StemCell Therapy

(CNN) Cats can infect other cats with the novel coronavirus, but they may not show any symptoms, according to a study published Wednesday.

The findings add to a growing body of research showing how cats, big and small, can contract the virus. But experts say there is no evidence felines are contributing to the spread of Covid-19.

In the study, researchers infected three cats and found that all of them were shedding the virus after three days. When the infected cats were paired with healthy ones housed together for a few days the healthy cats developed the virus, too.

None of the animals in the study showed any symptoms such as abnormal temperatures or substantial weight loss.

The first two cats in the United States to test positive both New Yorkersshowed mild respiratory symptoms, although both were expected to make a full recovery. Eightlions and tigersat the Bronx Zoo also tested positive.

The team behind the new study, led by international virus expert Yoshihiro Kawaoka of the University of Tokyo and scientists from the University of Wisconsin, said more research is needed to better understand whether cats could transmit the virus to humans as well. So far, there is no evidence that they can.

Given the need to stop the coronavirus disease 2019 pandemic through various mechanisms a better understanding of the role cats may play in the transmission of SARS-CoV-2 to humans is needed, they wrote in aletterto the New England Journal of Medicine.

The American Veterinary Medical Association noted that the new research was conducted in a lab and its unclear whether cats can be as easily infected in the real world. A small number of animals worldwide are confirmed to have the virus, the group said in a statement. There is no evidence to date that these relatively few naturally infected animals have played any role in transmitting COVID-19 to humans, it said.

While officials are still learning more about coronavirus and pets, the US Centers for Disease Control and Preventionrecommendslimiting interactions between pets and people or animals outside of a household.

Keep cats indoors whenever possible, the CDC says, and walk dogs on a leash, maintaining a distance of at least six feet from other people and animals. The agency also recommends keeping dogs away from public places where large numbers of people and animals gather, such as dog parks.

If someone is ill with Covid-19 whether suspected or confirmed officials recommend another member of the household care for pets. If thats not possible, people should wear cloth face coverings around animals, making sure to wash their hands before and after any interactions.

And when people are sick, officials say they should refrain from petting or snuggling with their pets and avoid being kissed or licked by them.

Click here for more coronavirus coverage.

The-CNN-Wire & 2020 Cable News Network, Inc., a WarnerMedia Company. All rights reserved.

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Cats can infect other cats with coronavirus, researchers find - Boston News, Weather, Sports | WHDH 7News

What do we know about animals and the coronavirus that causes COVID-19? Can a person spread the virus to their pets or contract it from their cat or dog? How is the virus able to move between species? Are zoo animals at risk?

The COVID-19 pandemic has many of us asking these and other questions. To help provide some answers, One Health at UCalgary is hosting a panel of human and animal health experts at a one-hour online conversation on May 27 at 7p.m. During the online event, Drs. Rebecca Archer, a small animal veterinarian, Craig Jenne, an infectious disease specialist, and Doug Whiteside, a zoo veterinarian, will discuss what we do and dont know about animals and COVID-19.

Pet owners are concerned. They want to understand the risk of transmission between them and their animals and how best to mitigate the possibility of spread, says Archer, DVM, a small animal clinical instructor at the University of Calgary Faculty of Veterinary Medicine (UCVM).

While the novel coronavirus is, as its name suggests, a new virus, infectious diseases spread from animals are not new. Three quarters of emerging infectious diseases in people come from animals. But how is the virus that causes COVID-19 able to move between species?

This, unfortunately is where most 'new'viruses come from, says Jenne, PhD, associate professor in the Cumming School of Medicine, member of the Snyder Institute for Chronic Diseases and Canada Research Chair in Imaging Approaches Towards Studying Infection.

This often occurs when a virus that is endemic or common within one species, or closely related species, acquires a mutation that allows it to 'jump'species.

Jenne says this often happens when a virus mutates the protein responsible for sticking to the host cells allowing the newly emerging virus to stick to the cells of a new host.

Although this process has been brought into the spotlight with the COVID-19 pandemic, it is always occurring, and increased interaction between humans and animals, whether wild or domesticated, increases the chances in the future that mutations allow other 'new' viruses to make the jump.

And its that fact that makes whats known as a One Health approach crucial in addressing the COVID-19 pandemic. One Health is a collaborative, transdisciplinary, and multisectoral approach to complex problems that recognizes the interconnection of people and animals in the spaces they share.

COVID-19 emerged at the interface of people, animals, and the environment, says Dr. Herman Barkema, DVM, professor, epidemiology of infectious diseases in UCVM and the Cumming School of Medicine, NSERC Industrial Research Chair in Infectious Diseases and director, One Health at UCalgary.

More than ever, we understand that complex problems that impact the health of people, animals, and their common environments must be addressed using a One Health approach one thats transdisciplinary and collaborative.

Have a question youd like answered? Register now and send your question before the event to onehealth@ucalgary.ca, inserting COVID-19 and Animals in the subject line.

Providing One Health leadership is one of the commitments of UCVMs One Community, One Health Strategic Plan.

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What's the risk of COVID-19 spread between people and animals? - UCalgary News

Eyeball-licking geckos, wiggling brain cells and a whole planets worth of weather are among the winners in the University of WisconsinMadisons 10th Cool Science Image Contest.

The quality of the images and videos produced on campus by scientists and people passionate about science is always so impressive, says Terry Devitt, a judge and one of the founders of the contest. It is always a very hard job, but a very enjoyable one, to choose the best among them.

A panel of nine experienced artists, scientists and science communicators judged the scientific content and aesthetic and creative qualities of the 101 images and videos entered in the 2020 version of the contest, which began as part of The Why Files, one of the first popular science news websites.

Cameron Batchelor and Ethan Parrish, graduate students, Geoscience, for a look at the climate-describing bands of color in a slice of stalagmite.

Natalie Betz, associate director, UWMadison Master of Science in Biotechnology, and Anya Wolterman, Macalester College undergraduate geology student, for their section of rock from a rift in the Earths crust in the Lake Superior region.

Caitlin Carlson, graduate student, Department of Bacteriology, for a view of a pair of leaf cutter ants sniffing out each others pheromone thumbprint.

Collin Roland, graduate student, and Lucas Zoet, assistant professor, Department of Geoscience, for a birds-eye view of bluff erosion on the Lake Michigan shore.

Guilherme Gainett, graduate student, and Prashant P. Sharma, assistant professor, Department of Integrative Biology, for an electron micrograph of the spiny leg of a new species of spider.

Ran Zhang, scientist, and Dalton Griner, graduate student, Department of Medical Physics, for an X-ray of flowers used to test and improve mammograms.

Nisha Iyer, postdoctoral fellow, Wisconsin Institute for Discovery, for a picture of a crested gecko licking its own eyeball.

Robert Morgan, graduate student, and Keith Bechtol, assistant professor, Department of Physics, for a snapshot of thousands of distant galaxies made while hunting for the source of a single subatomic particle.

Michael Petersen, Edward Williams and Ray Collier, all staff of the Wisconsin Crop Innovation Center; and Frank McFarland, graduate student, Department of Agronomy, for their image of the first transgenic hemp plants.

Miranda R. Sun, research specialist, Department of Comparative Biosciences, for a brightly colored section of a developing mouse embryo.

Rick Kohrs, instrument technologist, Space Science and Engineering Center, whose animation of 90,000 satellite images shows a full year of Earths weather.

Chris Morrow and Tiaira Porter, graduate students, Department of Neuroscience, for a video capturing the movement of neural stem cells switching from dormancy to activity.

STORY CONTINUES AFTER GALLERY

1 This slice of stalagmite at 250,000 years old, the oldest dated stalagmite in the Midwest is being used to study the climate of ancient mid-continental North America. The colored layers reflect changes in soil above the cave in which the stalagmite formed, with rich soil (and thicker vegetation) revealed in deeper orange bands and less organic matter (and fewer plants) in light green.

Cameron Batchelor, and Ethan Parrish, graduate students, GeoscienceDigital camera

2 This thin section of troctolite, an igneous rock composed of feldspar and olivine, was collected near Duluth, Minnesota, from the Proterozoic Midcontinent Rift. The rift is a tear in the Earths crust caused by continental plates colliding in the Lake Superior region. Polarized light accentuates vivid colors.

Natalie Betz, associate director, UWMadison Master of Science in Biotechnology; Anya Wolterman, Macalester College undergraduate geology studentPetrographic microscope

3 Each colony of leaf cutter ants has a unique chemical thumbprint, a combination of pheromones that members of the colony can recognize as their own. These two Acromyrmex echinatior ants from different colonies are inspecting each others pheromone signatures.

Caitlin Carlson, graduate student, BacteriologyDigital camera with macro lens

4 Storm-driven Lake Michigan waves cut away bluffs in Warnimont Park in Cudahy, Wisconsin, while the freeze and thaw of seeping groundwater wear at the crest. Researchers study the intertwined effects of waves and groundwater on erosion with three-dimensional models of coastal bluffs based on overhead images captured by drone flights.

