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FDA awards investigational new drug approval to two cancer vaccines
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The FDA has granted the Mayo Clinic in Rochester investigational new drug approval for two new cancer vaccines aimed to prevent cancer recurrence, according to a press release. The approval will allow phase I clinical trials to be conducted in women treated for ovarian or breast cancer.
"People who've had cancer are at high risk for relapse, and later rounds of treatment can become more difficult," Keith Knutson, PhD, Mayo Clinic immunologist who developed the vaccines with colleagues at Mayo Clinic, said in a press release. Knutson's group aims to immunize patients immediately after therapy, when they're healthy, to protect against relapse.
One of the new vaccines targets a protein in breast and ovarian cancer cells. The vaccine contains fragments of the folate receptor alpha protein and teaches the body's immune system to detect and eliminate diseased cells. The targeted protein is typical of nearly all breast and ovarian tumors, making the vaccine the first that could be appropriate for the majority of patients, as opposed to sub-populations with specific types of cancer.
"I'm quite optimistic that if we can combine early detection, effective conventional therapies and vaccination, we can reduce recurrence and long-term morbidity associated with breast and ovarian cancer," Knutson said. Ultimately, the vaccine may be useful as a preventive strategy for all women, according to the press release.
The second vaccine to receive FDA approval is designed to target the HER2/neu molecule and is administered to patients with breast cancer after conventional chemotherapy.
"One of the greatest fears for women who've been treated for breast cancer is that the cancer will return," Knutson said. "Our hope is that the vaccine will boost the cancer-fighting capabilities of the immune system and will be a leg up on this aggressive cancer after conventional treatment is complete."
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These [vaccines] may likely work in preventive settings; so if they work they could prevent recurrence and could prevent progression to metastatic disease, and that's what we're trying to do. The problem with cancer vaccines has been making them immunogenic enough and specific enough to actually attack the cells that you want.
This was really all a theory until a recent paper by Porter et al came out in the New England Journal of Medicine; they reengineered T cells to treat CLL. This has suddenly woken everyone up to show that there may be ways to harness the immune system to actually fight or prevent tumors. Really a lot of this was speculative until very recently. Now, with the NEJM article and more recent efforts from other investigators, this is something that may be coming down the pipe and may be a therapeutic advance. But these studies are still very early.
– Adam M. Brufsky, MD, PhD, FACP
Professor of Medicine and Associate Division Chief, Division of Hematology/Oncology,
both at the University of Pittsburgh School of Medicine;
Medical Director, Women's Cancer Center, Magee Women's Hospital, Pittsburgh
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