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UGA grad named winner of Nesbitt-Flatt Outstanding Senior award – Henry Herald

Posted: June 23, 2021 at 1:50 am

ATHENS William Flatt served as the dean of the University of Georgias College of Agricultural and Environmental Sciences from 1981 to 1994. Coming in as dean, Flatt recognized that college enrollment was low and tackled the challenge of recruitment using his problem-solving skills and charisma.

This years Nesbitt-Flatt Outstanding Senior Award recognized a student with the same charisma and determination as Dean Flatt. Arjun Bhatt was recognized as this years recipient during the 2021 Student Awards and Leadership Celebration held on YouTube. Bhatt recently graduated with bachelors degrees in both applied biotechnology and psychology.

Bhatt originally entered UGA as a biochemistry major in the Franklin College of Arts and Sciences, but he wanted to study something more tailored toward his interests of translational science, synthetic biology and genetics. After skimming through the UGA Bulletin, he found exactly what he was looking for applied biotechnology. Bhatt also decided to add a psychology major because of his interest in understanding the human experience.

The way we think, feel and behave is inextricably bound to the way we are built at a molecular level psychology helped me bridge the gap between the hard sciences and the soft sciences, Bhatt explained.

Through his involvement across several campus organizations and labs, Bhatt dived deeper in his chosen field of study. In Brian Kvitkos lab in the Department of Plant Pathology, Bhatt was president and lead researcher of UGA iGEM, an undergraduate-led research team that uses genetic engineering and synthetic biology to solve real-world problems. As he led the team to its first-ever silver medal, Bhatt learned to use both what is known and unknown to solve a problem and in the process, he discovered his true passion.

My passion is problem-solving, Bhatt said. Thats what keeps me up at night. Thats why I work in translational research. I enjoy using what we know and dont know to solve problems. That process helps someone, a community or a cause.

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Identifying the core of what made him tick was one big step forward for Bhatt, helping him to put things into perspective and leading to a philosophical revelation.

While reflecting on his time at UGA, Bhatt realized that for a portion of his college career he was in a rat race seeking external glorification and prestige. While mentoring freshmen, Bhatt noticed they were entering the same rat race he had escaped, and he wanted to help them realize there is more to success than external reward. His realization is what Bhatt calls the prestige trap, which he defines as chasing what others think is important rather than what we actually think is important.

This idea this thought led Bhatt to scrap his original idea for a TEDxUGA talk he was scheduled to submit just two days before the due date. He unveiled his prestige trap concept at the 2021 TEDxUGASalon series in a presentation called Escaping the prestige trap: How to reshape our definition of success.

Outside of his academic pursuits, Bhatt found comfort and support from the familylike environment he found in CAES as well as organizations like the Indian Cultural Exchange, Georgia Saazish and the Chess Dawgs.

Now a strategy consultant for Deloitte, a global professional services firm, Bhatt is excited to trade medical diagnostics for business diagnostics. He will be working in the companys government and public services branch, helping large federal, state and local organizations improve productivity, efficiency and overall performance. Much as Flatt brought skills and charisma to his challenges at CAES, Bhatt is ready to apply his passion and experiences to a new industry, motivating and aiding societal institutions as Flatt did the college.

Stacker explores the 100 top-rated TV shows of all time.The shows with the highest IMDb score are ranked the highest, with #1 being the best TV show of all time, as rated by IMDb users, and with ties broken by the number of votes. Click for more.

Courtney Cameron is a digital marketing intern for the UGA College of Agricultural and Environmental Sciences Office of Marketing and Communications.

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Scientists Discover Unreported Plant Body Part "I Thought It Must Be an Artifact of Genetic Contamination" – SciTechDaily

Posted: June 23, 2021 at 1:50 am

Cantils, so named for their cantilever function of supporting the flower-bearing stalk, are newly reported plant structures that develop in wild-type Arabidopsis as a consequence of delayed flowering under short-day lengths. The image shows a FLOWERING LOCUS T mutant strain (ft-10) flowering under a long-day length. One long and two short cantils are visible. Credit: Timothy Gookin

For many, the Thale cress (Arabidopsis thaliana) is little more than a roadside weed, but this plant has a long history with scientists trying to understand how plants grow and develop.Arabidopsiswas first scientifically described as early as the 16th century and the first genetic mutant was identified in the 1800s. Since the 1940s,Arabidopsis has increased in popularity within the scientific community, which continues to use it as a model system to explore plant genetics, development, and physiology to this day.

One might expect that after decades of scientific scrutiny the structure ofArabidopsishad been fully documented, but a new study from scientists from The Pennsylvania State University, USA, has revealed that this humble plant still has some surprises. The researchers describe a previously unreported structure called the cantil, which connects to the stem at one end and hangs in the air to hold up the flower-bearing stalk, similar to the function of a cantilever in structural engineering.

I first observed the cantils in 2008, said Dr. Timothy Gookin, a postdoctoral researcher working in the group of Professor Sarah Assmann. I initially didnt trust any of the results; I thought it must be an artifact of genetic contamination, perhaps combined with environmental contamination of the water, soil, fertilizer, or even the building air supply.

