Category: Covid-19 Vaccine

TAMPA, Fla. Researchers, scientists, and health professionals all over the world are working around the clock to find treatments for the coronavirus. There are several trials going on right now, but it could take months to find which ones work best.

They are also working to find a vaccine. But according to the New England Journal of Medicine that could take years.

Developing a vaccine takes time and is an expensive process. It is going to take multiple candidates and years to produce a licensed vaccine.

The New England Journal of Medicine

In the meantime, let's focus on some of the treatments currently on trial or being tested.

Remdesivir-- is currently at the top of the list of treatments the world is excited about.

On May 1, 2020, the Food and Drug Administration (FDA) allowed the emergency use of Remdesivir as a treatment for COVID-19. The experimental drug appears to help some coronavirus patients recover faster.

The research-based biopharmaceutical company, Gilead Sciences, Inc. has been studying Remdesivir for more than 10 years.

Gilead scientists tested the drug as a treatment for hemorrhagic fever viruses such as Ebola, Marburg, and Nipah viruses, as well as other coronaviruses such as SARS and MERS.

When COVID-19 started to turn into a global pandemic, Gilead Sciences put Remdesivir into clinical trials to test how it would work as a treatment. The National Institute of Allergy and Infectious Diseases sponsored the Adaptive COVID-19 Treatment Trial, ACTT.

In February 2020, the first study site opened at the University of Nebraska Medical Center. The trial stopped taking new volunteers on April 19.

One of the ACTT trial sites is right here in the Tampa Bay area at Sarasota Memorial Hospital (SMH.)

There are eight people enrolled in the ACTT trial at SMH. "We are using the experimental drug in very sick people on ventilators, so it is difficult to assess the benefit of the drug on our patients at this time, said Kirk Voelker, a critical care pulmonologist caring for COVID-19 patients in Sarasota Memorial Hospitals ICU and medical director and sub-investigator of the health systems COVID-19 research trials.

Although SMH is in the early phase of the ACTT trial, Voelker said things look promising. "We are seeing positive indications in the trial and are hopeful that this treatment, along with other therapies we are researching, will be effective.

The initial group of people in the ACTT trial are Americans who quarantined aboard the Diamond Princess cruise ship, which was docked in Yokohama, Japan.

There are 68 study sites around the world, including 47 in the United States. The other test sites are located throughout Europe and Asia.

This week, Dr. Anthony Fauci, director of the NIAID, said findings from the Remdesivir trial are promising. He said the drug reduced the time it takes people to recover by 31 percent 11 days on average versus 15 days for those just given usual care.

What it has proven is that a drug can block this virus. This will be the standard of care," Dr. Fauci said.

The National Institutes of Health (NIH) also followed up with its own study and found patients who took Remdesivir recovered faster than patients who did not.

However, the NIH study also found eight percent of patients who took the drug died versus 11.6 percent of patients who did not take Remdesivir.

Chloroquine This drug is primarily used to prevent or treat malaria, which is caused by mosquito bites.

Its currently in clinical trials. And as with any drug, researchers realized chloroquine is not ideal for every patient.

Research of how effective chloroquine is for COVID-19 is still in the beginning stages. And collecting enough data might take longer than anticipated because currently theres a shortage of the medication.

The FDA put out warning labels for users of Chloroquine Phosphate.

They list cardiac effects, hypoglycemia, retinopathy, central nervous system effects, muscular weakness, and potential carcinogenic risk as possible side effects.

A report from the Institute of Virology of the Chinese Academy of Sciences showed the dosing of Chloroquine is very sensitive and taking too much could have major side effects or even death.

The FDA has yet to approve chloroquine as a treatment for COVID-19

Hydroxychloroquine is less toxic than chloroquine.

It is prescribed to those with rheumatoid arthritis, lupus, and porphyria cutanea tarda, a blood disorder that affects 1 out of 25,000 people.

Hydroxychloroquine is being tested as a preventative for healthcare workers. If it works for health professionals, will the general population gain access to it as a preventative drug?

