Mayo Clinic receives grants for Alzheimer’s research, vaccine for early breast lesions


Researchers at the Mayo Clinic’s Jacksonville campus have received millions of dollars in new grants to fund research into Alzheimer’s disease as well as a new vaccine that could help develop immunity against precancerous breast lesions.

The Florida Department of Health recently awarded Mayo Clinic eight grants totaling $1.6 million to investigate the prevention or cure of Alzheimer’s disease. The eight projects will cover a wide scope of research in Alzheimer’s – a disease that affects more than 5 million people in the United States and is ranked as the sixth leading cause of death. Several of the projects will take steps to explore the intricate genetic pathways of the disease, while two projects will address developing methods of diagnosing Alzheimer’s and understanding disease risk in African-American patients. One project will explore a new avenue of treatment.

“Mayo Clinic’s Florida campus is home to international leaders in neuroscience research who are focused on addressing the unmet needs of patients,” said Gianrico Farrugia, M.D., CEO of Mayo Clinic in Florida. “We integrate basic and clinical research and immediately translate our findings into better patient care. We very much appreciate the state’s investment in finding solutions for Alzheimer’s disease.”

Funding for the awards is provided by the Ed and Ethel Moore Alzheimer’s Disease Research Program, an initiative passed by the Florida Legislature and signed into law by Gov. Rick Scott in 2014.

“We’re pleased by this ongoing recognition of our long-standing work and involvement in the State of Florida and for the continued investment in our goal, which is to translate research findings into treatments that can change lives,” Dr. Farrugia said.

Nearly 20 percent of Florida’s population is 65 and older ─ the highest percentage in the nation, according to a Pew Research Center analysis of the U.S. Census Bureau’s 2014 population estimates. With a 5,000-specimen brain bank for studying neurodegenerative disorders, Mayo Clinic’s Department of Neuroscience is considered a world leader in its field. The facility is also just one of two medical institutions in Florida funded by the National Institute on Aging as an Alzheimer Disease Center.

Breast lesion vaccine

In other Mayo Clinic news, Mayo researchers will soon test a vaccine they hope will help patients develop lifelong immunity against the development of precancerous breast lesions.

Keith Knutson, Ph.D., director of the Discovery and Translation Labs Cancer Research Program at Mayo Clinic’s Jacksonville campus, has received a $3.7 million grant from the U.S. Department of Defense to conduct a phase II clinical trial that, if successful, could substitute for current ductal carcinoma in situ therapy and may become part of a routine immunization schedule in healthy women.

While only about 35 percent of precancerous breast lesions morph into cancer if untreated, physicians cannot identify which lesions are potentially dangerous. As a result, all women diagnosed with ductal carcinoma in situ undergo traditional therapy of surgery and possibly hormonal therapy and radiation. If successful, researchers hope the new vaccine may one day replace these standard therapies and prevent recurrences in some patients.

“We ultimately want to eliminate ductal carcinoma in situ, which means preventing disfiguring surgeries and toxic therapies in the 60,000 women who receive this diagnosis every year in the U.S.,” said Knutson, who designed the vaccine.

Eliminating ductal carcinoma in situ also would reduce the overall breast cancer burden significantly, he added. “Ductal carcinoma in situ is a significant health problem, accounting for about 20 percent of U.S. cases of breast cancer.”

Beginning this year, Knutson and his colleagues at the Mayo Clinic will test the vaccine in up to 45 patients diagnosed with ductal carcinoma in situ. These patients will be treated with the vaccine first. Six weeks later, they will receive surgery (lumpectomy or mastectomy) and other standard therapy. During the initial six weeks, physicians will monitor patients to see if ductal carcinoma in situ lesions reacted to the vaccine.

“The hope is that they disappear,” Knutson said. If successful, advanced clinical trials could be designed to test the possibility that vaccination may be a “safe alternative to conventional and problematic” treatment for ductal carcinoma in situ.

The new grant is the second that Knutson and his team have received from the U.S. Department of Defense to test a breast cancer vaccine. In 2015, they received a five-year, $13.3 million DoD Breakthrough Award to fund a phase II clinical trial testing a different breast cancer vaccine that Knutson had developed. That vaccine is designed to prevent the recurrence of triple-negative breast cancer, which is a subset of breast cancer for which there are no targeted therapies. A phase I trial of the vaccine found it to be safe.

The vaccine to be tested on ductal carcinoma in situ also has been tested in a phase I clinical study. This vaccine is targeted against human epidermal growth factor 2 (HER-2), an oncogene known to play a role in the development and progression of an aggressive subtype of breast cancer known as HER-2 positive.

Knutson suspects that excess HER-2 proteins are expressed in all subtypes of breast cancer, including the most common one: estrogen-positive breast cancer. He said the phase I study of the HER-2 vaccine elicited an immune response in all tested individuals. The vaccine is designed to stimulate production of T cells that target initial development of ductal carcinoma in situ.

“We don’t know if the vaccine works just on HER-2 breast cancer,” he said. “We believe that once an immune response is generated against the ductal carcinoma in situ lesion, it doesn’t matter what subtype of cancer the lesion may become.”

Part of the funding also will go to Jacksonville biotech firm TapImmune, Inc., which will produce the clinical-grade vaccine.