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Cell atlas helps better understand the biology of tropical disease parasite – News-Medical.net

The first cell atlas of an important life stage of Schistosoma mansoni, a parasitic worm that poses a risk to hundreds of millions of people each year, has been developed by researchers at the Wellcome Sanger Institute and their collaborators.

The study, published today (18 December 2020) in Nature Communications, identified 13 distinct cell types within the worm at the start of its development into a dangerous parasite, including new cell types in the nervous and muscular systems. The atlas provides an instruction manual for better understanding the biology of S. mansoni that will enable research into new vaccines and treatments.

S. mansoni has a complex life cycle that begins when larval forms of the parasite emerge from snails into rivers and lakes. These larvae then enter humans through the skin after contact with infested water. Once inside the body, the parasite begins what is known as the intra-mammalian stage of its life cycle, undergoing a series of developmental transitions as it matures to adulthood.

Adult worms live in human blood vessels and reproduce, releasing eggs that pass from the body into water to continue the life cycle. But some eggs remain trapped in the body, leading to the disease schistosomiasis.

Schistosomiasis is a debilitating long-term illness that can lead to the inability to work, organ damage and death. It affects hundreds of millions of people each year, primarily in sub-Saharan Africa, and is listed by the World Health Organization (WHO) as one of the most Neglected Tropical Diseases. Currently, only one drug is available to treat the disease, but this is inappropriate for use in very young children and there are fears that overreliance on a single treatment will allow the parasites to develop resistance to the drug.

Researchers have been looking at ways to find new drug targets, but until now there has been no high-resolution understanding of the parasite's biology.

This new study sought to map all of the cells in the first intra-mammalian stage of the parasite using single-cell technology, which identifies different cell types present in an organism or tissue.

The early-stage parasites were broken apart into individual cells that were characterized by single-cell RNA sequencing by scientists at the Wellcome Sanger Institute. The data were then analyzed to identify cell types according to the genes expressed by individual cells, and where in the body these cells were located.

The team identified 13 distinct cell types, including previously unknown cell types in the nervous system and parenchymal system. Individual fluorescent probes were made for genes specifically expressed by each cell type. Scientists at the Morgridge Institute for Research in the USA then used these probes to confirm the position of the discovered cells within whole parasites under the microscope.

Dr Carmen Diaz Soria, a first author of the study from the Wellcome Sanger Institute, said: "Though significant advances in our understanding of Schistosoma mansoni have been made in recent years, we have yet to identify targets leading to a viable vaccine. Single-cell RNA sequencing provides a whole new level of biological detail, including previously unidentified cell types, that will allow us to better understand each cell population in the parasite."

To identify new drug targets, researchers most often look for differences between a pathogen and its human host. However, S. mansoni is far closer to us in evolutionary terms than most major parasites, such as those that cause malaria. It is hoped that these findings will reveal areas of the parasite's genetic code that are sufficiently different from our own to be viable treatment targets.

Dr Jayhun Lee, a first author of the study from the Morgridge Institute for Research, Wisconsin USA, said: "We found genes in the muscular system of Schistosoma mansoni that might be specific to schistosomes. Because they are found in these parasites but not in humans, they are one possible treatment target identified by the study. The muscle allows the parasite to travel through our bodies, so if we were able to hinder that ability, we may be able to halt its life cycle before reproduction takes place."

The authors also shed light on the parenchymal tissue of S. mansoni, the 'filler' tissue that connects all the tissues of the parasite together. Previous studies had found it difficult to isolate parenchymal cells for analysis. The cell atlas found that some genes that are important for the parasite to digest food are also associated with the parenchymal tissue. Disrupting how the parasite feeds by targeting these cells could be another avenue for therapies.

Schistosomiasis is one of the most serious neglected parasitic diseases and gaining a deeper understanding of the parasite's biology will help to expose vulnerabilities that could one day be targeted by new treatments. We hope that this cell atlas for the first intra-mammalian stage of Schistosoma mansoni will provide researchers with valuable clues to help accelerate the development of new treatments and eliminate this parasite from the lives of hundreds of millions of affected people each year."

Dr Matt Berriman, Senior author, Wellcome Sanger Institute

Source:

Journal reference:

Soria, C.L.D., et al. (2020) Single-cell atlas of the first intra-mammalian developmental stage of the human parasite Schistosoma mansoni. Nature Communications. doi.org/10.1038/s41467-020-20092-5.

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Cell atlas helps better understand the biology of tropical disease parasite - News-Medical.net

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

DetailsCategory: DNA RNA and CellsPublished on Friday, 18 December 2020 13:05Hits: 137

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

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

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

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

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

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

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

Taking cellular immunotherapy to the next level

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

About Glycostem

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

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

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

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

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

About Ghent University

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

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

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

SOURCE: Glycostem

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

ONK Therapeutics Announces Three Exclusive Option License Agreements, Which Extend and Strengthen its Dual-Targeted NK Cell Therapy Pipeline | More…

DetailsCategory: More NewsPublished on Friday, 18 December 2020 12:27Hits: 159

GALWAY, Ireland, & SAN DIEGO, CA, USA I December 17, 2020 I ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that it has secured three new exclusive option license agreements which strengthen its off-the-shelf, dual-targeted natural killer (NK) cell therapy platform and extend its pre-clinical pipeline to four programs across both hematological and solid tumors.

