DUBLIN--(BUSINESS WIRE)--The "Global Glycobiology Market By Type of Enzyme (Glycosidases & Neuramidases, Glycosyltransferases & Sialytransferases, Carbohydrate kinases, Carbohydrate Sulfotransferases, Others), By Type of Kit, By Application, By End User, By Region, Forecast & Opportunities, 2025" report has been added to ResearchAndMarkets.com's offering.

The Global Glycobiology Market is expected to grow at a formidable rate during the forecast period. The Global Glycobiology Market is driven by the growing prevalence of chronic diseases such as cancer, diabetics, renal diseases, among others, which has increased the demand for personalized medicines.

This in turn has increased the drug discovery process around the globe, which is anticipated to positively impact growth of the market during the forecast period. Also, increasing grants by different governments especially in the developing nations for R&D activities is further expected to bolster the growth of the market over the next few years.

The Global Glycobiology Market is segmented based on type of enzyme, type of kit, application, end-user, company and region. Based on type of enzyme, the market can be categorized into glycosidases & neuramidases, glycosyltransferases & sialytransferases, carbohydrate kinases, carbohydrate sulfotransferases, protein sulfotransferases and others. The glycosidases & neuramidases segment is expected to dominate the market during the forecast period. This can be ascribed to their pivotal role in metabolism, antibacterial defense & pathogenesis, glycosidase probe design for ABPP represents an important task in chemical proteomic & glycomic research.

Regionally, the glycobiology market has been segmented into Asia-Pacific, North America, South America, Europe, and Middle East & Africa. Among these, North America is expected to witness significant growth during the forecast period in the overall glycobiology market owing to the presence of many research laboratories and pharmaceutical and biotechnology companies in the region.

Companies Mentioned

Objective of the Study:

Key Topics Covered:

1. Product Overview

2. Research Methodology

3. Impact of COVID-19 on Global Glycobiology Market

4. Executive Summary

5. Voice of Customer

5.1. Brand Awareness (Aided/Unaided)

5.2. Product Awareness

5.3. Customer Satisfaction Analysis

5.4. Unmet Needs/Challenges

6. Global Glycobiology Market Outlook

6.1. Market Size & Forecast

6.1.1. By Value

6.2. Market Share & Forecast

6.2.1. By Type of Enzyme (Glycosidases & Neuramidases, Glycosyltransferases & Sialytransferases, Carbohydrate Kinases, Carbohydrate Sulfotransferases, Protein Sulfotransferases, Others)

6.2.2. By Type of Kit (Glycan Releasing Kit, Glycan Labelling Kit, Glycan Purification Kit, Others)

6.2.3. By Application (Drug Discovery, Disease Diagnostics, Virology, Cell Biology, Oncology, Others)

6.2.4. By End User (Research Institutes, Diagnostic Centers, Hospitals, Clinical Laboratories, Pharmaceutical & Biotechnology Companies, Others)

6.2.5. By Company (2019)

6.2.6. By Region

6.3. Product Market Map

7. Asia-Pacific Glycobiology Market Outlook

8. Europe Glycobiology Market Outlook

9. North America Glycobiology Market Outlook

10. South America Glycobiology Market Outlook

11. Middle East and Africa Glycobiology Market Outlook

12. Market Dynamics

12.1. Drivers

12.2. Challenges

13. Market Trends & Developments

14. Competitive Landscape

15. Strategic Recommendations

16. About Us & Disclaimer

For more information about this report visit https://www.researchandmarkets.com/r/vjs9ex

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Insights on the Glycobiology Global Market to 2025 - Featuring Shimadzu, Takara Bio & Waters Among Others - ResearchAndMarkets.com - Business Wire

Study sheds new light on the immune system response to COVID-19 – News-Medical.Net

Reviewed by Emily Henderson, B.Sc.Nov 16 2020

A team of immunology experts from research organizations in Belgium and the UK has come together to apply their pioneering research methods to put individuals' COVID-19 responses under the microscope.

Published today in the journal Clinical and Translational Immunology, their research adds to the developing picture of the immune system response and our understanding of the immunological features associated with the development of severe and life-threatening disease following COVID-19.

