An experimental vaccine could be on the market for ovarian-cancer patients as soon as 2022, according to the Jacksonville-based company that makes it.
The River City’s Mayo Clinic is participating in the trials.
The vaccine has won the FDA’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.
In a small-scale study of the vaccine’s safety, TapImmune CEO Peter Hoang said, 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 makes sure to reiterate 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 which were in ovarian cancer remission, was not enough to prove a pattern.
“With 10 patients, you haven’t dosed enough patients to rise to the level of statistical significance, but what you’re seeing here is clearly… a progression-free survival median that is considerably longer — at least 200 days and potentially as much as 300 and 400 days — longer than what you would expect to see in these patients,” he said.
A new phase two vaccine study involves 120 ovarian cancer patients and Hoang said that could be expanded to as many as 400 patients depending on the results of an intermediate study.
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.