There are currently no approved vaccines for breast cancer, which affects 1 in 8 women.
But clinical trials have now begun to test one developed right here in Cleveland that targets an aggressive form of the disease.
Cleveland Clinic researchers have launched a clinical trial testing a first-of-its-kind vaccine that could prevent triple-negative breast cancer - the most lethal form of the disease, officials said in a press release Tuesday.
The vaccine was developed by Vincent Tuohy, staff immunologist at the Clinic’s Lerner Research Institute.
“We have vaccinated the initial patient,” Tuohy said in a press conference Tuesday. “This day has been two decades in the making.”
Triple-negative breast cancer has a high death rate and is likely to return after treatment, said Dr. G. Thomas Budd, the study’s principal investigator. Researchers hope down the line, if the trials are successful, the vaccine could pave the way to preventing this form of the disease altogether, he said in the press conference.
“Every day, I see the needs of women who have triple-negative breast cancer, yet we don’t currently have suitable advanced treatment options for them,” Budd said. “Our ultimate goal is to offer a proactive approach to help women before they reach that point.”
The novel vaccine targets a lactation protein called α-lactalbumin, which is no longer found in women after childbearing years yet shows up in many cases of triple-negative breast cancer, Tuohy said.
“Why do these tumors express these proteins? We don’t know. They make a mistake,” he previously told Ideastream Public Media in a Dec. 2020 interview. “I’m trying to take advantage of the mistake the tumors make. We’d have to be crazy not to.”
Pre-clinical research led by Tuohy showed that activating the immune system against the α-lactalbumin protein was safe and effective in preventing breast tumors, as well as inhibiting the growth of already existing breast tumors in mice, he said.
The vaccine will now be tested on humans in a phase I clinical trial. Researchers are investigating how much of the dose and how many doses are needed to achieve an immune response, and they are also looking at side effects, Budd said.
The study will include 18 to 24 patients who have completed treatment for early-stage triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence, Budd said.
“We might be able to substantially reduce the risk of triple negative breast cancer. That would be a dream," Budd said in the press conference. "The first step will be in these high-risk groups, though.”
If the trials are successful, researchers hope to eventually test the vaccine on women in the general population.
Other breast cancer vaccines are currently in clinical trials, but this vaccination is unique because it can prevent the cancer altogether, rather than treating tumors that have already developed, Tuohy said.
“This should have a much greater impact on the control of these adult-onset cancers than treatment vaccines," Tuohy said. "I think it would be qualitatively more profound than the treatment vaccines that are ongoing.”
Triple-negative breast cancer is twice as likely to occur in African American women, and Budd said researchers are actively recruiting minority participants by reaching out to health centers in the Cleveland area that serve predominantly Black patients.
“I’m going to be working with the federally qualified health care sites here in Cleveland, just to try to make everyone aware that we are looking for minority participants to try to make this trial reflect America and Cleveland,” Budd said.
Ultimately, this vaccine needs years of more trials and regulatory review before it can be fully approved and available to all patients, Budd added. Tuohy is hopeful this could pan out within the next 10 years, he added.
If the trials are successful, Tuohy said he hopes people could eventually get the vaccine as part of their normal preventative care.
“The long-term vision is, a woman reaches 40 years old or so, she reaches the high-risk area age for breast cancer, she… could come in to her doctor and get her breast cancer vaccine,” Tuohy said.
Researchers also hope to eventually study this vaccine technology on other types of cancers and tumor types, he added.
The study is funded by the U.S. Department of Defense.
The vaccine technology developed by Tuohy is licensed to biotechnology company Anixa Biosciences, Inc., and Cleveland Clinic is working in partnership with the company for this study. Tuohy will receive a portion of commercialization revenues received by Cleveland Clinic and also holds personal equity in the company, according to a press release.
The study was initially set to begin in the spring but was pushed back due to supply chain issues, regulatory approvals and patient recruitment, Tuohy said.
The phase I clinical trial is expected to be completed by Sept. 2022.
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