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Coronavirus vaccine could come from California, with no shot needed

San Franscisco Chronicle

Bay Area researchers’ proximity to leading health care centers and Silicon Valley has given them a leading role in developing drugs to treat COVID-19.

It could also give local companies and institutions a leg up in the global race to create a vaccine. Several have set out to create a highly effective product that can be distributed widely.

The stakes could not be higher. Even as doctors learn more about drugs to help patients who have contracted the virus, a vaccine remains potentially the most effective — and elusive — tool to fight the pandemic. Answers are likely still months away at the earliest, but government officials and health companies are trying to accelerate the process.

The odds are long: More than 130 vaccines are in development worldwide, according to the Milken Institute, a Santa Monica think tank. Only a small subset of those will likely be put to use. And successful companies must not only build a product that stops the virus, but also manufacture it on a truly enormous scale as fast as possible.

Some of the vaccines being studied locally would not be administered through a shot.

Verndari, of Napa, is working on a potential coronavirus vaccine to administer through an adhesive patch. The idea is to take away the pain component, thereby circumventing anyone’s aversion to shots, and to make something that can be kept at room temperature. That could make the vaccine easier to distribute, especially in developing countries.

Dr. Daniel Henderson, Verndari’s CEO, said the patches could even be sent through the mail and use temporary dye to leave a mark on a patient’s arm. The patient could then take a photo of the dye and send that to their health care provider as proof they were vaccinated.

“We really do want to change the way vaccines are perceived,” Henderson said. “And of course this goes far beyond COVID-19. It goes to the global distribution of vaccines everywhere. You could make them cheaper and have better efficacy and do away with the fear of vaccines.”

Verndari’s potential vaccine, which the company is developing at the UC Davis Medical Center in Sacramento, uses the virus’ “spike” protein, which the virus uses to attach itself to human cells. By introducing that protein into a person’s body, Verndari hopes it can train their immune system to recognize the virus when exposed to it and thereby prevent the person from becoming ill.

Henderson said he hopes to be able to start clinical trials that would test the vaccine on humans this summer. Forecasting when the vaccine might be rolled out, if it works and is safe, is more complicated given that the company is also proposing a new delivery method.

But Henderson said Verndari has already demonstrated that its patch is effective in humans when it was studying a potential flu vaccine. The company has also established a relationship with a California manufacturer.

South San Francisco’s Vaxart is another one of the local companies that is working on a potential coronavirus vaccine. Like Verndari, Vaxart also wants to protect people from COVID-19 without giving them shots. But instead of using a patch, the company is exploring a vaccine that could be taken in pill form.

Vaxart CEO Wouter Latour said the company has already shown efficacy through a clinical trial of a flu vaccine pill. Now, it’s trying to develop a similarly effective tool for the coronavirus.

Latour said the company wants to use an inactivated common cold virus as a vehicle for DNA that could help train the body to fight off the new coronavirus. He said Vaxart is on track to start clinical studies in the second half this year.

Vaxart doesn’t expect to create the first viable vaccine for COVID-19 — Latour thinks there will be many. Demand for a vaccine will be so high that the world won’t have enough resources to get one vaccine in the hands of everyone who needs it, at least not initially.

“Get those early vaccines out,” he said. “We could be right behind with this fantastic tablet and make life a lot easier and much more efficient in terms of implementing a large vaccination campaign and getting it to parts of the world where it’s harder to get vaccines.”

In order to make a vaccine pill effective, developers would have to figure out how to make it strong enough to not be killed by stomach acid before the vaccine can do its job, said Dr. Lee Riley, an infectious disease expert at UC Berkeley. But if effective, such a vaccine would be safe and easy to give to a lot of people, he said. A patch could work well because skin is the body’s largest organ and it’s good at producing a strong immune response, Riley said.

But finding a vaccine that works is only one part of the equation. Once proved effective, the product has to be made widely available — which will be a major challenge if it needs to reach billions of people.
George Talbott, left, works on a coronavirus vaccine patch with Verndari CEO Dr. Daniel Henderson in Sacramento in May.

“It will take years to be able to have a production capacity to make that many vaccines,” Riley said. “It’s not just coming up with a vaccine that works. It’s also the production that’s going to take some time.”

Dynavax Technologies of Emeryville is taking a slightly different approach to vaccine development than some of the other companies. Instead of building a vaccine on its own, Dynavax is lending a helping hand to others.

The company has created a federally-authorized vaccine for hepatitis B that uses a modifying ingredient to improve the immune response in patients. So Dynavax is providing that ingredient, called CpG 1018, to help other companies that are developing potential vaccines.