Collin Roland, graduate student, and Lucas Zoet, assistant professor, GeoscienceDJI Phantom 4 Advanced unmanned aerial vehicle

5 The spines armoring the leg of a tiny, newly described species of huntsman spider, Zalmoxis adze, are a remarkable work of sexual dimorphism theyre completely absent in females. While leg details were an important way to differentiate this spider as a new species, little is known about how the heavy spikes serve males in the leaf litter on the forest floor of Papua New Guinea. But it may be very showy or very violent.

Guilherme Gainett, graduate student, and Prashant P. Sharma, assistant professor, Integrative BiologyField emission scanning electron microscope

6 Flowers stand in for healthy breast tissue in this mammography image, while added calcifications Can you spot them all? represent the sort features doctors look for in X-ray images in an effort to catch breast cancer in early, treatable stages. UWMadison researchers are working to improve detection of patterns of tiny calcifications for faster, safer, more effective diagnosis.

Ran Zhang, scientist, and Dalton Griner, graduate student, Medical PhysicsSelenia Dimensions Mammography System

7 Crested geckos have clear, immovable eyelids, and a swipe of the tongue is the best way to keep them clean and moist. With veritable superpowers like the ability to see in the dark and climb vertical surfaces, geckos often serve as models for bio-inspired engineering.

Nisha Iyer, postdoctoral fellow, Wisconsin Institute for DiscoveryDigital camera

8 This snapshot of the sky contains thousands of distant galaxies, each containing billions of stars. The UWMadison physicists who made it were looking for the flash of the explosion of a single star, the potential source of a sub-atomic particle called a neutrino, spotted zipping through the Earth by the IceCube Neutrino Observatory at the South Pole. The distant galaxies, swirling billions of light years away, are all the harder to see because of nearby objects, like the pictured Helix Nebula.

Robert Morgan, graduate student, and Keith Bechtol, assistant professor, PhysicsDark Energy Camera and Victor M. Blanco Telescope

9 Thanks to a gene similar to one that makes some fish glow, leaves of the first transgenic that is, augmented with genes from another species hemp plants appear red when seen through a special filter, while leaves of an unaltered plant are a familiar green. Successfully engineering changes in hemp opens the door to alterations that could affect disease resistance, crop yield, fiber quality and cannabinoid compounds. It offers potential benefits for farmers, consumers and medical applications.

Michael Petersen, Edward Williams and Ray Collier, all staff of the Wisconsin Crop Innovation Center; and Frank McFarland, graduate student, AgronomySmartphone with specialized filter

10 This section of the head of an 11-day-old mouse embryo was expertly prepared to highlight blood vessels marked by the green and red of endothelial cells and laminin protein, respectively in the developing brain (the heart-shaped structure at the center). The vessels are particularly dense at the lower end of the two black slits that will become nostrils, where tissue is fusing together to form the upper lip. If the tissue fails to fuse, the mouse will be left with a birth defect studied by the researchers in the lab that produced the image: a cleft lip.

Miranda R. Sun, research specialist, Comparative Biosciences, School of Veterinary MedicineEpifluorescence microscope

Combining more than 90,000 individual images taken by five satellites two American, one Japanese and two from the European Space Agency perched 22,000 miles above the Earth makes for an animated view of global weather patterns. Strong storms span many days, and seasonal shifts come and go as the sunlight over the poles waxes and wanes and the planet spins from March 2019 to March 2020.

Rick Kohrs, instrument technologist, Space Science and Engineering CenterGeostationary satellites

Neural stem cells switch from a dormant to an active very active, in many cases state in this video from the lab of Neuroscience Professor Darcie Moore. The vigorous wigglers are starting a protein-maintenance program critical for efficient activation and differentiation into health brain cells.

Chris Morrow and Tiaira Porter, graduate students, NeuroscienceConfocal microscope

CONTINUED FROM ABOVE

There was enthusiastic support right out of the gate, and that enthusiasm has grown year after year, says Devitt, once editor of The Why Files and the recently retired director of research communications at UWMadison. Sharing science through imagery is another way to show how science works, and what you can learn from getting a close-up view of nature. And we all love to see something new and amazing.

The contest winners along with a slideshow of all entries are typically displayed each fall in the McPherson Eye Research Institutes Mandelbaum & Albert Family Vision Gallery on the ninth floor of the Wisconsin Institutes for Medical Research, 1111 Highland Ave. An exhibit will be scheduled and announced as activity on campus allows.

The 2020 winners show off the breadth of research and technical and scientific expertise at UWMadison. The images were captured by experts in their scientific fields, trainees, students and curious amateurs, using flying drones, smartphones, cutting-edge electron microscopes and Earth-facing satellites orbiting tens of thousands of miles away.

Their subjects are both everyday and ephemeral, large enough to encompass billions of stars, and more minuscule than an ant.

The Cool Science Image Contest helps recognize the technical and creative skills required to capture images or video that document science or nature, and benefits from sponsorship by Madisons Promega Corp., with additional support from DoIT Digital Publishing and Printing Services and the UWMadison Division of the Arts.

Winning entries are shared widely on UWMadison websites and in public exhibitions, and all entries are showcased in a slide show at the Wisconsin Science Festival.

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Photo gallery The winners: Cool Science Images 2020 - University of Wisconsin-Madison

Dublin, May 26, 2020 (GLOBE NEWSWIRE) -- The "Non-Contact Infrared Thermometer Market - Global Outlook and Forecast 2020-2025" report has been added to ResearchAndMarkets.com's offering.

The infrared thermometer market is expected to grow at a CAGR of over 15% during the period 2019-2025.

The global infrared thermometer market is going to witness growth due to the worldwide outbreak of the COVID-19 pandemic. This pandemic has resulted in a spike in demand for several medical devices, which include nebulizers, blood pressure monitoring devices, medical ventilators along with the non-contact thermometer. In an attempt to contain the highly contagious virus, temperature monitoring has become an essential component across public places, including shopping malls, airports, offices, schools, thereby increasing the demand for non-contact thermometers.

The following factors are likely to contribute to the growth of the infrared thermometer market during the forecast period:

The study considers the present scenario of the infrared thermometer market and its market dynamics for the period 2019-2025. It covers a detailed overview of several market growth enablers, restraints, and trends. The study offers both the demand and supply aspect of the market. It profiles and examines leading companies and other prominent ones operating in the market.

This research report includes a detailed segmentation by product type, application, and geography. The infrared forehead non-contact thermometers market accounted for the largest share of 61% in 2019. Contactless thermometers are easy to use and provide faster results that are highly recommended to measure temperatures in babies and infants. This is increasing the share of the contactless thermometer market. They are considered as reliable, comfortable, and accurate option to measure body temperatures, especially for pediatrics.

Vendors are implementing new technology such as intelligent light indicators to indicate fever levels. They are likely to introduce smart technologies that allow the thermometer to be connected to an external mobile application via Bluetooth.

In-ear thermometers are more popular than forehead ones for measuring temperatures among pets. Due to the presence of fur and different sweat apparatus, forehead temperature scans are not proven to be helpful in veterinary medicine. However, in-ear and rectal temperatures have shown conflicting results. Thus, reliability remains a key challenge for the market.North America is expected to witness continued improvement, contributing to the highest incremental growth of $73.59 million by 2025. The evolving consumer confidence and technology is likely to increase the demand for non-contact thermometers in veterinary medicine.

The global infrared thermometer market size is undergoing major transformations. The demand is flourishing due to innovations and technological advancements. Therefore, global players are focusing on business expansion plans to increase the geographic reach of their products.

Global outreach efforts are particularly strong in many emerging economies of the APAC and MEA regions. Several infrared thermometer manufacturers in the US and Europe are beginning to design and manufacture their products locally. For instance, key players such as Medtronic, Braun, and Cardinal Health generate significant revenue from global sales. Hence, several large global players are willing to enter emerging markets to increase their sales volume and profit margins.

Prominent Vendors

Other Prominent Vendors

Key Questions Answered:

Key Topics Covered:

1 Research Methodology

2 Research Objectives

3 Research Process

4 Scope & Coverage4.1 Market Definition4.1.1 Inclusions4.1.2 Exclusion4.2 Base Year4.3 Scope Of The Study4.4 Market Segments4.4.1 Market Segmentation by Product Type4.4.2 Market Segmentation by Application4.4.3 Market Segmentation by Geography

5 Report Assumptions & Caveats5.1 Key Caveats5.2 Currency Conversion5.3 Market Derivation

6 Market at a Glance7 Introduction7.1 Overview

8 Impact Of Covid-198.1 Impact Of Covid-19 On Infrared Non-Contact Thermometer Market

9 Market Opportunities & Trends9.1 Growth In Medical Tourism9.2 New Product Development9.3 Growing Demand For Multifunction Non-Contact Thermometer

10 Market Growth Enablers10.1 Growing Prevalence Of Healthcare Acquired Infections10.2 Ban Of Traditional Mercury In Glass Thermometers10.3 Rising Expenditure On Preventive Healthcare

11 Market Restraints11.1 Availability of Innovative Temperature Monitoring Devices11.2 Stringent Regulatory Requirements

12 Market Landscape12.1 Market Overview12.2 Market Size & Forecast12.3 Five Forces Analysis12.3.1 Threat of New Entrants12.3.2 Bargaining Power of Suppliers12.3.3 Bargaining Power of Buyers12.3.4 Threat of Substitutes12.3.5 Competitive Rivalry