How have cantils eluded scientists for so long? First, cantils are rare; they only develop under certain conditions that cause the plant to delay flowering, such as short day lengths, and cantils only form at the precise point at which the plant begins to flower. In addition, as Dr. Gookin discovered, some popular Arabidopsisstrains have genetic mutations that make them incapable of producing cantils at all.

Nonetheless, Dr. Gookin set about the gargantuan task of proving that cantils are a naturally occurring structure and not an artifact of mutation or contamination an effort that took more than a decade. It took over 12 years of experimentation to really get a grasp on what we were seeing and to understand how cantils were regulated. This study required the growth of 3,782 plants to full maturity and the manual inspection of over 20,000 flower-bearing stalks in 34 unique plant lines, explained Dr. Gookin. I finally deemed the cantils a natural phenomenon after identifying them in wild-type (non-mutant) plants from different sources, which were growing in independent locations and diverse conditions.

During his extensive research, Dr. Gookin identified a number of mutant plants in which cantils appear more frequently, revealing some of the genetic factors that control cantil development. The discovery of cantils is not only a lesson in the virtues of perseverance, but their development also provides important clues for understanding the conditional growth of plant structures in response to their environment. One speculative interpretation is that the cantil represents a highly repressed ancestral linkage between different types of flowering plant architectures; the multiple layers of genetic and environmental factors that regulate cantil development are certainly quite striking, said Dr. Gookin.

Reference: Cantil: a previously unreported organ in wild-type Arabidopsis regulated by FT, ERECTA and heterotrimeric G proteins by Timothy E. Gookin and Sarah M. Assmann, 15 June 2021, Development.DOI: 10.1242/dev.195545

Timothy Gookin is a postdoctoral researcher, and Sarah Assmann is the Waller Professor of Biology at Pennsylvania State University. Timothy Gookin is the lead corresponding author of the article.

Funding: National Science Foundation, NIH/National Institute of General Medical Sciences

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Israelis taste the future with lab-grown chicken ‘food revolution’ – FRANCE 24

Posted: June 23, 2021 at 1:50 am

Ness Ziona (Israel) (AFP)

It looks like chicken and tastes like chicken, but diners in Israel are tucking into laboratory-grown "meat" that scientists claim is an environmentally friendly way to feed the world's growing population.

In a small restaurant in a nondescript building in a science park in the central Israeli town of Ness Ziona, diners munched burgers and minced meat rice rolls made with "cultured chicken" -- meat grown in the adjacent SuperMeat production site.

"It was delicious, the flavour was great," said Gilly Kanfi, a self-described "meat eater" from Tel Aviv, who had signed up for the meal months in advance.

"If I didn't know, I would have thought it was a regular chicken burger."

The Chicken, as the eatery is called, is a testing ground of sorts for SuperMeat, hosting periodical test meals to generate customer feedback while waiting for regulatory approval.

- Rapid growth -

The restaurant's dark and elegant interior is framed by large windows looking onto a bright-lit laboratory, where technicians monitor large stainless-steel fermentation vats.

"This is the first time in the world people can actually have a taste of a cultivated meat product, while observing the production and the manufacturing process in front of their eyes," said Ido Savir, SuperMeat's chief executive.

Here, at least, the laboratory has made redundant the age-old question of whether the chicken or the egg came first.

The process involves cultivating cells taken from a fertilised chicken egg.

Cell cultures are fed a plant-based liquid including proteins, fats, sugars, minerals and vitamins.

With all the feed going directly into production, it grows rapidly, with the mass doubling within a matter of hours, the company says.

Savir, a vegan with a background in computer science, sees himself as being at the "forefront of a food revolution" trying to help supply food while limiting the impact on the planet.

Developers said they are working to provide more ethical and sustainable ways to create cruelty- and slaughter-free meat, with the product grown without using genetic engineering or antibiotics.

The company is currently able to produce "hundreds of kilogrammes" each week, Savir said.

- 'Game-changer' -

But he hopes to earn regulatory approval from the US Food and Drug Administration, and would then increase production to a "commercial" scale.

"This way we'll be able to reduce the amount of land, water use and so many other resources, and keep the product very healthy and clean," he said, noting the high prevalence of diseases among chickens produced in factory-style production.

Global meat production is projected to rise 15 percent by 2027, according to the UN Food and Agriculture Organization.

SuperMeat is not the first to develop the technology. In December, a Singapore restaurant made history when it became the first to sell lab-grown chicken meat.

The Israeli firm has developed a versatile product, blending muscle, fat and connective tissue cells to create different cuts -- even including pet food.

Zhuzha, a white bull terrier attending the meal along with its owner, enthusiastically devoured the SuperMeat dog food it was handed.

"Pets love our meat as well," Savir said with a smile.

The human diners said the product was as good as the real thing.

"It really surprised me," said Lisa Silver, a regular meat-eater. "If I can get that in a restaurant, I will go vegan, totally. It's a game-changer."

