Category: Covid-19 Vaccine

Soon after the impact of the novel coronavirus that causes COVID-19 became apparent, academic researchers, public health institutions and private companies began the search for a vaccine to prevent infection and treatment to manage it. New trials are announced daily, and data sharing has been unprecedented. As part of efforts to encourage data sharing and progress toward vaccines and treatments, the Milken Institutes FasterCures has developed a tool for tracking that progress. SmartBrief spoke with Executive Director Esther Krofah about the tool, and the R&D and funding landscape.

Lets start with the COVID-19 vaccine and treatment tracker. Your team has created and is regularly updating this resource. Having looked at the landscape, how would you describe the movement toward a treatment and a vaccine?

There has been quite a significant level of activity toward development of a treatment and vaccine. I am quite heartened to see the all of the various research institutions, academic institutions and companies that are moving really rapidly to look at their libraries of compounds and identifying what could be useful for COVID-19.

And so we have a really broad landscape on the treatment side where we are looking at antibodies, antivirals and other mechanisms of action as well as on the vaccine front. Theres a significant amount being done.

On the treatment side, we have over 58 treatments that we are tracking and over 43 vaccine candidates that we are tracking. Of course, as we have seen in news reports, Moderna has the first clinical trial under way for a vaccine candidate, a first-in-human phase I trial, but we expect to see more coming down the pike.

Altogether, we have over 100 candidates that are being investigated for the coronavirus. Of course, attention is going to be on what can we get to patients as quickly as possible.

Can you talk about what looks most promising?

Its quite early to talk about what is most promising. It is helpful to see how quickly weve been able to sequence the virus and how quickly we have been able to initiate clinical trials. Everyone is moving at breakneck speed. A vaccine of course is going to take a little bit longer. It will likely be 12 to 18 months before we see a vaccine broadly available for a general population.

I have a lot of hope in the promise of treatments in the short term, whether antibodies or antiviral treatment. If we can start to extract from convalescent patients the antibodies that they have developed after infection and use that to treat ill patients, that might be a very quick treatment in the short term. And were seeing a lot of activity there.

Between the clinical trials under way with remdesivir and with Regenerons medicines, those might really be able to help in the short term. And clinical trials are under way with hydroxychloroquine and azithromycin as a combination. These trials are being used to make sure they are safe and effective for coronavirus, as many of these therapies have already been approved for other indications

How does the regulatory process fit into this picture?

The FDA and NIH are actually working quite quickly to ensure that there are no barriers getting in the way from a clinical trial perspective. That early coordination is quite helpful and provides some guidelines to the research community and companies that are looking at this. Of course, we have a quite defined process to ensure safety and efficacy. And those standards are not being diminished. What is happening is ensuring that guidance is being brought quickly around sites of care and patient enrollment, and information is being shared quickly and clearly with the appropriate parties.

So, the coordination is happening much more quickly, but the standards are being upheld to first ensure safety and then to get the appropriate dosage before expanding upon those clinical trials.

I will also say what the FDA has been doing quite well is ensuring compassionate use where there are trials under way and there may be potential for patient benefit. We are seeing compassionate use being approved very quickly for products like remdesivir and the extraction of serum, creating a pathway for patients to get access to potential treatments with approval from the FDA and their physician. Red tape is being broken down so patients who could benefit from potential treatments are getting them as quickly as possible.

We have heard a lot of concern about patient costs. Are treatments and vaccines going to be affordable to patients?

It is too early to tell, but we do not anticipate that we will have affordability challenges or questions. This is a public health crisis, and we fully expect that companies are going to price products with that in mind.

What about research funding -- is there enough of it, and is it in the hands of those who can put it to the best use?

Funding for the trials that are happening now, particularly for the NIH, is not a significant challenge, thanks to all the efforts that are happening right now on the Hill, and thanks to other funding that is being diverted from traditional trials that cannot immediately use them.

So, funding on the clinical trials side is moving rather quickly and we have been in conversations with the Gates Foundation, which has a $125 million initiative, and with Mastercard and Wellcome Trust. Seeing the private philanthropy side step up is also quite promising.

I will say that we are going to need significant funding to ramp up manufacturing once we have an FDA-approved therapy on the market or evidence supporting an existing therapy that has a different indication. The manufacturing needs are quite real, and we need to be sure we are prepared for that. But for the clinical trials, particularly those that are run by the NIH, the funding seems to be flowing.