13 Product Type13.1 Market Snapshot & Growth Engine13.2 Market Overview13.3 Forehead13.3.1 Market Size & Forecast13.3.2 Market by Geography13.4 In-Ear13.4.1 Market Size & Forecast13.4.2 Market by Geography13.5 Multipurpose13.5.1 Market Size & Forecast13.5.2 Market by Geography

14 Application14.1 Market Snapshot & Growth Engine14.2 Market Overview

15 Veterinary15.1 Market Size & Forecast15.2 Market By Geography

16 Medical16.1 Market Size & Forecast16.2 Market By Geography16.3 Adult16.3.1 Market Size & Forecast16.3.2 Market by Geography16.4 Children16.4.1 Market Size & Forecast16.4.2 Market by Geography

17 Geography17.1 Market Snapshot & Growth Engine17.2 Geographic Overview

18 North America18.1 Market Overview18.2 Market Size & Forecast18.3 Product Type18.3.1 Market Size & Forecast18.4 Application18.4.1 Market Size & Forecast18.5 Key Countries18.5.1 US: Market Size & Forecast18.5.2 Canada: Market Size & Forecast

19 Latin America19.1 Market Overview19.2 Market Size & Forecast19.3 Product Type19.3.1 Market Size & Forecast19.4 Application19.4.1 Market Size & Forecast19.5 Key Countries19.5.1 Brazil: Market Size & Forecast19.5.2 Mexico: Market Size & Forecast

20 APAC20.1 Market Overview20.2 Market Size & Forecast20.3 Product Type20.3.1 Market Size & Forecast20.4 Application20.4.1 Market Size & Forecast20.5 Key Countries20.5.1 China: Market Size & Forecast20.5.2 Japan: Market Size & Forecast20.5.3 India: Market Size & Forecast

21 Europe21.1 Market Overview21.2 Market Size & Forecast21.3 Product Type21.3.1 Market Size & Forecast21.4 Application21.4.1 Market Size & Forecast21.5 Key Countries21.5.1 Germany: Market Size & Forecast21.5.2 France: Market Size & Forecast21.5.3 UK: Market Size & Forecast21.5.4 Italy: Market Size & Forecast21.5.5 Spain: Market Size & Forecast

22 Middle East & Africa22.1 Market Overview22.2 Market Size & Forecast22.3 Product Type22.3.1 Market Size & Forecast22.4 Application22.4.1 Market Size & Forecast22.5 Key Countries22.5.1 Saudi Arabia: Market Size & Forecast22.5.2 South Africa: Market Size & Forecast

23 Competitive Landscape23.1 Competition Overview

24 Key Company Profiles

25 Other Prominent Vendors

26 Report Summary26.1 Key Takeaways26.2 Strategic Recommendations

27 Quantitative Summary

28 Appendix

For more information about this report visit https://www.researchandmarkets.com/r/cjv74e

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Global Non-Contact Infrared Thermometer Market (2020 to 2025) - Outlook and Forecast - Yahoo Finance UK

Cats can spread the new coronavirus to other cats without any of them ever having symptoms, a lab experiment suggests.

Scientists who led the work, reported on Wednesday, say it shows the need for more research into whether the virus can spread from people to cats to people again.

Health experts have downplayed that possibility. The American Veterinary Medical Association said in a new statement that just because an animal can be deliberately infected in a lab does not mean that it will easily be infected with that same virus under natural conditions.

Anyone concerned about that risk should use common sense hygiene, said virus expert Peter Halfmann. Dont kiss your pets and keep surfaces clean to cut the chances of picking up any virus an animal might shed, he said.

He and colleagues at the University of Wisconsin School of Veterinary Medicine led the lab experiment and published results Wednesday in the New England Journal of Medicine. Federal grants paid for the work.

Researchers took coronavirus from a human patient and infected three cats with it. Each cat then was housed with another cat that was free of infection. Within five days, coronavirus was found in all three of the newly exposed animals.

None of the six cats ever showed any symptoms.

There was no sneezing, no coughing, they never had a high body temperature or lost any weight, Halfmann said. If a pet owner looked at them ... they wouldnt have noticed anything.

Last month, two domestic cats in different parts of New York state tested positive for the coronavirus after mild respiratory illnesses. They were thought to have picked it up from people in their homes or neighborhoods.

Some tigers and lions at the Bronx Zoo also have tested positive for the virus, as have a small number of other animals around the world.

Those cases and the new lab experiment show there is a public health need to recognize and further investigate the potential chain of human-cat-human transmission, the authors wrote.

Guidelines from the U.S. Centers for Disease Control and Prevention say that based on the limited information available so far, the risk of pets spreading coronavirus to people is considered to be low.

The veterinary medicine group says there is no evidence to suggest that animals, including pets, that may be incidentally infected by humans are playing a role in the spread of COVID-19. It stressed that person-to-person transmission was driving the global pandemic.

However, the group noted that many diseases spread between pets and people, so hygiene is always important: Wash your hands before and after touching pets, and keep your pet and its food and water bowls clean.

Halfmann, whose two cats sleep near him, said the worry may be greater for animal shelters, where one infected animal could pass the virus to many others.

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Cats with no symptoms spread virus to other cats in lab test - Lewiston Morning Tribune

The Lund Report is offering this coverage for free to better inform the public at this difficult time. But we need your support to help us stretch our resources. Please sign up for a tax-deductible premium subscription or consider making a donation. That is also tax deductible because we're a 501(c)(3) organization.

Results from the third weekend of door-to-door sampling by Oregon State University suggest that one person in 1,000 in the Corvallis community had the novel coronavirus that causes COVID-19 on May 9-10.

The study, Team-based Rapid Assessment of Community-Level Coronavirus Epidemics, known as TRACE-COVID-19 for short, began the weekend of April 25-26 and continued the subsequent two weekends.

The fourth and final weekend of sampling, originally scheduled for May 16-17, will take place in June to help determine if the easing of stay-at-home orders leads to a jump in the prevalence of the virus in the Corvallis community, TRACE leaders say.

On the third weekend of sampling, 30 two-person field teams visited 346 homes spread among 30 census blocks in Corvallis. Seventy-eight percent of the households where someone answered the door had at least one person agree to participate, resulting in the sampling of 649 people.

The first three weeks of OSUs sampling for the virus in Corvallis presents a consistent pattern of low prevalence in the community, said Ben Dalziel, an assistant professor in OSUs College of Science and the project leader. Over three consecutive weeks, the prevalence has ranged from approximately 1 to 2 in 1,000. These results suggest that the sacrifices made by the community to follow stay-at-home policies have indeed flattened the curve as we hoped. The number of confirmed cases reported by the Benton County Health Department portrays a similar picture.

Corvallis population is 58,641, comprising more than half of the 93,053 people who live in Benton County.

TRACE uses a statistical model based on the number of samples, the number of positive tests and prior information on the prevalence of the virus to estimate the proportion of the community that is infected during the period when the samples were collected.

For example, during the third week of sampling there were no positive tests among TRACE participants, but prior information on prevalence in the community nonetheless led to TRACE models to estimate a prevalence of approximately one per 1,000 in the community as a whole.

In announcing weekly prevalence results, the TRACE team follows reporting policies used by the Oregon Health Authority and local health departments by not announcing numbers of positive cases between one and nine. Doing so may contribute to identifying an actual community member who tested positive, Dalziel said.

TRACE will expand to Bend on May 30-31 with funding from PacificSource Health Plans, which will also help pay for the final weekend of sampling in Corvallis next month. Also in Bend on May 30-31, a research project led by the OSU College of Engineering, Coronavirus Sewer Surveillance, will collect sewage samples that will be analyzed for the prevalence of genetic material from the virus.

While one case in 1,000 in the Corvallis sampling may seem like a low number, it is important to remember that prevalence is not the same as risk, said Jeff Bethel, an associate professor in OSUs College of Public Health and Human Sciences and part of the TRACE leadership team.

Even a low prevalence is still a threat to public health until there is a vaccine or until a large number of people in the community have immunity to this virus, Bethel said. It is important that everyone continues to follow the advice of public health officials regarding face masks, hand-washing and other sanitizing methods, and social distancing. All evidence suggests that SARS-CoV-2, the virus causing COVID-19, is highly contagious. The larger the gathering, the greater the likelihood that you will encounter an infected individual, regardless of whether they show symptoms.

The TRACE study is a collaboration of five OSU colleges Science, Agricultural Sciences, the Carlson College of Veterinary Medicine, Engineering, and Public Health and Human Sciences in partnership with the Benton County Health Department.

The study is being initially funded by OSU and a grant from the David and Lucile Packard Foundation, and has been aided by work from the OSU Foundation and the OSU Alumni Association. The diagnostic testing component of TRACE operates through a partnership between the Oregon Veterinary Diagnostic Laboratory, which is located at OSU, and Willamette Valley Toxicology.

These three weeks of data provide a very useful baseline from which we can monitor in close to real time how the prevalence of the virus changes as Corvallis begins to reopen, Dalziel said.

At each home visited by TRACE field workers, members of the household are invited to participate in the study. Those who choose to take part are asked to provide information such as their name and date of birth; to fill out a simple consent form; and to answer a few confidential, health-related questions.