Plasma Infusions Doctors are using plasma infusions on COVID-19 patients on ventilators.

Blood banks and the American Red Cross are asking for plasma donations from people who have tested positive for COVID19 and then negative. Donors should be symptom-free for 28 days.

According to the American Society of Hematology, convalescent plasma could provide short-term immunity against the SARS-CoV-2 coronavirus.

Most patients who recover from COVID-19 develop antibodies to various SARS-CoV-2 proteins two to three weeks after being infected. Transfer of plasma from these patients is supposed to neutralize the virus and stop tissue damage.

Plasma infusions should work best on those with less severe infection, according to the American Society of Hematology.

Azithromycin Is an antibiotic that has never been used for viral infections. According to the U.S. National Library of Medicine, Azithromycin is used to treat bacterial infections, such as bronchitis, pneumonia, sexually transmitted diseases and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs.

So far, there hasnt been any solid research, but some medical observers found that azithromycin could help reduce an overactive immune response to the COVID-19 infection. Harvard Medical School

Studies that have been done suggest azithromycin can be deadly if its used in combination with hydroxychloroquine. The human heart just couldnt hold up.

Vitamin C--Some people who are critically ill with COVID-19 have been treated with high doses of vitamin C through their IV. Doctors hope high doses of vitamin C will speed up the recovery process.

Theres no scientific evidence that a vitamin C IV drip works for COVID-19 infections.

Researchers in China are currently conducting a study to see if the high doses of vitamin C will help those with severe COVID-19. Results are expected in the fall of 2020. Harvard Medical School

Lopinavirritonavir is an antiviral drug used to treat patients with human immunodeficiency virus, HIV. The drug is currently on the Chinese clinical trial register and is administered to adults with severe COVID-19 symptoms.

So far, doctors have not seen any benefits of the drug as a treatment.

What are we missing?

As mentioned at the beginning of this article, everyone is chipping in to find an ideal treatment for COVID-19.

What treatments or clinical trials have you learned about?

E-mail your findings to TCody@wtsp.com and I'll dig into the research and then ask the experts how well the treatments are working.

RELATED: FDA approves first at-home coronavirus testing kit

RELATED: Virologist says it's "optimistic" to think a COVID-19 vaccine will be ready in a year

What other people are reading right now:

See more here:

Treatments and vaccines for COVID-19: Where are we now? - WTSP.com

Biopharma players worldwide have committed big money and talent to the hunt for a COVID-19 vaccine, striking some unprecedented partnerships along the way.

Behind the scenes, another joint effort has been taking shape at the White House, Bloomberg reports.

The Trump administration is working up a Manhattan Project-style joint initiative, bringing biotech, pharma and federal agencies together to speed up the workand let the U.S. government take on the financial risks.

FiercePharma Presents the Virtual eRegulatory Operations Summit

Join industry experts and learn how to build and manage cohesive, compliant, and timely electronic submissions through innovative technologies and seamless clinical documentation processes.

Dubbed Operation Warp Speed," the project's goal is delivering 100 million doses of a viable COVID-19 vaccine by the end of the year, according to the report. It would be a radical acceleration of the typical vaccine development timeline, which is typically described in years, not months.

To help move things along, the administration wants to help biopharma companies coordinate their separate efforts with assistance from federal agencies and the U.S. military, according to the report. U.S. taxpayers would fund the losses from failed projects, Bloomberg reports.

For instance, officials are exploring a master trial protocol that would allow researchers to study numerous vaccines at the same time rather than separately through independent studies by each company.

To speed up distribution, the team is planning to scale up manufacturing capabilities as the vaccines enter large human trials. Bill Gates has pitched such an approach, and hes acknowledged the strategy will result in billions of lost capital spending as many projects fail.