The first option agreement, with Cellerant Therapeutics, gives exclusive rights to a humanized CLEC12A scFv binder. CLEC12A is strongly expressed by blasts in the majority of AML patients. The option to license has enabled ONK to expand its pre-clinical product portfolio, launching a fourth program (ONKT104). This dual-targeted approach combines the CLEC12A CAR with a TNF-related apoptosis-inducing ligand variant (TRAILv) targeting death receptor 4 (DR4).

While expressed on leukemic stem cells, CLEC12A is absent from normal hematopoietic stem cells and we thus expect that our dual-targeted NK cell therapy approach should enable safe targeting, with a reduced risk of prolonged aplasia in AML, said Prof Michael ODwyer MD, ONK Therapeutics co-founder, and CSO.

The second agreement in-licenses a humanized, tumor-specific antibody targeting an aberrantly glycosylated tumor-associated form of MUC1 (TA-MUC1) from Glycotope GmbH. Multiple solid tumor types express the mucin MUC1, including non-small cell lung cancer, breast cancer, and ovarian cancer. This antibody will be integrated into ONKs pre-clinical program ONKT103, for solid tumors.

Non-selective targeting of MUC1 could be problematic since the target is also expressed by healthy tissues, but ODwyer explains how ONKs dual-targeted approach can be used to address this. We have designed a CAR tailored to the glycosylation pattern distinct to tumor-associated MUC1 with specific recognition of the carbohydrate antigens Tn and T on MUC1, the expression of which is restricted to cancer cells. Glycotope has identified the glycosylation pattern as a way to unlock the potential of TA-MUC1 as a solid tumor target. ONK is thus set to bring the natural benefits of NK cells over T cells to bear on TA-MUC1, in a tumor-specific fashion, while also further boosting efficacy and countering resistance through the use of our TRAIL variant targeting DR5, he said.

ONKs unique platform approach combines the expression of a chimeric antigen receptor (CAR) and a high affinity, membrane-bound TRAILv. The incorporation of these two humanized scFvs has the potential to minimize the risk of immunogenicity in the allogeneic setting.

ONK is also exploring several innovative strategies to improve the homing of NK cells. This is an important consideration as ex-vivo expansion can lead to changes in chemokine receptor expression. Through this new license agreement with the NIH, ONK plans to enforce the expression of CCR7, which is downregulated on NK cell expansion. This may improve the homing of NK cells to lymph nodes and is expected to be particularly useful for ONKs off-the-shelf CD19 program targeting B cell lymphoma, ONKT101, which is partnered with Avectas.

ONK is making rapid progress since it announced its most recent financing in October. Chris Nowers, ex Kite Pharma Head of Europe, who joined at that time as Chief Executive Officer, said: The recent American Society of Hematology meeting highlighted the NK cell therapy area as offering great hope as the next generation of advanced cell therapies. We believe our best-in-class off-the-shelf, dual-targeted NK cell therapy platform has the potential to improve performance and overcome some of the shortcomings seen with earlier approaches. These new licensing activities strengthen and expand our programs and illustrate our ambition and strategy to become a leader in this exciting field.

The company recently expanded its operations into the USA, moving into JLABS @ San Diego, Johnson & Johnson Innovations flagship facility, at the heart of San Diegos precision medicine and cell therapy cluster. This represents a second facility that complements its main R&D team and operations in Galway, Ireland. The companys recruitment drive across both facilities has been rapid and the company continues to expand its capability in key areas, including NK cell biology, construct design, gene editing, and process development.

-Ends-

ONK Therapeutics http://www.onktherapeutics.com ONK Therapeutics Ltd is an innovative cell therapy company dedicated to developing the next generation of off-the-shelf, dual-targeted NK cell therapies targeting solid and hematological cancers.

The company was founded in 2015, by Prof. ODwyer MD, of NUI Galway, an expert in translational multiple myeloma research, the tumor microenvironment, and exploitation of NK cells as cellular immunotherapy. Its core proprietary platform is based on a dual-targeted NK cell expressing both a chimeric antigen receptor (CAR) targeting a known tumor antigen and a TNF-related apoptosis-inducing ligand variant (TRAILv) targeting the death receptor pathway (i.e. DR4 or DR5). This unique approach has the potential to enhance efficacy by addressing both intrinsic (e.g. CAR engagement of a tumor-specific antigen) and extrinsic (e.g. signaling through the death receptor pathway) apoptotic pathways and to reduce the susceptibility to possible target antigen escape through the engagement of tumor antigen-independent TRAILv.

Its pre-clinical pipeline comprises four programs;

In addition to the unique dual-targeted NK cell therapy platform, the company has a strong research focus on strategies to enhance homing and persistence, and overcome exhaustion, including the exploration of proprietary gene edits, such as the deletion of checkpoint inhibitory receptors in NK cells.

ONK Therapeutics is headquartered in the med-tech hub of Galway, Ireland, with a wholly-owned US subsidiary, ONK Therapeutics, Inc. based at JLabs @ San Diego. Shareholders include Acorn Bioventures, ALSHC (principally Seamus Mulligan), and Enterprise Ireland.

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About Avectas - http://www.avectas.com Avectas is a cell engineering technology business that has developed a unique delivery platform, Solupore to enable the ex vivo manufacture of cell therapy products, which have high in-vivo functionality.

