Anixa Biosciences completed a data transfer agreement with Cleveland Clinic on November 5, 2025, moving the breast‑cancer vaccine clinical‑trial data and IND sponsorship into Anixa’s hands. The transfer gives the company full regulatory control and the authority to design and run a Phase 2 study of its α‑lactalbumin‑targeted vaccine, a key step toward commercialization.
The agreement transfers all Phase 1 data, including enrollment of 35 patients (26 triple‑negative breast cancer, 4 prevention, 5 pembrolizumab cohorts) and the associated safety and immunogenicity results. With the IND now under Anixa’s stewardship, the company can schedule a Phase 2 trial later in 2025, a study that will evaluate the vaccine in combination with standard chemotherapy and the checkpoint inhibitor Keytruda over a two‑to‑three‑year period.
The vaccine targets α‑lactalbumin, a protein normally expressed only during lactation but re‑expressed in many breast cancers. Phase 1 data, which will be presented by Cleveland Clinic at the San Antonio Breast Cancer Symposium on December 11, show that more than 70 % of patients achieved protocol‑defined immune responses, with no serious safety signals beyond mild injection‑site reactions.
Strategically, the DTA strengthens Anixa’s partnership with Cleveland Clinic, which will receive royalties and future commercialization revenue from the technology. The company’s balance sheet remains solid, with a current ratio of 8.45 and cash exceeding debt, giving it the financial flexibility to fund the upcoming Phase 2 program and other pipeline initiatives, including an ovarian‑cancer immunotherapy collaboration with Moffitt Cancer Center.
Management emphasized the significance of the milestone: “Execution of the DTA represents a critical step in transferring IND sponsorship to Anixa. We are eager to complete the remaining steps with Cleveland Clinic and advance to a Phase 2 trial under our sponsorship,” said Dr. Amit Kumar, Chairman and CEO. The move is expected to accelerate the vaccine’s path to market and enhance Anixa’s growth prospects.
Investors have responded positively to the announcement, reflecting confidence in Anixa’s progress and the strong financial foundation that supports its development trajectory.
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