AKS-452: The newest vaccine

Apr. 19—BEVERLY — A COVID-19 vaccine developed by a company in Beverly is being tested on volunteers in the Netherlands.

Akston Biosciences announced this week that the first participants in a clinical trial have received doses of its vaccine, called AKS-452. The company is hoping to get approval from European regulators and then seek approval in the United States.

"It's a great milestone," Akston Biosciences CEO Todd Zion said of making it to the trial stage. "It's quite a feat, especially for a small company."

Akston Biosciences is a company of about 30 employees located at Cummings Center in Beverly. It was co-founded by Zion, a Marblehead resident who helped to develop a new type of diabetes drug that led Merck to buy his former company, SmartCells, in 2010 for more than $500 million.

Zion said Akston Biosciences, which includes many of his colleagues from SmartCells, began working on a COVID-19 vaccine about a year ago. The company's main work has been designing "fusion proteins" to develop treatments for diabetes in humans as well as in dogs and cats.

Zion said the company discovered that same technology could be designed to induce or boost an immune response against the "receptor binding domain" of the novel coronavirus spike protein — the area where the virus attaches to cells.

Zion said AKS-452 has a couple of advantages over the COVID-19 vaccines in use. It can be stored at higher temperatures — 77 degrees for at least four months, and 95 degrees for one month. And it can be quickly manufactured at a large scale, because it is protein-based as opposed to the mRNA vaccines now in use, he said.

"What's different is this fusion technology that allows us to use a very small amount of material to get a very robust response," he said. "That translates into the ability to make literally a billion doses per year in the Beverly facility."

Zion said there are around 200 COVID-19 vaccines in development that people know about. The African Times published an editorial on Thursday touting AKS-452, saying the fact that it does not require refrigeration gives it a "critical advantage" in sub-Saharan Africa, where electricity is often unreliable or unavailable.

The clinical trial underway in the Netherlands, which is a combined phase 1/2 trial, involves 176 volunteers between the ages of 18 and 65. Participants will receive one dose, or two doses 28 days apart, and three dose levels will be tested. In phase 3, up to 30,000 people would participate, with half of them getting a placebo, according to Zion.

With 93% of the world yet to be vaccinated against COVID-19, according to Zion, the demand for new vaccines is strong. People who have already been vaccinated are likely to eventually need booster shots, he said.

"My vision is you want to have so much of it around that you constantly keep people's immunity up," Zion said.

According to the Massachusetts Biotechnology Council, more than 95 companies with a presence in Massachusetts have worked on COVID-19 through diagnostics, therapeutics or vaccine development. MassBio President and CEO Kendalle Burlin O'Connell said in an email that most of the companies aren't "big names."

"They are small biopharmas with nimble, emerging technologies," O'Connell said. "If given the right support — through continued major investor confidence and public policies that support innovative companies — the Massachusetts biopharma industry can continue to make the impossible possible for patients here and around the world."

Zion said Akston Biosciences has not received any federal funding for AKS-452, although "not due to a lack of trying." The vaccine's development has been supported entirely by "angel investor" stockholders as well as the company's management team, which he said has invested "quite a bit of its personal funds" in the vaccine.

"I have not seen a project that has been as unifying and as inspiring as this one is for the team," Zion said. "Everyone understands its impact and is willing to do whatever it takes to make this a go."

Staff writer Paul Leighton can be reached at 978-338-2535, by email at pleighton@salemnews.com, or on Twitter at @heardinbeverly.