Glycotope http://www.glycotope.com Glycotope is a biotechnology company utilizing a proprietary technology platform to develop highly tumor-specific monoclonal antibodies called GlycoBodies. GlycoBodies bind to targets (GlycoTargets) tumor-specific carbohydrate structure dependent, enabling the development of highly-specific immunotherapies across a broad range of cancer indications. Glycotope has to date discovered in excess of 150 GlycoTargets with GlycoBodies against eight of these targets currently under development.

Each GlycoBody can be developed in an array of modalities with different modes of action providing a unique offering in the (immuno) oncology space. Currently, six clinical and pre-clinical programs based on the GlycoBody technology are under development by Glycotope or its licensing partners.

SOURCE: ONK Therapeutics

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Op-ed: This Tampa ER doctor just got his COVID-19 vaccine and, when able, you should, too – Creative Loafing Tampa

C/O Jason Wilson, MD

By Jason Wilson, MD

Less than a year ago, I had no idea that a novel coronavirus had emerged.

Today, Ive taken care of hundreds of patients with that virus, redesigned an emergency department to safely care for patients with and without COVID-19, helped roll out 3D printed swabs to make up for a short supply of test kits, studied numerous potential viral therapeutics, found ways to virtually care for COVID-19 patients using wearable monitoring devices and telemedicine, and worked daily to show that data from our local community demonstrates that masks save lives and that we should stay out of crowded, indoor bars, restaurants and nightclubs when case numbers are high.

I can even hold my own speaking in R0 (pronounced R-naught) and exponential growth curves. Most stunningly thoughless than a year after the SARS-CoV-2 virus was genetically sequencedI have received my first dose of a COVID-19 mRNA vaccine. If given the chance, I think you should, too. Heres why.

Jason W. Wilson, MD is a clinical emergency medicine physician and critical medical anthropologist at Tampa General Hospital and the University of South Florida. Follow @tampaERdoc on Twitter.

Essential workers and vulnerable populations dont have the same option

The risk for who gets infected and who does not is partly structural and partly cultural (driven unnecessarily by heated political rhetoric and disinformation). Some people can stay at home, often struggling through web meetings, or with kids that have opted out of brick-and-mortar" for the year. Some of you have kidslike my 11-year-old currently playing Xboxon a mandatory two week quarantine after being exposed to another positive student.

Healthcare workers never could opt for safer at home, but have better access to PPE than other workers also deemed essential for service (some of whom are simultaneously deemed less essential for protection). Essential workers cannot choose to stay home. We need food and groceries, and incomes must be earned. Those essential workers are both at higher risk for contracting COVID-19, but also for transmitting the virus because of survival decisions that mean showing up to work even after exposure. Those same essential workers may also return to life in densely packed houses.A second relief packageespecially one that gives workers the tools (read: money) to stay home and not have to go out to earn a living to pay for food and rentwould help small business owners, workers and the unemployed make decisions that protect us all.

Vaccinations shouldnt be political

Equating mask requirements to an assault of freedoms, political rhetoric and disinformation are all weapons that could doom a large-scale rapid vaccine distribution campaign even before it ramps up. Couple that with more factorshistorical racism, trust of science, the vulnerability of undocumented residents, plus those weary of healthcare and Big Pharmaand you risk falling short on the herd immunity vaccines are supposed to help us reach so we get back our lives and stop this suffering.

In other words, while vaccine distribution may be political, we must ensure that vaccination remains medicine, allowing public health experts to speak loudest, tamping down on information that takes away from the clear message.

Almost everyone should get a COVID-19 vaccination

Almost everyone should get the vaccineunless you have had a significant allergic reaction to vaccines in the past. Eventually, there may be different vaccines best suited to different individuals, but right now mRNA-based vaccines are what is available and what I received. Some should get the vaccine before others (healthcare workers, long term care facility residents, EMS workers, teachers, and then older, more vulnerable people,further stratified by Centers for Disease Control and Prevention guidelines).

While there are still questions about how effective a vaccine will be for people who have weaker immune systems or take certain medications (chemotherapy, drugs like Humira, transplant meds, daily steroids), this does not mean that the vaccine is unsafe in people with weaker immune systems. It just means that the protection may not be as much given the lessened ability of immunosuppressed bodies to produce an immune response.

What about pregnant women and the COVID-19 vaccine?

We dont have a lot of data on pregnant and women who are breastfeeding since kids, pregnant,and lactating women are routinely excluded from clinical trials. However, the CDC and theAmerican College of Gynecology (ACOG)have both stated that the vaccine can be administered to pregnant and breastfeeding women and should be offered. If anything, an mRNA vaccine that leads to antibody production in a mom may convey benefit to an infant by passing antibodies through the placenta and breast milk.

What does an mRNA vaccine do?

There is a saying you learn in biology class: DNA makes RNA, and RNA makes protein. Hang with me for a second and lets do some quick Cell Bio 101.

A human cell has a nucleus inside of itlike the little rubber ball inside a baseball. That nucleus is where DNA lives. That DNAthe genetic sequence or genomeis constantly churning out a sorta mirror image middle step particle called RNA. That RNA is called mRNA (messenger RNA) because it acts as sort of a message with instructions telling the cell what to do next. The mRNA leaves the nucleus and hangs out in the celllike in the inside of the baseball, but not in the deep rubber part, just under the white leather surface.

What does mRNA do exactly? The millions of various mRNA sequences act as different instruction booklets for your cells to build all kinds of different proteinsproteins that move things around, attach to other things, make antibodies, pretty much all bodily functions.

