SAN JOSE, Calif., October 7, 2025 – Anixa Biosciences, Inc. (NASDAQ: ANIX), a clinical-stage biotechnology company dedicated to cancer treatment and prevention, announced the completion of the final patient visit in its first-in-human breast cancer vaccine clinical trial. The study, conducted in collaboration with Cleveland Clinic and funded by the U.S. Department of Defense, marks a major milestone in the development of a vaccine designed to stimulate the immune system to recognize and target breast cancer before recurrence or onset.
Science SignificanceAVB-114
The breast cancer vaccine developed by Anixa Biosciences in collaboration with Cleveland Clinic represents a novel approach in immuno-oncology, targeting “retired” proteins that are re-expressed in certain cancers. By stimulating the immune system to recognize these proteins, the vaccine aims to prevent cancer recurrence and potentially stop cancer before it develops. In this first-in-human Phase 1 trial, a total of 35 women were enrolled across three distinct cohorts: 26 in the TNBC group, four in the Prevention group, and five in the Pembrolizumab group. Preliminary results indicate that the vaccine is well tolerated, with more than 70% of participants exhibiting protocol-defined immune responses, demonstrating its ability to effectively engage the immune system. These findings suggest that the vaccine could serve as both a preventive and therapeutic strategy, offering a new paradigm in breast cancer management and potentially paving the way for broader applications in other cancer types.
Regulatory Significance
With the completion of all patient visits and sample collection, comprehensive analysis of immune response and safety data is now underway. A final study report will be submitted to the U.S. Department of Defense, and a Clinical Study Report (CSR) will be filed with the U.S. Food and Drug Administration (FDA). These submissions are crucial steps toward regulatory approval, as they will provide the foundation for subsequent clinical trials and eventual commercialization. Cleveland Clinic is scheduled to present full clinical results at the San Antonio Breast Cancer Symposium on December 11, 2025, which will further inform the scientific and regulatory community of the vaccine’s potential.
Business Significance
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Anixa’s innovative model leverages partnerships with world-class research institutions such as Cleveland Clinic and Moffitt Cancer Center to advance cutting-edge therapies. The company’s therapeutic portfolio spans ovarian cancer immunotherapy using chimeric endocrine receptor-T cells (CER-T) and multiple cancer vaccines targeting high-incidence malignancies, including lung, colon, and prostate cancers. By licensing the breast and ovarian cancer vaccines from Cleveland Clinic, Anixa maintains exclusive commercialization rights, while Cleveland Clinic retains royalties and other revenue-sharing agreements. This approach allows the company to scale its vaccine programs efficiently while tapping into emerging technologies for further development.
Patients’ Significance
For patients, the completion of this trial represents hope for a novel preventive strategy against breast cancer. Current treatment and prevention options are limited for high-risk groups, particularly for triple-negative breast cancer, which lacks targeted therapies. The vaccine’s dual potential to prevent recurrence and provide prophylactic benefits for genetically predisposed individuals could transform patient outcomes, offering a non-invasive, immune-mediated intervention. For those undergoing checkpoint inhibitor therapy, concurrent administration of the vaccine may enhance therapeutic response, potentially improving survival rates and quality of life.
Policy Significance
The trial’s funding by the U.S. Department of Defense underscores growing governmental interest in cancer immunotherapy, particularly strategies aimed at high-risk populations and novel vaccine platforms. Support from public institutions highlights the importance of collaborative research models that integrate clinical expertise, translational science, and immuno-oncology innovation. Policy frameworks that facilitate first-in-human trials, expedited review pathways, and funding for cancer prevention strategies are likely to be critical in advancing similar programs, bridging the gap between laboratory discoveries and patient care.
Transaction Highlights
Anixa Biosciences has completed the final patient visit in its Phase 1 breast cancer vaccine clinical trial, marking a critical milestone that allows the company to move into comprehensive data analysis and regulatory submissions. The trial enrolled 35 women across three cohorts: those with triple-negative breast cancer (TNBC), women undergoing preventive mastectomy due to genetic risk, and patients receiving pembrolizumab postoperatively. Preliminary results indicate the vaccine is well tolerated, with more than 70% of participants demonstrating protocol-defined immune responses, highlighting its potential efficacy. The full clinical results will be presented by Cleveland Clinic at the San Antonio Breast Cancer Symposium in December 2025, reinforcing the scientific and clinical credibility of the program. Developed at Cleveland Clinic and exclusively licensed to Anixa, the vaccine program involves royalties and commercialization revenue sharing, reflecting a strong institutional partnership. Supported by U.S. Department of Defense funding, the trial underscores the strategic collaboration between public institutions and biotechnology companies. The next steps include final data analysis, submission of the study report to the DoD, and filing the Clinical Study Report with the FDA, paving the way for regulatory evaluation and potential advancement to later-stage clinical trials.
Source: Anixa Biosciences, Inc Press Release