Participants are given a nasal-swab test kit that they administer to themselves inside their home and their minor children if they want them to take part. The field staff wait outside, and the participants leave the completed test kits outside their front door. Field staff maintain a safe distance at all times and do not enter anyones home. The safety of participants and TRACE field staff is a key part of the studys research design, Bethel said.

The tests used in TRACE-COVID-19 collect material from the entrance of the nose and are more comfortable and less invasive than the tests that collect secretions from the throat and the back of the nose.

The field workers leave participants with information about the project and how they will receive their results available in seven to 10 days as well as health guidance from the Benton County Health Department and the Centers for Disease Control and Prevention. Participants in the study are sent their results and those of their minor children by secure email with receipt by standard mail delivery as a backup. Everyones personal information is safeguarded.

Everyone is hoping to avoid a spike in number of infections as we reopen we think TRACE data can help, Dalziel said. Changes in prevalence of the virus in the community will be an early warning indicator to inform decisions about pace of reopening.

For more information about TRACE, visit the TRACE-COVID-19 website. The site includes a list of frequently asked questions.

COVID-19, first reported to the World Health Organization on Dec. 31, 2019, has been confirmed in more than 5.3 million people worldwide and has killed more than 344,000 people. In the United States, there have been more than 1.6 million reported cases including more than 3,900 in Oregon and more than 97,000 deaths nationwide. Benton County has had 53 confirmed cases and five deaths.

About Oregon State University: As one of only two universities in the nation designated as a land, sea, space and sun grant, Oregon State serves Oregon and the world by working on todays most pressing issues. Our more than 32,000 students come from across the globe, and our programs operate in every Oregon county. Oregon State receives more research funding than all of the states comprehensive public universities combined. At our campuses in Corvallis and Bend, marine research center in Newport and award-winning Ecampus, we excel at shaping todays students into tomorrows leaders.

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Press Release: TRACE Week Three Results Suggest One Person Per 1000 In Corvallis Infected With SARS-CoV-2 - The Lund Report

captionA dog sniffs out a chicken on a tour of backyard coops in Orange County, California, in 2015.sourceMindy Schauer/Digital First Media/Orange County Register via Getty Images

The staff at Murray McMurray Hatchery is exhausted.

The family-run business, based in Webster City, Iowa, sells rare chicken breeds, mostly to backyard farmers who raise them for eggs or to compete in shows.

Since the pandemic started, sales have doubled.

Even with six people manning the lines, the phones ring off the hook from 7 am to 6 at night, owner Tom Watkins says. He estimates his staff has taken an entire years worth of orders in just the past two months.

They want what they want right now, Watkins told Insider, and at this point, its probably too late.

The hatchery is sold out of chicks, he said, and will probably remain that way through at least August.

And its not just Murray McMurray. Hatcheries across the country have sold out in the wake of runaway demand, according to Mark Pogwaite, president of the American Poultry Association. Google searches for chicken coops have soared since March, according to People, and options continue to sell out online.

Its huge, from what I can see, Pogwaite said of demand. The feed stores cant keep chicks in, the catalogs cant keep up. It was like overnight, as soon as COVID-19 hit.

Sales at hatcheries often spike when theres economic uncertainty or rising food prices. When people are insecure about their financial future, they go back to the agrarian part of life, Watkins said.

Whats different this time, he added, is the number of first-time customers.

Watkins is doing his best to educate new buyers, but he and other breeders are worried that the boom in amateur chicken farmers could lead to outbreaks of dangerous poultry diseases.

If a virus spread to a commercial farm, it could interrupt the already strained food chain and cost millions of dollars.

In 2015, officials traced an outbreak of avian influenza in Iowa to a small backyard farm. Stopping its spread cost nearly $430 million and resulted in the destruction of 34 million birds across 77 farms, according to the Iowa Farm Bureau.

The outbreak also cost the nations largest egg-producing state nearly 8,500 jobs, and raised the prices of eggs and poultry for consumers nationwide for the next three years.

Another deadly poultry disease, Virulent Newcastle, has stubbornly resisted containment in Southern California for the past two years. Its found its way into backyard coops, too, making tracking and eradicating it especially difficult.

Commercial farms are inspected by the USDA and local public safety agencies. Authorities can detect outbreaks and react swiftly, ordering the destruction of infected birds and the monitoring of nearby farms.

But the government doesnt keep track of backyard chicken coops.

They represent a leaky channel by which contagion can spread undetected, according to Alan Rudolph, a biological researcher at Colorado State University.

And residential chicken farmers are less likely to maintain strict contamination protocols or check their birds for diseases, Rudolph said.

They might not even know what symptoms to look for. And that can be a real problem.

An outbreak in someones personal coop spreading to a major commercial farm could devastate the poultry industry, according to Brent Credille, a professor at the University of Georgias College of Veterinary Medicine.

And theres always the risk that an animal virus could mutate and infect humans. Thats what happened with avian flu and, experts believe, the novel coronavirus.

Infected birds are essentially virus factories while they are alive, Julie Gauthier, a poultry expert at the USDAs Animal and Plant Health Inspection Service, told Insider.

Theyre producing lots of virus and spreading it to other birds, the neighbors, and any other farms, she said.

The California Department of Food and Agriculture believes Newcastle has continued in Southern California because backyard farmers are ignoring orders to kill infected birds and stop buying new ones.

California teaches us that there can be a high enough density of backyard livestock that they can present hotspots that can lead to greater transmissibility, Rudolph said.

While the greatest risk is to other chickens, poultry can carry diseases that affect humans, too such as campylobacteriosis, E.Coli, and listeria.

On May 20, the CDC announced that it was investigating a 28-state outbreak of salmonella tied to backyard fowl.

Almost 100 people have been infected, according to the Centers for Disease Control and Prevention, including 17 who required hospitalization. A third of those who got sick are children under 5, CNN reported.

Salmonella bacteria are often transmitted through tainted food, but experts believe this outbreak was spread through humans who failed to take adequate precautions with infected chickens and ducks. The CDC had to issue guidelines warning owners to stop nuzzling or kissing their chicks.

Its important that we consider the human health risks of bringing chickens home, Gauthier said. We need to realize that salmonella and chickens go together.

Credille recommends poultry hobbyists reach out to experienced farmers for help. Commercial farmers should welcome their interest, he said.

Its something we need to embrace to not be their enemy but be their friend, Credille said. If theyre interested in this and go in with their eyes wide open, it can be quite a successful venture and very rewarding.

Whether we help them or not, my guess is theyre going to do it anyway, he added.

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Backyard chicken farming is exploding right now. But experts warn it could lead to outbreaks of diseases that kill millions of birds and potentially...

In recent years, we have seen a trend towards the launch of new gene and cell therapies with record-breaking price tags. Such headline-grabbing launches are becoming more and more frequent, as the pipeline for advanced therapies at all stages of development continues to grow at a rapid pace[1]. We are also seeing industry and payers adopting new innovative pricing models for those products, such as outcome-based reimbursement and annuity payment models. In this article, we discuss these emerging alternative pricing models and consider the impact they may have on related licensing arrangements.

Current trends

In May 2019 AveXis, a subsidiary of pharmaceutical giant Novartis, announced that it had received approval from the US Food and Drug Administration to market its gene therapy Zolgensma for the treatment of paediatric patients with spinal muscular atrophy (SMA). Although this is the first promise of a cure for this debilitating and lethal condition, the media coverage focussed instead on Zolgensmas price tag, which at $2.1 million per patient makes it (currently) the worlds most expensive single-dose medicine.

Zolgensma is illustrative of a general trend in gene and cell therapies that have reached the market in recent years and established a new standard of pricing for single-treatment medicines. While manufacturers point to the relative cost-effectiveness of such treatments (which may offer a one-off cure for severe conditions that otherwise would require several years worth of conventional treatments and care) public and private payers are concerned about this new escalating pricing paradigm.

Health care systems may be able to absorb such high prices for rare diseases with small patient populations. However, the current reimbursement systems will be under severe pressure if (as is hoped) pipelines for advanced cell and gene therapies result in treatments for common conditions such as diabetes or heart disease. The Institute for Clinical and Economic Review in the US has estimated that if gene therapies are developed to treat only one in ten American patients with a genetic condition approximately 1% of the total population the cumulative budget impact could rise to $3 trillion[2]. For comparison, the projected total healthcare spend in the US for 2019 is $3.8 trillion[3].

Alternative Pricing Models

The pharmaceutical industry has sought to counter criticism over the high price tags for gene and cell therapies by coupling these revolutionary therapies with new and unconventional pricing and reimbursement mechanisms.

One alternative structure that has been adopted is an annuity based model which spreads the payment for an expensive treatment over several years in a pre-agreed payment plan, thus minimising the up-front cost to payers.

Another approach adopted by the industry, and perhaps an even clearer way to demonstrate value to payers, has been to tie reimbursement to patient outcomes. The industry has negotiated several of these outcomes-based reimbursement models with public and private payers for cell and gene therapies. Reimbursement payments to the drug maker under this model are conditional upon the patient reaching specific clinical outcomes by set deadlines. Depending on the model, a patients failure to meet the specified clinical outcome can result in the drug maker having to refund payments received and/or forfeit any subsequent payments.

