Category Archives: Maryland Stem Cells

A woman whose body keeps rejecting her fetus after a few months of pregnancy. A man who, certain at 18 that he needs a vasectomy, suddenly finds in his late 40s that he wants children, but his vasectomy reversal fails. Thus opens The Genesis Machine, with the stories of its two authors.

Its an enticing opening to a fascinating book by quantitative futurist Amy Webb and microbiologist Andrew Hessel, but also a bit of a red herring. Hessel and his wife solved their problem through in vitro fertilization, Webb and her husband theirs through genetic testing and ovulation induction agents. Neither author needed synthetic biology, the field that has sprung up around CRISPR, the DNA-editing machine.

The Genesis Machine

Nevertheless, Webb and Hessel skilfully detail the history, endless possibilities and many upsides of synthetic biology. Via in vitro gametogenesis, same-sex couples will soon be able to have babies bearing their own genetic material, without requiring donors. Wheat DNA has already been edited to produce more fibre, tomatoes to require less water and sunlight. Using stem cells, biologists are already developing protein that is, at a molecular level, actual beef. No cows necessary. No cattle blowing their greenhouse gases into the atmosphere.

Synthetic biology has recently had signal success in Modernas development of mRNA COVID-19 vaccines. Despite anti-vaxxer conspiracy theories, these vaccines are even less dangerous than conventional vaccines.

When the pandemic first hit, Dr. Zhang Yongzhens team in Shanghai decoded the COVID-19 genome in 40 hours and, thankfully, published it to GenBank shortly thereafter, paving the road to several vaccines. Nowadays you can buy a sequencing machine for the price of an iPhone. Pharmaceutical companies are developing mRNA vaccines for malaria and other diseases. At the same time, university researchers are working on editing the genetic structure of the mouths of malaria-carrying mosquitos to make them incapable of biting and, thus, of laying their eggs.

Supplied photo

Authors Amy Webb and Andrew Hessel

Other advances, such as plastic trees whose leaves sequester far more C02 than real trees do, may be far less beneficial than claimed, because Webb and Hessel ignore the exorbitant cost of materials and production.

Older stories of synthetic insulin lead into the contemporary adventures of synthetic biology entrepreneur Craig Venter. Particularly interesting is the account of He Jiankui who, without getting Chinese governmental permission, edited a pair of human twin embryos (hoping to make them immune to AIDS), leading to live births. In 2019, he was sentenced to three years in prison.

Mark Teske / The Associated Press files

Members of the surgical team perform the transplant of a pig heart into patient David Bennett in Baltimore, MD in January 2022. Bennett died in early March.

Despite how the authors baby quests rig the deck emotionally in favour of synthetic biology, the late-arriving Nine Risks chapter offers readers a choice of nightmares. Worried about deepfakes worming their way into the public record and falsifying it? How about augmented viruses leaving the lab and worming their way into your body?

Or how about a near future in which the Haves all have enough genetic enhancements to make the Have-nots nostalgic for their present poverty? Upgrade your children before birth! Certainly, it makes sense to edit out sickle-cell anemia, but it would take a very self-controlled genie not to agree to splice superior looks, athletic ability and intelligence into a customers childrens DNA. Chinas BGI group is already touting IQ boosts.

The EU and a number of countries have legislated against germline engineering, but that was before CRISPR, and that number doesnt include the synthetic biology leaders: China and the U.S. Harvards George Church, who wants to create a mostly woolly mammoth by splicing preserved mammoth DNA with Asian elephants, has also declared an interest in splicing Neanderthal DNA into contemporary humans, and perhaps cloning a Neanderthal. But we really have no idea what will happen when genetically engineered organisms outcross with other organisms in the wild, also known as the world.

Towards the end of The Genesis Machine, Webb and Hessel present some futuristic scenarios: for example, the pamphlet Creating Your Child with Wellspring. Such flourishes might work well for business visioning retreats, but the results in print are weak. Webb and Hessel would be better off staying with the science and leaving fictionalizations of synthetic biology to Richard Powers Generosity (2009) or Margaret Atwoods MaddAddam trilogy (2003-13).

Too recent to have made it into The Genesis Machine is the attempt at the University of Maryland Medical Center to implant a gene-edited pig heart into a human, but Webb and Hessel do mention that Chinese scientists are developing super-pigs that are more virus-resistant, stronger and quicker to mature than the present models. Are we closing in on Atwoods 2003 fictional pigoons pigs spliced with human neocortical tissue?

Life is becoming programmable, say Webb and Hessel. Imagine a synthetic biology app store

Reinhold Kramer is a Brandon University English professor. His most recent book is Are We Postmodern Yet? And Were We Ever?

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Synthetic biology's past, present and future explored in timely new account - Winnipeg Free Press

In the last two years, the US National Institutes of Health (NIH) has invested nearly$29 million to breed more monkeys for biomedical research, with an additional $7.5 million to be spent by October. The investments, which include infrastructure improvements at the US National Primate Research Centers (NPRCs), have been made in the wake of the COVID-19 pandemic, as researchers have been testing numerous vaccines on non-human primates, most commonly rhesus macaques (Macaca mulatta)a species of Old World monkey commonly used to study infectious diseasesbefore human trials began.

Using the pandemic as the pretext, the Biden administration hasproposedusing even more taxpayer money to conduct primate research, suggesting a 27% funding increase for the NPRCs in its fiscal year 2022 budget request. If Congress gives the administration its stamp of approval, an additional $30 million would be given to the centres.

We have been making investments to bring the levels up and to plan for the future, James Anderson, director of the NIH Division of Program Coordination, Planning, and Strategic Initiatives in Bethesda, Maryland,toldNature. What happens if [a pandemic] happens again, with another virus in three years? We want to be ready for that.

A couple of years ago, we were feeling the pinch, Nancy Haigwood, director of the NPRC in Beaverton, Oregon,toldNature. Citing the pandemic, Haigwood said, we are truly out of animals, thoughNaturereports that the centre she runs houses some 5,000 primates.

Animal rights advocates are rebuffing the proposed increase in funding, which would subject many more animals to cruel and deadly experiments.

In an email to Earth | Food | Life, Barbara Stagno, president and executive director ofCitizens for Alternatives to Animal Research and Experimentation(CAARE), an animal rights non-profit organisation based in New York, countered the claim that there is a dearth in primates for research. The group has launched apublic petitionurging Congress to reject the additional funding for primate research.

While the centres are claiming that there are not enough primates to conduct research, Stagno presented figures from the US Department of Agriculture showing that the opposite is true. In 2019 there were40,269monkeys held on reserve, in addition to the68,257monkeys subjected to experiments, said Stagno. Not only were over 40,000 monkeys warehoused on hold for use in experiments, but that number is a 14 percent increase from 2018, clearly demonstrating a growing surplusnot a shortageof monkeys.

In contrast to the falsehoods being pushed by the primate centres, monkeys are not essential for COVID-19 research. In fact,due to vast differences in genetics and physiology, primates do not experience COVID-19 as humans do, said Stagno.

In fact, scientists at the NIHconcludedin 2015 that research on SARS and MERS, two strains of coronaviruses that crossed the species barrier to infect humans within the preceding 12 years, had been largely unsuccessful in part because of difficulties in developing animal models that provide consistent and reproducible results.

In addition, Stagno pointed out that the trajectory of the COVID-19 biomedical response actually proved that non-human animal testing for vaccines is unnecessary. With the urgency imposed by the pandemic, key vaccine developers Pfizer and Moderna were given approval to run human trials ahead of normally required animal testing, she said. The result was that vaccines for COVID-19 were developed and made accessible to the public in record time, with less animal testing than ever before. In bypassing animal testing to evaluate the vaccines, the scientific community acknowledged that these tests are not scientifically predictive of human response, but rather are based on regulatory requirements that are a hindrance to rapidly developing safe and effective treatments.

Indeed, as CAAREhighlights, the most informative work addressing the COVID-19 pandemic comes from human-based science. Other organisations, notably thePhysicians Committee for Responsible Medicine, a non-profit animal rights group based in Washington, D.C., also strongly support alternatives to non-human animal research, arguing that the US doesnt need more monkeys for vaccine testing, but rather a new strategy altogether.

Instead of monkeys and other animals, more ethical, effective, and sustainable human-based methods are the future, the groupsays. Because they use human cells and tissues, these approaches can better replicate the pathology of human diseases, including COVID-19 examples of powerful human-based COVID-19 research include studies that have used donated human tissue, human brain organoids, human lung airway chips, human stem cell-derived cardiac tissue, human intestinal organoids, and mini human lungs in a dish. Learning from these human-relevant findings and supporting much more of this kind of research is the only way we will solve this crisis and better prepare for future pandemics.

