Anixa Biosciences announced on December 15, 2025 that it has completed the transfer of the investigational new drug (IND) for its α‑lactalbumin breast‑cancer vaccine from the Cleveland Clinic, making Anixa the sole trial sponsor for all future development of the candidate.
The transfer follows a successful Phase 1 study that enrolled 35 patients and produced an immune‑response rate of 74 %. Safety signals were favorable, and the data were presented at the San Antonio Breast Cancer Symposium on December 11, 2025.
Anixa plans to launch a multi‑site Phase 2 program that will evaluate the vaccine in the neoadjuvant setting, in combination with standard chemotherapy and the immune‑checkpoint inhibitor Keytruda (pembrolizumab). Cleveland Clinic sites will remain part of the clinical network, and the study will assess both safety and early efficacy endpoints.
The IND transfer gives Anixa full authority over regulatory interactions, site selection, and enrollment, accelerating the path to regulatory submissions and potential licensing discussions. Cleveland Clinic will receive royalties and commercialization revenue under the partnership agreement, and Anixa has secured U.S. and Chinese patents that protect the technology through the 2040s.
Anixa’s most recent quarterly report shows more than $17 million in cash, no debt, and a runway exceeding two years of operations. Dr. Amit Kumar, Chairman and CEO, said the company is “excited about assuming sponsorship of the breast‑cancer vaccine IND and looks forward to advancing this potentially game‑changing cancer vaccine into future clinical trials.”
The company’s leadership emphasized that the IND transfer and Phase 2 plan position Anixa to move quickly through the regulatory process while maintaining strong financial flexibility to support the next phase of development.
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