These new models are also being blended to create payment plans which combine annuity-style payments with rebates and outcomes-dependent instalments. We expect that in the years to come other creative payment models will emerge and be adapted from other therapy areas. For example, in Australia, the government has used a subscription style model that allowed it to pay a lump sum to drug makers for unlimited access for patients to curative hepatitis C treatments such as Sovaldi for a period of time.

Example annuity and outcomes-based reimbursement models for cell and gene therapies:

Licensing challenges

Cell and gene therapies often have their roots in academic research laboratories and the main players in this field of treatments have close ties and valuable licensing agreements with academic research institutions. For example, AveXis, the biotech company that developed Zolgensma, started as a spin-out to continue research conducted at the Center for Gene Therapy at Nationwide Childrens Hospital in Columbus, Ohio. To further its spinal muscular atrophy work, the biotech also licensed a patent owned by Martine Barkats, a researcher at the Institut de Myologie, Paris. Shortly after, AveXis was bought by Novartis for $8.7 billion. Cell and gene therapies such as Zolgensma will generally have more constituent parts (such as promoters, viral vectors and cell lines) than other more conventional small molecule therapies. This means that a party commercialising a cell or gene therapy will often need to license in more third party intellectual property or materials than a manufacturer of a conventional small molecule therapy. Most cell and gene therapies reaching the market are therefore likely to be underpinned by one or more licence agreements.Licensing challenges

While much has been said about the impact of alternative pricing and reimbursement mechanisms on drug makers, payers and patients, we want to also consider the impact on licensors of the intellectual property which enables the development and manufacture of a therapy. In particular, how future pricing and reimbursement models can impact the royalties payable by licensees to their licensors. One inherent challenge is that these licences are generally negotiated many years before the commencement of discussions with payers on pricing and reimbursement mechanisms, making it very difficult to predict which scenarios will be relevant down the line. The positions of all of the stakeholders in the pricing debate are also constantly evolving, especially as data on the cost-effectiveness of annuity and outcomes-based models continues to accumulate. One factor which makes things particularly difficult for licensors in forecasting potential future royalty streams for these products is that a licensor would rarely have any involvement in negotiations regarding pricing and reimbursement so will have no control over the model adopted.

Annuity model challenges

Generally a licensor will only receive royalties once the licensee has itself received (or at least invoiced) payment from payers. An annuity payment model is therefore likely to mean that royalties will also be paid in instalments potentially spread over a number of years following treatment of a patient. While in practice this may not be a large change for licensors to adjust to (as annual payments for these high price treatments are not out of line with other orphan drug costs, most of which need to be taken over a long period of time) there are also other factors to consider.

One concern that has been raised with annuity payment models is that there may be an increased risk of non-payment as over time licensees may face difficulties in collecting payments, for example because a payer stops complying with payment schedules or becomes insolvent. This may have the knock-on effect of reducing royalties due to a licensor. Licensors may seek to reduce this non-payment risk by asking that royalties are payable on sums invoiced by a licensee, rather than sums received (although this is likely to be resisted by a licensee or perhaps only accepted with caveats). Annuity-based models are also typically more complicated and more expensive for a licensee to manage administratively and those costs are likely to be deductible from sales totals before a licensors royalties are calculated.

From a legal drafting perspective, care would also need to be taken by the licensor when defining payment terms and the royalty term (which is commonly linked to patent expiry) to ensure that the licensor continued to receive royalties in respect of patients who are treated within the royalty term, notwithstanding the fact that payment may not be received until after the patents and royalty term has expired.

Outcome-based model challenges

In relation to outcome-based models, a fundamental concern for both licensors and licensees is the uncertainty associated with a model which involves an upfront payment of the full treatment price but a refund payable some months or years down the line if the clinical outcomes are not met.

If royalties are payable on net sales of the therapy on a regular basis (e.g. quarterly or annually) then unless the licence includes a mechanism to take account of outcomes-based refunds made by the licensee to payers, the licensee could find itself out of pocket, unable to recover royalties paid to the licensor despite having had to refund the therapy price to the payer. To counter this risk, a licensee may seek to build in a royalty claw back mechanism into the licence, or to delay the point at which royalties are payable until after the relevant patient has met the required outcome. However, a licensor is unlikely to accept a significant delay in payment of royalties, particularly where the licensee has itself been paid. Academic licensors, with an obligation to invest income from technology transfer activities into research and the provision of education, are particularly unlikely to agree a royalty claw back structure which could force them to refund royalties or milestones a year or more after having received them.

One alternative option may be to agree that the licensee can make deductions against future royalty payments. A further alternative could be for some portion of the royalties paid to be retained in escrow for a period of time, to be released to the licensor upon achievement of a positive clinical outcome or expiry of a set period of time. However, escrow arrangements necessarily increase the complexity of agreements and are difficult to negotiate upfront when payment and reimbursement models and the associated outcome triggers have not yet been set.

A compromise?

As we have outlined in this article, although there are some things each party can consider at the outset of negotiating a licence, getting into protracted negotiations about hypothetical scenarios is unlikely to be attractive to either party.

The parties may wish to adopt an alternative approach of including robust governance provisions in the licence to deal specifically with this issue. For example, establishing a committee comprised of representatives of both parties to oversee and review issues relating to pricing and reimbursement. This may give the licensor a clearer oversight (and potentially input) into decisions which may impact future royalty streams and may present the licensee with an opportunity to propose alternative payment structures to support its desired pricing model. This could be combined with a mechanism for proposing and agreeing amendments to payment provisions in the licence if necessary to accommodate pricing and reimbursement issues which were unforeseen at the outset. Of course the success of such mechanisms will depend on the strength of the relationship between the parties and a combined willingness to work together and potentially compromise. It would also be important to ensure it is clear what happens where the parties cannot agree (e.g. escalation? expert determination? preservation of the status quo?). However, in a future where pricing and reimbursement issues are only likely to become more complex and of key importance to the success of complex treatments such as cell and gene therapies, it will be interesting to see whether this is a route industry explores.

Conclusion

The launch in recent years of a number of advanced cell and gene therapies with blockbuster price tags has heralded a new era for drug pricing and associated payment and reimbursement issues. It is a trend that looks likely to continue if current pipelines can also deliver much anticipated advanced therapies for common conditions. The high prices associated with these products present a myriad of issues however, not only for patients, payers and healthcare providers, but also for the licensors of the underlying intellectual property underpinning such treatments as industry adopts innovative new payment and reimbursement models which may impact on royalty streams.

When negotiating a licence to technology underpinning a cell or gene therapy the parties should consider how less conventional pricing mechanisms may impact the royalty structure. However, while there are some issues licensees and licensors may be able to consider upfront, it is difficult to anticipate the issues that may become relevant at a stage where pricing models have not been set, particularly as there is no one-size-fits-all pricing approach.

We have proposed an increased use of robust governance processes in a licensing relationship as one option to consider. It will also be interesting to see whether any trends emerge in relation to upfront and milestone payments in response to the challenges outlined above. In particular, licensees may push for more back-loaded or performance-related milestone payments to reflect the risks associated with pricing models which take a longer term view of the cost benefits of these types of therapies. We look forward to seeing what innovative approaches licensors and licensees adopt to adapt to these challenges in the years to come.

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Cell and gene therapies - Lexology

RESEARCH TRIANGLE PARK Theres a new biotech company setting up shop in the Triangle, and its flush with cash and headed up by some big names in the industry.

MeetKriya Therapeutics the brainchild of Dr. Shankar Ramaswamy, former chief business officer for Axovant Gene Therapies; Fraser Wright, co-founder of Sparks Therapeutics; and Roger Jeffs, the former United Therapeutics CEO who has deep rootsinNorth Carolina.

Launched in 2019, the biotech startup has dual headquarters in Durham and Palo Alto, California, and is billing itself as a next-generation gene therapy company focused on designing and developing treatments for highly prevalent and severe chronic conditions, like diabetes and obesity.

Earlier this month, it arrived in a big way after securing $80.5 million in Series A financing during a pandemic.

Its never easy. But itsa really significant pool of capital for us so were thankful to have been able to get it done,Ramaswamy, Kriyas CEO, told NC Biotech in a video interview this week.[Our] investors have a very long term vision of what a next generation gene therapy company could look like, and were very supportive building towards that vision.

Fraser Wright, PhDScientific Co-Founder and Chief Scientific Advisor; Shankar Ramaswamy, MDCo-Founder, Chairman, and CEO; and Nachi Gupta, MD, PhDChief of Staff.

Among the investors: QVT, Dexcel Pharma, Foresite Capital, Bluebird Ventures (associated with Sutter Hill Ventures), Narya Capital, Amplo,Paul Manning, andAsia Alpha. The round followed an initial seed financing led by Transhuman Capital late last year.

Itsis amilestone for the company andsets us up for success to goout and execute on the things that we really want to get done.

Ramaswamy says the company is now ready to scale, and is focused on building out its teams on both coasts.

We expect to grow very quickly both here in the Bay Area and in North Carolina, he said, emphasizing the Triangles importance as its manufacturing hub. That could be dozens of employees [here] in the not so distant future, if not larger over time.

How it will work: co-founders Ramaswamy and Wright will be based in the Bay area along with finance operations and early-stage research.

