January 21, 2019
Executive Profile

Kalinauskas' cancer vaccine aims to keep your pet living longer

HBJ Photo | Sean Teahan
HBJ Photo | Sean Teahan
Ashley Kalinauskas, 28, is the founder and CEO of Torigen Pharmaceuticals Inc., a veterinary pharmaceutical company currently testing a cancer vaccine for pets.

Ashley Kalinauskas

Founder & CEO, Torigen Pharmaceuticals Inc.

Highest degree: Master's in scientific entrepreneurship, Notre Dame

Executive insight: "Being able to build a team of people that is extremely motivated, and very talented is important. So, it's necessary to bring in good people whose hearts are in the right place."

The aphorism "Fake it 'till you make it" doesn't suit Ashley Kalinauskas.

In 2013, she refused investor funding for her startup Torigen Pharmaceuticals Inc., a veterinary biotech company that had just placed second in the University of Notre Dame's McCloskey Business Plan Competition.

"If we took money when those investors were handing us checks, we didn't really have a well-thought-out plan as to how we'd spend that," Kalinauskas said. "We would have made decisions that may not have been what was best."

Five years later, Torigen is now operating out of UConn's Technology Incubation Program (TIP) in Farmington after recently closing on a $2.3 million fundraising round from Connecticut Innovations and several outside investors looking to get in on a company testing a cancer vaccine for dogs called VetiVax.

Kalinauskas, 28, lives in Vernon, where she grew up, but Torigen and the technology behind its novel vaccine were born on Notre Dame's South Bend, Ind., campus.

After graduating from UConn with a bachelor's degree in veterinary pathology, she went to Notre Dame for her master's, enrolling in the Engineering, Science and Technology Entrepreneurship program.

"I love science, back in like 10th grade I remember my teacher had this big book on viruses, and I was like, 'I love viruses, and vaccines.' " Kalinauskas said. "(But) I always knew … that I didn't want to work in the lab."

In 2013, Mark Suckow — then a researcher and professor at Notre Dame, and now Torigen's chief technology officer — was working on a cancer vaccine for humans that could both treat and prevent the disease from recurring.

The tissue vaccine uses an animal's own tumor cells to create an immunotherapy — it basically trains the immune system to attack cancerous cells.

Suckow started testing the vaccine on rodents, but when his family dog, Sadie, developed cancer, his children begged him to try it on their yellow Labrador. He did and within a few weeks, Suckow said, the tumor was shrinking and eventually disappeared.

He relayed the story to Kalinauskas, his student at the time, who thought there was a business opportunity — to use the vaccine on dogs instead of people.

"She said 'Hey, there's something pretty exciting here, we should commercialize this,' " Suckow recalled.

Torigen's showing at the Notre Dame competition cemented Kalinauskas' resolve to make a go of it with Suckow to develop the vaccine. After turning down those initial investment dollars, she accepted about $30,000 from Notre Dame in 2014, and added two veterinarians to Torigen's staff to launch a study of the therapy's safety and efficacy.

The company moved to UConn's TIP space in Farmington in 2016, when it also embarked on its first round of fundraising, Kalinauskas said. It made sense to move operations to TIP, she added, because it was close to home and she still had connections within the UConn bioscience community. Working out of TIP also provides access to many university resources.

Serious investors

VetiVax is currently regulated by the U.S. Department of Agriculture as an experimental product with unproven safety and efficacy. It is not licensed.

To date, Torigen has treated about 400 cancer-diagnosed dogs that have participated in clinical studies, Kalinauskas said. It's also been tested on cats and a tiger.

Typically, the treatment for the approximately 6 million dogs diagnosed with cancer each year is a combination of radiation and chemotherapy, Kalinauskas said, which can cost around $5,000. The baseline cost of the VetiVax treatment is about $1,200.

In November, Suckow submitted a first manuscript of the company's testing data to Anticancer Research, a peer-reviewed international scientific journal.

"The data will demonstrate the strong safety profile of the vaccine in dogs," Suckow said.

Torigen is now pursuing conditional licensure, which would allow the company to expand studies after it proves to a "reasonable degree" the vaccine's efficacy to USDA officials.

"Now we have a plan, now we have serious investors," Kalinauskas said. "And now we're really capitalized for growth both within the veterinary community, and also with our research and development platforms."

The $2.3 million should tide over Torigen for up to two years, while the now 10-member team continues testing and developing the vaccine, Kalinauskas said.

After that, the company will likely try to raise another $5 million to $10 million, which will largely be spent on research and development. The product is currently being used in about 75 veterinary clinics nationwide, Kalinauskas said.

Kalinauskas predicts Torigen will remain in the veterinary-oncology realm, but in coming years, she could see licensing the technology to researchers looking into its applicability in humans.

"We have it all mapped and pipelined out," Kalinauskas said of the vaccine's development. "It's just a matter of getting the work done."

Correction: Due to a reporting error, a previous version of this story incorrectly stated the licensure status of VetiVax. VetiVax is unlicensed, and regulated by the U.S. Department of Agriculture as an experimental product of unproven efficacy.

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