Mayo Breast Cancer Vaccine Could Be Available In Less Than A Decade

In Clinical Trials by Barbara Jacoby

By: Robin Seaton Jefferson

From: forbes.com

Researchers at Mayo Clinic in Jacksonville, Florida say a vaccine they have developed could be available within eight years that may not only stop the recurrence of breast and ovarian cancers, but prevent them from developing in the first place.

“It is reasonable to say that we could have a vaccine within eight years that may be available to patients through their pharmacy or their doctor,” said. Mayo Clinic investigator, Keith L. Knutson, Ph.D. in an interview today.

Knutson said the research is in its early phases, and it will be at least three years before a phase 3 trial of Mayo Clinic’s cancer vaccine would be available to large numbers of patients.

But the fact is, Knutson said immunologists at Mayo already have two cancer vaccines against Triple Negative Breast Cancer and HER2 Positive Breast Cancer, respectively. They’re also working on a third against ductal carcinoma in situ, or DCIS, a noninvasive breast cancer that brings a staggering 300,000 new cases a year to oncologists in the United States.

“We know that they’re safe. We know that they stimulate the immune system [to fight cancer],” Knutson said in an interview. “We know that they have had a positive impact on ovarian and breast cancer. We haven’t seen any adverse events that are causing problems other than irritation in the area similar to a flu vaccination. Now we have to convince the FDA, through solid, rigorous clinical trials that we’re seeing what we’re seeing.”

But the process isn’t cheap, Knutson said. A typical phase 2 clinical trial can cost on the order of $12 to $20 million to carry out. And phase 3 trials can be double that, he said.

“What we’re interested in is moving vaccines from pre-clinical models into humans with cancer to prevent cancer, and also ultimately to develop cancer vaccines,” said Knutson, the principal investigator working with a $13.3 million, five-year Department of Defense grant to test a vaccine designed to prevent the recurrence of triple-negative breast cancer. Knutson also conducts research on cancer vaccines focused on T cell immunity and T cell therapy, as well as on tumors and the immune system. He and his colleague are attempting to learn how tumors evade the immune system.

“We’re also working on one to prevent cancer with the National Breast Cancer Coalition,” Knutson said. “We expect that to be in phase 1 clinical trials in 2020.”

Knutson’s and Mayo’s vaccines work by stimulating the body’s immune system—its natural defense mechanism—to attach to and kill cancer cells.

“If you develop a cold or something like that, you do develop an immune response, and that actually doesn’t necessarily prevent the disease, but it keeps it at bay and it helps clear it,” Knutson said on Mayo Clinic’s Medical Edge program.

Mayo researchers are applying the same idea to cancer—a vaccine that trains an individual’s immune system to attack cancer cells.

“If we’re able to have the immune system trained to recognize abnormal cells, or cancerous (or) precancerous cells, then maybe the immune system can eliminate them before they even develop,” Mayo Clinic Surgeon Dr. Amy Degnim said on the Mayo Clinic Minute. Degnim is one of the researchers evaluating Mayo’s vaccine against the so-called HER2 protein. Though it occurs naturally in the body, breast cancer cells make too much of it. And this HER2 protein is found in the majority of women with DCIS. Mayo researchers are hopeful that their vaccine will teach the immune system to recognize the over-expressed proteins as foreign and kill them.

With such advance imaging and early detection, doctors are finding cancers earlier than ever before. Because of this, women are being treated sometimes for tiny tumors. And since they are being detected and treated so early, no one really knows which cancers the human body might have taken care of on its own. Knutson said there is speculation that some cancers might be eradicated by an individual’s immune system without the intervention of modern medicine. “But we have no idea which ones are going to go away, so we want to develop strategies that can stimulate the body to take care of it—to stimulate the immune system, like with infectious disease so it’s ready for it,” he said in an interview.

“We think that the use of vaccines in combination with early detection, appropriate therapies to minimize disease may ultimately lead to reductions in morbidity recurrence in at least breast and ovarian cancers with these vaccines,” Knutson said.

It’s difficult to say when or if vaccines will be available for all cancers since every cancer is different, Knutson said. “Other individuals are working on lung and prostrate and other cancers,” he said. “Some are very similar to the approaches we are taking, but there are different cellular processes that have gone wrong in different cancers.”

For example, the Mayo’s HER2 vaccine is designed specifically to fight the breast cancer that occurs from the overabundance of the HER2 protein. The vaccine trains the immune system to recognize that specific protein. The first step with this vaccine will be to test it in high-risk patients who have had cancer to hopefully prevent a recurrence. If the phase 1 trial proves that the vaccine is safe for patients, investigators will move on to a phase 2 clinical trial to see how the vaccine works for a larger number of patients. If that is effective, the phase 3 trial would be available to many more people. And so goes is with every therapy against every type of cancer.

Still, Knutson is confident. “We have seen early signals that our vaccines have a very positive impact on disease. We are building on that foundation.”

For more information about Mayo’s and other clinical cancer trials, visit the Mayo Clinic Cancer Center or clinicaltrials.gov.