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Anixa Biosciences Reports Positive Phase 1 Data for Breast Cancer Vaccine

Anixa Biosciences, Inc., a prominent biotechnology firm focused on advancing cancer treatment and prevention, has recently announced the successful completion of Phase 1 clinical trial data for its innovative breast cancer vaccine. This groundbreaking vaccine, known as the α-lactalbumin (aLA) vaccine, was the topic of discussion at the 2025 San Antonio Breast Cancer Symposium (SABCS).

The Phase 1 trial was executed in partnership with the Cleveland Clinic and was funded through a grant from the U.S. Department of Defense. This trial aimed to explore the safety and immune response of the vaccine in a total of 35 participants, specifically targeting triple-negative breast cancer (TNBC), a subtype notoriously challenging to treat.

Positive Outcomes Highlighted

The trial's final results indicated that all primary endpoints were met, showcasing the vaccine's safety and tolerability at the maximum tolerated dose (MTD). Impressively, 74% of participants exhibited defined immune responses, reinforcing the vaccine's potential efficacy. The vaccinated participants primarily experienced mild adverse effects, such as irritation at the injection site, with no serious complications arising from the treatment.

Dr. Justin Johnson from the Cleveland Clinic, who holds the position of Program Manager and is a co-inventor of the vaccine technology, emphasized the importance of these findings. He stated, "In this trial, the investigational α-lactalbumin vaccine was found to be safe and well-tolerated at the MTD and generated protocol-defined immune responses in 74% of participants—results that encourage continued clinical evaluation."

Insights from Cohort Analysis

The trial was segregated into three cohorts.

• - Cohort Ia included women who were cancer-free after standard treatments within three years of diagnosis. At the MTD, this group reported no flu-like symptoms, emotional disturbances, or severe lab results, with injection-site irritation serving as the primary adverse event. Importantly, participants in this cohort displayed aLA-specific T cell responses, underscoring the vaccine's potential.
• - Cohort Ib consisted of women without cancer who opted for preventive mastectomy due to genetic predisposition (BRCA1, BRCA2, or PALB2 mutations). The safety and tolerability mirrored those of Cohort Ia, with ongoing investigations into the breast tissues resected from participants.
• - Cohort Ic examined participants receiving pembrolizumab (Keytruda) in an adjuvant setting, highlighting the combined safety of the vaccine and existing treatments without significant side effects. A few participants noted heightened irritation at injection sites, but no major adverse effects were attributed to the combined administration.

The Vaccine's Mechanism

The α-lactalbumin vaccine is designed to awaken the immune system, especially targeting T cells to fight against cancer cells expressing the α-lactalbumin antigen. This protein is typically produced during lactation and is generally absent in other tissues when not in a developmental stage. This unique approach aims to provide preemptive immune defense against the resurgence of tumors with this antigen, showcasing a novel preventive strategy in combatting breast cancer.

Looking Ahead

The encouraging Phase 1 results lay the groundwork for a Phase 2 study, which aims to test the vaccine further in conjunction with Keytruda for newly diagnosed patients. The team is keen to investigate the potential of this combination therapy in providing immunotherapeutic benefits without added complications.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, expressed optimism in moving forward. He stated, "We are very encouraged that the final Phase 1 data met all major primary endpoints, showing the vaccine's favorable tolerability profile and generating immune responses in most participants."

With continued collaboration with the Cleveland Clinic and potential further funding, Anixa aims to maximize the potential of immunotherapies in the ongoing battle against breast cancer, a journey initially dreamt of by the late Dr. Vincent Tuohy, under whom this research was initiated. These findings represent a significant leap forward in the quest to innovate cancer treatments.

For more information about Anixa Biosciences and its initiatives, please visit Anixa's official website.