On November 5, 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 executed a data transfer agreement ("DTA") with Cleveland Clinic, as a key step in the process of transferring the breast cancer vaccine clinical trial data and sponsorship to Anixa for future clinical development.
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With enrollment completed and encouraging immune response data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and will assume full sponsorship of the IND. The IND, currently sponsored by Cleveland Clinic, is in the process of being transferred to Anixa. The DTA will allow for the transfer of all relevant data and information, collected and generated from the Phase 1 clinical trial, to Anixa.
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.
"Execution of the DTA represents a significant step in the transfer of IND sponsorship to Anixa. We look forward to completing the remaining steps with Cleveland Clinic, and eventually advancing to a Phase 2 trial under our sponsorship," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We are pleased with the progress and preliminary findings from our Phase 1 clinical trial, and are excited about the presentation of the final Phase 1 data, by Cleveland Clinic, at the San Antonio Breast Cancer Symposium on December 11."
(Press release, Anixa Biosciences, NOV 5, 2025, View Source [SID1234659490])