Turns out, the surface of the coronavirus has an important protein on it called the spike protein. That spike protein is responsible for all this damage because it works by attaching the virus to human cells, allowing the virus to enter the cell, camp out and steal your cells tools to make copies of coronavirus. Spike proteins have become the major target of most of our therapies as well. The monoclonal antibody infusions people receive right now are synthetic versions of antibodies that attack spike protein.

The mRNA vaccine has the instructions to make its own spike protein to help your body mount an immune response should the coronavirus spike protein enter your system . Thats itthere are no viral particles in the vaccine, period.

What happened in the Pfizer-BioNtech vaccinestudy?

Phase three clinical trials are the big studies that directly test a new drug against a placebo or an existing treatment. On Dec. 10, the phase three study for the Pfizer vaccine was published in the New England Journal of Medicine. The major takeaway is that over 21,000 people received the vaccine and about the same number received placebo. The trial didnt examine whether a person gets COVID-19 or not, but whether a person gets sick from COVID-19 (this is why we still need to wear masks for now, even if were vaccinated). Instead, participants were followed after receiving the vaccine and were tested for coronavirus if they had COVID-19 symptoms. The mRNA technology alone was a moon-level landing breakthrough, but the results themselves matched the rigorous scientific awe! In the placebo groupthe group of people who did not get the vaccine169 people got sick with COVID-19. Among those who received the vaccine, only nine people developed COVID-19 symptoms and a positive test. In laymans terms, this means the vaccine was 95% effective in the phase three trial.

But it gets better.

Of those in the trial who had severe COVID-19requiring hospitalization, ICU level care and oxygen support, aka the really sick peoplenine were in the placebo group and only one was in the vaccine arm. Clearly, this vaccine prevents people from getting sick from COVID-19. Data released for the Moderna vaccine looks similar. And since the mRNA vaccines do such a good job of preventing symptomatic COVID-19, even those whove already had COVID-19 should be vaccinated.

C/O Jason Wilson, MD

You dont need to get tested before getting the vaccine

And, yes, getting the vaccine is definitely better than getting COVID-19 in order to obtain immunity. Having COVID-19 can not only make you very sickit also makes you very infectious.

Myth busting

How about the dangers of a new technology? Certainly, there are side effects? A few internet myths say the mRNA becomes part of your genome, or that the mRNA causes infertility (some healthcare workers who are often women of child-bearing age often fall prey to the latter).

Let me say this for the people in the back: The mRNA in this vaccine wont become part of your genome.

Remember, the mRNA is outside the cell nucleus (the inner rubber part of the baseball where the sausage making of DNA takes place). But what about all of these cells floating around with spike protein? How long will you be making this spike protein? Well, it turns out that eventually your very own cells that are making spike protein are also signing their own death warrants because that very spike protein will lead your body to come hunting for those cells as well when seeking out COVID-19 virus to destroy. In short, you wont be churning out weird spike protein cells or keeping spike protein instructions around forever (this is why we still dont know if the built in memory immunity your body gains will be enough to forgo future vaccine doses).

Let me also say this for the people in the back: The Covid Vaccine does NOT cause infertility!

I try not to engage too much in dispelling BS (because you just end up with more mounds of BS), but the nonsense that this vaccine can cause infertility must be shut down now before the rabbit hole continues to grow wider. This is an especially harmful form of disinformation because there are so many women of reproductive age on the frontlines who need this vaccine. The logic of the nonsense goes like this: A former Pfizer employee (who last worked there in 2011, but not on vaccines) notes that spike protein has some similar mRNA sequences with a broader group of proteins that support cell adherence (the process by which cells form contacts with each other). One of those similar proteins is found in humans and promotes placental growth.

Keep following me.

The logic behind the nonsense then says that since the mRNA sequences have similarities, the mRNA vaccine will cause infertility. Idaho is a state and New York is a state, so, they are basically the same, right? Wrong.

That nonsensical line of thinking falls apart pretty quickly and most easily by looking at reality. There have been millions of cases of COVID-19, but no corresponding infertility epidemic in the real world. Digging into the weeds a little more, the noted similarities are not in the area of the protein where our antibodies will attack.Myth busted!

What about side effects and the general safety of the mRNA vaccine?

As I sit here writing after my first dose, I am already developing some protectionand a little arm sorenessagainst COVID-19, and that protection will soar after I receive the second dose in 21 days (its 50% effective after dose one and 95% effective after the second dose administered 21 days later).

Seriously, am I going to grow a third eye?

What are the adverse effects, the bad things that happen? Two heads, extra arms, purple toes? The vaccine has not been around for long, and we should certainly monitor any development of downstream inflammatory mediated effects, no matter how unlikely.

OK, so tell me about side effects again.

Lets turn to the data we haveand some personal experience.

Side effects are mostly benign and seem more likely to occur after the second dose when the body is more primed to mount an inflammatory response. In fact, healthcare professionals may stagger second doses among our workforce in anticipation of some fatigue and, less commonly, low grade fevers after the injection.

On the day after I received my first dose, it felt like I got punched in the arm. In a completely unscientific poll conducted by a colleague of the other docs who received the vaccine with me, three of us had arm soreness, two docs felt completely fine and one, who had COVID-19 previously, developed some pain, skin sensitivity and a headache at the 24 hour mark48 hours later, all symptoms have resolved.

Thats it.