Meanwhile, in Durham, co-founder Jeffs will lead a team focused on development and manufacturing. It will include Britt Petty, AveXis former head of global manufacturing and Melissa Rhodes, former chief development officer at Altavant Sciences; and Mitch Lower, another Avexis veteran.

I dont view North Carolina as a satellite office.Thats where well be building our internal manufacturing infrastructure to solve for one of the key bottlenecks in gene therapy,which is manufacturing capacity and quality, saidRamaswamy.

Theres a very strong pool of talent in North Carolina, especially in biologics manufacturing. And [our team] has a very strong track record and history of success with biologics manufacturing, and strong experience there as well. So we think its a great place to be, given the past couple of decades, where there have been so many successful products actually manufactured in North Carolina.

Already, Kriyahas a number of gene therapies in the pipeline.

Among them: KT-A112, an investigational gene therapy administered by intramuscular injection that delivers the genes to produce insulin and glucokinase for type 1 and type 2 diabetes;KT-A522, an investigational gene therapy administered by salivary gland injection that delivers the gene to produce a glucagon-like peptide 1 (GLP-1) receptor agonist for type 2 diabetes and severe obesity; andKT-A83, an investigational gene therapy administered by intrapancreatic injection that delivers the gene to produce modified insulin growth factor 1 (IGF-1) for type 1 diabetes.

The team is currently set up in a temporary office in Durham, but plans to move intoamore permanent space somewhere in the Research Triangle in the near future.

Kriya is building a leading team and cutting-edge infrastructure to engineer best-in-class gene therapies for severe chronic conditions and accelerate their advancement into human clinical trials, saidJeffs, its vice chairman. Through its R&D laboratory capabilities in the Bay Area and in-house process development and manufacturing infrastructure inResearch Triangle Park, I believe that Kriya will be uniquely positioned to become a leader in the gene therapy field.

(c) North Carolina Biotechnology Center

Durhams Kriya Therapuetics lands $80M to advance gene therapies for diabetes, severe obesity

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Bicoastal startup Kriya Therapeutics to grow gene therapy manufacturing in NC - WRAL Tech Wire

ATLANTA, May 26, 2020 /PRNewswire/ -- Expression Therapeutics has announced that it has received clearance by the United States Food and Drug Administration (FDA) to proceed following review of its Investigational New Drug Application (IND) for clinical testing of its novel lentiviral vector-based gene therapy ET3 for hemophilia A. Hemophilia A is the most common severe congenital bleeding disorder and afflicts approximately 1 in 8,000 people. Without treatment, severe hemophilia is crippling and fatal by late adolescence to early adulthood.

The ET3 gene therapy developed by Expression Therapeutics combines innovative platform technologies in protein bioengineering and tissue-directed expression. ET3 consists of autologous mobilized peripheral blood stem and progenitor cells transduced with a recombinant lentiviral vector, encoding a bioengineered coagulation factor VIII transgene designed for highlevel expression at low vector copy number. In the ET3 trial, subjects will be preconditioned with low-dose stem and immune cell suppressing agents prior to receiving a single infusion of ET3. The high-expression factor VIII can correct the bleeding tendency in hemophilia A. The duration of ET3 activity is expected to be the normal lifetime of the patient. Expression Therapeutics expects to initiate a Phase 1 clinical trial titled ET3-201 at Emory University and enroll patients shortly.

"We are extremely pleased that the FDA has granted permission to proceed with this clinical study," said Trent Spencer, Ph.D., President of Expression Therapeutics and Director of the Cell and Gene Therapy Program in the Aflac Cancer and Blood Disorders Center at Emory University.

Hematopoietic stem and progenitor cell lentiviral gene therapy is currently the only approach that offers the possibility of permanent cure of hemophilia A and provides an opportunity to reach both pediatric and adult populations.

"We are very excited to get the hemophilia A clinical trial underway, the first of six gene therapy products currently under development at Expression Therapeutics," said Mohan Rao, Ph.D., CEO of Expression Therapeutics.

Expression Therapeutics is a biotechnology company based in Atlanta. The current therapeutic pipeline includes advanced gene therapies for hemophilia A and B; neuroblastoma, T-cell leukemia/lymphoma, and acute myeloid leukemia (AML); and primary immunodeficiencies such as hemophagocytic lymphohistiocytosis (HLH).

For inquiries, please contact:

Ashley WalshDirector of Corporate DevelopmentExpression Therapeutics 1860 Montreal RoadTucker, Georgia 30084[emailprotected]+1 312.637.2975

SOURCE Expression Therapeutics

http://www.expressiontherapeutics.com

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Expression Therapeutics Announces IND Approval by the FDA for Hemophilia A Gene Therapy - PRNewswire

Gene therapy does more than treat genetic diseases it can cure them. A one-time dose of a non-replicative viral vector, such as commonly used recombinant adeno-associated virus (AAV), delivers a functional gene to replace or compensate for a dysfunctional version that is causing a patients disease (Figure 1). As a cutting-edge biopharmaceutical technology, there are multiple gene therapies now FDA approved; with hundreds more in clinical trials, were likely to see many more of these therapies on the market soon.1 However, to keep up with the rapid pace of clinical research, developers are working to streamline the manufacturing and quality control process to improve quality and lower the cost of bringing these important drugs to market.Developers use a multitude of analytical tests to develop gene therapies and optimize their manufacturing process. When developers get aberrant test results, they must be able to interpret where the problem lies. Did the manufacturing process produce an undesirable product, or is the analytical testing method unreliable? Analytical testing companies that have the infrastructure, personnel, and experience often partner with developers to tighten up analytical variability so that results of tests clearly indicate where there are opportunities to increase efficiency and product quality.

Figure 1. Gene delivery by recombinant viral vector.During gene therapy, viral capsids containing the therapeutic gene are taken up by the patients cells and the genetic material is delivered to the nucleus. There, the gene gets expressed as a protein necessary for the patients health. Credit: Avomeen.

Figure 2. A full AAV capsid and associated capsid impurities. Complete viral capsids have AAV are assembled from 60 capsid proteins, with a defined stoichiometry and shape and contain a therapeutic gene. AAV vector impurities include capsids that contain too many copies of the gene (overfilled), those that contain lower copy numbers or truncations of the gene (partially full), or empty capsids that contain no genetic material. Credit:Avomeen.

There are several ways to measure the empty/full capsid ratio, and as developers are establishing their chemistry, manufacturing and control (CMC) protocol, it is important that they choose an optimized method, as they must use that method for effective quality control from early process development to lot release and stability.3 Gene therapy developers may choose analytical ultracentrifugation to evaluate capsids, but while highly effective, this method is not as quantitative, robust or efficient as some newer methods. High-performance liquid chromatography (HPLC) using AAV full/empty analytical columns have been demonstrated to be highly effective at separating full, empty, and improperly filled capsids for robust quantification. Additionally, this method is higher throughput than ultracentrifugation, and requires less precious AAV sample to run.

Cellular potency is evaluated by transducing cells with the AAV product and then measuring a phenotypic or functional outcome due to the transduction. Developing these tests can be challenging because there is no one-size-fits-all test that will give developers the answers they need. Developers often draw on the experience of analytical labs to determine how to best evaluate their AAV products transduction efficiency.A gene therapy in development must also be tested to ensure that it is free of residual, process-related impurities such as polyethylenimine, iodixanol, poloxamer, and other excipients that must be removed in the final product to ensure safety. Few research and manufacturing facilities have the equipment and expertise necessary to perform this kind of testing, and it is advisable to find one that has experience testing polymers, extractables and leachables to examine if components of the manufacturing equipment or drugs packaging are not contaminating the final product.

As fast-paced as the gene therapy field is now, it stands to become a true race to the finish line to bring new gene therapies to market in the near future. Regulatory bodies are becoming more familiar with reviewing gene therapies, and the road to commercialization will move more quickly. There is no denying that gene therapies will bring incredible benefits to patients, but it will be crucial to improve manufacturing efficiency and lower costs to make gene therapies more accessible to the patients who need them.References

1. Colasante, W., Diesel, P., and Gerlovin, Lev. (2018). New Approaches To Market Access And Reimbursement For Gene And Cell Therapies. Cell & Gene. Retrieved from: https://www.cellandgene.com/doc/new-approaches-to-market-access-and-reimbursement-for-gene-and-cell-therapies-0001

2. Fraser Wright, J. (2014). Product-Related Impurities in Clinical-Grade Recombinant AAV Vectors: Characterization and Risk Assessment. Biomedicines, 2, 80-97; doi:10.3390/biomedicines2010080

3. U.S. Food & Drug Administration (2019). Guidance for Human Somatic Cell Therapy and Gene Therapy. Retrieved from: https://www.fda.gov/animal-veterinary/guidance-industry/chemistry-manufacturing-and-controls-cmc-guidances-industry-gfis

4. Stein, R. (2019). At $2.1 Million, New Gene Therapy Is The Most Expensive Drug Ever. NPR. Retrieved from: https://www.npr.org/sections/health-shots/2019/05/24/725404168/at-2-125-million-new-gene-therapy-is-the-most-expensive-drug-ever

5. Cohen, J.T, Chambers, J. D., Silver, M. C., Lin, P., Neumann, P.J. (2019). Putting The Costs And Benefits Of New Gene Therapies Into Perspective. Health Affairs. Retrieved from: https://www.healthaffairs.org/do/10.1377/hblog20190827.553404/full/

6. ATCC (accessed May, 2020) ATCC Virus Reference Materials. Retrieved from: https://www.atcc.org/en/Standards/Standards_Programs/ATCC_Virus_Reference_Materials.aspx#

7. U.S. FDA (2020). FDA Details Policies on Gene Therapies in Seven Guidances. Retrieved from: https://www.fdanews.com/articles/195767-fda-details-policies-on-gene-therapies-in-seven-guidances

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Troubleshooting the Development of New Gene Therapies - Technology Networks

In March, Novartis was able to announce that Zolegensma (onasemnogene abeparvovec) that it had received a positive opinion on its application for marketing approval by the European Medicines Agency.