This understanding is crucial to guide the development of effective healthcare and 'early-warning' systems to identify and treat those at risk of a severe response.

One of the most puzzling questions about the global COVID-19 pandemic is why individuals show such a diverse response. Some people don't show any symptoms, termed 'silent spreaders', whereas some COVID-19 patients require intensive care support as their immune response becomes extreme.

Age and underlying health conditions are known to increase the risk of a severe response but the underlying reasons for the hyperactive immune response seen in some individuals are unexplained, although likely to be due to many factors contributing together.

To investigate the immune system variations that might explain the spectrum of responses, teams of researchers from the VIB Centre for Brain and Disease Research and KU Leuven in Belgium and the Babraham Institute in the UK worked with members of the CONTAGIOUS consortium to compare the immune system response to COVID-19 in patients showing mild-moderate or severe effects, using healthy individuals as a control group.

One of our main motivations for undertaking this research was to understand the complexities of the immune system response occurring in COVID-19 and identify what the hallmarks of severe illness are. We believe that the open sharing of data is key to beating this challenge and so established this data set to allow others to probe and analyze the data independently."

Adrian Liston, Professor and Senior Group Leader, Babraham Institute

The researchers specifically looked at the presence of T cells - immune cells with a diverse set of functions depending on their sub-type, with 'cytotoxic' T cells able to kill virus-infected cells directly, while other 'helper' T cell types modulate the action of other immune cells.

The researchers used flow cytometry to separate out the cells of interest from the participants' blood, based on T cell identification markers, cell activation markers, and cytokine cell signaling molecules.

Surprisingly, the T cell response in the blood of COVID-19 patients classified as severe showed few differences when compared to healthy volunteers. This is in contrast to what would usually be seen after a viral infection, such as the 'flu.

However, the researchers identified an increase in T cells producing a suppressor of cell inflammation called interleukin 10 (IL-10). IL-10 production is a hallmark of activated regulatory T cells present in tissues such as the lungs. While rare in healthy individuals, the researchers were able to detect a large increase in the number of these cells in severe COVID-19 patients.

Potentially, monitoring the level of IL-10 could provide a warning light of disease progression, but the researchers state that larger-scale studies are required to confirm these findings.

"We've made progress in identifying the differences between a helpful and harmful immune response in COVID-19 patients. The way forward requires an expanded study, looking at much larger numbers of patients, and also a longitudinal study, following up patients after an illness. This work is already underway, and the data will be available within months," says Professor Stephanie Humblet-Baron, at the KU Leuven in Belgium.

"This is part of an unprecedented push to understand the immunology of COVID-19", concludes Professor Liston. "Our understanding of the immunology of this infection has progressed faster than for any other virus in human history - and it is making a real difference in treatment. Clinical strategies, such as switching to dexamethasone, have arisen from a better understanding of the immune pathology of the virus, and survival rates are increasing because of it".

Source:

Journal reference:

Neumann, J., et al. (2020) Increased IL10producing regulatory T cells are characteristic of severe cases of COVID19. Clinical & Translational Immunology. doi.org/10.1002/cti2.1204

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Study sheds new light on the immune system response to COVID-19 - News-Medical.Net

FDA-Approved Peanut Immunotherapy Protocol Comes With a Cost – Medscape

Peanut allergy immunotherapy now comes with approval from the US Food and Drug Administration (FDA), but it also comes with protocols, standards, and paperwork. Whether it will be widely adopted has yet to be determined.

A few dozen allergists around the world have been offering food allergy immunotherapy for many years, having developed their own measuring techniques using store-bought food.

But the vast majority of allergists are not interested in developing home-grown treatments, not only because it involves research and development, but also because it comes with legal risks.

"Finally we have another treatment option," said Edwin Kim, MD, from the UNC Allergy and Immunology Clinic in Chapel Hill, North Carolina. "This is what we were waiting for. It's not cowboy stuff; this works."

In January, the FDA approved peanut allergen powder (Palforzia) for patients 4 to 17 years of age, as reported by Medscape Medical News.

The pill contains measured doses of peanut flour and comes with a protocol that will allow allergists to bring patients to a peanut tolerance of 300mg (about onepeanut) and a black-box warning about anaphylaxis risk.