I had no redness, no fever, no nausea, nothing else. Like me, most people (84%, data says) will report some pain at the injection site while only about one in 20 will have any redness or swelling. One in six people may have a low-grade fever after the second dose while half feel a little tired. Symptoms like diarrhea and vomiting occurred about the same amount in the vaccine and placebo arm (about one in 50 people).

What about the more serious side effects?

A handful of medical problemsheart attacks, strokes, hospitalizationsthat occurred in the study are expected when you follow a lot of people that are older than 55 around for a few months. Its important to note that there were not any differences between the vaccine and placebo groups.

There have been a few (three as of this writing) severe allergic reactions (probably from polyethylene glycol). In at least two of those people from the U.K., each had a previous severe allergic reaction. One woman in Alaska who had an immediate reaction after receiving the vaccine had no prior allergic reactions, but remarked that very day she was still glad she got the vaccine and recommended it to others! With the whole world watching and documenting, most side effects are going to come to light and for a new vaccine moving to the arms of thousands and thousands of people, this small number of allergic reactions helps reaffirm the safety data. Per the FDA guidelines, after receiving the vaccine, all patients are monitored for 15 minutes (TGH hands out timers and lets people wait in a socially distanced space) and those with known prior allergic reactions are monitored even longer.

Does the COVID-19 vaccine cause Bellspalsy?

Bells palsy is a neurological condition that, oddly, paralyzes half of the face but usually resolves. Not surprisingly, internet myth makers have picked up on four cases of Bells palsy that occurred in the vaccine group of the Pfizer study, claiming that the COVID-19 vaccine causes Bells palsybut there is no evidence for this. There were 21,000 people in the phase three Pfizer study who got the vaccine. Bells Palsy occurs normallyon its own in about 25 out of 100,000 peoplemeaning we expected there to be five cases of Bells palsy in the vaccine group. Certainly we can ensure that this math stays true, but, for now, thats another myth debunked.

Minority enrollment, trust and transparency

Minority enrollment was an important part of the vaccine study10% of participants were African-American and 26% were Hispanic/Latino. In addition, the first person to receive the Pfizer vaccine after the FDAs emergency use authorization was a Black nurse in New York City, Sandra Lindsay. With the atrocities of Tuskegee and the horrible record of gynecological experimentation on enslaved Black bodies still in the rearview mirror, this representation of people of color is important. But will that be enough to gain trust in the vaccine?

Florida Shotsa free, statewide, centralized online immunization information systemwill help monitor who has been vaccinated. Monitoring vaccination information and linking names and personal information creates worries that undocumented people may be scared away because theyre willing to take the risks of COVID-19 and transmission to family over the fear of deportation.

There are no easy answers to the long history of exploitation against those with less power than governments and corporate conglomerates. Recognizing these issues and attempting transparency is a start. Disinformation and histories of structural violence are complicated.

Again, you should definitely get vaccinated if you have the chance

In sum, the message around COVID-19 vaccination can remain simple, persistent and consistent. The best available data demonstrates that mRNA COVID-19 vaccines from Pfizer (and Moderna) are safe and effective. Almost everyone should plan to take some version of the COVID-19 vaccine when the time comes for you to choose. If you are not in the first wave groupthose getting vaccinated before Jan. 1go get your flu shot right now and help prevent a twindemic. We dont need a flu surge on top of this ongoing COVID-19 surge.

Plan for two doses of the Pfizer-BioNtech vaccine (21 days apart) or the Moderna vaccine (28 days apart) and get the same brand of vaccine at dose one and dose two. Keep wearing your mask, keep maintaining social distance and avoid crowded indoor spaces. Help your healthcare workers help you and help this society get past a horrible pandemic.There will likely be no cost to anyone receiving the vaccine for the foreseeable future.

We will struggle with the disinformation if we do not start battling back with the set of facts that arise from reality. Disinformation drives fear and fear leads to the symbolic transformation and heated rhetoric we have witnessed among masks. Vaccines cannot become the new mask!

Support local journalism in these crazy days. Our small but mighty team is working tirelessly to bring you up to the minute news on how Coronavirus is affecting Tampa and surrounding areas. Please consider making a one time or monthly donation to help support our staff. Every little bit helps.

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Op-ed: This Tampa ER doctor just got his COVID-19 vaccine and, when able, you should, too - Creative Loafing Tampa

Canadian company Inagene Diagnostics launches the other test you need to take to protect your health in case of COVID – GlobeNewswire

TORONTO, Dec. 17, 2020 (GLOBE NEWSWIRE) -- As we head into the winter months, Canadians are doing everything they can protect themselves from the risk of getting sick. It turns out that if you DO find yourself in hospital, you may face a different set of risks the risk of receiving the wrong medication based on your genetics. Now, a new test can help.

Genetic variations that affect how individuals respond to medications are not uncommon, according to Dr. Kathy Siminovitch Chief Scientific Advisor to Inagene Diagnostics; More than 98% of us unknowingly carries gene variants that will cause us to have an unexpected reaction to one or more commonly used drugs, either a lack of, or reduced clinical effect, or worse - unexpected, potentially serious side effects. Finding the best treatments and doses for every individual is a challenging process that can be greatly facilitated by incorporating genetic information so as to achieve the best possible outcome.

Now a new innovation called pharmacogenetic testing promises to significantly reduce the time and risk involved in finding the right drug and dose through medication trial and error. Inagene has introduced a simple cheek swab test that helps doctors predict how individuals will respond to commonly used drugs before they are administered. The test is ordered online and done at home, with results ready to share with prescribers within 7 days.

