JACKSONVILLE, Fla. - An experimental vaccine could be on the market for ovarian-cancer patients as soon as 2022, according to Taplmmune, the Jacksonville-based company that makes it.
News4Jax's news partner WJCT-89.9FM News reported Tuesday that the vaccine has won the U.S. Food and Drug Administration's “fast-track” designation, which could bring it to the broader public in as few as four years. Not many vaccines have shown promise in significantly extending cancer patients’ lives.
Cells called attack cells are the front lines of the immune system. While previous cancer vaccines focused solely on those, TapImmune’s also uses so-called “helper” cells, that guide the infantry to their target -- the tumor.
TapImmune is producing the vaccine and the Mayo Clinic is participating in the trials.
"We already conducted phase one of the clinical trial, which showed that it was safe. And that was in a smaller group of patients," Dr. Keith Knutson, an immunologist at Mayo Clinic told News4Jax on Wednesday. "What that also told us, gave us an early signal of potential clinical activity. And what I mean by clinical activity is it did protect against disease recurrence and the data seemed to indicate that it did."
In the small-scale study of the vaccine’s safety, TapImmune CEO Peter Hoang told WJCT, an interesting result popped up -- some first-time ovarian cancer survivors saw remission periods significantly longer than the median of 313 days.
“What we found in our patients is that if you put them into remission and you give them our cancer vaccine rather than just asking them to wait, which is the current standard of care for these patients in remission. Then we were seeing a median progression-free survival of 528 days,” he said. “So, these patients were going much, much longer before seeing any recurrence of the disease.”
Hoang reiterated the original study was not about how effective the medication is but about whether it’s safe for people. He also admitted the phase one study’s sample size of 22 women, 10 of whom were in ovarian cancer remission, was not enough to prove a pattern.
In total, TapImmune and its partners are studying the vaccine’s effect in 280 women in different stages of breast and ovarian cancer remission in four trials.
Knutson said they’re currently in the clinical trial phase, which will give more information on whether the vaccine actually prevents cancer from coming back.
“We have enough patients in the U.S. to test this vaccine and to get an answer by 2022, there’s no question about that," he said.
Knutson said there are more than 50,000 deaths from ovarian and breast cancer each year.
"We're very excited about the prospects of being able to prevent ovarian or breast cancer from coming back," Knutson said. "Hopefully, we can do it in a timely fashion and get it to people who it can benefit."
Click here to read and listen to WJCT's original story.