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KaliVir Immunotherapeutics secures FDA approval to hold cancer treatment clinical trials


Helena Chaye
KaliVir CEO and co-founder Helena Chaye
KaliVir

O'Hara Township-based KaliVir Immunotherapeutics received approval from the U.S. Food and Drug Administration to take its experimental oncolytic cancer treatment to human trials.

"One of the reasons why I left academia and founded KaliVir was in order to have the opportunity to actually develop the therapies that I was building in the lab and to actually take them to the step where we can treat patients," Chief Scientific Officer Stephen Thorne said. "To actually have gotten to that stage is fantastic and is obviously a big career goal."

Thorne co-founded KaliVir in 2019 alongside CEO Helena Chaye. The two both have experience spanning the past two decades working in the field of oncolytic viral immunotherapy. Thorne said that the field shows promise, but has setbacks, and that what differentiates KaliVir's treatment is that it is able to be administered intravenously, while other oncolytic cancer treatments must be injected directly into the tumor.

"That's a big limitation because almost 80% of solid tumors can't be injected," Thorne said. "Even when they can be injected, you need a surgeon to do the injections. So we've built on what's been available previously and one of the major advances that we've looked to do is to be able to deliver these viruses intravenously."

He added that it typically takes companies three months after receiving FDA approval to fully begin treating patients at the clinical level, but that KaliVir is "hoping to move a little bit quicker" and that "we will treat patients this year and hope to work through the initial safety testing in about 18 months."

"We can't make any promises about what will happen once we get to the clinic, but in a preclinical setting, the viruses that we are working with at the moment are a lot better than anything I have seen previously, and I have been working in the space for over 20 years," Thorne said.

The company, which was one of Pittsburgh Inno's Startups to Watch this year, employs approximately 50 people, "over 40" of which work in the Pittsburgh area.


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