A recent study confirmed that 90% of patients hospitalized with COVID-19 end up receiving at least one medication that is affected by pharmacogenetics, and almost a quarter receive four or more. Because very ill patients cannot afford treatment failure or adverse effects, quickly finding the most effective and safe treatments and doses is critical. The authors concluded that having pharmacogenetic test results to guide treatment would have provided the opportunity to improve clinical care for nearly all individuals hospitalized with COVID19 by helping to guide clinicians to the most optimal drugs and doses, while avoiding the rest.

Inagene Diagnostics Inc. is a CLIA accredited Canadian pharmacogenetic testing company located in Toronto. Inagenes Personalized Insights tests focus on providing comprehensive and reliable genetic tests to guide drug section and treatment. Learn more at inagene.com.

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For all inquiries contact:

Nancy White

CEO Inagene Diagnostics Inc.

customerservice@inagene.com

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Canadian company Inagene Diagnostics launches the other test you need to take to protect your health in case of COVID - GlobeNewswire

Garcia to head Department of Biochemistry and Molecular Biophysics – Washington University School of Medicine in St. Louis

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Renowned biochemist known for contributions to field of epigenetics

Benjamin Garcia, PhD, has been named head of the Department of Biochemistry and Molecular Biophysics at Washington University School of Medicine in St. Louis. His appointment is scheduled to begin July 1.

Benjamin A. Garcia, PhD, a noted leader in the field of biochemistry, especially for his work advancing mass spectrometry techniques, has been named head of the Department of Biochemistry and Molecular Biophysics at Washington University School of Medicine in St. Louis. Garcia, whose appointment tentatively is set to begin July 1, also will become the Raymond H. Wittcoff Distinguished Professor.

The schools Department of Biochemistry and Molecular Biophysics has an illustrious history as home to some of the nations most distinguished scientists, including scientific innovator Roy Vagelos, who headed the department then called the Department of Biological Chemistry from 1966-75 and went on to lead the development of cholesterol-lowering statin drugs at Merck; and Nobel laureates Carl Cori and Gerty Cori, known for their work showing how muscles manufacture and store energy. Understanding this process shed light on treatments for diabetes.

Garcia comes to Washington University from the University of Pennsylvania Perelman School of Medicine, where he is the John McCrea Dickson, MD, Presidential Professor in the Department of Biochemistry and Biophysics, and director of quantitative proteomics.

Dr. Garcia was selected from an impressive pool of candidates and was unanimously endorsed as the most exceptional person to launch the next era of advancing knowledge and discovery in this vitally important department, said David H. Perlmutter, MD, executive vice chancellor for medical affairs, the George and Carol Bauer Dean of the School of Medicine, and the Spencer T. and Ann W. Olin Distinguished Professor. We found ourselves energized by his vision for the department to continue to be at the forefront of the field and to leverage the breadth of collaborative opportunities within our biomedical research community. His personal research program, in proteomic analysis of epigenetic regulation, supports our long-term strategic institutional goal to transition our leadership in genomics into multi-omic systems medicine, which will serve as an engine producing the most imaginative approaches to personalized health care.

Garcias research has focused on developing new and advanced methods for using mass spectrometry and to analyze proteins called histones that help regulate DNA. Such analyses can shed light on basic biology and disease processes. His methods have revolutionized analysis of the proteins and genetics of cells from animal models and human samples. The research has led to important observations about the regulation of cell differentiation, growth of tissues, and the development of cancer. He has developed an extensive research network that has been supported by the National Institutes of Health (NIH) throughout his career. He is active in partnerships with industry, previously establishing a technology alliance partnership with Thermo-Fisher to develop advanced mass spectrometry instruments and methods.

After earning a bachelors degree from the University of California, Davis, Garcia pursued a doctorate in chemistry at the University of Virginia, where he had a specific interest in developing expertise in mass spectrometry, a technique used to analyze the sequence and composition of compounds and molecules, such as DNA. He continued his training with a postdoctoral fellowship at the University of Illinois, Urbana-Champaign. In 2008, he joined the faculty of Princeton University in the Department of Molecular Biology and was later recruited to the University of Pennsylvania School of Medicine in 2012.

Garcia also is known for his dedication to teaching, mentorship and increasing diversity in scientific research circles. He serves as vice chair for the biochemistry and molecular biophysics graduate program at Penn, a role that includes leadership in recruitment, outreach and promotion of diversity within the department. He also serves as chair of the University Council for Diversity and Equity at Penn and has developed strategies for attracting and supporting minority students into successful careers in science.

Garcia has been recognized for his research contributions with several honors including the NIH Innovator Award, the Presidential Early Career Award for Scientists and Engineers, the American Chemical Society Arthur F. Findeis Award, the Protein Societys Protein Science Young Investigator Award, the Human Proteome Organization Discovery in Proteomic Sciences Award and the prestigious American Society for Mass Spectrometry Biemann Medal, among numerous others.

He serves on the editorial boards of Molecular Omics, and the Journal of Proteome Research, and Molecular &Cellular Proteomics, and was formerly associate editor of BMC Genomics. He also served as chair of the Enabling Bioanalytical and Imaging Technology study section of the NIH and has served in other important national scientific leadership positions, including with the National Science Foundation Biological Science Advisory Committee, governing council for the World Human Proteome Organization, and board of directors for the U.S. Human Proteome Organization.