RELATED: Gates is ableand willingto lose big money funding factories for COVID-19 vaccines

Over the past two months, drugmakers, academics and others have started dozens of COVID-19 vaccine projects. Johnson & Johnson has inked manufacturing deals in recent days to prep for its rollout, while GlaxoSmithKline, Sanofi, Pfizer and Merck also have R&D projects underway.

The "Warp Speed" program arises from the administrations desire to smash the 12- to 18-month timeline often quoted for developing a COVID-19 vaccine, which itself is optimistic. Analysts and others have predicted it could be several years before the world sees a vaccine, and, historically, some vaccines have taken decades to develop.

RELATED: Biopharma's no-holds-barred fight to find a COVID-19 vaccine: The full list

Still, some vaccine programs are moving ahead with unprecedented speed. Researchers with Oxford University's Jenner Institute plan to start a 6,000-participant trial next month, The New York Times reports. The team is also working with drug manufacturers in Europe and Asia to quickly produce up to 1 billion doses upon a potential approval.

Also this week, Pfizer said it might be ready for an emergency rollout by the end of 2020, The Wall Street Journal reports.

See more here:

'Operation Warp Speed' aims to deliver a COVID-19 vaccine by year-end: Bloomberg - FiercePharma

SPRINGFIELD, Mass. (WWLP) Most public health officials had been saying it would take at least a year to develop a vaccine for COVID-19 but now, scientists in England are claiming that one could be ready by this fall.

Researchers at Oxford University have made significant progress recently in the global race to develop a vaccine. Human testing is now underway for their vaccine, and theyre hoping to have it ready for public use by September.

The FDA has strict requirements for vaccines before they are released to the public. But due to the severity of this health crisis, local doctors say they may ease back those requirements.

They may say theres no long term data but we know it protects for a couple months at least, so lets roll it out and watch how it does once its already available, said Dr. Daniel Skiest, an Infectious Disease Specialist at Baystate Medical Center.

Dr. Skiest told 22News progress is also being made right now on an antiviral medication that could help reduce the severity of symptoms.

He added that social distancing protocols would most likely continue for much longer, if it ends up taking longer to develop both a successful vaccine or an antiviral medication.

Follow this link:

Covid-19 vaccine could be ready sooner than expected - WWLP.com

The urgent search for a vaccine to protect against COVID-19 is well underway, with a number of experimental gene-based vaccines in various stages of development by biotech companies and academic scientists worldwide. Yale pathologist John Jack Rose believes a proven vaccine platform he pioneered decades ago using a livestock virus called vesicular stomatitis virus (VSV) could produce better immunity than other candidates, and be scaled up quickly to meet global demand.

The VSV platform was used to develop the Ebola vaccine that received FDA approval in December 2019 and has since been effectively administered to more than 235,000 people, including over 60,000 health care and frontline workers.

Rose, professor emeritus of pathology and senior research scientist at Yale, and a small team of researchers that includes pathology chair Dr. Chen Liu and Craig Wilen, assistant professor of laboratory medicine and of immunobiology, are now working around the clock to develop a VSV-based COVID-19 vaccine and begin animal testing.

It is so critical that we provide at least an alternative approach for a vaccine, said Liu, who enlisted Rose in the challenge and set up his own lab alongside Roses to share in the work. There are DNA or protein-based vaccines for COVID-19 in trials, but, in my opinion, the viral vector [a vaccine using a live virus] would be more robust in generating immunity.

To make a vaccine using the VSV platform, scientists insert a protein from the virus they are trying to protect against such as Ebola or SARS CoV-2, the virus strain that causes COVID-19 into the livestock virus. The livestock virus is well suited for safely passing genetic material into cells and stimulating an immune response, Rose said. It is genetically stable, does not cause illness in humans, and generates a very strong antibody and T-cell response.

And a livestock virus can be reproduced much more easily than messenger RNA and DNA vaccines.

It would be easy to scale up production of a VSV vaccine for SARS CoV-2. We could get to millions of vaccine doses easily.

John Jack Rose

It would be easy to scale up production of a VSV vaccine for SARS CoV-2, said Rose. We could get to millions of vaccine doses easily.

