A clinical trial of a vaccine to prevent breast cancer is showing early promise, prompting Cleveland Clinic researchers to move ahead with a second stage of testing.
Most participants tolerated the vaccine well, and the majority showed a strong immune reaction, a key early sign that the vaccine is working as intended. However, researchers caution Phase 1 trials are not designed to show whether the vaccine can actually treat or prevent breast cancer.
Thirty-five women, mostly from Northeast Ohio, took part in the first clinical trial. Participants reported only mild side effects such as redness or soreness at the injection site. Nearly three-quarters of participants had a strong immune response, meaning their bodies reacted to the vaccine as expected, said Dr. Thomas Budd, a Cleveland Clinic oncologist.
“What made me most hopeful was that the majority of patients had an immune response,” Budd said. “Without that, we would have been very disappointed.”
The vaccine targets a protein called α-lactalbumin. Normally, this protein appears in breast tissue only during breastfeeding, but it can reappear in breast cancer. The vaccine trains the immune system to attack cells with this protein, which could help prevent or treat the disease. The research began with the late Dr. Vincent Tuohy at Cleveland Clinic.
The next phase of the study will include more participants than the first phase, with a control group receiving a placebo to compare results, said Dr. Amit Kumar, CEO of Anixa Biosciences, which is taking over as lead on the next phase of trials.
“The two main things are safety and efficacy,” Kumar said. “Our goal is a medicine that can not only treat breast cancer but also prevent it in women at high risk.”
Kumar added that the company is actively recruiting a more racially and ethnically diverse group for the next stage of clinical trials.
Phase 2 is expected to begin late next year and run for up to three years.