And before allergists can prescribe it, they must take a Risk Evaluation and Mitigation Strategy course to learn about dosing and the allergic reaction protocol.

"That may scare some away," said Kim, who discussed the FDA-approved option during his presentation at the American College of Allergy, Asthma& Immunology 2020 Annual Scientific Meeting.

Allergic reaction, including the potential for anaphylaxis, has always been an issue with immunotherapy.

"People make the argument that there is a difference" between an expected allergic reaction such as one that occurs after the administration of immunotherapy and an unexpected reaction, he said. Because an expected reaction can be treated quickly, "some feel these expected reactions don't matter so much."

"Others say a reaction is a reaction," and argue that if a treatment causes reaction, then it doesn't make sense, he explained.

It comes down to patients they must be willing to take a risk to develop tolerance and improve their quality of life and the allergists willing to treat them.

The peanut powder involves paperwork, preauthorization forms, denials of care, a higher price tag, regimented procedures, and a prerequisite number of visits with patients. "Not everyone will want to do this," said Kim.

This product offers some reassurance, and that matters.

The regimen involves three phases. During initial dose escalation, five doses are administered in the office on day1. Then, over the next 6 months, updoses are administered during 11 in-office sessions and a 300mg tolerance is achieved. Finally, to maintain tolerance to one peanut, daily doses are administered at home.

The drug cost alone is about $4200 a year, according to Institute for Clinical and Economic Review. Peanut flour from the grocery store is cheaper, but comes with the risk of bacteria or other contamination.

"This product offers some reassurance, and that matters," Kim said.

It's good to have more options for food allergy treatment. "We need a more proactive way to treat food allergy; avoidance is not good enough," he explained. "And presumably, at some point, the patient will be able to eat a grocery-store peanut instead of buying the pills."

But not all allergists will be able to make the protocol work. And it's not clear whether there is room to alter treatment and offer patients with a higher tolerance a higher starting dose. What we do know, though, is that "the product leaves little room for 'the art of medicine'," Kim said.

That art is practiced by Arnon Elizur, MD, from the Shamir Medical Center in Tzrifin, Israel, but it's backed by a rigid home-grown protocol.

Since 2010, he has treated 1800 patients for peanut allergy, updosing slowly to a tolerance of 3000mg of peanut, the equivalent of 10 peanuts. He keeps the maintenance dose at four peanuts (1200mg). His center takes a personalized approach, starting patients on the highest dose they can tolerate and working up, with daily patient check-ins from home and a staff available around the clock to answer questions and deal with reactions.

"We aim for full sensitization," Elizur told Medscape Medical News.

The peanut pill is "a big step forward" for immunotherapy, he said. It is "a standardized product, checked for bacteria and allergen content, which is available to a wide community of physicians."

But, he pointed out, "it's expensive." And it's only for peanut. "There are millions of food-allergic patients around the world dying from adverse reactions to many different kinds of food. We don't want to wait for years for a product for all of them. We can use the actual food."

He questions the lifelong maintenance protocol with a daily 300mg pill. "If you can't eat a peanut, why would you buy a drug that's a peanut?" he asked.

He also said he's disappointed that the product is not indicated for adults.

At the Shamir clinic, reactions are closely monitored. "Some are mild, others we treat with autoinjectors, epinephrine," he reported. "Those are the most undesirable."

Data from his center show that reactions occur in about 15% of patients. But his treatment success rates are good. In an average of 8 months, he is able to get 80% of his adult patients to full sensitization.

But it's not for all patients or for all clinics, he acknowledged. "We continue to look at this balance in quality of life throughout the process. Our goal is to improve the quality-of-life threshold."

Treatment that involves "native food" is "a lot of work" and requires "a lot of investment," Elizur said. His center uses a web reporting system to maintain a 24/7 dialog with patients, "and we look at the reports every day." They also have a physician on call at all times. "Not everyone can commit to providing care throughout the day and night."

His center charges the equivalent of $US3000 per food allergy treated. "That's whether it takes 6 months or 2 years," he said.

There are more than 1000 people on his 3-year waiting list.

