A vaccine designed to prevent and potentially treat triple-negative breast cancer is showing promise in human trials and could be available by 2030.
Cleveland Clinic researchers began exploring a breast cancer vaccine decades ago. In 2018, Anixa Biosciences CEO Dr. Amit Kumar learned of their research and partnered with Cleveland Clinic to move the vaccine from lab testing toward FDA approval for human trials.
WATCH BELOW: WPTV's Meghan McRoberts' speaks Anixa Biosciences CEO Dr. Amit Kumar
Dr. Kumar said the FDA approved testing in women in late 2021, leading to the start of the first trial phase in 2022. Since then, 35 women—including one from Florida—have participated.
“The data is looking incredibly promising,” Dr. Kumar said. “In fact, the data that we have seen is more promising than any other cancer vaccine data that has ever been tried before. That’s one of the reasons we’re very excited,” Dr. Kumar said.
Phase 1 focused on safety and early effectiveness. “We found it to be perfectly safe, with no side effects. The only side effect women saw was irritation at the injection site,” said Dr. Kumar.
Participants were divided into three groups:
-Women who had triple-negative breast cancer and feared recurrence. “We chose those women because we wanted to test safety on women who had already gone through breast cancer,” said Dr. Kumar.
-Women carrying the BRCA gene mutation who had not been diagnosed but were at high risk. They received the vaccine before voluntary mastectomies. "After they have their mastectomy, then we have a chance to get a look at their purportedly healthy tissue. But what we think we’re going to find is that the vaccine has induced their immune systems to surveil the tissue to look for micro tumors that we believe might exist in these women,” said Dr. Kumar.
-Women who had undergone treatment for triple-negative breast cancer but still had residual disease. “We’re trying to develop a vaccine that kills the cancer cells themselves,” Dr. Kumar said.
According to Dr. Kumar, all participants showed a positive immune response—75% with a “good” response and the rest with a “moderate” one.
Phase 2 will involve a larger, more diverse group of newly diagnosed patients to further evaluate effectiveness. Half will receive the vaccine and half a placebo. “We want to be able to show the vaccine trains the immune system to try to reduce the cancer tumor, the size of the tumor, the number of cells, and the strength of the tumor,” Dr. Kumar said.
Phase 2 is expected to begin early next year and last two to three years, followed by Phase 3. Dr. Kumar hopes continued success will bring researchers closer to making breast cancer “a diagnosis of the past.”
“The holy grail is to prevent breast cancer… and maybe do to breast cancer what we’ve done to polio and smallpox,” Dr. Kumar said. “We’re not trying to treat or cure a small number of women. We’re trying to eliminate this as a disease.”
WPTV’s Meghan McRoberts asked if this research could lead to vaccines for other cancers. “Yes,” Dr. Kumar said. “We already have another program with Cleveland Clinic on ovarian cancer and that is being funded by the National Cancer Institute,” Dr. Kumar said. "And then we’ve just initiated programs in lung, colon, and prostate cancer. Based on the success we’ve seen in the breast cancer situation in human women, we feel this approach could be used for multiple other types of cancer.”