For her sister Annabelle, it was the first time in years she had eaten meat.

"One of the reasons that I became vegetarian originally was because it's not ethical, it's not sustainable," she said.

"To get meat minus the cruelty is just amazing, it's perfect, I could eat this every single day."

- Vegetarian-friendly? -

But the question whether the product should be considered meat is one faced not only by vegetarians -- but also Jewish rabbinic authorities.

Producing meat in a cruelty-free way that does not harm the environment is a positive development that will "save the world problems", said Rabbi Eliezer Simcha Weisz, a member of Israel's Chief Rabbinate Council.

While rabbis would have to learn the novel process and supervise it, Weisz said he expected the product would eventually receive a kosher designation.

Tal Gilboa, a prominent veganism activist who served as an adviser to former prime minister Benjamin Netanyahu, said Israel was leading the way on cultured meat technology.

Gilboa would like the world to turn to a plant-based diet, and sees cultivated meats as a pragmatic way for people to take the first steps to vegetarianism.

"The world population is increasing at a break-neck speed," she said, adding that the only way to keep up will be "through technology".

Savir believes the technology could change humanity for the better.

"Like we saw with the revolution of the smart phone, once this is available, we'll start producing so much meat," he said.

"It would increase food security for nations around the world, a very sustainable, animal-friendly and efficient process."

2021 AFP

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Kytopen Awarded NIH Grant of Up to $2M to Unlock the Power of Engineered Natural Killer (NK) Cells via Flowfect Platform – Business Wire

Posted: June 23, 2021 at 1:50 am

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Kytopen., a transformative biotechnology company offering non-viral delivery that links the discovery, development and manufacturing of engineered cell therapies, today announced it was awarded a SBIR Fast Track grant from the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institute of Health (NIH). Kytopen is eligible for up to $2M over the course of the 3-year award as project milestones are successfully completed within the Phase I and Phase II portions of the grant.

Natural killer (NK) cells represent a high impact population for cell therapy, but due to limitations in current methodologies for gene delivery, NK cells remain a largely untapped resource. This SBIR grant will be used to demonstrate that non-viral delivery via Kytopens Flowfect platform can alleviate this limitation on NK cell gene editing at both research and manufacturing scale, which is needed for pre-clinical and clinical studies. Due to the major potential impact NK cells represent in a clinical setting, non-viral Cas Ribonucleoprotein (RNP) gene knockout will allow for novel therapeutic applications in infectious disease, autoimmune disorders, and immuno-oncology.

Paulo Garcia, Kytopens CEO and Co-Founder will serve as the Principal Investigator (PI) on the grant. Dr. Garcia explains that engineered NK cells have tremendous therapeutic promise including the potential to treat solid tumors in an allogeneic modality. The Flowfect platform will facilitate high-throughput target discovery while providing a clear path towards clinical manufacturing of next-generation cell products.

NK cells are a subset of innate immune cells that can respond to threat without antibody priming. This quick response to stimuli makes them an ideal immunotherapy candidate. Yet, genetic modification in NK cells has proven to be difficult using conventional viral and non-viral transfection methodologies. Alternative delivery methods are necessary in order to make genetic modifications at reproducible and efficient rates, while maintaining high cell viability and functionality.

The awarded study leverages continuous fluid flow coupled with low energy electric fields for transfection via a proprietary Flowfect platform (Figure 1). This platform represents a novel approach to non-viral delivery in historically hard-to-transfect human cells. The current research proposes to engineer non-activated NK cells with Cas RNPs for gene editing using the Flowfect platform. To achieve this goal, Kytopen has outlined a two-phase research strategy which focuses on stability and functionality of edited NK cells both in vitro and in vivo.

NIH sponsored grant programs are an integral source of capital for early-stage U.S. small businesses that are creating innovative technologies to improve human health. These programs help small businesses break into the federal research and development arena, create life-saving technologies, and stimulate economic growth. Kytopen is honored to be a recipient of this competitive award from the NIH/NIAID and looks forward to unlocking biological capabilities of engineered NK cells for improving patients lives during the performance of this project.

About the Flowfect Technology

Kytopens proprietary Flowfect platform eliminates the complexity of gene editing and integrates discovery, development and manufacturing in one flexible and scalable non-viral delivery solution. The Flowfect technology utilizes electro-mechanical energy to disrupt the cell membrane and introduce genetic material (such as RNA, DNA, or CRISPR/Cas RNP) to a wide variety of hard-to-transfect primary cells. During the Flowfect process, a solution containing cells and genetic payload suspended in a proprietary buffer flows continuously through a channel while the solution is exposed to a low energy electric field. Due to the continuous flow and low electrical energy required, cells engineered using Flowfect exhibit high viability while also exhibiting high transfection efficiency post-processing. The Flowfect technology utilizes relatively high flow rates enabling cell engineering in minutes for discovery and optimization (e.g. 96 well plate in <10 minutes) and direct scale up to manufacturing volumes of >10mL, engineering over 2 billion cells per minute in a single channel.