Wilens lab is growing the live SARS CoV-2 virus strain, necessary for testing the new vaccines effectiveness.

Hes also making synthetic versions of the virus spike protein that will be inserted into the livestock virus. In high-resolution electron micrographs of the SARS CoV-2 virus, the spike proteins appear as protrusions emerging from the central mass like so many sucker feet. Its these proteins that allow the virus to bind to human cells and cause infection.

Because SARS CoV-2 is so contagious and potentially lethal, the Yale scientists wear complete protective gear including respirators and work in an isolated, negative-pressure room.

The coronavirus is similar in terms of virology to the norovirus, Wilens focus before the pandemic hit, he said. We were the first lab at Yale to culture the virus. Were working to pop out the normal VSV protein called G and swap it with the coronavirus protein.

Wilen said he and two postdoctoral students have taken over additional lab space in order to practice social distancing while they work.

The scientists have reason to hope that their VSV-based COVID-19 vaccine will work. Beyond its successful use in protecting against Ebola, the VSV platform has been used to develop other vaccine candidates that have shown promise in animal models for protecting against avian flu, HIV, and SARS CoV-1. The latter virus spread across 26 countries in 2013 and led to over 8,000 cases and 774 deaths.

SARS CoV-2 is a stealth version of SARS, Rose said. The original SARS made people very sick much faster and it was easier to trace contacts.

In his work creating the original SARS vaccine, Rose was able to successfully insert the spike protein into the VSV virus and engineer protection against SARS in mice. Because that virus was easier to contain than the slow-to-emerge SARS CoV-2, the work ended before the vaccine reached human trials.

But he learned important lessons about how the novel coronavirus operates. For one, its hard to generate immunity against it.

Even with the live virus, SARS CoV-1 didnt get a strong immune response [in mice], Rose said. It was protective, but low. It suggests we need a robust vector system.

Preliminary data shows that inserting SARS CoV-2 into the VSV platform will work to generate that protective immune response, Rose said.

Said Liu: This has a really good chance.

More here:

Yale researchers pursuing COVID-19 vaccine based on powerful Yale platform - Yale News

Pfizer and partner BioNTech are right in the middle of one of the most important vaccine trials in the world right now, but that doesnt mean the Big Pharma is taking its eyes off the inoculation ball elsewhere.

In the same week it announced dosing had been finished in its pandemic mRNA vaccine test, Pfizer also said it had penned a $308 million Lyme disease vaccine R&D pact with French biotech Valneva.

The deal focuses on development of Valnevas Lyme disease vaccine candidate, VLA15, which is currently in phase 2. VLA15 is the only active Lyme disease vaccine program in clinical development today and covers six serotypes that are prevalent in North America and Europe.

FiercePharma Presents the Virtual eRegulatory Operations Summit

Join industry experts and learn how to build and manage cohesive, compliant, and timely electronic submissions through innovative technologies and seamless clinical documentation processes.

Collectively, around half a million people across the two regions are infected with the bacteria Borrelia, causing in many long-term debilitating disorders if not treated quickly. Its predominately spread to humans by infected Ixodes ticks.

The multivalent protein subunit vaccine targets the outer surface protein A (OspA) of the Borrelia bacteria: OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick.

VLA15 has demonstrated strong immunogenicity and safety data in preclinical and phase 1 studies, Valneva said, and was given a fast-track label by the FDA back in 2017. Phase 2 enrollment is done, and the French biotech expects to post data from that study in the coming months.

It gets $130 million upfront, $35 million in development milestones and $143 million in early sales milestones, should it gain approval.

Under the nuts and bolts of the deal, Valneva will fund 30% of all development costs through completion of the development program, while Pfizer will pay Valneva tiered royalties starting at 19%. Pfizer will then lead late-stage development and have sole control over selling the vaccine.