Stagno criticised the federal governments request for more funding for primate research by comparing the US position to that of Europe. At a time when theEuropean Parliament voted [on September 15] to phase out animal experiments, the US Department of Health and Human Services [under whose jurisdiction the NIH falls] is asking for another $30 million to expand primate research. This is totally out of step with where modern science needs to go.

While the past decade has seen amazing new developments in alternatives to animal testing, policymakers, regulators and parts of the scientific community are yet to fully recognize the potential of these new methods,saidMember of the European Parliament Tilly Metz. The resolution we voted on today aims to accelerate the shift in mentalities, regulation and funding.

Sheadded, There are no excuses to perpetuate the current level of reliance on animal experiments. It is clear that an ambitious phase-out plan, with clear milestones and achievable objectives, is the next step needed to start reducing significantly the use of animals in science. And while Europe is leading todays charge to eliminate animal testing, animal welfare in general has also beengaining ground across Asia in recent years.

When it comes to cruel, deadly and unnecessary experiments, particularly on our close evolutionary cousins, its time for the United States to get in sync with modern science. Congress shouldnt just reject additional funding for primate researchit should ban it altogether.

Reynard Loki is a writing fellow at theIndependent Media Institute, where he serves as the editor and chief correspondent forEarth | Food | Life.

This article was produced byEarth | Food | Life, a project of the Independent Media Institute.

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US is Out of Step on Primate Research With Rest of World - NewsClick

Fabiancaptured this video using a research microscope from the 1970s, utilizing polarized light. He aimed to visually illustrate the symbiotic relationship between termites and these particular protists, to help audiences better understand the unseen role they play in our natural world. Fabian meticulously created an environment with a pH, chemical composition and temperature suited to keep the symbiontsalive. These symbionts are difficult to film due to their sensitivity to light and oxygen, and any slight changes to their environment can cause both the insect and the protists in its gut to perish.

"The most challenging part of capturing this video was finding the right solution for the creatures themselves," said Fabian. "I tried a lot of methods, even preparing my own saline solution. They're very sensitive to oxygen, so I had to remove as much gas from the solution as possible. It was very tricky, and I had to work fast. The video you're seeing is the result of months of trial and error, a lot of research and perseverance."

Protists are a wide and highly diverse array of single-celled organisms, but those featured in the winning video have formed a relationshipwith termites to process the cellulose they eat and help them derive nutrition from it and cycle carbon back into the soil. "Protists, while largely unknown to the generalpublic, are indeed the most abundant creatures on the planet," said Fabian. "There is a significant gap in our understanding aboutthese termite symbiontsand how this unique evolutionary relationship developed with its host, making it well worth exploring and presenting."

Fabian added, "The beautiful thing is that easy access to modern imaging and the internet has allowed those with an interest in microscopy to share their discoveries globally, across all boundaries of culture, language and age. The world is so small, and we can connect easily with anyone across the globe." Fabianhopes that his video will spark greater interest in Protists, as well as inspiring and encouraging more young peoples interested in STEM subjects.

"We're living in an amazing time when we have the ability to capture and share high-quality scientific imagery," said Eric Flem, Communications Manager, Nikon Instruments. "This year's winning entry highlights the power that microscopy has to connect like-minded individuals, educate others using engaging visuals, and spread scientific knowledge to the general public"

Second place was awarded to Dr. Stephanie Hachey and Dr. Christopher Hughes for their time-lapsed fluorescence microscopy video of an engineered human micro-tumor forming and metastasizing. In order to capture this video, stromal cells and cancer cells were introduced into a microfluidic platform under dynamic flow conditions and placed into a customized CO2 and humidity-controlled chamber. The platform was imaged every 15 minutes for 10 consecutive days.

The 2021 judging panel included:

For additional information, please visit http://www.nikonsmallworld.com, or follow the conversation on Facebook, Twitter @NikonSmallWorld and Instagram @NikonInstruments.

NIKON SMALL WORLD IN MOTION WINNERS

1st PlaceFabian J. WestonPennant Hills, New South Wales, AustraliaMicrofauna in a termite gutPolarized Light10X, 20X & 40X (Objective Lens Magnification)

2nd PlaceDr. Stephanie Hachey & Dr. Christopher HughesUniversity of California, IrvineDepartment of Molecular Biology and BiochemistryIrvine, California, USA10-day time-lapse of an engineered human micro-tumor forming and metastasizing. Vessels (red) support the growing tumor (blue).Confocal, Fluorescence10X (Objective Lens Magnification)

3rd PlaceAndrei SavitskyCherkassy, UkraineWater flea (Daphnia pulex) giving birth to cubsDarkfield4X (Objective Lens Magnification)

4th PlaceDr. Alexandre DumoulinUniversity of ZurichDepartment of Molecular Life SciencesZurich, SwitzerlandCommissural axons turning in an organized manner just after having crossed the midline of the central nervous systemConfocal40X (Objective Lens Magnification)

5th PlaceDr. Sachie Kanatani & Dr. Photini SinnisJohns Hopkins Bloomberg School of Public HealthDepartment of Molecular Microbiology and ImmunologyBaltimore, Maryland, USAInfected mosquito salivating fluorescently-labeled malaria parasites Confocal10X (Objective Lens Magnification)

HONORABLE MENTIONS

Sophie-Marie Aicher & Dr. Delphine PlanasInstitut Pasteur ParisDepartment of VirologyParis, le-de-France, FranceSARS-CoV-2 infection triggering cell fusion and cell death (red) in bat (Myotis myotis) brain cellsFluorescence, Phase Contrast20X (Objective Lens Magnification)

Richard AlbrechtAltenstadt, Bavaria, GermanyMosquito (Culex pipiens) laying eggsReflected Light, Stereomicroscopy5X - 20X (Objective Lens Magnification)

Bernard Allard & Didier BarbetClub Franais de MicroscopieSucy-en-Bry, FranceHydra and Trichodina parasitesBrightfield4X - 20X (Objective Lens Magnification)

Giulia L. M. Boezio & Dr. Radhan RamadassMax Planck Institute for Heart and Lung ResearchDepartment of Developmental GeneticsBad Nauheim, Hessen, Germany3-day old zebrafish (Danio rerio) showing the beating heart, aorta, and connecting vessels (endothelial cells: white; blood cells: red)Confocal40X (Objective Lens Magnification)

Dr. Dylan T. BurnetteVanderbilt University School of MedicineDepartment of Cell and Developmental BiologyNashville, Tennessee, USAEpithelial cells in cultureDifferential Interference Contrast (DIC)60X (Objective Lens Magnification)

Dr. Dylan T. BurnetteVanderbilt University School of MedicineDepartment of Cell and Developmental BiologyNashville, Tennessee, USADNA during cell division and deathConfocal60X (Objective Lens Magnification)

Dr. Nan-Shan Chang, Pei-Yi Chou, Yu-An Chen & Chen-Yu LuNational Cheng Kung UniversityDepartment of Molecular MedicineTainan, TaiwanMetastatic 231 breast cancer cells meet with L929 fibroblastsBrightfield10X (Objective Lens Magnification)

Yen Fook ChewWoodend, Waimakiriri, New ZealandA cladoceran (Chydorus sp.) moving on the cocoon of a caddisfly nymph prompting a reaction. The caddisfly spends its youth as an aquatic insect before leaving the water to become airborne.Darkfield4X (Objective Lens Magnification)

Yen Fook ChewWoodend, Waimakiriri, New ZealandHaving ingested nine Chydrorus, this oligochaete worm (Chaetogaster sp.) is having difficulty with the tenth, expelling it twice. This worm feeds by powerful suction rather like a vacuum cleaner.Darkfield, Polarized Light4X (Objective Lens Magnification)

Momir FutoRudjer Boskovic InstituteDivision of Molecular Biology / Laboratory of Evolutionary GeneticsZagreb, Grad Zagreb, Croatia5-day time-lapse of Bacillus subtilis biofilm growth and developmentStereomicroscopy0.65X (Objective Lens Magnification)

Dr. Jasmin Imran Alsous, Jonathan Jackson & Dr. Adam MartinSimons Foundation Flatiron InstituteCenter for Computational BiologyCambridge, Massachusetts, USANurse cells (cyan) contract and shrink in response to myosin waves (red) as they transport their contents to the egg cell in a fruit fly egg chamber.Confocal40X (Objective Lens Magnification)

Dylan Jones & Dr. Brian AtkinsonUniversity of NottinghamDepartment of Plant ScienceSutton Bonington, Leicestershire, United KingdomLaser ablation and reconstruction of pearl millet crown root Laser Ablation Tomography5X (Objective Lens Magnification)

