It's a critical moment for an 11-year-old startup founded by Harvard Business School students and based on science from Tufts University and MIT. If the research goes well, Vaxx will raise an additional $10 million from its existing investors and begin seeking additional funds for larger trials of the technology.
The success bodes well for other startups and university labs developing their own skin vaccines. These experimental vaccines replace a large needle with dozens of small needles. These tiny needles are small enough to push the vaccine below the surface of the skin, but too short to allow nerve puncture.
"Conceptually, the idea is simple," says Mark Prausnitz, a chemical and biomolecular engineer at Georgia Tech. You have a first aid kit with a few things in it and you tape it to your skin. Micron Biomedical, founder of the microneedle vaccine.
However, scientists have been working on microneedle patch vaccines for more than two decades. Some of them were able to enter the first clinical trials. None of this is allowed. Venture capitalists and big pharma are reluctant to invest in this approach.
However, the global challenges of storing COVID-19 vaccines in refrigerators or freezers highlight the need for new approaches, said Dr. Mark Poznansky, MD, director of the Center for Immunization and Immunization at Massachusetts General Hospital. "The pandemic has made real vaccines important again," he said.
"Now there has to be a human study that really works," he added.
Vaxess was founded by four Harvard Business School students interested in a method that uses silk proteins to stabilize vaccines. Schrader hopes the trick developed by Tufts University scientists Fiorenzo Ominito and David Kaplan can be used to create vaccines that don't require refrigeration.
"Vaccine developers were fascinated by the technology, but they didn't know how to make more money out of it," Schrader said.
In the year 2014, Schrader saw a paper by MIT scientists Darryl Irvine and Paula Hammond that combined the stabilizing properties of silk with a microneedle patch to create a vaccine that was slowly released into the skin over several weeks to stimulate strong immune responses. A perfect complement to our work,” Schrader said.
With funding from the Bill and Melinda Gates Foundation, Vaxx worked with the MIT team for several years to develop its own microneedle patch. It was not easy.
"You almost have to be naïve to try to do what we're doing," Schrader said. Maintaining vaccine stability, filling the thin syringes evenly and ensuring that the vaccine releases slowly are all "extremely complex" issues, he said. Combining them is more difficult.
The result is 2.5 centimeters wide, with 121 crystalline needles, each one millimeter long, made from a mixture of silk, sugar and other polymers. A small spring device ensures that the adhesive adheres directly to the skin.
"It feels like a rubber band, but you don't feel like needles," Shirres said. "You just put it on for five minutes and take it off. But the vaccine stays in your skin and slowly releases after two weeks."
Until recently, the company relied on grants from the Gates Foundation and government agencies to support its operations. Raising money from venture capital firms that eschew vaccine startups has been particularly difficult for biotech companies working on more profitable drugs for cancer or rare diseases. “A lot of times we were told to forget about vaccines and focus on low-dose, high-margin products,” Schrader said.
“Coronavirus has changed dramatically,” Schrader added, adding that vaccines against the disease are not only useful, but also very cost effective. "We've had calls from investment funds who didn't want to touch vaccines five years ago and are now interested," he said.
Mario Barro, chief innovation officer at RA Capital, said in an email that the pandemic "prompted" the company to make vaccine innovation a clear part of its investment strategy. He added that Vaxx is different from the rest of the company because of its "unique approach" to eliminating the need for cold storage and facilitating delivery.
Motor, Mission Bio Capital and MIT Global Health Investment Corporation contributed to the new Vaxess fund. Anne DeWitt, general partner at Enjin, hopes the startup's flu study will be the first of many to come. "This lays the foundation for future sets of vaccines and drugs that can be integrated into this platform," she said.
Vaxx must first demonstrate that fine-needle vaccines are as safe and effective as seasonal flu vaccines. A study on mice showed that the patches better protected mice from the flu. However, Bosnanski warned that keeping the vaccine in the skin for two weeks could cause other negative reactions to the vaccine, such as swelling, pain or fever. “There is such a thing as yin and yang.
Even if these patches are successful, Vaxx will face the hurdle of figuring out how to mass-produce them at an affordable price. The startup's Woburn factory makes just 1,000 pieces a week by injecting tiny droplets of the silk dust mixture into tiny holes in the mould. "Doing it right was a big challenge," Schrader said.
Vaxess hopes to eventually produce 100 million patches per year. Schrader said the Advanced Biomedical Research and Development Authority, part of the US Department of Health and Human Services, pushed for the design of a facility of this size. But turning those blueprints into buildings could cost hundreds of millions of dollars, he added. I know how big the bottleneck is for us.
Omenetto, one of the Tufts engineers behind Silk Technology and a Vaxx consultant, hopes the startup's clinical trial will be a long-awaited game-changer for the company. “They took a very, very difficult project and turned it into something ready to be done,” he said. "It gives me a really good idea of where the technology is going."
Ryan Cross can be contacted at ryan.cross@globe.com. Follow him on Twitter @RLCscienceboss.