Immunotherapy is not easy to do, whether it's FDA-approved or not.

"This is the first year that the American College of Allergy, Asthma, and Immunology is not hosting a procon debate on oral immunotherapy," Kim pointed out. "We have a therapy now."

However, the pandemic has slowed treatment uptake. "Immunotherapy is not easy to do, whether it's FDA-approved or not," he explained. With at least 11 doctor visits in the first 6 months each visit is between 30 minutes and 2 to 3 hours it hasn't been possible to set up this year. "It's not ideal."

It will be interesting to see "how this will roll out and how it will be adopted," Kim said. "From a food allergy point of view, the next 12 months are going to be very interesting."

Kim reports receiving consulting honorarium from Aimmune, the maker of Palforzia; being on the clinical medical advisory board for DBV Technologies; and consulting for DBV, Aimmune, Allakos, Allergenis, Ukko Incorporated, Vibrant America, Duke Clinical Research Institute, and Kenota Health. Elizur has The disclosed no relevant financial relationships.

American College of Allergy, Asthma & Immunology (ACAAI) 2020 Annual Scientific Meeting.

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FDA-Approved Peanut Immunotherapy Protocol Comes With a Cost - Medscape

RAPT Therapeutics Reports Third Quarter 2020 Financial Results – BioSpace

SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc.. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical companyfocused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, today reported financial results for the third quarter ended September 30, 2020 and provided an update on recent operational and business progress.

Earlier today, we reported positive initial data from our ongoing Phase 1/2 clinical trial evaluating FLX475 in multiple cancer indications, said Brian Wong, M.D., Ph.D., President and CEO of RAPT Therapeutics. With the advancement of this program and continued enrollment for our ongoing Phase 1b study of RPT193 in atopic dermatitis, which we now expect to read out in the first half of 2021, we are well positioned for multiple catalysts in 2021.

Financial Results for the Third Quarter and Nine Months Ended September 30, 2020

Third Quarter Ended September 30, 2020Net loss for the third quarter of 2020 was $14.6 million, compared to $10.0 million for the third quarter of 2019.

Research and development expenses for the third quarter of 2020 were $12.9 million, compared to $8.6 million for the same period in 2019 due to increased clinical costs for FLX475 and RPT193, increased personnel costs and stock-based compensation expense, an increase in preclinical program costs and laboratory supplies.

General and administrative expenses for the third quarter of 2020 were $3.2million, compared to $1.7million for the same period of 2019. The increase was primarily due to an increase in stock-based compensation expense, personnel costs, legal and accounting fees and insurance expense offset by a decrease in consulting costs.

Nine Months Ended September 30, 2020Net loss for the nine months ended September 30, 2020 was $40.2 million, compared to $29.8 million for the same period in 2019.

Research and development expenses for the nine months ended September 30, 2020 were $34.6 million, compared to $24.7 million for the same period in 2019. The increase was primarily due to an increase in clinical costs relating to FLX475 and RPT193, increased preclinical program costs as well as increased stock-based compensation and personnel expenses, offset by decreases in lab supplies and travel costs.

General and administrative expenses for the nine months ended September 30, 2020 were $9.3million, compared to $6.1million for the same period of 2019. The increase in general and administrative expenses was primarily due to increased stock-based compensation expense, increased personnel costs, an increase in legal and accounting fees as well as insurance expense offset by a decrease in travel and consulting costs.

As of September 30, 2020, we had cash and cash equivalents and marketable securities of $122.8 million.

AboutRAPT Therapeutics, Inc.RAPT Therapeutics is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases. Utilizing its proprietary discovery and development engine, the Company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. RAPT has discovered and advanced two unique drug candidates, FLX475 and RPT193, each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of cancer and inflammation, respectively. The Company is also pursuing a range of targets, including hematopoietic progenitor kinase 1 (HPK1) and general control nonderepressible 2 (GCN2), that are in the discovery stage of development.

Forward-Looking StatementsThis press release contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about clinical development progress and the timing of results from clinical trials of FLX475 and RPT193. Detailed information regarding risk factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in RAPTs most recent Form 10-Q filed with the Securities and Exchange Commission and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements.