“We have a technology that’s proven in our vaccine that can be possibly very valuable to helping address this issue, and therefore it has to be evaluated,” said Dynavax CEO Ryan Spencer. “We have, I think, a responsibility to be in the game here.”

At UCSF, immunology Professor Raul Andino is taking his time to study exactly how the coronavirus works before trying to devise a new way to protect people. He’s closely examining how the virus progresses in animals, and he thinks he’s at least six months away from moving into the clinic.

“While everybody is trying to jump ahead and get the answer in humans, basic studies are very important to understand the mechanisms by which this virus causes the disease,” Andino said.

He knows the world can’t wait for him to finish his work before advancing ways to make people immune to COVID-19. But his ultimate goal is still to create a live-attenuated vaccine, which uses a weakened form of a virus to create immunity.

That type of vaccine has proved broadly effective at combating other dangerous illnesses such as polio, mumps and smallpox, Andino said. Because using a weakened form of the virus is so similar to a natural infection, live-attenuated vaccines have the power to induce long-lasting immunity — but they require a sophisticated understanding of how the virus works.

“I understand everybody wants a vaccine yesterday,” he said. “But what I’m thinking of is the second generation of vaccines ... maybe a live-attenuated vaccine will be better in the long run.”

An ideal coronavirus vaccine might look like previous vaccines developed for hepatitis B and whooping cough that used certain proteins to provide protection, said Dr. Yvonne Maldonado, an epidemiologist and infectious disease specialist at Stanford University’s School of Medicine. Part of the challenge now is that doctors do not yet fully understand the virus that caused the current pandemic.

“It’s like the normal coronaviruses that cause colds in human beings, but it’s much more likely to cause serious disease as well,” she said. “We’re trying to understand why that is.”

One way to speed up the vaccine development process may be to let volunteers be given a potential vaccine or placebo, then injected with the virus or placebo while researchers study the effects. A new campaign called 1 Day Sooner has sprung up in support of that goal. It’s already registered thousands of people, including hundreds in California, who have said they’re willing to participate in “challenge trials” — if and when they occur in humans.

Josh Morrison, a New York resident who co-founded the campaign, said the goal is to have a list of people who are willing to participate should researchers take the step of asking for volunteers. More screening would be required if that happens.

While such trials would only accept people who are at lower risk of developing severe or deadly cases of COVID-19, Morrison knows that asking people if they are willing to be injected with a live coronavirus may sound like a dicey proposition.

“This is definitely a significant risk ... but it’s also a type of risk that is consistent with other risks we let people take,” he said. “We think, if you have intelligent and well-educated volunteers, we should let those people make those choices if it’s likely that you have a meaningful gain in vaccine development, which to us is as little as one day.”

J.D. Morris is a San Francisco Chronicle staff writer. Email: jd.morris@sfchronicle.com Twitter: @thejdmorris


Napa company begins testing a potential COVID-19 vaccine

Napa Valley Register

Could a vaccine for COVID-19 come from Napa?

Daniel Henderson, John H. Brown and Jan Van Prooyen, founders of Verndari, a Napa- based biotechnology company, hope so.

The three men have been working on a potential vaccine that could potentially save millions of lives around the world.

On Thursday the company announced that it will begin preclinical testing at UC Davis of a potential COVID-19 coronavirus vaccine, which will be administered using its patented microneedle array dermal patch.

“This is what I’ve trained to do,” said Daniel R. Henderson, Ph.D., CEO, and chief scientific officer of Verndari, Inc., during a phone interview. “The need is great.”

The medical scientist is optimistic about finding a vaccine, noting, “I’m working as hard now as I ever have in my life.”

However, “The scary thing is that we’re not in control,” said Henderson. “The virus is in control. The virus has no purpose in life other than to replicate.”

“We’re passing 60,000 deaths (in the U.S.) and we’re still in the second inning. This isn’t anywhere close to over.”

Verndari, Inc. was founded in 2015 after the three men met through connections at St. Mary’s Episcopal Church in Napa. Verndari is an Icelandic word that means guardian or protector, said Henderson.

The company has since developed the potential COVID-19 vaccine using single, purified protein antigens produced by genetic engineering, said a news release.

The vaccine candidate uses the COVID-19 “spike” protein that enables the virus to infect human cells.

Verndari, Inc. was founded “to enable a rapid response to new viral threats as well as to produce more effective vaccinations for existing viruses, such as seasonal flu, while sharply reducing costs and making vaccine administration much simpler,” said Henderson.

The testing will be conducted in laboratories at the University of California, Davis. “Our new approach and previous vaccine work have enabled us to quickly develop a potential vaccine for COVID-19. UC Davis provides a world-class forum for testing,” said the news release.

