Anixa Biosciences Announces Transfer of IND for Breast Cancer Vaccine from Cleveland Clinic

On December 15, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has completed the transfer of the Investigational New Drug application ("IND") for its breast cancer vaccine from Cleveland Clinic. Anixa is now the trial sponsor for future development of its breast cancer vaccine. The transfer of the IND is a natural and planned step in the progresson of the vaccine’s development.

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With enrollment completed and encouraging immune response and safety data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and has assumed full sponsorship of the IND. Anixa plans to utilize multiple clinical sites, including Cleveland Clinic, for the Phase 2 and other clinical trials.

Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets α-lactalbumin—a lactation-associated protein that is typically expressed only in breast tissue during lactation, but which re-emerges in many forms of breast cancer. By establising an immune response against α-lactalbumin-expressing cells, the vaccine may offer both therapeutic and preventive benefits for patients with tumors expressing this protein. The vaccine is based on preclinical research led by the late Vincent Tuohy, Ph.D., who served as the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic.

"We are excited about assuming sponsorship of the breast cancer vaccine IND, and we look forward to advancing this potentially game-changing cancer vaccine into future clinical trials," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We are pleased with the progress and findings from our Phase 1 clinical trial, which were presented at the San Antonio Breast Cancer Symposium on December 11."

(Press release, Anixa Biosciences, DEC 15, 2025, View Source [SID1234661443])