About Kytopen

Kytopen, an MIT spin-out, is a transformative biotechnology company that offers a customizable yet scalable multi-solution platform, which seamlessly links the discovery, development and manufacturing phases of cell engineering. Flowfect, a gentle, non-viral delivery method unlocks new therapeutic approaches, by engineering immune cells with minimal disruption, preserving the functionality and viability of human cells and enhancing the cells biology. The Flowfect platform accelerates therapies from the bench to clinical through flexibility and scalability, which drives higher cell yields, faster approvals, and better outcomes from potentially curative cell-based treatments. Kytopens goal is to enable simple and efficient non-viral manufacturing of cell therapies in days versus weeks to increase access to many more patients. For more information, visit: http://www.kytopen.com

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Kytopen Awarded NIH Grant of Up to $2M to Unlock the Power of Engineered Natural Killer (NK) Cells via Flowfect Platform - Business Wire

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Tumors Next Target for T Cell Therapies with U Minnesota Research – BioSpace

Posted: June 23, 2021 at 1:50 am

New research from a University of Minnesota team shows T cells can be engineered to migrate more effectively inside tumor microenvironments, raising hopes of reproducing the remarkable outcomes seen for certain hematological cancer patient subsets in broader populations and indications.

T cells have been key to two promising families of cancer immunotherapies, chimeric antigen receptor (CAR) T cells and immune checkpoint inhibitors. After two new U.S. Food and Drug Administration (FDA) approvals earlier this year for Bristol Myers Squibbs Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel), there are now five marketed CAR T cell therapies for a range of hematological cancers, including large B-cell and mantle cell lymphoma, acute lymphoblastic leukemia and multiple myeloma. These therapies are patient-derived T cells engineered to express a CAR that directs them to a specific tumor.

By contrast, immune checkpoint inhibitors function by targeting sets of natural immune system brakes, either on a tumor or directly on immune cells. The seven FDA-approved immune checkpoint inhibitors allow T cells to kill a growing list of hematological and solid tumors, and show impressive outcomes but in a fraction of patients.

Both approaches have been more effective in hematological cancers, and one obstacle in solid tumors is a literal barrier. T cells have to migrate through the complex, dense, and rigid tumor microenvironment, which can misdirect and slow down the immune cells.

The new paper, published in Nature Communications, shines a light on how T cells move within these physical features, informing new methods to rationally engineer the cells for more effective therapies.

T cell engineering has focused on cancer identification and targeting, said Paolo Provenzano, associate professor at the University of Minnesota Masonic Cancer Center and an author on the paper.

Were trying to add on a piece to that: they know what to kill, how do they get there? he said.

The researchers looked at pancreatic ductal adenocarcinoma (PDAC), a particularly fibrotic cancer known for limited cytotoxic T cell infiltration. Provenzano and colleagues had previously shown that antifibrotic therapies could improve immune cell infiltration in PDAC, but the group is now focused on rationally designing physical attributes of the T cells themselves.

Provenzanos team started by testing T cell migration on specialized artificial 2-D nanotextured platform that mimicked elements of the stromal extracellular matrix of tumors. T cells use lamellipodia and filopodia to sense biophysical cues and guide migration, and can switch between more flexible and stiffer phenotypes, to adapt to different conditions.

Theyre never all or one, theyre on this sliding scale, mediated by the muscle-like contractions of microtubules, Provenzano said.

The researchers found that while in a more amoebalike phenotype, cells had enhanced speed and motility, improving how quickly and effectively the cells could navigate the matrix. The researchers used the chemotherapeutic nocodazole, known to destabilize microtubules, to increase contractility and induce more amoebalike phenotypes, and another chemotherapeutic, paclitaxel, for the inverse. Cells with the nocodazole-induced amoebalike phenotypes could contract into smaller balls, and could shoot out protrusions faster, allowing for better motility than the paclitaxel-induced stiffer ones, and migrating between 50-100% faster in artificial 3-D matrices and mouse PDAC model tumor slices.

Thinking about personalized combination approaches to cancer treatment, this raised a red flag for Provenzano, as taxane agents are commonly used to treat solid tumors like breast and pancreatic cancer. The findings suggest certain chemotherapies might not be right if youre trying to elicit the bodys own immune response against these tumors, or mixing with a T cell therapy, he said.

The effect of chemotherapies on T cell microtubules is transient, so next the researchers explored a genetic engineering approach, using CRISPR technology to engineer T cells lacking GEF-H1, a gene they hypothesized mediates cell contractility. In a 3-D matrix, the knockout lines migrated 50% compared with controls.

Provenzano envisions different T cell engineering tweaks as part of the increasingly personalized approach to cancer treatment. Cells engineered to migrate faster have promise particularly in fibrotic tumor microenvironments, where T cells move about half as fast.

They get to sample less volume before they become exhausted, he said.

T cell exhaustion is a key limitation for CAR-T therapies and combining them with T cells that are physically optimized for faster migration could be synergistic in these patients.

If tumors are like unique obstacle courses for T cells, though, then different athletes or teams might be suited for different cancer types and patients.