RELATED: Valneva looking to buy small, overlooked vaccines from Big Pharma: CEO

Valneva already sells vaccines to protect against cholera and Japanese encephalitis and has R&D programs in chikungunya.

Thomas Lingelbach, CEO at Valneva, said: This collaboration is extremely exciting as it provides the opportunity for the rapid development and launch of a vaccine that has the potential to address a major unmet medical need. It validates Valnevas strong vaccine R&D capabilities. We believe that Pfizer is the best partner for our Lyme disease vaccine given their outstanding development and commercial capabilities. Our team is thrilled about the prospect of working with such a successful partner.

The biotech has had pharma partners before, though back in 2016 one didnt work out when it gave up on its vaccine against hospital-acquired infection Pseudomonas aeruginosa. The vaccine was positioned to be picked up by GlaxoSmithKline, but weak phase 2/3 data torpedoed both that possibility and Valnevas interest in forging ahead with development.

It will hope to have better luck with Pfizer.

Nanette Cocero, global president of Pfizer Vaccines, added: Lyme disease is the most commonly reported tick-borne illness in the United States and is growing in its prevalence and geographic reach. We look forward to working closely with Valneva to continue advancing the VLA15 program and potentially bring a new solution to patients for this significant unmet need.

As both a research company, and a manufacturer of pediatric and adult vaccines including a vaccine for tick-borne encephalitis in Europe, we believe that Pfizers vaccine heritage, scientific expertise, and global commercial capabilities will help allow the VLA15 program to reach its maximum potential in helping protect children and adults from Lyme disease.

View post:

COVID-19 the focus, but Pfizer isn't ignoring other vaccine R&D as its pens new deal - FierceBiotech

Hours after Gilead announced that an NIH trial testing their antiviral drug remdesivir in Covid-19 patients had succeeded, NIAID director Anthony Fauci sat on a couch in the Oval Office and gave the world the top-line readout.

The drug induced a 31% improvement on the primary endpoint of time to recovery: 11 days in the drug arm compared to 15 days in the placebo arm, he said, adding that patients taking the drug appeared less likely to die, with an 8% mortality rate in the drug arm compared to 11% in patients given the placebo.

The mortality data were not yet statistically significant, he cautioned but were trending in the right direction. Fauci, surrounded by President Trump, Vice President Mike Pence and several other advisors, said the news was a very optimistic sign in the hunt for treatments to fight the virus.

Although a 31% improvement doesnt seem like a knockout 100%, it is a very important proof of concept, he said. Because what it has proven, is that a drug has blocked this virus.

Fauci said more details would come and that the study would be submitted to a peer-reviewed journal. Trump, who deferred to Fauci in giving the readout, echoed Faucis commentary.

Its a beginning, that means you build on it, Trump said. But its a very positive event.

Shortly after the briefing, the New York Times reported that the FDA was preparing to issue an emergency use authorization for the drugs use in Covid-19. In an email to Endpoints News, the FDA did not confirm or deny the Times report, but a spokesperson said the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate.

Unlock this story instantly and join 80,400+ biopharma pros reading Endpoints daily and it's free.

SUBSCRIBE SIGN IN

Read the rest here:

AstraZeneca vaults to the front of the Covid-19 vaccine race, teaming up to globalize Oxford candidate - Endpoints News

The federal governments response to the coronaviruspandemic could turn out to be a policy mistake of epic proportions. The successof the current response depends on the development of an effective vaccine inrecord time which allows the country to quickly return to its pre-viruseconomic boom. Should reality fall short, Congress will have created a massiveamount of new federal debt with no plan B.

Policies that provide temporary support to shuttered businesseskeeping their non-working employees on the payroll are tremendously expensive.They will only work if the public-private initiatives underway can engineer aquick reduction in the virus spread that allows the nation to return tobusiness as usual, which is why the success of the governments response hingeson the rapid development of an effective vaccine.

