Anixa Biosciences Completes Major Milestone in Breast Cancer Vaccine Clinical Trial

Anixa Biosciences Achieves Key Milestone in Clinical Trial for Breast Cancer Vaccine

San Jose, California – Anixa Biosciences, Inc., a prominent name in biotechnology focused on cancer treatment and prevention, has announced a significant advancement in its mission: the completion of final patient visits in a pioneering clinical trial for a breast cancer vaccine. This notable accomplishment not only highlights the company's commitment to innovative cancer solutions but also highlights the collaborative effort with the revered Cleveland Clinic.

The breast cancer vaccine, a result of extensive research at Cleveland Clinic, is currently undergoing a Phase 1 trial, fully funded by the U.S. Department of Defense. This trial aims to assess the vaccine's ability to stimulate the immune system to identify and combat breast cancer before it emerges or recurs, addressing a crucial need in cancer care.

The study involved 35 women divided into three patient cohorts:
1. TNBC Group: 26 participants who have completed treatment for triple-negative breast cancer and are currently cancer-free but at risk of recurrence.
2. Prevention Group: Four women with genetic mutations predisposing them to breast cancer who opted for preventive mastectomy while remaining cancer-free.
3. Pembrolizumab Group: Five participants who are receiving pembrolizumab, a checkpoint inhibitor, concurrently with the vaccine in a post-operative setting.

Following the completion of patient visits and sample collection, Anixa will proceed with a comprehensive analysis of the collected data. The results of this analysis will ultimately be submitted to the Department of Defense and will also culminate in a Clinical Study Report (CSR) to the FDA.

Cleveland Clinic is set to unveil the complete clinical findings at the highly anticipated San Antonio Breast Cancer Symposium scheduled for December 11, 2025. Dr. G. Thomas Budd, Principal Investigator of the study, expressed optimism regarding preliminary data, noting that over 70% of participants exhibited protocol-defined immune responses, indicating that the vaccine is well tolerated.

Anixa's Chairman and CEO, Dr. Amit Kumar, reinforced this optimistic outlook, emphasizing the unique nature of their vaccine strategy focusing on targeting a novel antigen that hasn't been previously addressed. He believes this innovative approach could forge a new path in immuno-oncology, playing a significant role in both breast cancer prevention and treatment.

In addition to its efforts in breast cancer, Anixa Biosciences is engaged in developing therapies for ovarian cancer, collaborating with Moffitt Cancer Center to introduce a distinct class of CAR-T cell therapy, called chimeric endocrine receptor-T cells (CER-T). This unique approach could extend the horizons of how cancer immunotherapies are designed and implemented.

Anixa's commitment to establishing profound partnerships with leading research institutions allows the company to stay at the forefront of emerging technologies, thus ensuring that it continues to investigate and develop new solutions to combat various cancers, including those with high incidence rates such as lung, colon, and prostate cancers. The breast and ovarian cancer vaccines developed at Cleveland Clinic and licensed exclusively to Anixa embody a promising future for innovative cancer treatments.

Stay connected with Anixa through its social media channels on LinkedIn, X, Facebook, and YouTube, as the company prepares to unveil its findings and share progress in the quest to revolutionize cancer treatment and care.

This clinical trial's results signify a step forward not only for Anixa but for the millions impacted by breast cancer, providing hope for improved therapeutic options in the near future.