Martin Kaae KristiansenMy Microscopic WorldAalborg, Nordjylland, DenmarkTardigrade showing individual muscle strands (muscles glow with different colors depending on the orientation to the light source)Polarized Light10X (Objective Lens Magnification)

Ana Gabriela MadrigalMcGill UniversityInstitute of ParasitologySte-Anne-de-Bellevue, QC, CanadaNeutrophils (type of white blood cell) rolling through mouse blood vesselConfocal20X (Objective Lens Magnification)

Dr. Alvaro MigottoCentro de Biologia MarinhaSo Sebastio, So Paulo, BrazilSea cucumberDarkfield1.6X - 40X (Objective Lens Magnification)

Danielle Parsons & Alan deHaasWonder ScienceLos Angeles, California, USATwo liquid crystals crystallizing on the same microscope slidePolarized Light20X (Objective Lens Magnification)

Dr. Eric Peterman & Jeff RasmussenUniversity of WashingtonDepartment of BiologySeattle, Washington, USADebris from degenerating axons (magenta) engulfed by an immune cell (cyan) in zebrafish (Danio rerio) skin Confocal25X (Objective Lens Magnification)

Wojtek PlonkaKrakow, Malopolskie, PolandTen day time-lapse of moss growthImage Stacking6X (Objective Lens Magnification)

Wojtek PlonkaKrakow, Malopolskie, Poland10-day time-lapse of Lobelia pendula seed developmentImage Stacking6X (Objective Lens Magnification)

Martina Schaettin & Dr. Fabian F. VoigtUniversity of ZurichDepartment of Molecular Life SciencesZurich, SwitzerlandFly-through of the nervous system of a 7-day old chicken embryoLight Sheet0.8X - 4X (Objective Lens Magnification)

Dr. Shinji ShimodeYokohama National UniversityManazuru Marne Center (MMCER)Manazuru-machi, Kanagawa, JapanPelagosphaera larva (planktonic larval stage) of sipunculid worms (peanut worms)Stereomicroscopy60X - 120X (Objective Lens Magnification)

Francesca StranoVictoria University of WellingtonSchool of Biological SciencesWellington, New ZealandSea slugsStereomicroscopy6X (Objective Lens Magnification)

Maria F. Ullo & Jeremy S. LogueAlbany Medical CollegeDepartment of Regenerative and Cancer Cell BiologyAlbany, New York, USAFluorescently tagged actin filaments flowing within a blebbing human melanoma cellDeconvolution, Fluorescence60X (Objective Lens Magnification)

Gaurav Upadhyay, Vedant Kumar & Dr. Rajneesh BhardwajIIT BombayDepartment of Mechanical EngineeringMumbai, Maharashtra, IndiaWater droplet bouncing over a superhydrophobic cantilever beamBrightfield7X (Objective Lens Magnification)

Wim van EgmondMicropolitan MuseumBerkel en Rodenrijs, Zuid Holland, NetherlandsMudflat diatomsBrightfield, Darkfield, Differential Interference Contrast (DIC), Reflected Light5X, 16X, 25X (Objective Lens Magnification)

Thomas A. Zangle & Soorya PradeepUniversity of UtahDepartment of Chemical EngineeringSalt Lake City, Utah, USA5-day time-lapse of rat hippocampal neurons showing development of networks and interconnections. Contrast enhanced to highlight neurites.Quantitative Phase Microscopy20X (Objective Lens Magnification)

About Nikon Small World Photomicrography CompetitionThe Nikon Small World Photomicrography Competition is open to anyone with an interest in photography or video. Participants may upload digital images and videos directly at http://www.nikonsmallworld.com. For additional information, contact Nikon Small World, Nikon Instruments Inc., 1300 Walt Whitman Road, Melville, NY 11747, USA, or phone (631) 547-8569. Entry forms for Nikon's 2021 Small World and Small World in Motion Competitions are available at https://enter.nikonsmallworld.com/

About Nikon Instruments Inc. Nikon Instruments Inc. is the US microscopy arm of Nikon Healthcare, a world leader in the development and manufacture of optical and digital imaging technology for biomedical applications. For more information, visit https://www.microscope.healthcare.nikon.com/ or contact us at 1-800-52-NIKON.

SOURCE Nikon Instruments Inc.

http://www.nikonsmallworld.com

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A Look Inside A Termite's Gut Wins The 11th Annual Nikon Small World in Motion Competition - PRNewswire

Lies in Lancet

When the Covid pandemic erupted, 27 top virologists got together and wrote an article in the prestigious Lancet journal (19 February 20), absolving China of all blame and asserting that it was a natural zoonotic epidemic that had emerged from the wet markets of Wuhan. In the highly polarized presidential campaign in America, this scientific judgment was used to dismiss all strident claims of President Trump and his cabinet members, accusing China of generating this virus in a lab from where it appeared to have leaked out. These were then cynically branded as mere conspiracy theories.

With the heat and dust of the presidential campaign behind us, we have had time for more sober reflection and the picture that is emerging is not pretty. A number of disclosures have come under the Freedom of Information Act in the USA and the scientific community has taken a second hard look at the data. It now turns out that one of the lead authors of this defense of China in Lancet, was Peter Dasazak, head of the NGO, the Eco Health Alliance. He had a serious conflict of interest which should have disqualified him from commenting on issues pertaining to the Wuhan institute of Virology (WIV). It turns out that during President Obamas tenure, the gain of function research was being undertaken in some virology labs in US. This had been initiated by DARPA as part of its pre-empt programme (to anticipate nature and hostile counties) by producing souped up viruses (before nature could) and developing medicines and vaccines to counter them. Primary establishment was the US Army Research Institute of Infectious Diseases at Fort Detrick, Maryland. There were serious concerns of leakage and all such research was halted for two years. It was then that Dr Fauci of the NIH decided to offload all such research to foreign countries thru NGOs. As part of this, $3.7 million was given to Peter Dasazks Eco Health Organisation. He, along with the Chinese governments Ministry of Science and Technology, had jointly funded the gain of function research at the Wuhan institute. Subsequently, he was part of the WHO Team sent for investigations to Wuhan. He did not recuse himself and gave a second clean chit to WIV in the 30 March 21 WHO report. The lid was blown off this cover-up really by Nicholas Wades meticulously researched article in the Bulletin of Atomic Scientists, one of the most prestigious scientific journals. He pointed out how Maj Gen Shi Zheng li, who was heading the WIV, had cooperated with Prof Ralph Baric of the North Carolina University for gain of function research on bat corona viruses. In fact, he had tutored her on the technique of serial passage through cell cultures that make the modified virus look natural. With Prof Barics help, she had been able to splice a SARs hook molecule on to the backbone of a bat coronavirus so that it would now attach on to the cells of human air ways in November 2015 itself.

Chinese Miltary Interest in Bio Warfare

Back in 1999, I was serving in the Military Operations Directorate with NBC (Nuclear Chemical and Biological Warfare) as part of my charter. We were jolted to see a Book on Unrestricted Warfare by two Chinese Senior Colonels-Quiao Liang and Wang Xiangsi (they later rose to be generals). It was on how China could take on and defeat a super power like the USA by waging a no-holds-barred conflict that involved a multitude of means, including military and non- military. Non-military means included terrorism, biological warfare, cyber warfare, information warfare, economic warfare and a host of others. The aim was to bring the enemy to his knees, without a shot being fired, by non- contact warfare

This was followed up by a book War for Power by Guo- Jeiwi, a military researcher, in 2010. This openly talked of a new concept of war with biological characteristics. Further books followed, including one by Lt Gen Zhang Zibu, who openly talked of weaponising the virus.

Official Military Doctrine: All these books by individual military officers could be taken as mere kite flying or veiled threats. However, in 2017, China updated its official military doctrine enshrined in the science of Military Strategy. This updated edition added a new chapter on biological warfare, titled Biology as a Domain for Military Strategy. China is a signatory to the biological warfare convention banning such weapons. How then could China include bio-warfare in its official doctrine? The world should have protested loudly, but it did not.

Smoking Gun

The Smoking Gun document, however, had been written even earlier. In 2015, Xu Dezhong, a senior Chinese Airforce virologist, had led a team of 18 scientists and authored an exhaustive study on biological warfare. Their findings were presented to the CMC and the highest leadership in China over 24 sessions- in itself a clear indication of the overwhelming significance allocated to this subject. This document actually explains what precisely has happened since then. Some of the crucial findings/ recommendations of this study merit highlighting in detail:

This report clearly stated that the SARS virus was a genetically engineered virus specifically designed to target China. This was startling and indicates a siege mentalitya deep seated Chinese perception that it is the victim of biological war. Ergo sum, China is fully justified in retaliating in kind. Such a Chinese mindset in itself is dangerous and has possibly precipitated the indiscriminate Wuhan virus release.