Maybe we engineer five different T cells that navigate different obstacles, then mix them in cocktail and bring them back in. Thats what were thinking as our ultimate goal, he said.

Provenzanos lab is now using physics-based mathematical models to predict what the optimal cell would be.

We dont know the most physically optimized cell looks like yet, he said. But the paper represents just the first foray into the optimization process for just the first athlete. This will be what at least half my lab will be publishing on for the next decade.

There is active interest in the approach, but Provenzano said the work is not yet being commercialized. He hopes to find a partner with an ongoing T cell therapy clinical trial that could add an arm with his groups physically optimized cells, but trials are probably still years away.

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This Startup is Changing the Way Spinal Cord Injury Is Treated Around the World – Entrepreneur

Posted: June 23, 2021 at 1:49 am

Hear from the CEO of NurExone Biologic Ltd, Israel's promising new start-up which aims to utilize innovative Exosome-based technology and smart delivery platforms in order to revolutionize the way spinal cord injury (SCI) is treated around the world

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June22, 20215 min read

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On Wall Street and prominent global stock exchanges, the emergence of innovative start-up companies has become an Israeli phenomenon. Today, the innovation nation gains unprecedented international recognition as well as investment for a country the size of the (US) state of New Jersey. Based in the northern city of Haifa, one of the newest Israeli startups building upon the countrys profound reputation is NurExone Biologic Ltd. The company, founded just last year, aims to change the way spinal cord injury (SCI) is treated around the world by utilizing exosomes as smart delivery platforms.

Over the past few decades, stem cells have become a significant interest for the scientific community as well as popular culture, and the preliminary results have been incredible. Now, stem cell research and therapy development are at an all-time high with accompanying experimental trials to apply decades of analysis into real-life medicinal practice. In regard to treating SCI, traumatic and non-traumatic, Stem Cells were tested on patients, which some of the patients have benefitted from the use of the stem cells, but due to various challenges, the treatment was not approved yet. However, NurExone promising exosome-based research proof of concept results, shown on animal, has to offer new treatment to SCI patients as well as same potential in traumatic brain injury.

NurExone is led by CEO Dr. Lior Shaltiel, who maintains an impressive background in biotech entrepreneurship, in addition to biomedical engineering, pharmacology and the advancement of smart delivery systems all of which are vital components to the companys mission. The formula behind NurExones solution is a two-prong strategy to concentrate exosome technology as the main fuel and practically treating SCI patients via a smart delivery platform. This combination, which is planned to medically transferred into the body through the nose, has a natural effect in targeting neuron damage. According to Shaltiel, while many companies are using stem cells which release exosomes naturally and attempt to regenerate neurons through local injections, our loaded exosomes have the potential to be transferred into the body nasally which is a considerable game-changer for the industry.

Furthermore, NurExone is equipped with an experienced Board of Directors, including from some of Israels leading pharmaceutical and biotech brands listed on international stock exchanges such as Executive Chairman Ron Mayron of Teva (NYSE: TEVA) and Founder & Director Yoram Drucker of Pluristem (NASDAQ: PSTI) and Brainstorm (BCLI). These substantial decision-makers in the medical technology as well as the Israeli innovation scene is indispensable and attests to the potential of the offer of the company from global operational management to strategic marketing to attracting major investors.

From its inception, NurExones extensive research and ability to conduct experimental testing comes from the companys collaboration with top professors from two of Israels elite universities Technion (noted as Israels MIT) and Tel Aviv University. As part of the companys Co-founders and Scientific Advisory Board, NurExone has partnered with Professor Daniel Offen, Head of Tel Aviv Universitys Neurology Lab, and Professor Shulamit Levenberg, the former Dean of Technions Biomedical Engineering Department and Director of the Technion Center for 3D Bioprinting. The board also features Professor Nashson Knoller, MD, Head of the Neurosurgery Department at Sheba Hospital.

This month, NurExone also implemented notable moves to prepare the company for the subsequent stage developing a promising product for the clinical phase. The company has received important approvals, which allow them to further their developing SCI treatments around the world. This significant advancement in the Israeli start-ups early focus on next stage financial efforts will play a principal role in persuading interested parties and serious investors to the table to help the company progress to become listed on international stock exchanges.

According to Shaltiel, while it usually will take several years for companies during the research and development (R&D) phase to secure investment, we are progressing with our funding model due to the exponential potential of our product. At the moment, NurExones plans to move towards entering the Toronto Stock Venture Exchange (TSXV), a Mecca-like market for penny stocks and new companies attempting to build an investor following for more global exchanges in the future.

In the world of start-up and innovation companies, a companys infrastructure, vision, and basis for research development is crucial to the success and longevity of the business. For NurExone, the companys successful Board of Directors, ambitious and experienced CEO Dr. Lior Shaltiel, together with the Scientific Advisory Board should not merely satisfy these prerequisites but galvanize the biotech community. While the company, after only a few months, has provided an important genesis for potential investors as well as medical professionals to learn from it also shows the teams efficiency and maturity. In order for NurExone to change how SCI is treated around the world, its next pragmatic step will be to analyze and optimize the product to take another step towards making its goal to treat SCI closer to becoming a reality.

