Anixa Biosciences is advancing its breast cancer vaccine program toward Phase 2 after reporting positive final Phase 1 results and announcing a manufacturing agreement to support the next clinical stage.
On April 1, 2026, the company said it had entered into a development and manufacturing agreement with Cytovance Biologics to produce cGMP clinical materials for its planned Phase 2 clinical trial.
Cytovance Biologics Cytovance Biologics also highlighted the partnership on LinkedIn
“Today, Cytovance is proud to announce a new partnership agreement with Anixa Biosciences, Inc. to support the clinical manufacturing of their groundbreaking breast cancer vaccine candidate, developed in collaboration with the Cleveland Clinic. Following promising Phase 1 clinical trial results, Anixa plans to advance the investigational vaccine program into Phase 2 studies.
“We are pleased to partner with Anixa to manufacture clinical materials for its Phase 2 breast cancer vaccine trial,” said Ping Zhang, CEO of Cytovance Biologics. “We look forward to leveraging our development and production capabilities to help advance this promising immunotherapy candidate.”
Read the full release.”
Cytovance Biologics/LinkedIn
According to Anixa, the Phase 1 study met its primary endpoints, showed safety and tolerability at the maximum tolerated dose, and generated protocol-defined immune responses in 74% of participants. The company said these results are now supporting preparations for a Phase 2 trial, marking an important step forward for a cancer vaccine program that has attracted attention for its preventive and therapeutic potential.
The breast cancer vaccine was developed in collaboration with Cleveland Clinic and targets α-lactalbumin, a protein normally expressed in breast tissue during lactation but one that can re-emerge in many forms of breast cancer. By training the immune system to recognize and attack cells expressing this protein, the vaccine is being developed with the goal of offering both treatment and prevention potential in appropriate patient populations.
This latest milestone builds on earlier steps taken to shift the program into company-led development. In November 2025, Anixa announced a data transfer agreement with Cleveland Clinic as part of the process of transferring trial data and IND sponsorship to the company for future clinical development. At that time, the company said it planned to assume full sponsorship of the IND as it moved the vaccine toward Phase 2.
Earlier public reporting on the program also provided more context around the Phase 1 study. Cleveland Clinic researchers said the first trial enrolled 35 women, most from Northeast Ohio, and that participants generally experienced mild side effects such as redness or soreness at the injection site. Researchers also emphasized that Phase 1 trials are meant to assess safety and immune response rather than prove definitive clinical efficacy, meaning the next stage will be critical in determining whether the vaccine can generate a measurable therapeutic or preventive impact.
The significance of this update lies not only in the positive immune response data, but also in the operational progress behind the scenes. Securing cGMP manufacturing support for a Phase 2 study signals that Anixa is actively moving from early proof-of-concept into more advanced development. In a competitive cancer vaccine landscape, that makes this a meaningful biotech milestone to watch.
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