After leading the department for the past seven years, John A. Cooper, PhD, a professor of biochemistry & molecular biophysics, will step down from his position to focus on his laboratory research program.

We thank John Cooper for his exceptional, gracious and selfless leadership over the last seven years and through the remaining months of the coming academic year, Perlmutter said.

Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

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Garcia to head Department of Biochemistry and Molecular Biophysics - Washington University School of Medicine in St. Louis

Cardiovascular Testing Applications of Biochemistry – News-Medical.net

Tests that look at changes in biochemistry have an important application in medicine, including point-of-care cardiac testing and monitoring heart failure. Biochemical tests can also be used to determine if an individual is at risk of certain diseases, including cardiovascular disease.

Image Credit: Rattiya Thongdumhyu / Shutterstock.com

Acute myocardial infarction, where the blood supply to cardiac myocytes is compromised leading to cardiac myocyte death, is an important disease that results in morbidity and mortality across the world. Despite this, it is a condition that is often misdiagnosed, leading to either unnecessary death or inappropriate hospitalization. Therefore, it is important to establish a quick, reliable test that can accurately diagnose patients.

Currently, the diagnosis of myocardial infarction is typically achieved through the presence of symptoms such as chest pains and the use of ECG and cardiac troponin assay, which look for damage to the heart muscle. While cardiac troponin assay is a good biochemical test, it is thought that there is a delay in the increase of circulating cardiac troponins of around 3-4 hours.

This means that to ensure accurate diagnoses, this test needs to be repeated multiple times over 6-12 hours, which impacts how quickly treatment can be started. High-sensitivity cardiac troponin testing has become available, but an unexpected result of this was the discovery of other cardiac conditions.

Researchers have, therefore, been investigating other molecules that could potentially be used as a diagnostic test for acute myocardial infarction. One potential candidate for such a biochemical test is a heart-type fatty acid-binding protein (H-FABP). H-FABP is a small protein that is found in cardiac myocytes, and its small size and solubility mean that it is released faster from the cardiac myocytes compared to cardiac troponins.

Xu and co. carried out a meta-analysis investigating whether H-FABP is a good biomarker that can be used in a biochemical test for early diagnosis of acute myocardial infarction. Here, the authors looked at the results from 22 studies, which included a cumulative total of 6602 patients. The authors concluded that H-FABP testing is moderately accurate at diagnosing acute myocardial infarction between 3-6 hours after the onset of symptoms. However, when used in conjunction with high-sensitivity cardiac troponin testing, the sensitivity of the diagnostic testing was improved.

Heart failure is when the heart stops functioning effectively, leading to symptoms such as shortness of breath and fatigue. A biochemical test looking at the levels of B-type natriuretic peptide (BNP) has been used to diagnose and monitor patients with heart failure.

BNP is a peptide hormone, whose functions include vasodilation and smooth muscle relaxation. While BNP testing cannot replace a full assessment, it is a useful addition to diagnostic testing, in particular, to rule out heart failure in patients with symptoms such as breathlessness.

Oxytocin is a hormone that has various functions mainly related to fertility, such as the development of gonads and promoting romantic and parental behaviors, but studies have also noted that oxytocin also affects cardiometabolic function and is involved in stress-related disorders. Due to this, there is interest in developing a biochemical test to measure levels of oxytocin.

Various testing methods have been applied, but the most common are immunoassays; this group of biochemical tests includes enzyme-linked immunosorbent assays (ELISA). These tests have been performed on various starting materials, including serum, plasma, and saliva. However, currently, these are not fully validated and there are no standards available for these tests to become routine clinical biochemistry testing.

Apolipoproteins are an important part of lipoprotein metabolism, and they also act as templates for lipoprotein synthesis as well as aiding the maintenance of lipoprotein structure. Lipoproteins are involved in transporting triglycerides to different organs, maintaining extracellular cholesterol levels, and reverse cholesterol transport.

Abnormal lipoprotein metabolism has been linked to atherogenesis, obesity, insulin resistance, and diabetes. As such, studies have investigated whether testing for lipoproteins and apolipoproteins can be used to determine dyslipidemia and cardiovascular risk.

Two apolipoproteins, apolipoprotein A (apoA) and apolipoprotein B (apoB) are associated with cardiovascular risk; apoA is inversely linked, while apoB is positively linked to cardiovascular risk. Therefore, a biochemical test that looks at the levels or ratios of these apolipoproteins has the potential to be used to determine cardiovascular risk.

Various studies investigated this potential and found that testing for apoB or apoA levels, or their ratio, could be a better marker for cardiovascular risk than other markers such as total cholesterol. This includes one study on 175,553 individuals who were followed for 65 months which showed an increase in relative risk of fatal myocardial infarction with an increase in apoB concentration.

Another study involving around 27,000 participants showed that an increase in the ratio of apoA and apoB was linked to myocardial infarction.