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Genmab Announces that Janssen has Received European – GlobeNewswire

Posted: June 23, 2021 at 1:49 am

Company Announcement

Copenhagen, Denmark; June 22, 2021 Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted marketing authorization for the daratumumab subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj), known as DARZALEX SC in the European Union, in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adult patients with newly diagnosed systemic light-chain (AL) amyloidosis. The EC also approved DARZALEX SC in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor (PI) and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a PI and have demonstrated disease progression on or after the last therapy. The approvals follow Positive Opinions by the CHMP of the European Medicines Agency in May 2021. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

AL amyloidosis is a potentially fatal blood disorder for which there is no cure, so we are extremely pleased that patients with AL amyloidosis in Europe may soon have a regimen including DARZALEX SC as a treatment option, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. We are also pleased that, with the approval based on the APOLLO study, the combination of daratumumab with pomalidomide and dexamethasone will now be a treatment option for certain patients with relapsed or refractory multiple myeloma in Europe.

About the ANDROMEDA (AMY3001) studyThe Phase 3 study (NCT03201965) included 416 patients newly diagnosed with AL amyloidosis. Patients were randomized to receive treatment with either daratumumab and hyaluronidase-fihj in combination with bortezomib (a proteasome inhibitor), cyclophosphamide (a chemotherapy), and dexamethasone (a corticosteroid) or treatment with VCd alone. The primary endpoint of the study was the percentage of patients who achieve hematologic complete response.

About the APOLLO (MMY3013) studyThe Phase 3 (NCT03180736), randomized, open-label, multicenter study included 304 patients with multiple myeloma who have previously been treated with lenalidomide and a PI. Patients were randomized 1:1 to either receive daratumumab in combination with Pd or Pd alone. In the original design of the study, patients in the daratumumab plus Pd arm were treated with the intravenous (IV) formulation of daratumumab. As of Amendment 1 to the study protocol, all new subjects in the experimental arm were dosed with the SC formulation of daratumumab and patients who had already begun treatment with IV daratumumab had the option to switch to the SC formulation. The primary endpoint of the study was progression free survival (PFS). The study was conducted in Europe under an agreement between Janssen, the European Myeloma Network (EMN) and Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON).

About AL AmyloidosisAmyloidosis is a disease that occurs when amyloid proteins, which are abnormal proteins, accumulate in tissues and organs. When the amyloid proteins cluster together, they form deposits that damage the tissues and organs. AL amyloidosis most frequently affects the heart, kidneys, liver, nervous system and digestive tract. There is currently no cure for AL amyloidosis or existing approved therapies for AL amyloidosis patients in Europe, though it can be treated with chemotherapy, dexamethasone, stem cell transplants and supportive therapies.1 It is estimated that in 2019 there were 4,388 diagnosed incident cases of AL amyloidosis in the five major European markets.2

About Multiple MyelomaMultiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.3 Approximately 18,114 new patients were diagnosed with multiple myeloma and approximately 11,063 people died from the disease in the Western Europe in 2020.4 Globally, it was estimated that 176,404 people were diagnosed and 117,077 died from the disease in 2020.5 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.6

About DARZALEX SC (daratumumab and hyaluronidase-fihj)Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. DARZALEX SC (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved in the Europe for the treatment of both multiple myeloma and AL amyloidosis. Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death). 7,8, 9, 10, 11

For the full EU Summary of Product Characteristics, please click here.

About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients with cancer. Founded in 1999, Genmab is the creator of multiple approved antibody therapeutics that are marketed by its partners. The company aims to create, develop and commercialize differentiated therapies by leveraging next-generation antibody technologies, expertise in antibody biology, translational research and data sciences and strategic partnerships. To create novel therapies, Genmab utilizes its next-generation antibody technologies, which are the result of its collaborative company culture and a deep passion for innovation. Genmabs proprietary pipeline consists of modified antibody candidates, including bispecific T-cell engagers and next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. The company is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com.

Contact:Marisol Peron, Senior Vice President, Global Investor Relations & CommunicationsT: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations: Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. DARZALEX is a trademark of Johnson & Johnson.

1 Mayo Clinic website: http://www.mayoclinic.com/health/amyloidosis/DS004312 Global Data, Amyloidosis: Epidemiology Forecast to 2029, June 20203 American Cancer Society. "What is Multiple Myeloma." Available at http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma.Accessed May 2021.4 Globocan 2020. Western Europe Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/populations/926-western-europe-fact-sheets.pdf Accessed May 20215 Globocan 2018. World Fact Sheet. Available at https://gco.iarc.fr/today/data/factsheets/cancers/35-Multiple-myeloma-fact-sheet.pdf Accessed May 20216 American Cancer Society. "Sings and Symptoms of Multiple Myeloma" https://www.cancer.org/cancer/multiple-myeloma/detection-diagnosis-staging/signs-symptoms.html. Accessed May 20217 DARZALEX Prescribing information, March 2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761036s033lbl.pdf Last accessed May 20218 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.9 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.10 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.11 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974