And finally, for individual investigators at universities, obviously they are looking for funding to scale their efforts as they typically do.

FasterCures has a long history around patient engagement and advocacy. In what ways are patients being engaged with this type of research?

There is a lot of work happening to get patients mobilized into clinical trials, and we are seeing significant participation on that front. As you see in the Seattle region, patients are quite willing to step into clinical trials, and they are quite eager to see what they can do to help ensure we can get a treatment or a vaccine quickly to market.

We are communicating and working quite closely with our disease foundations, which represent a significant portion of the community of patients that have very complex care needs. These are individuals who have chronic diseases and underlying medical conditions that make them the most vulnerable to COVID-19. Whats important for that population is getting the right information and education to them so they understand how they can protect themselves during this time and continue following the appropriate treatment protocols for their existing conditions.

Can you talk about the state of collaboration among researchers, companies and the federal government?

Yes. One example is the Biomedical Advanced Research and Development Authority, which recently issued a call to companies that want to work with them to submit applications that is wonderful to see. We see a lot of collaboration already happening between university research institutions here in the US in collaboration with those abroad. We see NIH mobilizing their trial networks quite quickly to start clinical trials to collect evidence for treatment protocols.

Data is being shared. Even on Twitter, different scientific communities are really creating great opportunities to discuss and share data and studies in advance of being published.

So, there is a lot that is happening on the collaboration front. What we still need is greater coordination of the academic scientific community so we ensure we are not duplicating efforts. We need to have really good quarterbacking behind the scenes, whether FDA or NIH working in collaboration with the scientific community, to make sure teams have the appropriate standards, and even a master protocol for clinical trial design, which would be quite helpful during this time.

Scientists have been warning us for decades that our world was primed for a pandemic like this. What effect will this experience have on funding for emerging infectious diseases moving forward?

This is a reality check, right? The world that we predicted would happen has now come before us.

And so, my hope is that this motivates funders and policymakers to plan for long-term responses, so we are not responding continually in a crisis situation. I am quite hopeful we can get the right funding to BARDA for them to develop platform technologies and other solutions that will be helpful to turn the capability of R&D quite readily to whatever virus shows up.

We have seen a lot of quick action on the part of BARDA and others that are working in collaboration with them, but what we want to see is longer-term funding directed to BARDA, to the NIH and other parts of the federal government -- DOD and others -- that can really help us establish longer-term platforms. Now is the time to fund these agencies at sufficient levels.

Melissa Turner is director of content for health care and life sciences at SmartBrief. For more content like this delivered straight to your inbox, check out SmartBrief's Life Sciences newsletters, covering medical devices, drug development and regulation, biotech and more.

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FasterCures: 100-plus vaccines and treatments fill the growing COVID-19 pipeline - SmartBrief

GAITHERSBURG, Md. (WJZ) As the number of coronavirus cases continues to grow both in Maryland and around the world, the race is on to find a vaccine.

At Novavax lab in Montgomery County, researches said they are seeing some positive results after just a few weeks of trial.

CORONAVIRUS COVERAGE:

Maryland officials are reporting at least 423 cases of coronavirus across the state as of Wednesday morning.

The state is now up 74 cases from Tuesday the biggest one-day jump to date since cases began in the state. Of the total cases, 217 cases are for people ages 20-54. There are also five pediatric cases in the state.

The rest is here:

Researchers In Gaithersburg Making Progress On COVID-19 Vaccine - CBS Baltimore

Sean Diehl likens the development of a new vaccine to the construction of a house. Before workers can turn a shovelful of dirt or hammer a nail, an architect must create a blueprint that shows how the building's thousands of components fit together and in what order.

Similarly, vaccine researchers trying to stop the spread of a deadly virus must start by mapping its messenger RNA. Decoding that genetic blueprint allows them to construct a safe and reliable vaccine that, they hope, will provide immunity for decades.

This time, researchers are racing to devise a vaccine that will stop a pandemic that's already upon us, using a never-before-tried method. It's akin to erecting a storm shelter using a new construction technique just as a Category 5 hurricane makes landfall.

