Thomas Breen photo
Chemical engineer Edwin Cardenas at vax-building work in ACT's local lab.
A new all-synthetic vaccine against malaria may emerge from a third-floor laboratory in Science Park if research underway there comes to fruition.
Chemical engineers like Edwin Cardenas are working to make that vision a reality, as a small local biotech company recovers from a recent financial scandal and pushes forward on the frontiers of medical technology development.
That company is called Artificial Cell Technologies, or ACT. The eight-employee business currently occupies an expansive, quiet third-floor office-and-lab space at 5 Science Park.
Founded in 2006, the New Haven-based company has made some strides as of late in its years-long effort to develop vaccines against malaria and respiratory syncytial virus (RSV), according to the firm’s President and CEO Donald Masters and Vice President of Immunology Jeff Powell.
That includes the successful completion in 2021 of a Phase 1A trial for a new vaccine against malaria.
That first trial involved 25 participants and was conducted in Australia, Masters told the Independent. Masters and Powell both said that the vaccine, developed in New Haven by Artificial Cell Technologies, caused trial recipients to develop antibodies that could protect people from the deadly global mosquito-born scourge. ACT’s under-development vaccine also did not lead to anyone getting sick or having any other adverse reactions.
Now the company is gearing up for a potential Phase 1B trial of that same vaccine, likely to be held next year at a location closer to home, in the area of the Naval Medical Research Center near Washington, D.C. If that Phase 1B trial takes place, it will see participants actually infected with malaria to see how the ACT-developed vaccine does at protecting them from the disease.
Masters and Powell also said that their company recently made a breakthrough in its early-stage development of a RSV vaccine, which has “elicited a protective immune response in mice while simultaneously lowering pulmonary inflammation after exposure to the virus,” according to a late January press release. Click here to read more about their findings, as published last fall in the journal Vaccines. And click here to read a recent press release about that RSV vaccine development project.
ACT VP Jeff Powell and CEO Donald Masters.
All of this comes roughly four years after the company’s former chief financial officer, Thomas Malone, was sentenced to two years in prison and three years of supervised release for embezzling roughly $1 million from ACT. Malone wound up pleading guilty to four counts of theft from a program involving federal funds after a forensic audit found that he had been paying himself $660,000 per year instead of his salary of $281,000, and that he had been “been writing checks to himself that were disguised as bonuses, that he had been giving himself unauthorized additional salary payments, that he had been using the ACT credit card for personal expenditures, and that he had used ACT’s funds to make unauthorized donations to an organization that Malone personally supported,” according to a March 2019 U.S. Attorney’s Office press release.
“This 2019 incident put a tremendous strain on the staff and company resources and slowed down product development work by at least two years,” a spokesperson for the company told the Independent on Wednesday. “The guilty person has no involvement in the company’s day to day operations or research. ACT’s leadership team and researchers are moving forward toward new drug discovery focused on RSV and Malaria through its innovative research.”
ACT’s malaria vaccine development work also comes after the World Health Organization recently approved another new malaria vaccine for wide-spread use across the globe.
Powell in ACT's third-floor Science Park lab space.
During an interview with the Independent in ACT’s third-floor office space at Science Park on Tuesday, Masters focused on the medical benefits of the company’s vaccine technology.
Unlike most vaccines, which depend on dead versions of the germs that a shot is trying to protect a patient from, ACT’s vaccines are entirely synthetic.
The malaria vaccine, for example, involves the coating of a calcium-carbonate “bead” with “ultra-thin polypeptide nanofilms” that elicit an immune response from recipients without actually injecting those patients with germ itself. Masters described the creation of such a synthetic vaccine as visually akin to taking a “beachball and layering it with wet spaghetti.”
“The good news,” he said, “is you can’t get the disease from the vaccine.” Such technology allows biotech manufacturers like ACT to “get as far away from the actual germ as we possibly could” while still coming up with a vaccine that seeks to elicit a protective immune system response.
Powell said that the Phase 1A trial recipients in Australia received doses ranging from 1 microgram to 100 micrograms. “We were able to get a good antibody” response and did not see any “dose-limiting toxicity” — meaning, the trial participants who received the sample vaccine did not experience any negative side effects.
In Phase 1B, he said, the company will be “looking for protection from infection” by “challenging” those who receive the vaccine with the malaria germ itself.
One of the key hurdles in the way of actually starting such a Phase 1B trial, Masters said, involve supply chain delays.
“There isn’t a single thing we use that isn’t on back order,” he said, from plasticware to tubing to salt water.
What kind of work takes place in the ACT’s New Haven office and lab?
“We make the vaccines here,” Masters said, in a “clean,” “sterile” room downstairs at 5 Science Park. The company also tests out its vaccines on mice at Science Park. And its employees “develop chemical mixtures to make the vaccine stable” on site.
“We do farm out the manufacture of the drug used in human beings” elsewhere, he continued, because the rules set up by the federal Food and Drug Administration (FDA) for the development of vaccines received by human beings and not just mice are too “complex” for the company to handle at its New Haven lab.
ACT's home at 5 Science Park.
Science! On the board at ACT's headquarters.
Why has the company decided to stay in New Haven?
“We’ve stayed mostly out of inertia,” Masters said. He said the company would be open to moving to Boston or elsewhere if it needs to. For now, it’s going to stay put.
Masters said that ACT inherited its current third-floor office and lab space from another Science Park biotech company that went “belly up.” They currently have more space than they can use, and they have more trouble than Masters would like in attracting top-grade scientists to relocate to New Haven to work for ACT.
Despite New Haven’s booming biotech sector and the development of new lab space at under-construction new buildings like 101 College St., Masters doesn’t have high hopes for New Haven becoming the next Boston as an epicenter for biotech businesses.
“I don’t think [New Haven] is ever going to be a major hub of biotechnology” in the way that, say, Boston has become, Masters said. “Boston has taken off like crazy.” Why? In Boston, you’ve got both Harvard and MIT churning out some of the best scientists in the country.
“My biggest problem with New Haven is you’ve got Yale, and that’s the only source you really have of top-flight scientific minds” in the area, he said. “It’s more difficult when you don’t have a bigger source” of employees to grow businesses like his.
My dad had malaria. It was nasty, and, of course, incurable, although he did say it made his urine a most beautiful color. Moreover, based on my statistically insignificant survey of two men and two women, the prophylactic course creates havoc in men's intestines. In addition to inconvenience, though, I did incur a needed weight loss in my travels.