RAPT Media Contact:Angela Bittingmedia@rapt.com(925) 202-6211

RAPT Investor Contact:Sylvia Wheelerswheeler@wheelhouselsa.com

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RAPT Therapeutics Reports Third Quarter 2020 Financial Results - BioSpace

RAPT Therapeutics Reports Positive Initial Data from Ongoing Phase 1/2 Clinical Trial of FLX475 in Multiple Cancer Indications – BioSpace

-Evidence of Monotherapy and Combination Activity in Charged Tumor Types--Company Advances Several Cohorts into Phase 2 Expansions--Conference Call and Webcast to be Held at 8:30 a.m. ET Today-

SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc.. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical companyfocused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, today announced positive initial clinical data from its ongoing Phase 1/2 trial for FLX475 in multiple cancer indications.

Initial observations as of November 10, 2020 from the ongoing trial for FLX475 include preliminary:

In addition, FLX475 demonstrated a favorable safety profile, both as monotherapy and in combination with pembrolizumab.

We are pleased with the early evidence of clinical activity of FLX475, both as monotherapy and in combination with pembrolizumab in multiple charged tumor types, said Brian Wong, M.D., Ph.D., President and CEO of RAPT. Based on these encouraging data, we have determined that three cancer indications, EBV+ lymphoma, nasopharyngeal cancer and head and neck cancer, have generated sufficient early evidence of efficacy to advance into expanded Phase 2 evaluation. We continue to enroll patients and generate data in this multi-cohort, multi-indication trial and look forward to providing updates on all remaining cohorts and additional go-forward decisions next year.

Scott Antonia, M.D., PhD., Professor of Medicine and Director of the Duke Cancer Institute Center for Cancer Immunotherapy and a member of RAPTs Scientific Advisory Board, added, FLX475 is a potent non-depleting CCR4 antagonist that is designed to block regulatory T cells that interfere with an effective anti-tumor immune response. These data are particularly impressive as the immunotherapy field has long recognized Treg as important targets in oncology, but until FLX475, others have not been able to selectively target these cells in the tumor microenvironment without affecting beneficial cells. These data demonstrate that RAPTs oral small molecule approach with FLX475 holds promise in treating a variety of charged cancers.

Charged cancers are tumors that contain high levels of both regulatory T cells (Treg) and CD8 T cells and express high levels of the ligands for CCR4.

Phase 1/2 Clinical Trial DesignThe ongoing open-label Phase 1/2 study is enrolling patients with multiple types of cancer at leading cancer centers across the United States, Australia and Asia. The Phase 1 portion of the trial is focused on evaluating the safety, pharmacokinetics and pharmacodynamics of FLX475 as a monotherapy and in combination with pembrolizumab. The Phase 2 portion is designed to evaluate the degree of antitumor activity of FLX475 as a monotherapy and in combination with pembrolizumab specifically in patients with several types of charged tumors. Changes in the tumor microenvironment and other biomarkers are being evaluated in both phases of the study. For more information please visit clinicaltrials.gov identifierNCT03674567.

Phase 1 Dose Escalation DataThe dose escalation Phase 1 portion of the trial enrolled a total of 37 patients with cancers of different types. Nineteen patients were treated with one of four doses (25 mg, 50 mg, 75 mg or 100 mg once daily) of FLX475 monotherapy and 18 were treated with one of three doses (50 mg, 75 mg or 100 mg once daily) of FLX475 in combination with the standard dose of pembrolizumab. Disease control, defined as a best response of stable disease (SD), an unconfirmed or confirmed partial response (PR) or complete response (CR), was observed in 14 of the 17 evaluable monotherapy patients, including an unconfirmed partial response in a patient with relapsed metastatic cervical cancer. In the combination cohorts, disease control was observed in 13 of the 14 evaluable patients. This includes two confirmed partial responses: a patient with NSCLC who had progressed on prior checkpoint treatment (atezolizumab) and who remains on study after 18 months of treatment, and a patient with checkpoint inhibitor-nave urothelial cancer who was on study for over nine months of treatment. In addition, preliminary data show an increase in the CD8 to Treg ratio after treatment, which is consistent with the hypothesis that a CCR4 antagonist can block the recruitment of tumor Treg, increase the CD8 to Treg ratio and potentially enhance antitumor immunity.