Diehl is an assistant professor in the Department of Microbiology and Molecular Genetics at the University of Vermont's Larner College of Medicine. Since 2008, he's collaborated with the college's Vaccine Testing Center on projects involving infectious diseases, autoimmune disorders and vaccine development. In the past few years, Diehl's laboratory has focused on developing new protections against rotavirus, which is one of the most common and deadly causes of childhood diarrhea, and two mosquito-borne viruses dengue and Zika which infect tens of millions of people worldwide each year.

The 44-year-old Shelburne resident agreed to an interview with Seven Days months before the novel coronavirus made headlines. Since then, Diehl has joined the global effort to develop a vaccine against COVID-19.

On that front, researchers are already working at breakneck speed. They began in late December, when health authorities in Wuhan, China, first reported the outbreak of a viral pneumonia of unknown origin. On January 12, Chinese health authorities and the World Health Organization announced that they had mapped the entire sequence of the new coronavirus genome and shared it with researchers around the world.

On March 16, the National Institutes of Health announced the launch of a Phase 1 clinical trial to evaluate an experimental COVID-19 vaccine. In that study, being conducted at the Kaiser Permanente Washington Health Research Institute in Seattle, 45 healthy volunteers, ages 18 to 55, were injected with different doses of an experimental vaccine to evaluate its safety and efficacy in inducing immune responses.

Diehl is not involved in the Washington study. But, using the expertise he gained from researching dengue and Zika vaccines, he explained how a COVID-19 vaccine will be developed, how long it could last and how we can create more effective versions in the future.

"This is a brand-new approach," he said of the experimental coronavirus shot. "There is no current vaccine that's ever been developed this way."

How long before the public can be immunized? That's difficult to say. Diehl wouldn't offer a prediction beyond saying that "there are some aggressive timelines being talked about."

Ordinarily, vaccines involve years of research before human trials begin. But advanced genetic technologies and reductions in bureaucratic red tape could significantly shorten that timeline for COVID-19, with some estimates saying a vaccine could be available as early as this fall.

Several methods are used to create a vaccine, Diehl said. Under normal circumstances, the most common is to start with an attenuated, or weakened, version of a virus. Scientists inject this weaker version into laboratory animals, typically mice and nonhuman primates, hoping to trigger an immune response that doesn't make the animal sick. Only after long and rigorous study do vaccine developers request approval from the U.S. Food & Drug Administration to move on to human trials.

Consider the lengthy path that brought researchers to a vaccine for just one of four serotypes, or strains, of dengue (known as "Dengue 1, 2," etc.). Versions of the deadly virus are found in more than 100 countries around the world, posing a risk to about 40 percent of the world's population, or 3 billion people. According to the U.S. Centers for Disease Control and Prevention, as many as 400 million people are infected with dengue each year, of whom 100 million get sick and 22,000 die.

Though dengue's mortality rate is about 0.1 percent, comparable to seasonal flu, Diehl pointed out that its symptoms are much worse. "Dengue" may derive from the Spanish word for fastidious or careful, which describes the gait of a patient suffering from the disease.

The disease causes a very high fever that progresses into terrible joint, muscle and bone aches hence its nickname, "breakbone fever." Patients feel that their eyes are about to pop out of their heads.

Dengue is a particularly complicated disease to combat because of its four serotypes; an immunity to one offers no protection against the other three. If a person contracts Dengue 1 in, say, the Dominican Republic, they may recover without even knowing they were infected. However, if that person later travels to Puerto Rico and contracts Dengue 2, they have a greater chance of getting sick from the second exposure.

"For dengue," Diehl said, "it's taken, so far, 20 years and several billion dollars to get to the point of [having] the one vaccine that's on the market right now, for a very limited use."

What does this mean to researchers racing for a coronavirus vaccine? Speaking in "really broad brushstrokes," Diehl said, the way genetic material is encoded in the coronavirus is "very similar" to the coding of dengue. Both viruses have one long, continuous string of nucleic acid, or mRNA, that is "read" as a series of letters representing its chemical components: adenine (A), guanine (G), cytosine (C) and urasil (U).*

In the case of dengue, that string is 10,000 letters long. In COVID-19, Diehl said, it's 29,289.*

Working with a much longer string of information naturally presents more challenges. But, Diehl said, COVID-19 researchers don't need a full understanding of how all 29,289 letters of the genome function. The novel approach they're using to develop a vaccine is focused on the 3,000 to 5,000 letters that they believe may induce an early protective immune response. If they can pinpoint those letters, they will, in effect, buy themselves more time.