History suggests that expectations of a quick vaccine are heavily optimistic. After almost 40 years of research, there is no vaccine for the HIV. Similarly, there are no vaccines for SARS, MERS, or the common cold. It took 10 years to develop a vaccine for the Avian H5N1 virus. Moreover, vaccines do not offer complete protection. According to the CDC, the current seasonal flu vaccine is estimated to be only 45 percent effective.

The probability of death after contracting COVID-19 is unknown but not insubstantial. In Connecticut, 7.6 percent of all confirmed COVID-19 patients have died. Death rates are similarly high in Massachusetts (5.3 percent), Louisiana (6.2 percent), and Minnesota (7.5 percent). Once asymptomatic cases are accounted for, experts expect the average mortality rate to be much lower, perhaps under 1 percent. Still, without an effective vaccine, the overall risks of the coronavirus are material because a person with the coronavirus likely infects on average between two and 2.5 other people. Without an effective vaccine, informed consumers are likely to demand social distancing mitigation once businesses reopen with or without a government social-distance mandate.

If social distancing remains the only practicalmitigant for the foreseeable future, then many businesses will be forced toadapt to remain viable. It is hard to imagine that airlines, cruise ships, masstransit, eat-in restaurants, sporting events, and all other types of activitiesthat rely on large concentrated gatherings of people will be able to resumepre-crisis operations profitably in this new environment. Taxpayers cannotafford to continue to support these businesses payrolls indefinitely. If the probabilityof survival of these types of businesses is remote in a COVID-19 world, it isshortsighted for Congress to be mortgaging Americas future on programs that freezethese potentially obsolete businesses in time, betting on the unlikely possibilitythat they can quickly and profitably be revived. Congresss failure to devote atleast some of these resources to developing a plan B a plan that does notrely on the timely development of a successful vaccine could end up being anexpensive policy mistake.

It is not surprising that funding for programs that maintain the businesses and lifestyles of voters harmed by the virus through no fault of their own garner unanimous political support. Politicians of all stripes favor programs that grease their own reelection chances, especially when the inevitable spending constraints imposed by shortsighted bailout programs are realized in the future.

However, while there is no doubt the economic transitions catalyzed by the COVID-19 pandemic will be painful for many, they are also unlikely to be avoidable. Congress and the executive branch need to rise above narrow self-interest and focus more attention on formulating a plan B with programs designed to transition the economy so it can continue grow and prosper should the world fail to develop an effective coronavirus vaccine.

See the original post here:

If we can't develop a COVID-19 vaccine, is there a 'plan B' for the economy? - American Enterprise Institute

Researchers at the University of Montana and two Missoula-based biotech companies with ties to venture capitalist Mike Goguen are engaged in separate efforts to develop a COVID-19 vaccine and gain authorization for a mass-scalable viral test.

Inimmune, a private company involved in UMs vaccine work and founded by nationally reputed vaccine scientists, is also gearing up to test an intranasal spray that researchers say has proven in animal testing to protect against other diseases and could offer protection against coronavirus. That testing will be conducted at the Rocky Mountain Laboratories in Hamilton.

Additionally, the biotech firm FYR Diagnostics is seeking emergency-use authorization from the U.S. Food and Drug Administration for a viral-detection test that it developed and which it believes could offer a viable solution to mass testing in Montana and elsewhere. Two Bear Capital, the Montana-based venture capital firm that Goguen launched in 2019, has provided FYR with seed funding and additional investments.

Goguen said this week that Two Bear Capital is also in venture capital funding discussions with Inimmune.

Inimmunes co-founder and CEO is Dr. Jay Evans, director of UMs Center for Translational Medicineand a research professor in biological sciences who is also the principal investigator on the universitys research team that was recently awarded $2.5 million from the National Institutes of Health (NIH) to identify and advance a COVID-19 vaccine candidate.

Evans and two other scientists founded Inimmune in 2016 after their employer, the pharmaceutical giant GlaxoSmithKline, closed its research and development center in Hamilton, leaving a stable of respected vaccine researchers out of a job. The founders established a partnership with UM and launched Inimmune in conjunction with the formation of the colleges Center for Translational Medicine to maintain and expand scientific research in Montana.