Yesterday this was followed up by the announcement that the European Commission (EC) had provided the gene therapy conditional approval for the treatment of patients with spinal muscular atrophy. The treatment will be available for those with a bi-allelic mutation in the SMN1 gene and a diagnosis of SMA type 1; or for patients with SMA with the mutation and up to three copies of the SMN2 gene.

The company added that the approval also covers babies and young children with SMA, up to a body weight of 21kg (46 pounds).

Novartis stated that the treatment will be made available immediately in France and that Germany would gain access shortly.

In terms of pricing, the company noted that it was working with stakeholder organizations across Europe, so that pricing would "work within existing, local pricing and reimbursement frameworks."

The pricing has proved a controversial aspect of the one-time gene therapy, which entered the US market at a cost of $2.1m (1.9m) per patient.

In its announcement, the company countered that the cost of caring for a child with SMA to the healthcare system is approximately 2.5m to 4m for 10 years of care.

In fourth quarter results, the treatment saw sales of $170m in the US.

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Novartis' gene therapy approved in Europe, talks ongoing on price - BioPharma-Reporter.com

This agreement covers the manufacturing of the Adeno-Associated Virus (AAV)

LYON, France and PARIS, May 26, 2020 /PRNewswire/ -- Novasep, a leading supplier of services and technologies for the life sciences industry, and Lysogene (FR0013233475 LYS), a phase 3 gene therapy platform company targeting central nervous system (CNS) diseases, today announced the signature of an agreement for the development and manufacturing of LYS-GM101, an AAVrh10-based gene therapy drug candidate for the treatment of GM1 Gangliosidosis, a rare neuronopathic lysosomal storage disorder.

With this collaboration, the two companies consolidate their long-lasting partnership initiated with the development and manufacturing of Lysogene's lead gene therapy product, LYS-SAF302, currently in clinical phase 2/3.

Mark Plavsic, Lysogene's Chief Technical Officer, said: "Following the successful relationship developed during the past 4 years, I am very pleased to continue working with Novasep, which is emerging as a true leader in gene therapy development and manufacturing. By extending our collaboration, we secure the clinical production of our experimental treatment for GM1 gangliosidosis and take an option for a smooth and effective technical transfer to a future commercial process."

Cedric Volanti, Novasep's President of Biopharma Solutions, said: "We, at Novasep, are delighted to pursue and extend our partnership with Lysogene. Novasep will bring its expertise and mobilize its production capacities to first help Lysogene in the clinical development of its innovative gene therapy treatment for GM1 gangliosidosis; and secondly, to shorten the transition to a commercial product manufacturing by ensuring a smooth process transfer to our commercial manufacturing facility."

About Lysogene

Lysogene is a gene therapy company focused on the treatment of orphan diseases of the central nervous system (CNS). The company has built a unique capability to enable a safe and effective delivery of gene therapies to the CNS to treat lysosomal diseases and other genetic disorders of the CNS. A phase 2/3 clinical trial in MPS IIIA in partnership with Sarepta Therapeutics, Inc. is ongoing and a phase 1/3 clinical trial in GM1 gangliosidosis is in preparation. In accordance with the agreements signed between Lysogene and Sarepta Therapeutics, Inc., Sarepta Therapeutics, Inc. will hold exclusive commercial rights to LYS-SAF302 in the United States and markets outside Europe; and Lysogene will maintain commercial exclusivity of LYS-SAF302 in Europe. Lysogene is also collaborating with an academic partner to define the strategy of development for the treatment of Fragile X syndrome, a genetic disease related to autism. http://www.lysogene.com.

About Novasep

Novasep provides cost-effective and sustainable manufacturing solutions for the life sciences industries.

With 20 years' experience in the development and manufacturing of biomolecules, Novasep offers a full range of CDMO services for:

- Viral vectors (AAV, Adenovirus, Lentivirus, HSV, VSV, VEEV) for cell and gene therapy, immunotherapy and vaccination, from process development to cGMP production

- Fill & Finish services for viral vectors, attenuated and live viruses, mAbs, plasmids and other biologics, from formulation to packaging

As part of its growth strategy Rise-2, Novasep recently unveiled a new facility, Senrise-IV, dedicated to the commercial production of viral vectors which has been completed last year by Senefill, a new Fill & Finish commercial facility for aseptic operations. Both facilities located in Seneffe, Belgium, will contribute to the success of biopharmaceuticals' projects.

Follow Novasep on LinkedIn.

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SOURCE Novasep

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NOVASEP and LYSOGENE Announce Their New Collaboration for Development and Production of GM1 Gangliosidosis Gene Therapy Product - BioSpace

LONDON, May 26, 2020 /PRNewswire/ -- Beacon Targeted Therapies, a Hanson Wade Ltd company, is a leader in bespoke and tailored clinical trial and drug development database products in targeted therapies providing accurate, in-depth, and real-time information on the rapidly evolving drug development landscapes.

Today we announce the launch of our latest database solution Beacon Gene Therapy, which addresses the growing demands on accurately tracking the gene therapy space with the latest scientific and technological innovations and monitoring competitors.

Our sector-specific, modular solution brings together all publicly known available sources of data on gene therapies and houses them under one repository. It is manually curated and includes clinical trial and drug records for preclinical, active, approved, and discontinued assets for all types of therapies where the gene/genetic material is being transferred to the patient, either through cell-free or cell-based mechanisms, aimed at treating non-oncology indications.

Beacon Gene Therapy Includes:

Beacon Gene Therapy allows you to search the clinical trial and drug landscape by:

Allowing you to cut through the noise and focus in on the literature and insights you need for evidence decision-making on your drug development programs.

Our sources cover (but are not limited to):

"Beacon is in a unique position to provide drug developers in the gene therapy space a complete clinical trial and drug development pipeline overview. To keep up with the many technological innovations and challenges in the space such as immunogenicity." - Curtis Dingley Commercial Director, Beacon Targeted Therapies

For more information the Beacon Gene Therapy database solution, please visit: https://beacon-intelligence.com/gene-therapy.

About Beacon Targeted Therapies:

Beacon Targeted therapies is a Hanson Wade Ltd company a world leader in conference and data products in high growth industries. Beacon Targeted Therapies is a clinical trial and pipeline database solution, designed in partnership with pharmaceutical professionals, tracking targeted therapies to provide accurate, in-depth, and real-time information in the rapidly evolving landscape of drug development.

For Media Enquiries: J-Ney AntiqueBeacon Targeted Therapies Hanson Wade+44-(0)203-141-8700Beacon@hansonwade.comwww.beacon-intelligence.com

View original content:http://www.prnewswire.com/news-releases/beacon-targeted-therapies-launches-its-latest-clinical-trial-and-drug-database-solution---beacon-gene-therapy-301060198.html

SOURCE Beacon Targeted Therapies

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Beacon Targeted Therapies Launches Its Latest Clinical Trial and Drug Database Solution - Beacon Gene Therapy - BioSpace

By Jonny Lupsha, News Writer

According to the Fierce Biotech article, the mice who underwent the new gene therapy were injected with a gene that makes the protein follistatin, which in turn blocks a protein called myostatin. Myostatin regulates muscle growth. The therapy caused a significant buildup of muscle mass in the mice while also preventing obesity, the article said. The mice didnt just build muscle; they also nearly doubled their strength without exercising any more than they usually did. Despite being fed a high-fat diet, they had fewer metabolic issues and stronger hearts than did animals that did not receive the follistatin gene.

Scientists have been developing gene therapy for many years. It can change our bodies in many ways, and has potential serving as a treatment for cancer and muscular dystrophy.

The procedure that the mice underwent encapsulates what gene therapy isalthough scientists generally focus on people.

I define [gene therapy] as the addition of genes to humans for medical purposes, said Dr. David Sadava, Adjunct Professor of Cancer Cell Biology at the City of Hope Medical Center.

Dr. Sadava said gene therapy is based on four assumptions. First, whoever is doing the gene therapy has to know the gene thats involved in whichever problem needs to be treated. Second, they must have a normal, healthy copy of that gene available in the lab. Third, they must know where and when the gene is normally expressed. Finally, they have to be fairly certain what will happen when the gene is expressed normally.

Additionally, gene therapy must do several things in order to be considered successful.

First, gene therapy must get the gene into the appropriate cells, Dr. Sadava said. Second, gene therapy must get the gene expressed in those cells. Third, we have to get the gene integrated into the genome of the target cells so itll be there permanently. And fourth, you better not have any bad side effects to gene therapy, like any therapy in medicine.