By now, most people who are following news of the unfolding pandemic have seen images of the COVID-19 virus, which resembles a fuzzy tennis ball riddled with darts or crowns. Those darts, which are called spike proteins, enable the virus to attach itself to a target cell, pass along its genetic material and reproduce.

A vaccine is essentially useless, Diehl said, if it triggers an immune response "post-fusion," or after the virus binds to the cell. The aim of this experimental vaccine is to induce an immune response before fusion happens.

"If we can block that," he said, "the virus has nowhere to go, and it dies."

The good news: Vaccine developers now have machines that can rapidly synthesize and mass produce the crucial 3,000- to 5,000-letter sequences that can be used to induce a pre-fusion immune response.

The bad news: That immune response won't last for long, because the mRNA used to produce it is an unstable molecule that degrades quickly in the body. "A good vaccine will last decades. This is probably single years," Diehl said.

That may be enough, though. Here's where Diehl joins the global effort: He has submitted a protocol seeking permission to collect and study blood samples from patients who have recovered from COVID-19. Once researchers better understand how all of the nucleotides work together, he said, they can move on to developing vaccine "versions 2.0, 3.0 and beyond" that will induce "immune memory."

It's no surprise that Diehl uses construction metaphors to describe the microscopic workings of cells and viruses; his father, who's now retired, worked for years in construction. To his mother, a nurse, Diehl attributes his desire to work in a public health field and help others.

A native of Rome, N.Y., Diehl earned a bachelor's degree in chemistry at the State University of New York Geneseo. There, he developed an interest in immunology, and a professor suggested he pursue a doctoral degree. The first member of his family to attend a four-year college, Diehl hadn't known until then that students could get funding to pursue graduate degrees.

Earning his PhD at UVM, Diehl met his now-wife, Sandra. When he completed the degree, they moved to the Netherlands, where Sandra was born and raised.

After spending 2003 to 2008 at the University of Amsterdam, Diehl returned to Vermont and joined the faculty at UVM, where he's been ever since. Sandra works as a pediatric nurse at the UVM Medical Center. The couple has two daughters, Jill, 11, and Vera, 9.

Diehl admitted that it's frustrating to see vaccines demonized by the public when he knows how much "blood, sweat and tears" go into making them. He sees them as a "miracle product" that saves lives. "And then some people just choose not to believe in them."

What keeps him interested in immunology?

"The fact that we'll never figure it all out," he said. Unlike the study of many processes in the human body, such as the cardiopulmonary system, immunology is constantly evolving and discovering new cell types. And those discoveries almost always have real-world health applications, whether it's combating an autoimmune disorder or working to end a global pandemic. Given its complexity, COVID-19 could keep researchers busy for years to come.

"At the root of it," Diehl said, "I always know that there's so much still to be learned."

Correction March 26, 2020: This article originally misidentified one of the components in the coronavirus mRNA, and the number of letters in the string.

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UVM Researcher Offers Insights on Vaccines and COVID-19 - Seven Days

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New Delhi: Over 20 research institutes are working overnight to develop vaccines for the treatment of the highly infectious novel coronavirus, said a top government official.

The National Institute of Virology (NIV), Pune, and the Indian Council of Medical Research (ICMR) are among these research institutes.

According to Renu Swarup, Secretary, Department of Biotechnology (DBT), which functions under the Ministry of Science and Technology, the government has received over 7,000 tech-based proposals from private companies and individuals across the country to fight Covid-19.

In an interview to ThePrint, Swarup further said the government is dealing with several aspects from scaling up production of low-cost Covid-19 testing kits and ventilators to expediting research for the development of vaccine to fight the novel coronavirus.

We are working on several aspects right now. First is scaling up the manufacturing capacity of those start-ups and incubators, who have made low-cost testing kits and ventilators. They got early approval from the NIV and ICMR also. Eight to nine companies are in the process to get approval for their kits and ventilators, said Swarup.

We are also supporting those companies who got approval for commercial production of testing kits and ventilators. Besides, all IIT-incubators have been asked to focus on research and development of portable ventilators, on genome sequencing and on isolation of the strain of the novel coronavirus from blood samples, she added.