Company Announcement no. 53CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Genmab Announces that Janssen has Received European - GlobeNewswire

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(PDF) Testosterone Replacement Therapy Sales Market | Detailed Study by Stratagem Market Insights with Upcoming Trends The Manomet Current – The…

Posted: June 23, 2021 at 1:45 am

Testosterone Replacement Therapy SalesMarket Outlook 2021

Testosterone Replacement Therapy Salesmarket report is the major research for those who look for an entire analysis of markets. The report covers all information on the Global and regional markets, including old and future trends for market demand, size, trading, supply, competitors, prices, and globalpredominant vendors information. We have provided CAGR, value, volume, sales, production, revenue, and other estimations for the global as well as regional markets.

The market is designed to serve as a ready-to-use guide for developing accurate pandemic management programs allowing market players to successfully emerge from the crisis and retract numerous gains and profits. The SMI analyzes recent strategic activities, such as partnerships, acquisitions, mergers, collaborations, and joint ventures. The report analyzes the demographics, growth potential, and capability of the market through the forecast period 2021 to 2027. The players included in this report are chosen in terms of their product portfolio, market share, brand value, and the well-being of the organizations. Our report is based on current situations across the globe.

Top players listed in Testosterone Replacement Therapy Sales report:AbbVie, Endo International, Eli lilly, Pfizer, Actavis (Allergan), Bayer, Novartis, Teva, Mylan, Upsher-Smith, Ferring Pharmaceuticals, Kyowa Kirin, Acerus Pharmaceuticals

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The report forecasts revenue growth at all geographic levels and provides an in-depth analysis of the latest industry trends and development patterns from 2020 to 2027 in each of the segments and sub-segments.

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TheTestosterone Replacement Therapy Sales market research follows a four-step methodology: primary research, secondary research, market estimation, and final presentations. Data is collected through self-conducted research methods in the primary research, whereas in secondary research, data is collected from previously conducted studies.The market estimation involves data processed in primary and secondary research. The final step is a holistic representation of the data and analysis made to make the report highly comprehensible for the reader.

Impact of Covid-19: Since the COVID-19 virus outbreak in December 2019, the disease has spread to almost every country around the globe with the World Health Organization declaring it a public health emergency. The global impacts of the coronavirus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect this industry in 2021.

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A top doctor on the truth about hormone imbalances and how to tackle them – Tatler

Posted: June 23, 2021 at 1:45 am

Hormones are chemical messengers secreted by various glands in the body, and provide a delicate balance between metabolic functions. These include insulin, cortisol (steroid), adrenaline, thyroid, oestrogen/progesterone and testosterone, to name but a few. They are responsible for the body's core temperature, appetite/weight, reproductive cycle/libido, growth/development, sleep cycles, mood and stress levels. Any disruption can lead to key changes in many of the body's organs, leading to brain, skin, gut and cardiovascular symptoms.

Some sex hormone imbalances can quite literally change your persona, with levels of irritability, low mood and altered perception. This can happen for women in the menstrual cycle or menopause, and occasionally in men from the age of 40 onwards (but with more subtle effects).

There are many different treatments available, not all carry the health risks the media have portrayed, and to the contrary, may offer substantial benefits.

Male Hormone Replacement:

From the age of around 40, men's testosterone can reduce by two per cent every year. Over time, this may cross the threshold of deficiency, causing low mood, reduced libido and the redistribution of body fat/muscle, as well as diminishing bone density. However, there is still controversy over whether testosterone replacement therapy, on balance, provides more health benefits versus the risk of prostate/cardiac issues and blood clots, if it is not carefully monitored. A morning blood test (pre-10am) can help to identify your levels, and an endocrinologist should advise on supplementation. A better way to naturally provide more testosterone to the body, is through resistance training (a good personal trainer can help to avoid injury), good quality sleep, optimal weight and a healthy balanced diet (ensuring adequate nutritious vegetables, fats, protein, zinc, magnesium and vitamin D).

Female Hormone Replacement (HRT):

The menopause can happen early for some women, but most occur around the age of 50. The symptoms can vary widely and usually starts before the periods stop (peri-menopause), they can include: anxiety, mood swings, hair/skin issues, hot flushes and memory loss. It is often misdiagnosed as depression and incorrectly treated with antidepressants. Up to 75 per cent of women do not know enough about HRT to make an informed choice, and a review of the initial scaremongering studies have shown that used correctly, HRT can provide many benefits with very few risks. HRT has shown some reduction in Alzheimer dementia, diabetes, osteoporosis, heart attacks and bowel cancer. The oestrogen in HRT can also increase skin collagen and have anti-ageing properties. Obesity, alcohol and lack of exercise increases the risk of breast cancer considerably more than HRT.

The treatments are usually a combination of oestrogen and progesterone.