This study spoke of how the new found technique of freeze drying micro-organisms has enabled storage of bio-war agents. These can subsequently be aerosolized whenever a biological warfare attack has to be mounted. Such an attack is so easy to mount and cannot really be traced back to source. There is complete deniability in such attacks.

The study spoke of how the entire health care system in a society can be collapsed and crippled with such a biological attack. Not only will this cause mass casualties and widespread morbidity but induce tremendous psychological stress in victim countries. It can have long term disruptive impact and bring about economic collapse. Hence such bio agents are ideal to bring a country to its knees without a shot being fired. This actualizes Sun tzus axiom of subduing the enemy without fighting. At the very least it would set up the target country for a follow up military strike to exploit the severe disarray and disruption.

Chinese Biological War Preprations

The unfortunate fact is China did not stop at theorizing and writing about bio-warfare. It took active and concerted steps to create this capability in a useable form. Consider the following:

There are two virological labs in Wuhan itself. The WIV lab was set up with French assistance as a level Four facility. It is headed by two PLA general rank officersMaj Gen Shi Zhengli (famed as Chinas bat woman and worlds leading expert on bat corona viruses) and Maj Gen Cao wei (who had served in Africa and dealt with MERS and Ebola epedemics).The very fact that Chinas virological labs are headed by military officers, indicates the military dimension of their programs.

The trail goes back to 2012 when six Chinese miners in a disused Copper mine died of Pneumonia with lung patches similar to Covid. Gen Sheng Li rushed teams there and collected and studied samples from 276 bats in 2013. They published findings in2016 and identified the bat corona virus strain as RaBTCov/ 4991. (This was later found to be the same as the infamous strain Ra TG 13 which has 96.2% match with the genome sequence of Covid-19 virus.)

In 2015, Gen Shi Zheng li had written four papers on how the SARS hook virus could be spliced on to the bat corona backbone to make it a highly lethal and communicable virus as part of gain of function.

She was mentored by Prof Ralph Baric of the University of North Carolina in USA. Not only did he help her with this gain of function research, he also taught her to do it via serial passage through cell cultures to mask it and make it look like a natural virus. Nicholas Wade has disclosed this. By Nov 2015 this souped up virus was ready in the Wuhan institute of Virology. This research continued through 2016. In 2017 an American team that had visited Wuhan, warned of lax protocols there and how these very dangerous pathogens stored there could leak out. Contact between US and Chinese scientists seemed to have declined steeply thereafter and Dr Sheng lis four papers were suddenly taken off the net. The whole program was suddenly made quite opaque.

A recent study by a UK and Norway based duo of Micro- biologists called Dr Anges Dalgaleh and Berger Soransen has now quite conclusively proved that that the Wuhan coronavirus is not a natural virus but is definitely lab engineered. They noted that the SARS hook molecule had been spliced on to the backbone of the bat carona virus. This hook molecule had four positively charged amino acids which made them easily attach to negatively charged human cells and become far more infectious. Here is the catch. Positively charged ions repel each other. Hence in natural organisms finding two such positively charged amino acids in a row is difficult. Three is a rarity. Four in a row gives the show awayit is definitely a lab-engineered virus.

Holes in the Zoonotic Theory: The Zoonotic theory that this pandemic emerged from the Wuhan wet market is full of holes. To start with No bats are sold in the Wuhan wet markets. The nearest they are found is in the caves of Nanjing some 550 km away. The only people who went there to collect bats from Nanjing and Yunan caves were six operatives from the WIV. Three of them died in autumn 2019 of a disease with remarkably similar symptoms to Covid. All such viruses from animal vectors usually come thru an intermediary host. Thus SARS came via bats to civet (cats) to humans. This link was discovered in a matter of days. MERS came to man from bats via camels to humans. This link was discovered in just 4 months. Its over 18 months since the Covid pandemic hit us, till now there is no trace of the intermediary host. The reason is simple. There is none because it is not a natural virus. It was most deliberately engineered in a lab.

What Really Happened at Wuhan? Circumstantial Evidence

We have sufficient circumstantial evidence that by 2015, the top Chinese leadership was convinced that it was the victim of biological warfare via the SARS genetically engineered virus. Right or wrong is immaterial, what matters is the strong perception and siege mentality. We find that in 2015 itself, energetic steps being taken in WIV to weaponise the bat corona virus isolated from the defunct Copper mines. This gain of function virus was ready by November 2015 and China was ready to strike back! The updated edition of the official PLA doctrine in 2017 had a whole new chapter on biological warfare .Bio war was now official doctrine of PLA. Meanwhile, Donald Trump had become the president of USA and with great clarity, he identified China as the main adversary and challenger. He took very proactive steps to contain the rise of a highly aggressive China. He put tremendous pressure via arming Taiwan, stoking/ highlighting unrest in Hongkong, Xinjiang and Tibet and then via an all out Trade war. The US Navy pushed back strongly in Taiwan straits and South and East China seas.

Thus, by 2019 China was under tremendous pressure. In September 2019, the military games took place in Wuhan and later Zhao lijian, official spokesperson of Chinese Foreign ministry, accused the US Special Forces of spreading the coronavirus in Wuhan under cover of the games. The veracity of the charge is another matter. I am highlighting the Chinese perceptions that could have become motivations for action. There are some media reports that in 2019, China made vaccination compulsory for all citizens. US intelligence reports indicate that in November 2019, three Chinese workers in the WIV had fallen sick with symptoms very similar to the Covid outbreak. The first Covid case was acknowledged only on 8 December 2019. Thereafter, starts a deliberate trail of obfuscation and deliberate suppression of information. Whistleblower doctors and researchers were killed or jailed; even in late December, WHO was being told that this disease was not communicable from human to human. Dr Guissepe, a top Italian Micro biologist, tells us that the PLA was given charge of containing the virus in Wuhan. For a nation supposedly taken by surprise, they did an amazingly efficient job. Beijing, a 1000 km away, and Shanghai, just 800 km away, were unscathed. However, 20 flights a day from Wuhan to New York and a similar number to Europe and other destinations were allowed to continue unchecked.

On 20 January 2020, the WIV filed a use patent for Remdesivir, the much-touted cure for corona. To file a use patent, you have to test at least for two/three months. Thus, the Chinese knew all about Covid from at least November 2019 onwards, if not earlier. Yet, deliberate suppression of information continued. In fact, in February 20, over two months after acknowledgement of Covid, the Chinese Foreign Minister was calling upon all neighbouring countries to keep their borders open (ostensibly for prestige reasons). Whether the release was accidental or deliberate, China was certainly doing everything to spread the coronavirus and weaponise its release.

Accident or Staged Accident?

We now come across a strange coincidence. By 8 December 2019, the first Covid patient had been acknowledged in Wuhan. On 28 December 2019, the Chinese Aircraft Carrier Liaoning had sailed out into the Taiwan straits and East and South China seas. The Chinese Navy and Air Force had started a series of muscular exercises against Taiwan, Japan and South China sea countries Two US Nuclear Powered Aircraft carriers had to be withdrawn from the Pacific as their crews were infected with Covid. China hurriedly readied and deployed its second Air craft carrier and became dangerously provocative, especially with its Air Force incursions into Taiwans AIZ.

In end Mar-Apr 2020, China staged two mechanized divisions from Xinjiang and started Incursions against India in Ladakh. Does a country surprised suddenly by a pandemic start war like moves against all its neighbours concurrently? Or does it hunker down to protect its population and deal with the pandemic? There is something seriously sinister in this juxtaposition of the pandemic and very aggressive military moves on all fronts. It almost smacks of an attempt to exploit a biological strike. In World War II, Japan and Germany had started invasions of China and Poland with staged incidents. That leads to the uncomfortable questionwas the Wuhan accidental release, a staged accident? The world is now veering around to the view that what happened in Wuhan was an accidental release. I have pointed out to a whole lot of circumstantial evidence that seems to suggest that given Chinas fear psychosis, it could well have been a Staged Accident. Such actions stem from perceptions and Chinas clear perception since 2015 has been that it has already been attacked by biological weapons- retaliation is therefore justified.

Where do we go from here?

There is a sadly capitulationist mindset, that the world can do nothing to China, so let sleeping dogs lie. I would contest that strongly. Phillipines had taken China to the ICJ and won its case on the South China Sea dispute. China ignored the ICJ verdict with contempt, but has had to pay a heavy price with the US Navy and other Quad nations Carrier battle groups steaming into South China Sea to strongly contest the restrictions on freedom of navigation in a big way.

The IAEA is the worlds watchdog on nuclear proliferation. It has strong teeth to carry out intrusive inspections of nuclear reactors even in rouge nations. We need to rework the Biological Warfare Convention and create international watch dog bodies to carry out intrusive inspections of virological laboratories in all countries.