According to Dr. Sadava, one kind of gene therapy is referred to as gene augmentation, and it comes into play when the functional product of a gene has been lost and no longer gets produced normally. By injecting a gene into someone, healthy copies of a protein product will be made and function restored.

We could hypothetically think of muscular dystrophy as a good target for gene therapy, he said. We know that muscles lack the protein dystrophinits an organizing proteinso well put in the good gene for good dystrophin.

Another kind of gene therapy is called target cell killing. Dr. Sadava said it uses a gene that either produces a poison that kills certain types of cells or it stimulates the immune system to do so. Target cell killing can be applied to cancer.

A gene is put into cancer cells that allows them to produce a protein that will make a toxic drug from a harmless chemical, Dr. Sadava said. So the idea is we inject a harmless chemical into the body, it goes all over the body and when it enters a tumor cell, its converted into a poison by the gene product of the gene that weve put in for gene therapy. So we might put in a gene that will cause a protein to be made that attracts killer T cells so the tumor will stick up its hand and say Come kill me now.'

Gene therapy is an exciting field in science and medicine with a lot of potential for humans. For now, it may seem like its just helping some overweight mice get a confidence boost, but the practical applications should shore up within our lifetime.

Dr. David Sadava contributed to this article. Dr. Sadava is Adjunct Professor of Cancer Cell Biology at the City of Hope Medical Center in Duarte, CA, and the Pritzker Family Foundation Professor of Biology, Emeritus, at The Claremont Colleges. Professor Sadava graduated from Carleton University with a B.S. with first-class honors in biology and chemistry. He earned a Ph.D. in Biology from the University of California, San Diego.

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Lab Mice Shed Fat and Build Muscle with Gene Therapy - The Great Courses Daily News

OXFORD, England, May 27, 2020 /PRNewswire/ -- Evox Therapeutics Ltd ('Evox' or the 'Company'), a leading exosome therapeutics company, is pleased to announce the appointment of Martin Andrews as a Non-Executive Director. Martin is a highly experienced senior pharmaceutical executive with broad R&D, commercial and operational experience, and has deep specialist expertise in rare diseases, gene therapy and vaccines.

Martin is an experienced Non-Executive Director and commercial leader, with a strong track record of strategy development and operational delivery. He has had a long and successful career at GlaxoSmithKline, where he has held many senior positions. Most recently, Martin was Senior Vice President, Rare Diseases. Here, he led the global rare disease business and oversaw the development of a portfolio of ex vivo gene therapies, and the launch of Strimvelis, the world's first life-saving gene therapy for children. Furthermore, under his leadership, GlaxoSmithKline transferred its gene therapy portfolio to Orchard Therapeutics. Prior to that, Martin was Senior Vice President, Global Vaccines Commercial, where he led the development of the growth strategy and transformation of the commercial capability in GlaxoSmithKline's Vaccines division.

Martin has previously held Board positions at Orchard Therapeutics and the Alliance for Regenerative Medicine. He is currently a Non-Executive Director of Freeline Therapeutics, where he brings his commercial expertise to their gene therapy portfolio of drugs.

Dr Antonin de Fougerolles, Chief Executive Officer of Evox, commented:

"We're very pleased to welcome Martin as a Non-Executive Director. With his rare disease drug development experience and strong track-record of commercial success, Martin will be a great asset to the company. His expertise will play an important role in helping guide our business growth."

Commenting on his appointment, Martin Andrews said:

"I'm delighted to be joining the Board of Evox.This is an exciting period for the Company and I believe its technology has the potential to transform how medicines are developed and delivered for patients with conditions that are not possible to treat adequately today, especially those with rare diseases. I am thrilled to be part of the team and look forward to contributing."

About Evox Therapeutics

Evox Therapeutics is a privately held, Oxford-based biotechnology company focused on harnessing and engineering the natural delivery capabilities of extracellular vesicles, known as exosomes, to develop an entirely new class of therapeutics. Backed by leading life sciences venture capital groups and supported by a comprehensive intellectual property portfolio, Evox's mission is to positively impact human health by creating novel exosome-based therapeutics for the treatment of various severe diseases with limited options for patients and their families. Evox has created substantial proprietary technology to modify exosomes using various molecular engineering, drug loading, and targeting strategies to facilitate targeted drug delivery to organs of interest, including the brain and the central nervous system. Exosome-based drugs have the potential to address some of the limitations of protein, antibody and nucleic acid-based therapies by enabling delivery to cells and tissues that are currently out of reach using other drug delivery technologies, and Evox is leading the development within this emerging therapeutic space.

For further information visit: http://www.evoxtherapeutics.com

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Evox Therapeutics Appoints Martin Andrews as Non-Executive Director - WFMZ Allentown

BOSTON and LONDON, May 27, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that presentations by the management team will be made at the following investor conferences in June:

Live webcasts of the presentations will be available under "News & Events" in the Investors & Media section of the company's website at http://www.orchard-tx.com. Webcast replays will be archived on the Orchard website following the presentation.

About OrchardOrchard Therapeuticsis a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Ourex vivoautologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSKs rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and theSan Raffaele Telethon Institute for Gene Therapy inMilan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.

Orchard has its global headquarters inLondonandU.S.headquarters inBoston. For more information, please visitwww.orchard-tx.com, and follow us onTwitterandLinkedIn.

Availability of Other Information About OrchardInvestors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (twitter.com/orchard_txandwww.linkedin.com/company/orchard-therapeutics), including but not limited to investor presentations and investor fact sheets,U.S. Securities and Exchange Commissionfilings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchards investor relations website and may include additional social media channels. The contents of Orchards website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Contacts

InvestorsRenee LeckDirector, Investor Relations+1 862-242-0764Renee.Leck@orchard-tx.com

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Orchard Therapeutics to Present at Virtual Investor Conferences in June - GlobeNewswire

CAMBRIDGE, Mass.--(BUSINESS WIRE)--ElevateBio, LLC, a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies, announced that the company will present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 8:30 a.m. ET.

About ElevateBio

ElevateBio, LLC, is a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies. It begins with an environment where scientific inventors can transform their visions for cell and gene therapies into reality for patients with devastating and life-threatening diseases. Working with leading academic researchers, medical centers, and corporate partners, ElevateBios team of scientists, drug developers, and company builders are creating a portfolio of therapeutics companies that are changing the face of cell and gene therapy and regenerative medicine. Core to ElevateBios vision is BaseCamp, a centralized state-of-the-art innovation and manufacturing center, providing fully integrated capabilities, including basic and transitional research, process development, clinical development, cGMP manufacturing, and regulatory affairs across multiple cell and gene therapy and regenerative medicine technology platforms. ElevateBio portfolio companies, as well as select strategic partners are supported by ElevateBio BaseCamp in the advancement of novel cell and gene therapies.

ElevateBios investors include F2 Ventures, MPM Capital, EcoR1 Capital, Redmile Group, Samsara BioCapital, The Invus Group, Surveyor Capital (A Citadel company), EDBI, and Vertex Ventures HC.

ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass. For more information, please visit http://www.elevate.bio.

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ElevateBio to Present at the Jefferies Virtual Healthcare Conference - Business Wire

NewsEnvironmentResearchers at Queen Mary University of London and the Royal Botanic Gardens, Kew, discovered genes that create chemicals harmful to insects

Monday, 25th May 2020, 11:22 pm

A set of genes has been identified that could protect ash trees from a deadly beetle, which attacks by burrowing into their stems.

Named the Emerald Ash Borer (EAB), the killer pest is expected to destroy hundreds of millions of trees worldwide in the years to come without any intervention.

Researchers at Queen Mary University of London and the Royal Botanic Gardens, Kew, discovered genes that create chemicals likely to be harmful to the insects.

They sequenced the genomes of 22 types of ash tree and used this information to analyse how the different species are related to each other.

Help trees fight deadly beetles

Meanwhile, the US Department of Agriculture Forest Service, in Ohio, tested the resistance of more than 20 ash species to EAB by hatching eggs on the bark of trees, and following the fate of the beetle larvae.

Resistant ash trees killed the larvae when they burrowed into their stems, but susceptible ones did not.

The scientists discovered 53 candidate resistance genes, several of which are involved in making chemicals that are likely to be harmful to insects.

The findings suggest that breeding or gene editing could be used to place these resistance genes into ash species currently affected by EAB.

Dr Laura Kelly, an academic visitor at Queen Mary and lead author of the study, published in the journal Nature Ecology & Evolution, said: Knowledge of genes involved in resistance will...help efforts to identify trees that are able to survive the ongoing threat from EAB, and in turn, could facilitate restoration of ash woodlands in areas which have already been invaded."

Originally posted here:
Gene therapy could help millions of ash trees fight deadly beetle Emerald Ash Borer - inews

Gilead CEO Dan ODay has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosens Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. ODay also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. Theres $500 million in potential TIGIT milestones on US regulatory events likely capped by an approval if Gilead partners on it and the stars align on the data. And theres another $150 million opt-in payments for the rest of the Arcus pipeline.

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European regulators accept FibroGen's anemia drug for review; Passage Bio's lead gene therapy gets more love from the FDA - Endpoints News