Anixa Biosciences Announces Phase 1 Breast Cancer Vaccine Data

• Anixa Biosciences presents Phase 1 data for breast cancer vaccine. • Vaccine shows potential to transform treatment and prevention. • Trial conducted at Cleveland Clinic, funded by US Dept. of Defense. • Results to inform FDA discussions and advance Phase 2 development. • Presentation at San Antonio Breast Cancer Symposium on Dec. 11, 2025.

Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on cancer treatment and prevention, has announced that final results from the Phase 1 clinical trial of its breast cancer vaccine will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Thursday, December 11, 2025. The trial, conducted at Cleveland Clinic and funded by the U.S. Department of Defense, evaluated the safety and immunogenicity of an alpha-lactalbumin (aLA) vaccine for breast cancer Cleveland Clinic to Present Final Results of Phase 1 Clinical Trial for Anixa Biosciences' Breast Cancer Vaccine at 2025 San Antonio Breast Cancer Symposium^[1].

The presentation, titled "Final Results of a Phase I Trial of alpha-lactalbumin (aLA) Vaccine for Breast Cancer," will be delivered by Dr. Justin Johnson, Program Manager at Cleveland Clinic and co-inventor of the vaccine technology. The comprehensive data release is expected to provide detailed insights into the vaccine's potential to transform breast cancer treatment and prevention. The findings will be submitted to both the Department of Defense and the U.S. Food and Drug Administration (FDA) to inform upcoming Phase 2 development plans Cleveland Clinic to Present Final Results of Phase 1 Clinical Trial for Anixa Biosciences' Breast Cancer Vaccine at 2025 San Antonio Breast Cancer Symposium^[1].

The vaccine technology builds on decades of pioneering preclinical work led by the late Vincent Tuohy, Ph.D., and his team at Cleveland Clinic. The vaccine targets alpha-lactalbumin, a protein expressed in lactating breast tissue and in many breast cancers. The trial's completion represents a significant milestone in the company's development pipeline, as the data will guide future FDA discussions and Phase 2 planning Cleveland Clinic to Present Final Results of Phase 1 Clinical Trial for Anixa Biosciences' Breast Cancer Vaccine at 2025 San Antonio Breast Cancer Symposium^[2].

The presentation at SABCS will mark the most detailed data release to date, providing insights into the vaccine's safety and immune response. However, the article notes that specific efficacy or immunogenicity results are not shared ahead of the December presentation. The vaccine's ability to demonstrate robust immune responses specifically targeting breast cancer cells without concerning safety signals will be crucial for its success in late-stage development Cleveland Clinic to Present Final Results of Phase 1 Clinical Trial for Anixa Biosciences' Breast Cancer Vaccine at 2025 San Antonio Breast Cancer Symposium^[2].

Anixa Biosciences' breast cancer vaccine phase 1 trial completion is a critical step forward, but it is essential to note that the pathway from successful Phase 1 trials to market approval remains exceptionally challenging. The vaccine's potential to prevent breast cancer in addition to treating it is a distinctive characteristic that sets it apart from other cancer vaccines Cleveland Clinic to Present Final Results of Phase 1 Clinical Trial for Anixa Biosciences' Breast Cancer Vaccine at 2025 San Antonio Breast Cancer Symposium^[2].