The world cannot afford to let China get away scot-free on Covid. 167 million people have been infected and 3.5 million are dead. 3 lakh citizens have died in India itself. China and other nations (including Pakistan) will have to deterred if such mayhem has to be stopped. The world needs to get to gather and name and shame as the first step. Concerted multi-domain pressure is called for to deter China in a credible fashion.

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What really happened in Wuhan? - The Sunday Guardian Live - The Sunday Guardian

Winning the Inventor Pitch Award at UMD Bioscience Day

Telugu and his team pitched this work at UMD Bioscience Day on behalf of his company, RBI, and received the Inventor Pitch Award and the UMD Invention of the Year Award in 2018. In order to protect the intellectual property, Telugu worked with the UMD Office of Technology Commercialization (OTC) to secure patents and open the work up for additional fundraising to carry this technology through the preclinical and clinical stages. The Maryland Stem Cell Foundation provided some funding to advance this work, and Telugu is thankful that Maryland funds technologies in the human stem cell space.

There are many terminal cases where people need some sort of an organ replacement, like organ failure and degenerative diseases that cannot be cured by drugs, explains Telugu. The traditional paradigm is to find a donor organ, but as of today there are still thousands of patients waiting for transplants, and there is no keeping up with the demand. Researchers have thought for a long time that stem cells could help solve this problem, and these stem cells have the ability to go into a specific organ as opposed to those that go into any lineage. In this case, you can differentiate the cells and place them where they are needed to help rescue a diseased organ, eliminating the need for transplant or at least buying the patient some time. Just making the human liver and collecting them early from a neonatal piglet, the hepatocyte [liver] cells alone are a $3 billion opportunity per year. And in the future, we can move into organ transplantation, first with the liver, and then looking at other organs of interest like the pancreas and lungs.

According to Telugu, this has distinct advantages over other methods that researchers are currently using to create donor organs in pigs, since the organs Telugu and his team are working with are actually of human origin and are therefore more likely to be accepted when transplanted. Transplant rejections are pretty common even between humans and humans, says Telugu, and if it is such a problem normally, you can imagine how an organ from a pig could be difficult to accept and may not essentially perform the same functions. Pig proteins may not function the same, so that remains a huge barrier for other methods that are not actually growing fully human organs like ours.

This work has the potential to solve a major problem in the treatment of organ failure and other degenerative diseases, which is what Telugu and his work is all about. Being a veterinarian by training, we always look at the problem and try to find solutions to them, says Telugu. Most animal scientists operate by looking for solutions, so integrating research and entrepreneurship to get this to the market where it is needed is essential. We are one of the few groups on the planet that are working in this space, and we have a great team of embryologists here at Maryland to do this work. We are uniquely positioned to accomplish this with both genome editing and stem cell biology expertise, and being able to prove the concept with this paper is a great first step towards our goals.

The paper, entitled Extra-embryonic endoderm (XEN) cells capable of contributing to embryonic chimeras established from pig embryos, is published in Stem Cells Reports, DOI: 10.1016/j.stemcr.2020.11.011.

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UMD Researchers Perform Crucial Proof-of-Concept ...

The FDA has authorized Moderna's COVID-19 vaccine for emergency use in the U.S. The first shots of the vaccine are expected to be given Monday. USA TODAY

CAMBRIDGE, Mass. Americans will soon have access to a second COVID-19 vaccine.

Stephen Hahn, commissioner of the U.S. Food and Drug Administration, granted emergency authorization Fridayto a vaccine made by Moderna,a week after giving similar clearance to one made by Pfizer and its German collaborator, BioNTech.

His is "authorizing" rather than approving the vaccine, because longer-term research is needed to meet the full standards for approval, which officials don't want to wait for during the public health emergency.

The speedy path to authorization was possible because the agencycut through regulatory red tape,Hahnsaid at a Friday night press conference. "We worked quickly based onthe urgency of this global pandemic ... we have not cut corners."

The announcementmakesthe U.S.the first country to authorize two COVID-19 vaccines that demonstrate "clear and compelling efficacy, Dr.Peter Marks director of the Center for Biologics Evaluation and Research at the FDA said during the press conference.Marks said it isanother milestone as we work to end the COVID-19 pandemic.

The move comes a day afterthe U.S. reported its 17 millionth case of COVID-19and an independent advisory committee reviewed data from human trials of Moderna's mRNA-1273 vaccine, deciding its benefits outweighed its risks. The vaccine, according to a trial that included 30,000 volunteers,protected more than94% of recipients from active disease, without causing major safety concerns.

Trucks will begin moving the vaccine this weekend, with the first of 5.9 million already manufactured Moderna shots expected to be given on Monday.

Your vaccine questions, answered:I had COVID, should I still get vaccinated? What are the side effects? What are its 'ingredients?'

In this special edition episode of States of America, experts answer the biggest questions Americans have about the vaccine, side effects, how it's getting to you and more. USA TODAY

It's a triumphant moment for the 10-year-old Cambridge, Massachusetts, biotech companythat until nowhad never brought a product to market.

Now, both its vaccine and the one byPfizer-BioNTecharepoised to change the course of the worst pandemic in a century.

The virus that causes COVID-19 hasswept the world and particularly devastated the United States, which accounts for 4% of the world's populationbut nearly 23%of its COVID-19 cases and 19%of its deaths.

During the current winter surge, anAmerican is reported dead about every 34 seconds from the virus, and 150 are diagnosed every minute.

But it will take time to roll out vaccine across the country and the world, achieving the 70% protection from both vaccination and natural disease that experts say will be needed to stop widespread infections.

In this file photo taken on November 18, 2020 shows a syringe and a bottle reading "Vaccine Covid-19" next to the Moderna biotech company logo.(Photo: JOEL SAGET, AFP via Getty Images)

Moderna, which developed its vaccine in collaboration with government scientists,says it will be able to deliver 20 million doses of its vaccine by the end of December. Another 80 million will be available in the first few months of 2021, under a contract signed in Augustthat brought the U.S. government's direct financial backing of the companyto $2.5 billion.

"It is through the dedicated efforts of our federal scientists and their collaborators at Moderna and in academia, the clinical staff who conducted the vaccine's rigorous clinical trials, and the tens of thousands of study participants who selflessly rolled up their sleeves, that another safe and highly effective vaccine to protect against COVID-19 will soon be rolled out to the American public," Dr. Francis Collins, director of the National Institutes of Health, said Friday.

Just last week, the government closed a deal for a second 100 million doses to be delivered in the second quarter of next year, bringing taxpayers' total investment in mRNA-1273 up to$4.1 billion.

Another candidate vaccine, from Johnson & Johnson, fully enrolled its large-scale humantrial Thursdayand expects to report its first safety and effectiveness data in January.

A fourth, created by AstraZeneca and Oxford University, is a few weeks behind, and a fifth candidate, by vaccine developer Novavax ofGaithersburg, Maryland, is expected to begin its major U.S. trial shortly.

If all or most of these come through, there shouldbe plenty of vaccine by the endof next summer to cover every American who wants one.

"It's just incredible science and human achievement,"said Dr. Steven Joffe, a professor of medical ethics and health policyat the Perelman School of Medicine at the University of Pennsylvania."Not just the science that went into the vaccines, but the organizational effort to pull off those trials it's marvelous."

Although Moderna moved extremely fast, winning authorization just 11 months after beginning work on mRNA-1273, ithas been developing the technology behind its vaccinefor a decade.

The company was founded in 2010 on the banks of the Charles River, a short walkfrom the Massachusetts Institute of Technology, where one of its founders was a faculty member,and another a graduate and board member.

That MIT gradand board of trustees member, venture capitalist Noubar Afeyan,said he was intrigued at the time by the idea of making drugs inside the human body.

Messenger RNA, which the body uses to translate the DNA code into the proteins that do all the body's work, seemed like the right tool to address a whole host of medical problems, he said.

Operation Warp Speed has helped Moderna move faster in vaccine development.(Photo: JOSEPH PREZIOSO/AFP via Getty Images)

Afeyan saidhe likes to start companies with big ideas that seem like science fictionand then "take the fiction out" by finding the science to make it real.

Moderna was initially namedLS18 to indicate it was the 18th life sciences company Afeyan had started. (He's lost track of whether his latest company is LS79 or LS80, he said.) The idea was seeded by a stem cell scientist at nearby Harvard University, Derrick Rossi, who was trying to commercialize his research using the body's most versatile cells to make medicines.

Afeyan said it was a provocative concept. But by May of the following year, when the company was officially launched as Moderna, they had dropped the idea of using stem cells, which Afeyan said were too unstable in the body, and focused instead on messenger RNA (hence the name ModeRNA).