Evans said the relationship between the company and university is a mutually beneficial public-private partnership that bolsters research, funding and commercialization opportunities. The center alone has brought the university nearly $70 million in vaccine research funding since 2016.

The research center boasts unique expertise in adjuvants, which are the components added to vaccines to improve the immune response, and novel delivery systems to ensure vaccines are safely and efficiently delivered to the right cells.

These technologies now are being used for the COVID-19 project to rapidly advance a safe and effective vaccine toward human clinical trials, UM stated.

Evans said the 40 people at UM and additional personnel at Inimmune who are involved in vaccine discovery and development form a powerhouse research team. And hes hoping to recruit 10 more researchers as the university center grows.

Theres a reason that NIH comes to our team when theres a national crisis and they need a vaccine developed quickly with good delivery systems and adjuvants, Evans said in an interview earlier this week.

I dont know of another group in the world that has the capacity we do, he added. When we say that were a world-class vaccine discovery and development team, I dont think thats an overstatement.

The university notes that its research team works on a range of new or improved vaccines for influenza virus, tuberculosis, pertussis, Pseudomonas aeruginosa, Lyme disease, E. coli and opioid addiction. After the NIH contacted the university in February, the researchers shifted their attention to developing a vaccine for SARS-CoV-2, the virus strain that causes COVID-19.

We quickly adjusted lower-priority vaccine projects to focus our efforts on this urgent need, Evans said, adding that researchers have navigated school closures, stay-at-home orders and social distancing to rapidly advance this vaccine and continue working on other essential research projects of critical importance to our community and the nation.

Its not every day you can be involved in an essential vaccine project with global health implications, added Dr. Stephanie Lathrop, a UM immunologist and COVID-19 project leader who has been instrumental in designing studies and coordinating staff schedules during the pandemic. It has been amazing to see the UM community rally behind us in support of our efforts.

Evans said the UM team is currently conducting animal testing on COVID-19 vaccine candidates. Although the university was the sole recipient of the recent NIH award, the vaccine development work involves technology produced by both UM and Inimmune.

The $2.5 million allows us to take the technology that currently exists at the university and Inimmune and apply that technology to identify a coronavirus vaccine candidate, Evans said.

After UMs testing is complete, likely in a couple months, the universitys partner in the research, the Icahn School of Medicine at Mount Sinai in New York City, will conduct further testing, moving it closer to human clinical trials, which will require another infusion of funding.

In theory, in six months, we could be in a position to apply for a larger batch of funding that could take us through Phase 1 clinical trials, Evans said, noting that such additional funding could come from agencies or private sources such as venture capital.

Thats where someone like Mike Goguen could really come into the story, he added, noting that Goguen has been assisting Inimmune in an unofficial capacity by helping navigate the different aspects of how to make a company successful in this environment.

More broadly, Evans said Two Bear Capital has emerged as a critical driver of the biotech sphere in Montana.

What Mike is doing for biotech in Montana is pretty incredible, Evans said. Between Next Frontier Capital and Two Bear, if youre a biotech company in Montana, theyre propping up the whole system.

Inimmune has worked for years, independent of UM, to develop an intranasal spray that can protect against certain diseases such as influenza and RSV. If found to work on COVID-19, Evans said the spray could be administered every couple weeks for prolonged protection.

Theres a strong reason to believe these treatments would be effective with the current coronavirus outbreak, Evans said.

Since launching last year, Goguens venture capital firm has focused much of its attention on biotech companies. One such firm is FYR Diagnostics, a Missoula-based molecular diagnostics company that has been developing a mass-scalable and cost-effective COVID-19 viral infection test.

The FDA has approved two different types of COVID-19 tests: antibody tests that detect an individuals immune response to the virus and viral tests that detect the presence of the SARS-CoV-2 virus itself. FYR Diagnostics product is a rapid virus-detection test called Adaptive Low Resource Testing (ALRT), which the company says is effective at identifying a potentially active and contagious infection, even in asymptomatic individuals, but not effective at identifying those who have recovered from the virus.