Yang, Z. and Zhou, D. M. (2006) Cardiac markers and their point-of-care testing for diagnosis of acute myocardial infarction Clinical Biochemistry https://doi.org/10.1016/j.clinbiochem.2006.05.011

Xu, L-Q. et al. (2018) Early Diagnostic Performance of Heart-Type Fatty Acid Binding Protein in Suspected Acute Myocardial Infarction: Evidence From a Meta-Analysis of Contemporary Studies Heart, Lung and Circulation https://doi.org/10.1016/j.hlc.2017.03.165

bhf.org.uk Heart Failure

Cowie, M. R. et al. (2003) Clinical applications of B-type natriuretic peptide (BNP) testing European Heart Journal https://doi.org/10.1016/S0195-668X(03)00476-7

Gruson, D. (2018) Oxytocin testing and reproductive health: Status and clinical applications Clinical Biochemistry https://doi.org/10.1016/j.clinbiochem.2018.10.016

Dominiczak, M. H. and Caslake, M. J. (2011) Apolipoproteins: metabolic role and clinical biochemistry applications Annals of Clinical Biochemistry: International Journal of Laboratory Medicine https://doi.org/10.1258/acb.2011.011111

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Cardiovascular Testing Applications of Biochemistry - News-Medical.net

Automated Biochemistry Analyzers Market by Manufacturers, Regions, Type and Application, Forecast To 2026 Abbott, Danaher, Hitachi, Roche, Siemens -…

The Global Automated Biochemistry Analyzers Market Status and Trend Analysis 2017-2026 (COVID-19 Version) 2020-2026 report is one of the most comprehensive and important data about business strategies, qualitative and quantitative analysis of Global Market. Automated Biochemistry Analyzers Market research report offers extensive research and analysis of key aspects of the global Automated Biochemistry Analyzers market. The report provides deeper understanding of the competitive landscape and its future scenarios, crucial dynamics, and leading segments of the global Automated Biochemistry Analyzers market. The report also provides accurate PESTLE, SWOT and other types of analysis on the global Automated Biochemistry Analyzers market. The market study has examined the competitive trend apart from offering valuable insights to clients as well as industries. This report concentrate on the global Automated Biochemistry Analyzers status, future forecast, development opportunity, key market and key players.

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Automated Biochemistry Analyzers Market by Manufacturers, Regions, Type and Application, Forecast To 2026 Abbott, Danaher, Hitachi, Roche, Siemens -...

Global Biochemistry Analyzing Systems Market 2020 Technological Strategies, Business Advancements and Top-Vendor Landscape by 2025 – BAVIATION…

A recent market study published by MarketandResearch.biz with the title Global Biochemistry Analyzing Systems Market Growth 2020-2025 is an expert and top to bottom investigation of the market condition with an attention on the market. The report conducts thorough research on the historical, as well as current growth parameters of the market, the growth prospects of the market, are obtained with maximum precision. The report covers key insights available status of the producers and is an important source of direction and course for organizations and people keen on the business. By and large, the report gives an inside and out understanding of the 2020-2025 worldwide market covering extremely significant parameters. The market is segmented in detail to cover every aspect of the market and present complete market intelligence to readers.

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Digital Therapeutics Startup S-Alpha Therapeutics Raises $2.7M in Seed Funding – BioSpace

Dec. 16, 2020 17:00 UTC

SEOUL--(BUSINESS WIRE)-- On November 20th, S-Alpha Therapeutics (S-Alpha Seung Eun Choi, CEO), a digital therapeutics startup, completed a $2.7 Million USD (3 Billion KRW) seed round of funding from Hana Ventures, STIC Ventures, AJU IB Investment, SJ Investment Partners, and TONY Investment. This seed round follows an initial strategic investment from LegoChem Biosciences in February 2020.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201216005185/en/

S-Alpha Therapeutics completed a $2.7 Million USD (3 Billion KRW) seed round of funding from Hana Ventures, STIC Ventures, AJU IB Investment, SJ Investment Partners, and TONY Investment. (Photo: Business Wire)

Hana Ventures led the seed round funding with the expectation of high growth in the digital therapeutics market. The company intends to use funds to execute clinical trials in the US to study their development stage digital therapeutic application intended to treat eye disease.

Dr. Myung Joon Kim, Chief Medical Officer at S-Alpha, leading the team to secure proprietary technologies for the discovery and development of the pipeline and internalization of the technology, commented, The fact that S-Alpha consists of specialists from various areas including domestic and international clinical experts, biochemistry experts, and software application development experts, collaborating to develop digital therapeutics was highly valued by the investors. S-Alpha will continue its effort to develop cutting-edge digital therapeutics in several disease areas.

About S-Alpha Therapeutics, Inc.

S-Alpha Therapeutics Inc., established in July 2019, is a digital therapeutics company with platform technologies that enable digital devices to treat different diseases. S-Alpha has a pipeline of products in the areas of ophthalmology, neuropsychiatry, cancer, and immunology.

S-Alphas lead product, SAT-001, is currently in the process of regulatory submission to start clinical studies in Korea as a therapeutic device for treating eye disease following MFDSs guidance in June 2020. S-Alpha also completed a successful meeting in July 2020 with the USFDA on developing SAT-001 and is preparing to launch clinical studies in the United States. S-Alpha has an extensive product pipeline and collaborates actively with academic and industry partners to develop their R&D programs.

S-Alpha actively engages with the global digital therapeutics community and presented at the Digital Therapeutics East Conference (DTx East 2020) in September 2020 as the first Korean company to be invited to the conference.

S-Alpha is also a member of DTA (DTx Alliance), a non-profit trade association of industry leaders and stakeholders engaged in the evidence-driven advancement of digital therapeutics.

http://www.salphadtx.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20201216005185/en/

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Digital Therapeutics Startup S-Alpha Therapeutics Raises $2.7M in Seed Funding - BioSpace