The Phase 1 results also show FLX475 had a favorable safety profile, with no maximum tolerated dose reached. Two dose-limiting toxicities (DLTs) of asymptomatic QTc prolongation were observed in the monotherapy cohorts, one in the 75 mg cohort and one in the 100 mg cohort. No DLTs were observed in the Phase 1 combination cohorts. Based on the Phase 1 data, 100 mg was selected as the recommended Phase 2 dose for both the monotherapy and combination therapy cohorts.

Phase 2 DataThe ongoing Phase2 portion of the trial is enrolling a minimum of 80 patients with several types of charged tumors, 10 in each of eight cohorts, with four cohorts evaluating FLX475 as a monotherapy and four cohorts evaluating FLX475 in combination with pembrolizumab. The charged cancers include Epstein-Barr Virus (EBV)- or Human Papillomavirus (HPV)-associated cancers such as nasopharyngeal cancer, cervical cancer, and subsets of Hodgkin and non-Hodgkin lymphomas as well as head and neck cancer. Other charged tumor types include non-small cell lung cancer and triple-negative breast cancer. The protocol calls for expansion of cohorts to generate additional data based on promising clinical activity.

Based on the promising early results from the Phase 1/2 trial with FLX475 observed to date, RAPT has selected three cancer indications for expansion:

In these Phase 2 cohorts, FLX475 demonstrated a favorable safety profile with once-daily oral dosing both as monotherapy and in combination with pembrolizumab.

a Interim data as of November 10, 2020 from the ongoing FLX475-02 Phase 1/2 study; data subject to change.bORR = objective response rate defined as unconfirmed and confirmed PR or CRcDCR = disease control rate defined as unconfirmed and confirmed PR or CR and SD as best response

Conference Call InformationThe Company will host a webcast conference call accompanied by a slide presentation to discuss initial data from the Phase 1/2 study of FLX475 today at 8:30 a.m. Eastern Time. The call can be accessed by dialing (833) 672-0665 (domestic) or (929) 517-0344 (international) and refer to conference ID 6772479. The webcast will be available for replay for two weeks.

About FLX475FLX475 is a small molecule CCR4 antagonist designed to block the migration of regulatory T cells (Treg) specifically into tumors, but not healthy tissues. Tregrepresent a dominant pathway for downregulating the immune response, generally correlate with poor clinical outcomes and may limit the effectiveness of currently available therapies such as checkpoint inhibitors. RAPT is developing FLX475 for the treatment of a broad range of charged tumors, which represent cancer types the Company believes are most likely to respond to FLX475, where a large quantity of Tregcells are likely to be the cause of immune suppression within the tumor. FLX475 may restore naturally occurring antitumor immunity alone and may synergize with a variety of both conventional and immune-based therapies, such as radiation, chemotherapy, checkpoint inhibitors, immune stimulators, cancer vaccines and adoptive T cell therapy.

AboutRAPT Therapeutics, Inc.RAPT Therapeutics is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases. Utilizing its proprietary discovery and development engine, the Company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. RAPT has discovered and advanced two unique drug candidates, FLX475 and RPT193, each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of cancer and inflammation, respectively. The Company is also pursuing a range of targets, including hematopoietic progenitor kinase 1 (HPK1) and general control nonderepressible 2 (GCN2), that are in the discovery stage of development.

Forward-Looking StatementsThis press release contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about clinical development progress, the significance of early results from Phase 1/2 clinical trials of FLX475 and plans with respect to Phase 2 expansions. Detailed information regarding risk factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in RAPTs most recent Form 10-Q filed with the Securities and Exchange Commission and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements.

RAPT Media Contact:Angela Bittingmedia@rapt.com(925) 202-6211

RAPT Investor Contact:Sylvia Wheelerswheeler@wheelhouselsa.com

Continued here:
RAPT Therapeutics Reports Positive Initial Data from Ongoing Phase 1/2 Clinical Trial of FLX475 in Multiple Cancer Indications - BioSpace