Also read: How do you test for coronavirus? All you want to know about testing kits, process, results

Swarup said IIT-Kanpur and IIT-Roorkee incubation centers are working on making portable ventilators.

We are also supporting three indigenous companies in scaling up their manufacturing capacity of providing ventilators at a fast pace. A Mysuru-based firm is also ramping up its capacity to make more ventilators. It is working with the NITI Aayog, DBT, DRDO (Defence Research and Development Organisation) to manufacture more ventilators, she said.

The DBT is also supporting private companies to procure local components to manufacture ventilators because there is a problem in sourcing them from outside now (in the wake of the lockdown), she added.

An ICMR official told ThePrint ventilators and testing kits are extremely essential if the outbreak reaches the third stage.

India, with less than 1 lakh intensive care units and a bed ratio of 1:1,000, will be at risk if outbreak reaches the third stage. The unique nature of the disease requires 3-4 week of recovery and 21-day ventilator support, said the official.

Ventilators are the next level weapon after a test kit, which is required in sufficient numbers in case of a mass outbreak, he added.

Swarup said the coronavirus research consortium, which has experts from the ICMR, DBT, NIV, are working to develop a vaccine for Covid-19.

We are researching new molecules for treatment. We are researching repurposed drugs to treat patients. More than 45 drugs have been identified that may be effective and research is going on. Several DBT institutions are working to see which formulations can work effectively against Covid-19, she said.

We are also sharing our research with international consortium, which are working on vaccine development. But in any case, it will take time. They are at the animal trial stage and it will reach stage three of human trail not before year end, she added.

Over 7,000 technological solutions were received by the government as part of its COVID-19 Solution Challenge.

Under the initiative, individuals and companies can submit their tech-based ideas for strengthening the fight against coronavirus.

Several tech giants such as Microsoft, Intel, Amazon, Google have pitched ideas for making artificial intelligence-based solutions to detect suspected cases of coronavirus using the ICMR data. Ideas to manufacture low-cost ventilators, low-cost test kits and herbal sanitisers also came, the DBT secretary told ThePrint.

Swarup said all these ideas are being vetted.

A committee headed by K. VijayRaghavan, principal scientific adviser to the government, is evaluating the ideas and the DBT will support the selected research proposal, she added.

The DBT has also invited proposals from companies working in the field of research and development to manufacture ventilators, testing kits, for which it will provide the required funding, the DBT secretary added.

Also read: By failing to scale up testing coronavirus, India may have lost crucial time

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20 Indian institutes working to find Covid-19 vaccine, IITs focused on portable ventilators - ThePrint

Shares of clinical-stage biopharmaceutical company, Hoth Therapeutics, Inc. HOTH, surged 35.26% after it announced that it has reached an agreement with Voltron Therapeutics, Inc. to form a joint venture for a Self-Assembling Vaccine (SAV) for the potential prevention of the coronavirus (COVID-19).

The joint entity will be called HaloVax. Based on VaxCelerate, this SAV platform was exclusively licensed by Voltron from the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital (MGH). The VaxCelerate vaccine platform enables the rapid generation and pre-clinical testing of a new vaccine against specific pathogen targets.

The technology has obtained funding from the Department of Defense (DoD) and demonstrated proof of concept in Lassa Fever, which is an emerging infectious disease.

Both companies will jointly explore and develop this SAV technology as a means to help patients at risk of being infected with COVID-19. The vaccine focuses on both DNA and internal/external mutated proteins providing the immune system with more potential targets to attack.

Per the agreement, Hoth shall be granted the right to receive single-digit royalties from the sale of any products developed. It shall also have the right to acquire up to a 30% equity interest in HaloVax.

Hoths shares have lost 39.6% in the year so far compared with the industrys 16.6% decline.

Given the widespread outbreak of COVID-19, many pharma/biotech companies are joining the race to develop treatments for the same. In particular, efforts to develop a vaccine to combat this deadly virus have accelerated in the last couple of weeks and Hoth is the latest company to join this bandwagon. Earlier, Moderna, Inc., MRNA dosed the first participant in the phase I study of mRNA vaccine (mRNA-1273) against SARS-CoV-2. A few others like Novavax, Inc. NVAX and Inovio Pharmaceuticals, Inc. INO are developing vaccines to address this disease. Big pharmas like Johnson & Johnson and GlaxoSmithKline are making efforts as well to develop a vaccine.

