DEC 14, 2023 3:00 AM PST

New Data from Phase 1 Study of a Triple-Negative Breast Cancer Vaccine Reported

WRITTEN BY: Katie Kokolus

Anixa Biosciences, a publicly traded (Nasdaq: ANIX) biotechnology company based in San Jose, California, recently announced in San Jose, California, recently announced the newest data from a Phase 1 clinical trial testing their unnamed drug to prevent triple-negative breast cancer (TNBC). According to their website, Anixa focuses on both cancer treatment and prevention, including vaccines that immunize against “retired proteins,” which, while expressed at certain times, no longer remain in healthy individuals.

The press release notes that the United States Department of Defense (DOD) funded the Phase 1 study conducted in collaboration with Cleveland Clinic.  Data presented at the 2023 San Antonio Breast Cancer Symposium (PO2-17-12) showed some exciting and promising results from the trial, which included 16 TNBC survivors who were cured with prior treatment.  Every two weeks, patients received a vaccination for a total of three treatments. 

In addition to testing the vaccine's safety, the Phase 1 study also evaluated immunogenicity and immune cells' ability to elicit an immune response.  The researchers assessed the effects of the vaccine regimen by monitoring immune readouts, including the expression of two key cytokines, interferon-gamma (IFNγ) and interleukin-17 (IL-17).  These cytokines indicate a beneficial cellular immune response (immunity resulting in the destruction of a cancer cell).  In addition, the researchers measured antibody production as an indication of humoral immune response (immunity directed against a specific antigen). 

The vaccine targets α-Lactalbumin (aLA), a protein expressed in breast tissue during lactation, but otherwise remains undetectable in healthy women.  However, about 70% of TNBC tissues express aLA.   Thus, Anixa developed the vaccine against aLA, a “retired protein.” 

The data revealed that 75% of the participants exhibited antigen-specific cytokine responses.  Compared to baseline, IFNγ became significantly elevated by Day 56.  Similarly, the researchers observed IL-17 elevated by Day 14 compared to baseline.   The researchers noted no severe side effects like myalgias or flu-like symptoms.  The only side effect reported was irritation after the injection site. 

Dr. Amil Kumar, the Chairman and CEO of Anixia Biosciences, explained that the data presented currently “exceeded our expectations, and we are pleased with our progress.  This vaccine is designed to direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine development.”  In addition, the statement continued to explain the intention to move into Phase 2 and 3 trials to test the ability of the vaccine to prevent recurrence of TNBC in survivors. 


Sources: Anixa Press Release, Semin Immunol, SABCS 2024 Abstracts, Immunobiology (Chapter 8), Immunobiology (Chapter 9), Cancers

About the Author
Doctorate (PhD)
I received a PhD in Tumor Immunology from SUNY Buffalo and BS and MS degrees from Duquesne University. I also completed a postdoc fellowship at the Penn State College of Medicine. I am interested in developing novel strategies to improve the efficacy of immunotherapies used to extend cancer survivorship.
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