Messenger or mRNA is the body's own delivery system, taking "messages" from the DNA code in the cell's nucleus to a protein manufacturing center.

Where's the COVID-19 vaccine? Who's been vaccinated?Here's how we'll know.

These proteins direct every activity of life, so figuringout how to make them on demand could help people who suffer severe diseases because their bodies make faulty proteinsas with sickle cell disease, cystic fibrosis and myriad rare diseases. Such proteins could alsoprime the immune system to target cancer cells, or infectious diseases.

Afeyan and his collaborators wanted to tackle this whole range of medical challenges.

But first, they needed a CEO to run the company.

Afeyan said he had been negotiating with a French entrepreneur who was, like him, a biomedical engineer. ButStphane Bancel wasn't sure he wanted to leave a stable job as CEO of an established diagnostics company for the risk of a startup with a never-before-tried idea.

Bancel was walking home across the Longfellow Bridge from Cambridge to Boston one winter night, when Afeyan called and turned on the hard sell.

Afeyan said he would never have a bigger idea to offer Bancel. If this becomes the next Genentech, "you're going to hate yourself" for not being involved, Afeyan told him, referring to the South San Francisco company that launched the entire biotechnology industry with its birth in 1976.

Later that year, Bancel signed on to run Modernaand continues to lead the company, which has now made several founders and its CEO into billionaires.

Moderna IPO(Photo: Flagship Pioneering)

The earliest seeds of Moderna

There werea few key scientific advances that led mRNA to where it is today.

Onecame from another Moderna co-founder, Robert Langer, a professor at MIT and a serial entrepreneur.

Early in his career, Langer, who had recently earned his doctorate in chemical engineering from MIT, was struggling to find a job. He didn't want to work in the oil industry, though he'd gotten 20 job offers, including fourfrom Exxon alone.

After months of searching, Dr. Judah Folkman, a passionate doctor at what is now called Boston Children's Hospital finally took a chance on him. Folkman believed he could cure cancer by cutting off the blood supply to tumorsbut he couldn't figure out how to slowly release drugs to work effectively.

Nevermind the political messenger: When it comes to COVID-19 guidance, trust the message, experts say

Langer spent years developinga way to encapsulatenucleic acids the same building blocks as in mRNA vaccines into tiny particles that could make their way into cells.

"At first people didn't think it was possible," Langer said. He published a 1976 paper showing it could be donebut still, it was a slog to get people to believe in its potential.

"After that paper came out, I must have had 10 years of people rejecting grants" to support the work, he said. (His work with Folkman provided the underlying science for the drug Avastin, which earned $7 billion in sales in 2019 and is used to treat many types of cancer as well as wet age-related macular degeneration, the leading cause of blindness in older adults.)

Langer and others made additional improvements over the years, includingadding polyethylene glycol to the surface of particles, which enabled them to survive in the body for longer. That's one of the key ingredients of Moderna and Pfizer-BioNTech's vaccines.

A subject receives a shot in the first-stage safety trial of a potential vaccine by Moderna for COVID-19 at the Kaiser Permanente Washington Health Research Institute in Seattle on March 16.(Photo: Ted S. Warren, AP)

In 2010, when Langer was one of the world's best knownbioengineers and a leader in the field of drug delivery, Rossi came to see him with a scientific insight he hoped would be the basis for starting a company. Langer introduced him to Afeyan, and the idea for LS18was born.

By the following year,Rossi moved on and the core group includedLanger, Afeyan, Dr. Kenneth Chien, a prominent cardiologist and researcher, andTimothy Springer, an immunologist at Harvard Medical School.

The four met once a week tobrainstorm, while a handful of scientists at Afeyan's Flagship Pioneering advanced their ideas in the lab.

Moderna's first real home wasan underwhelming office half basement, half ground floor just a few blocks away.

The vision from its earliest days, Langer said, was to build a "platform" that could be used as the basis for drugs, vaccinesand even tissue engineering another field he had helped pioneer.

Some Americans aren't in a rush to get a COVID-19 vaccine: Experts understand, but say there's no need to wait.

For several years, Moderna has been collaboratingon vaccine development withscientists at the National Institute of Allergy and Infectious Diseases, the agency led by Dr. Anthony Fauci.

By the end of 2018 when Moderna went public,it was the biggest initial public offering ever for a biotech company, though shares fell 19% that first day as investors worried it was overpriced.

A year later the company was testing 20 different mRNA's in humans five or six times more research programs than the typical biotech.

That was enough, said Nina Deka, a senior research analyst at ROBO Global, for her fund to decide to make Moderna one of the 85 companies included in its portfolio of health care technology and innovation stocks.

Moderna had recently announced plans to develop a COVID-19 vaccine when ROBO Global decided to invest.

"Not because of what they did this year, but what they've done since the start of the company," Deka said.

With two mRNA vaccines under development, ROBO Global expected that even if Moderna's vaccine didn't succeed, the technology would advance, buoying everyone in the industry.

"It's not just vaccines. It's also cancer. It's also orphan drugs" for rare diseases, she said.

The company had just built a brand new production facility in the Boston suburb of Norwood, and it was using advanced artificial intelligence to direct its research, which ROBO Global appreciated,Deka said.

Plus, it was breaking speed records with its candidate COVID-19 vaccine.

"The next question is," Deka said,"if they can do this quickly, what else can they do?"

Contact Karen Weintraub at kweintraub@usatoday.com

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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US gets more help in raging battle against COVID-19 as FDA authorizes Moderna vaccine, the second allowed for emergency use - USA TODAY

DetailsCategory: DNA RNA and CellsPublished on Friday, 04 December 2020 14:55Hits: 1020

GAITHERSBURG, MD, USA and SUZHOU BIOBAY, China I December 3, 2020 I Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, announced today that the company has received feedback from the U.S. Food and Drug Administration (FDA) and may now proceed with a planned Phase I clinical study of its leading drug candidate, STP705, for treatment of multiple types of liver cancer.

The FDA has provided valuable feedback on the company's proposed trial design for a "Phase 1 Multicenter, Open-Label, Dose Escalation Study and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of STP705 Administered Intratumorally in Cholangiocarcinoma, Hepatocellular Carcinoma or Liver Metastases in Subjects With Advanced / Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy." The first patient is expected to be enrolled in the study in the first quarter of 2021. STP705 is a small interfering RNA (siRNA) therapeutic that utilizes a proprietary polypeptide nanoparticle (PNP)-enhanced delivery system to inhibit expression of TGF-1 and COX-2 in targeted tissue and cells. Preclinical animal models have demonstrated its effective anti-tumor activity for treatments of cholangiocarcinoma and hepatocellular carcinoma.

"Receiving the required feedback from the FDA now permits us to proceed with this Phase Istudy that represents an important step forward in demonstrating the broader clinical utility of our siRNA therapeutic candidates," said Patrick Y. Lu, PhD, Sirnaomics' Founder and CEO. "Liver cancer treatment remainsacritical unmet need globally and especially in Asian countries. Ourclinical strategy leveraging STP705's FDA Orphan Drug designation for the treatment of cholangiocarcinoma and hepatocellular carcinoma will potentially be highly beneficial to patients suffering these life threatening diseases in both the US and Asia. We are anticipating that this clinical study will contribute to the expanding clinical evidence supportingextensivetherapeutic potential of STP705 against various cancers."

"Liver cancer continues to be a devastating disease for patients with high mortality and high unmet medical need," stated Michael Molyneaux, MD, Sirnaomics' Chief Medical Officer. "This disease fits with Sirnaomics mission to bring lifesaving drugs to patients with severe debilitating medical illness. We hope to gain important insight into the potential safety and efficacy of STP705 in this Phase I trialand we expect to build on the data from this study to expand into other oncology indications."

About Liver Cancer

Liver cancer is a global health problem, with liver neoplasms representing the second-most frequent cause of cancer-related death. There are many different types of liver cancers including hepatocellular carcinoma (HCC), cholangiocarcinoma (CCA), liver angiosarcoma, hepatoblastoma and others. Additionally, liver is a highly metastasis-permissive organ. It is the most frequently afflicted organ by metastasis and liver metastases are much more common than primary hepatic tumors. The distinctive biology of the liver renders it intrinsically susceptible to metastases. The true prevalence of liver metastasis is unknown, but between 30% and 70% of patients dying of cancer have liver metastases and most patients with liver metastases will die of their disease.

STP705 and Liver Cancer

Over expressions of TGF-1 and COX-2 have been well-characterized as playing key regulatory roles in tumorigenesis. TGF- is produced by different liver cells and is demonstrated to induce tumor cell migration and survival. TGF- has been found to be overexpressed in metastatic HCC tissues. Overexpression of TGF- is generally accepted to be associated with metastasis and poor prognosis. COX-2 is reported to be highly expressed in cancer stem cells and promotes cell migration in HCC cell lines. Additionally, inhibition of COX-2 suppresses cell migration and induces apoptosis. As such TGF-1 and COX-2 are excellent therapeutic targets for treatment of liver cancer.