Hoth currently carries a Zacks Rank #3 (Hold). You can see the complete list of todays Zacks #1 Rank (Strong Buy) stocks here.

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Hoth Surges on Collaboration With Voltron for COVID-19 Vaccine - Yahoo Finance

Inovio Pharmaceuticals (NASDAQ:INO) has received quite a bit of help in its quest to develop a vaccine for SARS-CoV-2, the coronavirus that causes COVID-19.

For instance, on Jan. 23, the Coalition for Epidemic Preparedness Innovations awarded a grant of up to $9 million to Inovio to fund pre-clinical and clinical development of its vaccine candidate,INO-4800. Also, on March 12, the company received a grant of $5 million from the Bill & Melinda Gates Foundation to test and scale up the manufacture of the Cellectra 3PSP, a smart device for the intradermal delivery of INO-4800.

Now, Inovio is teaming up with Ology Bioservices, a privately held company that focuses on the development and manufacturing of vaccines and biologics. The two biotech companies received a grant of $11.9 million from the U.S. Department of Defense to manufacture INO-4800. Given the urgency of the situation, Inovio and OlogyBioservices are expected to expedite the manufacture of INO-4800 and deliver some to the Defense Department for clinical trials as soon as possible.

Image Source: Getty Images.

Inovio famously claimed that it created INO-4800 in just three hours after the genetic sequence of SARS-CoV-2 was made public by Chinese researchers on Jan. 10. The company expects to start its own clinical trials for the vaccine next month.

Meanwhile, other companies are pushing ahead in their attempts to develop a vaccine for COVID-19. Most notably, the U.S. National Institutes of Health is currently leading a phase 1 clinical trial for a potentialSARS-CoV-2 vaccine that was developed by Moderna (NASDAQ:MRNA). The trial will enroll 45 healthy adult volunteers who will each receive two doses of the vaccine. The goals of the trial are to test the safety of the vaccine, its ability to trigger the body's immune response, and the dosage that causes expected side effects.

Originally posted here:

Inovio Pharmaceuticals Gets Help From Ology Bioservices and the Defense Department with Its COVID-19 Vaccine Candidate - The Motley Fool

A new study from Italian researchers suggests that the SARS-CoV-2 coronavirus, which is the cause of the COVID-19 disease currently causing a global health crisis, is relatively slow to mutate meaning that any effective vaccine that is developed to prevent people from getting infected should be broadly effective across geographically separated populations over a relatively long period of time.

The research, conducted by two independent teams working separate from one another, including scientists at the Lazzaro Spallanzani National Institute for Infectious Diseases (IRCCS) in Rome and the Forensic Division of the Department of Biomedical Sciences and Public Health (DSBSP) at Ancona University Hospital, performed genetic sequencing tests using tech developed by Thermo Fisher Scientific on samples of the virus taken from Italian patients. They then compared these samples to a reference genome that was sequenced from a sample of the virus taken from the original Wuhan outbreak some two months prior.

The differences between the two virus samples was very small, speaking in terms of genetic variation only five new variants appeared in the later Italian samples, which is an early indication that the SARS-CoV-2 coronavirus remains fairly stable even over the course of a long train of transmission across multiple individuals and populations.

This is heartening news, especially given that other viruses can be quick to mutate. Consider the standard seasonal flu, which is much less severe but still a consistent challenge for health professionals; it essentially constantly mutates, which is why each year a new flu vaccine is developed, with researchers essentially racing the clock to anticipate which newly mutated strains will pose the greatest threat in each flu season, adapting the inoculation and urging the public to get their updated shot.

Other viruses either mutate very slowly or dont mutate at all, and the coronavirus that leads to COVID-19 appears to be among the former. In addition to this Italian study, work done by John Hopkins University and other health science researchers around the world have supported this view. An endeavor by a U.K. consortium to more comprehensively track mutations over time should provide an even clearer view.

As far as the COVID-19 pandemic goes, this new support for the theory that the virus behind it is a slow-moving one in terms of its genetic makeup is very good news indeed. Any vaccine is still likely at least a year way, but this research at least suggests that when it does arrive, itll be effective broadly and for at least a few years at a time.