Preclinical testing begins this week at UC Davis’ Mouse Biology Program.

Verndari, Inc. is also in discussions with the California National Primate Research Center at UC Davis to conduct further testing in nonhuman primates.

If the preclinical testing meets safety and efficacy goals, Phase 1 human clinical trials would begin.

Verndari estimates that testing from inception through Phase 1 human clinical trials will take approximately six months. The company is in consultation with the U.S. Food and Drug Administration using its Investigational New Drug (IND) submission.

The company isn’t the only one working on a possible vaccine. There are as many as 70 other such companies racing towards that goal, he said.

“We are excited to work with Verndari, Inc. to move its vaccine candidate through preclinical, and potentially clinical, studies,” said Prasant Mohapatra, vice chancellor for research at UC Davis.

“This collaboration illustrates one of many ways that UC Davis is leveraging our unique expertise and established platform built on previous research for HIV, Zika and human cytomegalovirus in order to advance knowledge and solutions specific to COVID-19,” he said.

“When we founded Verndari, Inc. we set about to transform the entire vaccination process, from development through vaccination,” said John H. Brown, president, and co-founder of Verndari, Inc.

“Our goal is to enable more rapid development of more effective vaccines for both existing and emerging diseases that can be delivered at lower cost to populations around the world.”

Verndari’s VaxiPatch is a complete single-dose vaccination kit that uses a dermal patch with a microneedle array to deliver vaccines to the arm.

The patch itself is a big deal because the technology eliminates the need for refrigeration, a major cost factor in vaccination, and facilitates high-volume, automated manufacturing of vaccines. The vaccine technology can be used for both existing vaccines and new vaccines developed to meet emerging threats.

The VaxiPatch kit reduces or eliminates the reliance on healthcare professionals to administer vaccines and the need for sterile use of a needle and syringe, said a news release. The vaccination is accomplished with a painless microneedle patch applied to the arm, which can potentially be self-administered.

The single-dose vaccination kit has the potential to be shipped around the world to enable simple shelter-in-place inoculation using a microneedle patch placed on the back of the arm.

What does Henderson want Napans to know about the company’s possible vaccine?

“I’d like them to know that one of their neighbors is trying to help. And that I’m optimistic that we will come up with a vaccine,” he said.

“You’ve got a bunch of guys in Napa that are trying to help and by the way we might really transform the way we do vaccines going forward,” with the VaxiPatch, “and that’s pretty cool.”


Company testing Covid-19 vaccine, new delivery method at UC Davis

Sacramento Business Journal

Biopharmaceutical company Verndari Inc. announced it will begin preclinical testing in Sacramento and Davis on a potential Covid-19 vaccine that can be sent by mail to people sheltering in place.

The Napa-based company does its research in labs on the campus of University of California Davis and at the UC Davis Medical Center campus in Sacramento, said Dr. Daniel Henderson, CEO and chief science officer of the company.

“When you think of traditional vaccinations, they are administered by professionals in white coats with needles,” Henderson said. “We eliminate all that.”

Most current vaccines must be refrigerated, but Verndari’s technology is temperature stable, so its VaxiPatch can be sent by mail and administered by the patient, he said.

Henderson said the vaccine and the patented VaxiPatch delivery system won't be on the market soon, as they need many months of testing. The company is beginning testing on mice this week on its vaccine that targets a so-called “spike” protein in viruses that allows the coronavirus to infect cells.

Verndari started up in 2015 to reduce threats due to viral outbreaks and to create a more effective way to distribute vaccinations for existing viruses, such as the seasonal flu, Henderson said.

The VaxiPatch uses tiny needles a half millimeter long that transfer vaccine into a layer of skin at the back of the arm within 10 minutes. It doesn’t hurt, Henderson said, and it also has a dye package, so a person can take a picture of the grid pattern left by the micro-needles if they need to provide verification that they took the vaccine.

Verndari is funded by angel investors, and is currently looking to raise more money, Henderson said. He declined to say how much the company has raised since it started, but he told the Business Journal in 2018 that the Verndari had raised $2.7 million at that time.
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The company has 10 people working on the development of its technology, but it has only five paid employees, at this point. 

In 2016, Verndari joined UC Davis’ Venture Catalyst START Program, which offers entrepreneurs resources, contacts and services to form and grow startups.

“We are excited to work with Verndari to move its vaccine candidate through preclinical, and potentially clinical, studies,” said Prasant Mohapatra, vice chancellor for research at UC Davis, in a news release. “This collaboration illustrates one of many ways that UC Davis is leveraging our unique expertise and established platform built on previous research for HIV, Zika and human cytomegalovirus in order to advance knowledge and solutions specific to Covid-19."