In today’s fight against cancer, there are few developments as transformative as liquid biopsies and vaccines. For Phoenix-based biotech company, Calviri, its goal to end cancer worldwide has been focused on pioneering new approaches to these technologies, beginning with man’s best friend.
The Calviri Story
Founded in 2017, Calviri’s mission is straightforward – to end cancer.
Driven by the company’s discovery of an “unappreciated, yet fundamental, molecular characteristic” of all tumors that distinguishes them from healthy host cells, Calviri invented technologies that merge biology with semiconductor chips.
Behind these pivotal discoveries is inventor and Calviri CEO and co-founder, Stephen Albert Johnston.
Johnston, a former Professor at Arizona State University and a National Academy of Inventors inductee, told Breaking Cancer News that when Calviri was founded, its focus was on transforming the cancer space through two key avenues – the development of inexpensive, off-the-shelf vaccines to both treat and prevent cancer, and a system for advanced detection. But not just any detection, early detection.
“We believed that if we could detect cancer early enough, that even with standard of care, it would have a potential curative effect,” explained Johnston. “Which has to be at stage one.”
A Different Diagnostic
Calviri’s initial focus on diagnostics was driven by the need to better support its vaccine clinical trials.
“We started pursuing the diagnostic because we realized to do these vaccine trials would take quite a while,” said Johnston. “But we could really shorten the trials and make them less expensive if we had a highly sensitive detection system for cancer. So, we actually started developing the diagnostic as a complement to the vaccine trials.”
But as the diagnostic began to take shape, its potential became clear. It was succeeding where other technologies had failed.
“Other diagnostics have very low sensitivity for stage one tumors,” said Johnston. “If you can’t do stage one, then you’re really not that useful to do widespread screening. So, that’s a prerequisite.”
The reason Calviri’s test was so successful, says Johnston, is that the company had built a different diagnostic.
While other companies use nucleic acids and blood as their protocol, Calviri’s approach is based on antibodies being generated by the tumor and using those as the basis for detection.
But this revolutionary new approach required a new technology suited for the task.
“We had to invent a new technology to make all these peptides, Johnston told Breaking Cancer News. “The tumors could potentially make these foreign peptides and then synthesize them on these silicon wafers. Each one of those little squares has between 200 and 2 million Peptides on it and those are the neoantigens that tumors make. So, by putting all those neoantigens on there, all we had to do was say, ‘Okay, do you have any antibodies to them? If you do, you have a tumor.’”
Calviri’s diagnostic is not only highly sensitive, but also minimally invasive; doing all of this with only a drop of blood.
Beginning with Dogs
With a new technology in hand, Calviri began its diagnostic journey with what may seem an unlikely cohort, dogs. The reason? Tumors in canines grow five times faster than in their two-legged companions, offering a much smaller window in which to detect them.
“Dogs are more in need of an early diagnostic, because their tumors grow faster, they don’t complain, and they don’t have regular screening protocols like mammography or CT scans,” said Johnston. “Almost all dog tumors are discovered at later stages, so there’s a big need to be able to detect dog cancers at an early stage.”
Calviri’s new diagnostic test for dogs, dubbed the CanineGuard Diagnostic Test, will soon be available for purchase.
Vaccine-Focused
Vaccines have always been at the forefront of Calviri’s innovation. In 2024, the company announced the successful conclusion of its Vaccine Against Canine Cancer Study (VACCS). The five-year clinical trial investigated a novel preventative cancer vaccine in dogs.
VACCS was a multi-center, double-blind, placebo-controlled study – the largest of its kind in veterinary oncology.
The results are promising, and Calviri has begun production of an improved version of the vaccine for approval and conditional sales.
The company has also launched another immunotherapy clinical trial, which is now enrolling dogs diagnosed with splenic hemangiosarcoma (HSA). The study, conducted at three veterinary school hospitals, is designed to evaluate the safety and effectiveness of a vaccine in combination with the standard care chemotherapy, after surgery.
The ultimate goal, says Johnston, is to offer the vaccine as a companion to the diagnostic test at an affordable price point.
“A dog would come in, get diagnosed with a stage one tumor and would immediately get this vaccine off the shelf,” he says.
Innovating for Humans Too
Calviri has its sights set not only the detection and prevention of cancer for man’s best friend, but for man as well.
The company is comprised of two divisions – Calviri Animal Health and Calviri Human Health. Plans are currently underway for human clinical trials, utilizing the same chips to analyze stage one tumor samples from humans.
According to Johnston, these trials will initially focus on breast cancer, as a major cancer and a disease for which samples are often difficult to obtain.