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New coronavirus research suggests vaccines developed to treat it could be long-lasting - TechCrunch

New York, New York--(Newsfile Corp. - March 24, 2020) - Soligenix Inc. (NasdaqGS: SNGX), through its Public Health Solutions business segment, announced on Monday that the company is expanding its ongoing collaboration with the University of Hawai'i at Manoa to assess potential coronavirus vaccines, including COVID-19. More specifically, the study is evaluating the application of the company's heat-stabilization technology that has the potential to substantially alleviate the strains of cold-storage and distribution challenges associated with vaccines that need to progress quickly through supply channels.

The heat-stabilization technology has demonstrated the feasibility of developing heat-stable subunit filovirus vaccines, including the Ebola virus disease caused by either Zaire or Sudan ebolavirus variants, as well as Marburg virus disease, with both monovalent and bivalent vaccine combinations.

Investors sent shares higher by more than 17% at the market open. Zacks Small-Cap Research updated its coverage on Soligenix as well and raised its valuation of the stock to $12.00 per share. The increase is based on its adjusted DCF model that takes into account potential future revenues from SGX301 and SGX942.

Vaccine Heat-Stabilization Can Be A Substantial Franchise

According to Soligenix, formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit). Soligenix and its collaborators are expanding the technology platform to assess compatibility with coronaviruses, including SARS-CoV-2, the cause of COVID-19.

The funding for the expanded program is expected to be financed by non-dilutive funding sources, such as the US government.

Most certainly, heat-stabilization technology can be a lucrative franchise. It would enable the distribution of vital vaccine products to get distributed almost seamlessly through distribution channels that are not favorable to cold-storage. The technology has proven an ability to maintain therapeutic potency at holding temperatures as high as 104 degrees Fahrenheit.

Soligenix highlighted three essential components of the heat-stabilization platform:

1) a protein antigen, specifically a viral surface glycoprotein, which mediates entry and fusion of the virus with host cells and is manufactured with a proprietary insect cell expression system coupled with protein-specific affinity purification;

2) an adjuvant which has been shown to enhance both cell-mediated and humoral immunity; and

3) a formulation which enables thermostabilization of the resulting mixture, avoiding the need for cold chain storage and shipping

Combined, the resulting vaccine is broadly applicable, including individuals often excluded from common viral vector vaccine approaches such as children, the elderly, and the immunocompromised. These same components can now be applied to coronavirus vaccine, using well-defined surface glycoprotein(s) from one or more coronaviruses, which will include critical antigens expected to be protective for COVID-19. The protection of elderly and immunocompromised populations is particularly important in the context of COVID-19.

Data Supports Heat-Stabilization Compatibility For Coronavirus

The platform has already produced encouraging results. Dr. Lehrer, Assistant Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology at the JABSOM, stated, "Our work to date has demonstrated not only the feasibility of rapid and efficient manufacturing, but also the potential for a broadly applicable and easily distributed vaccine. We are delighted with our successes on development of filovirus and flavivirus vaccines using our platform and look forward to accelerated studies with the coronaviruses.

Also, JABSOM Dean Jerris R. Hedges, MD, MS, MMM, said, "It is rewarding to see ongoing work by JABSOM investigators and collaborators expanding on successful research on filovirus vaccines (protecting against viruses such as Ebola and Marburg virus) that may help us make unique life-saving contributions during this difficult time in healthcare. The prospect of a science lab in Hawaii helping develop a vaccine amid the COVID-19 pandemic is a testament to the importance of local research in Hawaii."

Soligenix Well-Positioned To Contribute To COVID-19 Platform

Through its Public Health Solutions business segment, Soligenix is well-positioned to create a subunit vaccine with enhanced stability at elevated temperatures. Undoubtedly, the result can prevent the costs and logistical burdens associated with cold chain storage and distribution, and has the potential to provide a distinct advantage over other vaccines currently in development and simplifies worldwide delivery.

Because of the pace of advancement of the filovirus vaccine platform, Soligenix added in its release that the program is optimally poised to look at other viruses and infections, including COVID-19.

The news on Monday followed the company's release last Thursday that reported positive statistically significant topline data for its pivotal Phase 3 SGX301 FLASH trial. That Phase 3 study is evaluating SGX301 to treat patients with CTCL. A report of those findings can be found here.

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Soligenix Inc. Heat-Stabilization Platform Evaluating Use With COVID-19 Vaccine; Zacks Small-Cap Research Increases Valuation To $12.00 Per Share -...

Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, and Clover Biopharmaceuticals, a China-based global clinical-stage biotechnology company focused on developing novel and transformative biologic therapies, today announced that they have entered into a research collaboration to develop a vaccine candidate to prevent COVID-19. Clover is advancing evaluation of its protein-based coronavirus vaccine candidate (COVID-19 S-Trimer) in preclinical studies. Dynavax is providing technical expertise and the companys proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, to support this initiative.

In late-January 2020, upon knowing the genomic DNA sequence of the newly identified SARS-CoV-2 virus, which causes a disease named COVID-19, Clover scientists started designing the viral spike (S)-protein construct and completed its gene synthesis. Utilizing its patented Trimer-Tag technology, Clover has produced a COVID-19 S-Trimer subunit vaccine candidate that resembles the native trimeric viral spike via a rapid mammalian cell-culture based expression system. Having one of the largest in-house, commercial-scale cGMP biomanufacturing capabilities in China, Clover could potentially rapidly scale-up and produce large-quantities of a new coronavirus vaccine.

"At Clover, we are eager to begin evaluating the combination of our S-Trimer vaccine candidate and Dynavaxs CpG 1018 adjuvant, as we believe adjuvants could play an important role in developing a successful and widely-available vaccine for this pandemic," said Joshua Liang, Chief Strategy Officer at Clover and co-inventor of COVID-19 S-Trimer vaccine. "Leveraging our proprietary Trimer-Tag technology, S-Trimer is being rapidly developed to support global efforts in combating the current and any future coronavirus outbreaks."

CpG 1018 is the adjuvant used in HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA). Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 provides a welldeveloped technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.

"Successfully responding to this public health emergency will require a collaborative approach, combining technologies and sharing data, to rapidly develop a vaccine to prevent COVID-19," commented Ryan Spencer, Chief Executive Officer of Dynavax. "We are proud to contribute to this global effort with the goal of supporting rapid development and enabling large-scale manufacturing through the utilization of CpG 1018 which has already been successfully implemented in an approved, marketed vaccine in the U.S."

About the Novel Coronavirus SARS-CoV-2 (and COVID-19 Disease)

SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported in late-2019, the virus has infected over 334,000 people and has caused over 14,600 reported deaths (as of 23 March 2020). It has been declared a pandemic by the World Health Organization (WHO). Currently there is no vaccine available for COVID-19.

About COVID-19 S-Trimer Vaccine

Utilizing Trimer-Tag technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope. The trimeric S protein of SARS-CoV-2 is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry, making it the primary target antigen for vaccine development. S-Trimer resembles the native trimeric viral spike protein and is produced via a rapid mammalian cell-culture based expression system.

About Clover Biopharmaceuticals

China based Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing transformative biologic therapies, with a focus on oncology and autoimmune diseases, as well as viral vaccines. Having raised more than US$ 100 million in total capital since 2016, Clover is utilizing its proprietary Trimer-Tag technology platform to develop novel biologics targeting trimerization-dependent pathways. Additionally, Clover is leveraging its in-house cGMP biomanufacturing capabilities to develop select biosimilars. For more information, please visit our website: http://www.cloverbiopharma.com.

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About Dynavax

Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company launched its first commercial product, HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018, following U.S. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 as an advanced vaccine adjuvant through research collaborations and partnerships. For more information, visit http://www.dynavax.com.

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View source version on businesswire.com: https://www.businesswire.com/news/home/20200324005368/en/

Contacts

Contact - Clover BiopharmaceuticalsJoshua Liang, +86 028-63925705joshua.liang@cloverbiopharma.com

Contacts - Dynavax Nicole Arndt, Senior Manager, Investor Relationsnarndt@dynavax.com 510-665-7264

Derek Cole, PresidentInvestor Relations Advisory Solutionsderek.cole@IRadvisory.com

See the article here:

Dynavax and Clover Biopharmaceuticals Announce Research Collaboration to Evaluate Coronavirus (COVID-19) Vaccine Candidate with CpG 1018 Adjuvant -...

Scientists race to find COVID-19 vaccine, as global cases of infection climb  Yahoo Finance

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Scientists race to find COVID-19 vaccine, as global cases of infection climb - Yahoo Finance