1. Synthetic HRT. It is regulated by the Medicines Authority (MHRA), is easy for compliance (a single oestrogen/progesterone tablet) and the risks of breast cancer and blood clots are very small if started around the time of menopause (50+) for seven to 10 years.2. 'Bio-identical' HRT. It is not regulated and despite being promoted as 'natural', it is not an exact science, has no safety/efficacy data and can be expensive, but is preferential to some patients.3. 'Body-identical' HRT. Consisting usually of an oestrogen patch and progesterone pill (surprisingly plant-based, derived from yams/soy). 'Body identical' HRT, is regulated by MHRA and has shown to be highly effective; it also significantly reduces the risks of blood clots and breast cancer seen with synthetic HRT.4. Natural options. Lifestyle changes through regular exercise, low alcohol, a Mediterranean diet, low refined carbs/sugar, vitamin D/calcium supplementation and quality sleep may all help to reduce the effects of menopause (but may only be modest). There are some 'natural' products which can be found in most chemists (eg black cohosh, red clover, gingko, St John's wort), but all have limited scope. Acupuncture and homeopathy has also been used, but with little evidence.

Some add-on treatments include: vaginal oestrogen creams and testosterone if libido or energy levels have not benefited from standard HRT (quite surprisingly, reproductive women produce four times more testosterone than oestrogen).

As you can see, it can be a complex area, even for many GPs. So you may want to see a GP or gynaecologist who has an interest in hormone replacement.

Dr Tim Lebens is a private GP in Central London, with a subspecialty in health optimisation and latest advances in medicine. You can follow him on Instagram @_modernmedicine

Although every effort has been made to ensure that all health advice is accurate and up to date, it is for information purposes only and should not replace a visit to your doctor or health care professional.

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Testosterone Replacement Therapy Market 2021-2026 Industry Size and Share, Recent Enhancements and Regional Analysis | Key Vendors: AbbVie, Teva,…

Posted: June 23, 2021 at 1:45 am

Reports Globe has added a new report entitled Global Testosterone Replacement Therapy Market which describes a systematic picture of the market and provides a detailed explanation of the various factors that are expected to drive market development. In addition, a comprehensive analysis and an in-depth study of the current state of the Testosterone Replacement Therapy industry is explained. The report serves as an expert and in-depth analysis of important business trends and future development opportunities in the market, important driving forces and constraints, profiles for important market players, market scenario, regional presence and development opportunities., Segmentation and forecasting. The global market analysis report provides a detailed overview of the product specification, product type, production analysis and technology, taking into account important factors such as revenue, cost and margin.

The Testosterone Replacement Therapy report provides significant information such as market growth including driving forces, constraints, lucrative opportunities, industry-specific challenges and recent challenges. The report also provides additional information such as interesting insights, important industry developments, detailed market segmentation, a list of key market players and other global trends for Testosterone Replacement Therapy.

The Testosterone Replacement Therapy market report includes endless knowledge and information about the market definition, classifications, applications and commitments and also explains the market drivers and limitations from the SWOT analysis. The Testosterone Replacement Therapy report delivers remarkable data along with future forecasts and comprehensive market analysis at the international and regional levels. The market report also provides a list of the largest competitors as well as strategic information and analysis of key factors affecting the Testosterone Replacement Therapy industry.

Get FREE Sample copy of this Report with Graphs and Charts at:https://reportsglobe.com/download-sample/?rid=108000

Top Key Players Profiled in this report are:

The report is an assortment of direct information, subjective and quantitative assessment by industry specialists, contributions from industry examiners and Testosterone Replacement Therapy industry members over the worth chain. The report offers a top to bottom investigation of parent market patterns, macroeconomic measures, and control components. Besides, the report likewise overviews the subjective effect of unmistakable market factors on Testosterone Replacement Therapy market sections and geologies.

Testosterone Replacement Therapy Market Segmentation:

Based on Type

Based on Application

Global Testosterone Replacement Therapy Market: Regional Segments

The different section on regional segmentation gives the regional aspects of the worldwide Testosterone Replacement Therapy market. This chapter describes the regulatory structure that is likely to impact the complete market. It highlights the political landscape in the market and predicts its influence on the Testosterone Replacement Therapy market globally.

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The Study Objectives are:

This report includes the estimation of market size for value (million USD) and volume (K Units). Both top-down and bottom-up approaches have been used to estimate and validate the market size of Testosterone Replacement Therapy market, to estimate the size of various other dependent submarkets in the overall market. Key players in the market have been identified through secondary research, and their market shares have been determined through primary and secondary research. All percentage shares, splits, and breakdowns have been determined using secondary sources and verified primary sources.

Some Major Points from Table of Contents:

Chapter 1. Research Methodology & Data Sources

Chapter 2. Executive Summary

Chapter 3. Testosterone Replacement Therapy Market: Industry Analysis

Chapter 4. Testosterone Replacement Therapy Market: Product Insights

Chapter 5. Testosterone Replacement Therapy Market: Application Insights

Chapter 6. Testosterone Replacement Therapy Market: Regional Insights

Chapter 7. Testosterone Replacement Therapy Market: Competitive Landscape

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