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Cleveland Clinic researchers share promising results from experimental breast cancer vaccine trial

The vaccine targeting alpha-lactalbumin was safe and induced immune responses in 74% of participants, supporting a planned Phase II trial to further evaluate efficacy.

  • On Thursday, Cleveland Clinic researchers presented Phase I trial results at the San Antonio Breast Cancer Symposium showing the vaccine was safe and induced immune responses in 74% of participants.
  • The vaccine targets alpha-lactalbumin, found in most triple-negative breast cancer tumors but absent from normal aging breast tissue, addressing a need for treatments in aggressive TNBC.
  • The Phase I trial enrolled 35 patients across three cohorts and determined a maximum tolerated dose with mainly mild injection-site inflammation.
  • Anixa Biosciences plans a multicenter Phase 2 trial beginning late next year, which it will perform and direct under license from Cleveland Clinic, projected to last two to three years.
  • Built on decades of preclinical work by Vincent Tuohy, Ph.D., supported by philanthropic donors over 12 years, four trial participants experienced cancer recurrence though the study wasn’t designed to assess efficacy.
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Researchers expect this vaccine to teach the immune system to attack and destroy tumor cells

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WKYC broke the news in Cleveland, United States on Thursday, December 11, 2025.
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