STP705 is composed of two siRNA oligonucleotides targeting TGF-1 and COX-2 mRNA respectively and formulated in nanoparticles with a proprietary Histidine-Lysine Co-Polymer (HKP) peptide. Each individual siRNA has demonstrated the ability to inhibit the expression of their target mRNA and combining the two siRNAs produces a synergistic effect that diminishes pro-fibrogenic, pro-inflammatory, and pro-tumorigenic factors. Sirnaomics has completed numerous pre-clinical studies that demonstrate that inhibition of TGF-1 and COX-2 is expected to result in the inhibition of tumor growth and provide an alternative approach for the treatment of various liver cancers. Molecular analyses of the effects of administering the combination demonstrated that the inhibition of these targets had effects on downstream gene products associated with numerous oncology targets. Additional immunohistochemistry and image analyses of the liver and tumor tissues demonstrated that animals treated with STP705 resulted in increased CD4+ and CD8+ T cell infiltration within the tumor microenvironment. Using STP705 for treatments of hepatocellular carcinoma and cholangiocarcinoma have been designated as Orphan Drug indications by U.S. FDA. STP705 has also been evaluated in a Phase IIa clinical trial for treatment of Non-melanoma skin cancer.

About Sirnaomics, Inc.

Sirnaomics, Inc., a leading privately held biopharmaceutical company for discovery and development of RNAi therapeutics, is a Delaware corporation headquartered in Gaithersburg, Maryland, USA, with subsidiaries in Suzhou and Guangzhou, China. The Company's mission is to develop novel therapeutics to alleviate human suffering and advance patient care in areas of high unmet medical need. The guiding principles of the company are: Innovation, Global Vision with a Patient Centered focus. Members of the senior management team have a combined experience in the biopharmaceutical industry, spanning clinical development, regulatory, financial and business management in both the USA and China. The company is supported by funding from institutional investors, corporate partnerships and government grants. Sirnaomics has developed a strong portfolio of intellectual property with an enriched product pipeline. The therapeutic areas of focus include oncology, anti-fibrotic, anti-viral and metabolic therapeutics. Learn more at http://www.sirnaomics.com.

SOURCE: Sirnaomics

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Sirnaomics to Initiate Phase I Study of STP705 in Treatment of Primary and Metastatic Liver Cancer | DNA RNA and Cells | News Channels -...

Donald Trump

A car with US President Trump drives past supporters in a motorcade outside of Walter Reed Medical Center in Bethesda, Maryland on October 4, 2020. - US President Donald Trump drove past supporters outside the hospital where he was being treated for Covid-19, after announcing on Twitter a "suprise visit" to his backers. ALEX EDELMAN/AFP via Getty Images

Ahead of President Donald Trump's Monday discharge from the care of Walter Reed Medical Center, where hehad been treated forthree days for symptoms of COVID-19, came atweet.

"Don't be afraid of Covid," the presidentclaimed, inpart because the country had developed "some really great drugs."

However, the president himself who once suggested injecting household disinfectants to treat the deadly disease had just become one of thefirst 10 patients granted anextraordinarily rare level of access toan experimental antibody infusion to combathis COVID-19 infection, Salon hasconfirmed.

The treatment, a cocktail of human antibodies and anti-bodies cloned from stem cells, was manufactured by Regeneron. The pharmaceutical company onlyannouncedthe results of a phase 1/2/3 trial onSept. 29, or two days before the president tested positive. The treatment, which is still pending approval from the Food and Drug Administration,proved most effective for patients with weak immune systems.

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Hours afterreceiving the treatment on Friday, Trump was flown from the White House to Walter Reed Medical Center. The White House saidat the time that the president had"mild symptoms." Trump's personal physician, Dr. Sean Conley, later acknowledged that he exhibited low oxygen levels and a fever.

Story continues

But Conley would not disclose the results of Trump's lung scans, only saying they showed "expected findings." Experts noted that Conley did not say the president's lungs appeared healthy,leaving open the possibility ofinflammation or pneumonia.

Trump returned to the executive mansion three days later. After a balcony photo-op appearance, during which time his breathing appeared labored, the president remains at 1600 Pennsylvania Ave. Conley says Trump reports no symptoms medically different from "showing signs," which are noticed and reported by an attending physician.

After his experience at Walter Reed, Trump declared that Americans should not let the coronavirus, which has killed more than 210,000 people in the U.S. over the last seven months, "dominate your life."

Outside of clinical trials, almost no American has access to the treatments which were available to the president.The Food and Drug Administration limits compassionate use ("expanded access")to patients with "animmediately life-threatening condition or serious disease or condition" when "no comparable or satisfactory" alternativesare available.

Patients often wait for approval, which can includean involved review and regulatory processbetween the patient, the physician, the pharmaceutical company and the government. Typically, companies grant compassionate use free of charge, but other monoclonal antibodies currently on the market cost thousands of dollars.

"All we can say is that they asked to be able to use it, and we were happy to oblige," RegeneronCEO Dr. Leonard Schleifer toldThe New York Times. Though Trump was not the first patientgranted expanded access to the drug, Schleifer said, "When it's the president of the United States, of course, that gets obviously gets our attention."

"Presidential medicine is and has been unique," Arthur L. Caplan, professor of medical ethics at the N.Y.U. Grossman School of Medicine, toldThe Times. "If his doctors think an intervention might be helpful, and if that judgment is confirmed by outside experts they talk to and if things look dire or serious, then the president will get access to any and all agents."

Schleiferhas been a member atTrump's Westchester, N.Y., golf club,and his companytook$450 million in federalfunding this summer from Operation Warp Speed, which is the administration's moonshot projectto fast-trackCOVID-19 vaccines andtreatments, according toCNN Business.

"Len and President Trump are acquaintances from both living in the Westchester area for many years but didn't have any regular contact until this year, when they've discussed matters around COVID on occasion," a Regeneron spokesperson told CNN Business.

Schleifer is an active political donor, who predominantly gives to Democratic candidates. In 2016, Schleifergave more than $55,000 to committees supporting Hillary Clinton, but he has not yet donated to Democratic nominee Joe Biden, per FEC records. Hisson, Adam,lost a Democratic primary bid this summer for New York's 17th Congressional District.

"We don't share details on who has/hasn't submitted a compassionate use request, but as we've stated, only a small number of these requests have been approved forrareand exceptional circumstances, and that will continue to be the case," a Regeneron spokesperson told Salon in an email.

The spokesperson said the company was notaware of any side effectsoccurring in compassionate use cases and referred Salon to the FDA. The FDA did not reply to Salon's requests for comment.

In order to qualify for compassionate use, the FDA says, patients must meet a number of requirements: the disease or condition must be seriousor "immediately" life-threatening;there can be "no comparable or satisfactory alternative therapy to diagnose, monitoror treat the disease or condition"; clinical trials must be out of the question; potential benefitsmust justifypotential risks; and the treatment must not interfere with clinicaltrials that could supportproductdevelopment "or marketing approval for the treatment indication."

Given its extremely limited supply, Schleifer told CNBC that the international headlines put his company in a "very tough situation."

"Giving it to [Trump] or to others who might not be able or don't qualify for clinical trials is the right use of compassionate use. That's for small numbers of people, for these exceptions,"he said. "We want everybody to be potentially able to benefit. We understand we don't make that decision. This is a decision the FDA has to make."

Through no fault of Regeneron's own, however, the company may have harnessed one of the most powerful marketing platforms on the planet Trump's Twitter feed.

Fox News Geraldo Rivera criticizes Trump for not wearing a mask: "This disease kills old people!"

Kellyanne Conway curses out daughter in TikTok video: Youve lied about your own f*cking mother"

"They gave me Regeneron. It's called Regeneron," the president said in a Wednesday video published tohis feed, erroneouslynaming the drug company instead of its treatment."And other things, too. But I think this was the key. But they gave me Regeneron. And it was,like, unbelievable. I felt good immediately."

Trump claimed that he had "authorized" the treatment.However,it wasunclear what steps, if any, had been taken to expand its availabilityto more Americans.

More here:
Trump was one of the first 10 patients to get an experimental COVID-19 treatment under special use - Yahoo News

It successfully launched on an Antares rocket from Virginia Space's Mid-Atlantic Regional Spaceport at NASA's Wallops Flight Facility.

Toilets in space

Removing gravity from the equation means that nothing functions in space the way it does on Earth -- toilets included.

While the existing toilets are reliable, the new design is more user-friendly and easier to maintain, Morgan said.