We are proud to be doing our part to address the COVID-19 crisis, said FYR Diagnostics CEO Chris Booth, Ph.D.

FYR President Sarjubhai Patel is a research professor at UM. Another company cofounder, Braxton Norwood, Ph.D., grew up in Kalispell and graduated from Flathead High School in 1999.

Officials at FYR Diagnostics say several viral-detection diagnostic tests have been approved by the FDA and are in use across the country, but supply chain and equipment shortages have inhibited their capability on a mass scale.

FYR Diagnostics ALRT test opens this bottleneck through alternative reaction components and technologies that do not require scarce equipment or costly specialized devices, the company states. The ALRT test is designed to be low cost, simple to administer without specialized training, and suitable for use at low-resource testing sites beyond hospitals and clinics. It can produce a yes/no test result in 30-40 minutes.

Patel said emergency-use authorization from the FDA would allow for the tests deployment on a broad scale. Goguen, who is FYR Diagnostics executive chairman, noted that insufficient testing capacity here in Montana and throughout the U.S. is amplifying and prolonging the COVID-19 crisis while putting more lives at risk.

FYRs highest priority is to quickly enable mass COVID-19 testing in our home state, and then expand elsewhere, Goguen said.

Goguen founded Two Bear Capital after previously spending 20 years at one of the worlds leading venture capital firms in Silicon Valley, Sequoia Capital. He said the research and development occurring in the state, from universities to private companies, is a badge of honor for Montanans.

In my opinion, we have a lot to be proud of in Montana to have such important work being done right here in our state because of the expertise of folks at UM and at these companies, Goguen said.

If you enjoy stories like this one, please consider joining the Flathead Beacon Editors Club. For as little as $5 per month, Editors Club members support independent local journalism and earn a pipeline to Beacon journalists. Members also gain access to http://www.beaconeditorsclub.com, where they will find exclusive content like deep dives into our biggest stories and a behind-the-scenes look at our newsroom.Join Now

See original here:

Development of COVID-19 Vaccine, Tests Advancing in Montana - Flathead Beacon

As the number of coronavirus infections worldwide surpasses 3 million, the hunt for a vaccine against COVID-19 grows ever more urgent. At least 13 potential vaccines are in development, with three already being tested in humans, but scientists say the public may have to wait months, if not a year or more.

Here & Now's Tonya Mosley speaks withHelen Branswell(@HelenBranswell), infectious diseases and global health reporter for STAT.

View post:

Tracking The Growing List Of COVID-19 Vaccine Developments - WBUR

Youve heard about hydroxychloroquine, but do you know about Remdesivir, Roivant, and Athersys? If youre keeping an eye on a possible vaccine, do you know there are more than a dozen vaccine candidates that are either doing trials now or hoping to start soon? This tracker from healthcare news outlet STAT has you covered.

The tracker doesnt include every possible drug and vaccine effort, but it does list some of the most talked about and sorts them to put the ones whose development is the furthest along at the top of the chart.

For drugs, the top entry is Remdesivir, which has begun phase 3 trials. It was previously tested on SARS, MERS, and Ebola, in the hopes that it could act as an all-purpose antiviral. Now its being tested on COVID-19 patients, although the phase 3 trials in China were both suspended due to a lack of eligible patients.

G/O Media may get a commission

Among vaccines, the top entry is Modernas mRNA vaccine, which began its phase 1 trials in March. None of the vaccine candidates have yet begun phase 2 trials, meaning it will be a while before we even know if any of them work, much less get a worldwide supply manufactured and distributed. We may be years away from the first vaccine (the fastest vaccine ever developed took four years), but with this chart we can keep an eye on how that process is going.

Original post:

Track All the COVID-19 Drug and Vaccine Candidates With This Chart - Lifehacker