The new compact toilet includes a funnel and hose for urine and a seat for bowel movements. In the absence of gravity, air flow pulls these away from the body.

The new design begins air flow automatically as soon as the lid is lifted on the toilet. This also helps control odor.

The new design is about 65% smaller and 40% lighter, with more efficient waste management and storage. This will come in handy as more crew members come to stay on the space station with the addition of the Commercial Crew Program, which can carry more astronauts in a single launch.

Astronaut feedback from using the existing toilets on the space station went into this new design, which is more ergonomic, requires less cleanup, is easier to maintain, has parts that are durable and is resistant to corrosion. The funnel and seat of this design can also be used simultaneously, which was incorporated

after feedback from female astronauts.

"The toilet is a great example of including all the feedback from various crewmembers," Meir said. "This better accounts for those, much easier for everyone to use up there."

The existing toilet was designed some time ago when there were few, if any, female astronauts staying on the space station. This design now better accounts for anatomical differences between men and women, Meir said.

Since water is a key factor of the life support systems on the space station, as well as those that will be used in future exploration of the moon and Mars, the astronauts' urine does not go to waste.

"We recycle about 90% of all water-based liquids on the space station, including urine and sweat," Meir said in a separate statement. "What we try to do aboard the space station is mimic elements of Earth's natural water cycle to reclaim water from the air. And when it comes to our urine on ISS, today's coffee is tomorrow's coffee!"

The toilet's urine transfer system will pretreat the urine and feed it into a regenerative system that recycles the water.

A second toilet like this will be installed in the Orion spacecraft to be used for the Artemis II flight test, which will send astronauts on a 10-day mission beyond the moon and back in 2023.

A virtual reality spacewalk

If you've ever watched astronauts conducting a spacewalk outside of the space station and wanted to know what it was like, a new camera will capture that experience in immersive 3D.

Felix & Paul Studios, helmed by creative directors Felix Lajeunesse and Paul Raphael, have partnered with the ISS National Lab in its ongoing "ISS Experience" virtual reality series. They previously sent up a camera in 2018 to document life inside the space station.

Now, the team, along with commercial partner Nanoracks, has modified a camera to withstand exposure to space and handle variable light exposure as the station passes through various sunrises and sunsets each day.

The camera will be mounted on the robotic arm Canadarm2 and film a spacewalk, from beginning to end, as well as the exterior of the space station and perspectives of the Earth.

These will be included in the final episodes of the series "Space Explorers: The ISS Experience." It will be available to watch on multiple platforms.

"This new EVA camera will enable that 3D immersive experience during a spacewalk," Meir said. "Spacewalks are the most challenging things that we do, both mentally and physically, and also the most exciting. You're out there in your own little spacecraft looking down on Earth with nothing between the void of space except for the thin visor of your helmet."

Meir participated in multiple spacewalks, including the first all-female spacewalk with fellow NASA astronaut Christina Koch in 2019.

Taking this camera outside of the space station after seeing the power of it inside the station will really make people feel like they're there, Morgan said. He also sees potential for the camera to be used as a way to train astronauts as they prepare for spacewalks.

When gravity isn't a factor

A variety of scientific experiments have taken place on the space station because the orbiting laboratory provides a unique environment that removes gravity as a factor.

One of the growing areas of research on the space station includes therapies for diseases like cancer.

Kernal Biologics is sending up an investigation that will use the microgravity environment to improve messenger RNA immunotherapy treatment for leukemia. Messenger RNA, or mRNA, is in all human cells to help create proteins, but it can differ in cancer cells compared to healthy cells.

Under the normal gravity conditions we experience on Earth, drugs tested for this are onco-selective, which means they can identify cancer cells from healthy cells and destroy the malignant cells. The microgravity environment of the space station can cause changes in mRNA. If these drugs are also effective in the microgravity environment, they could provide safer, more affordable and effective therapies for leukemia and other cancer treatments.

Other things are possible on the space station that simply can't happen on Earth, like cool diffusion flames. These flames, which burn at temperature below 752 degrees Fahrenheit, were first witnessed in an experiment on the space station in 2012. They don't exist on Earth.

"All flames have cool temperature chemistry that's going on," said Peter Sunderland, investigator of the experiment and a professor at the University of Maryland's A. James Clark School of Engineering. "Gravity is ubiquitous in combustion because hot gases rise, and a candle flame is narrow and tall. In microgravity, you get a much larger and spherical flame."

His experiment, funded by the National Science Foundation, could have implications for the efficiency of combustion engines and even help reduce emissions on Earth. During the investigation, researchers will look to observe spherical flames in microgravity to better understand the physics of cool diffusion flames.

Multiple experiments by students sponsored by the ISS National Lab also are included in the launch.

Researchers and graduate students at the University of Adelaide in Australia have an experiment that will help determine how microgravity and radiation impact the stability of pharmaceutical tablets. This will take place inside the space station, and a second experiment will occur in Alpha Space's MISSE (Materials International Space Station Experiment) Flight Facility on the exterior of the space station.

The University of Georgia is sending up its Spectral Ocean Color Satellite, a CubeSat, or miniaturized satellite, that can capture images used to monitor water quality and determine the health of ecosystems like coastal wetlands. Once it has arrived, this loaf-size satellite will launch from the space station on a Nanoracks deployer.

"The ISS National Lab takes great pride in working with our education and implementation partners to enable student researchers to take their science, engineering and technology questions to space far beyond their normal lab settings on Earth," said Michael Roberts, interim chief scientist at the Center for the Advancement of Science in Space and manager of the ISS National Lab.

"By collaboration with educators to support education projects on the space station, we hope to instill in students a lifelong interest in science and inspire them to pursue exciting career opportunities available in STEM fields."

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New toilet, a VR camera and science experiments are heading to t - KAKE

EASTON ShoreRivers has announced the receipt of a Maryland Department of Natural Resources Trust Fund grant to complete two large ecological restorations on the Eastern Shore that will significantly reduce nutrient and sediment pollution entering local rivers.

In the Wye River watershed, ShoreRivers will restore 29 acres of marginal cropland to ponds, wetlands, and forest.

In the Sassafras River watershed, ShoreRivers will restore 16 acres of floodplain and 4,800 feet of stream. This project will result in the complete restoration of the entire length of the stream, from a headwater agricultural ditch to the main stem of the Sassafras.

The projects are slated to begin this fall and be completed by December 2021.

Wye River Restoration at Chesapeake College

The Chesapeake College Agriculture to Ecosystem project will convert 28.72 acres of an agricultural field with a badly incised ditch that drains nutrient and sediments to the Wye East River.

The land will be removed from production, converted into two ponds, a series of wetland cells with habitat islands, planted infiltration berms and approximately 13.5 acres of tree plantings. The campus of Chesapeake College is located at the headwaters of the Wye East River.

This site will undergo a total conversion from an agricultural field to high quality wetland and forest habitat, all in view of heavily trafficked U.S. Route 50. This project will complement ShoreRivers regenerative stormwater conveyance project installed on a separate stream on the Chesapeake College campus, in addition to bioretentions, tree plantings, wildflower meadows, switchgrass buffers and a wetland that have been installed throughout the campus.

The project will also incorporate a walking path to allow students to use the project as an outdoor laboratory.

Sassafras River Stream Restoration

The project in the Sassafras River watershed will restore 16 acres of floodplain wetlands and 4,800 feet of a headwater stream in the upper Sassafras. Combined with a recently completed restoration of 3,800 feet of stream also funded by Maryland DNR, this project represents 8,000 consecutive feet of stream restoration beginning in a headwaters agricultural ditch and flowing all the way to the main stem of the Sassafras River.

This restoration site is directly downstream of a ShoreRivers sampling site that historically has the highest monitored nutrient concentrations in the non-tidal Sassafras. The drainage is mainly agricultural but includes 43 acres of state and county roadways.

Heavy stormflow runoff events have incised the stream channel with steep, eroding banks that are disconnected from its historic floodplain and subsequently unable to disperse stormflow energy, continually increasing the severity of bank erosion and over-widening of the channel.

This restoration, designed by Ecotone Ecological Restoration in consultation with ShoreRivers, goes beyond the consideration of nutrient processing and sediment storage, placing significant emphasis on promoting quality of in-stream and floodplain habitat, ecological uplift and biodiversity.

The restoration will promote higher dissolved oxygen levels within the stream system and lower water temperatures. This, along with connectivity of the floodplain, restoration of groundwater hydrology, seep habitat and vernal pool wetlands, will provide critical habitat for a range of amphibians, reptiles, insects and fish, and improve fish passage through the system to the Sassafras River headwaters.

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ShoreRivers awarded DNR grant for two restoration projects - MyEasternShoreMD