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Phase 1 Trial of Alpha-Lactalbumin Vaccine in High Risk in TNBC – SABCS 2023

Allen Wilbanks stands at the forefront of SABCS 2023, the setting for a conversation with Thomas Budd, MD, a medical doctor and oncologist from the Cleveland Clinic Cancer Center. In this discussion, Allen introduces the focus—the Phase 1 trial of the Alpha-Lactalbumin vaccine in high-risk operable triple-negative breast cancer (TNBC) patients and those with a genetic predisposition to TNBC.

Dr. Budd elaborates on the primary objectives of the trial, emphasizing the critical role of determining the appropriate vaccine dosage for future applications. The trial evaluates toxicity, primarily manifested as local injection site reactions, and measures immune responses through Alispot assays.

The safety and efficacy data gleaned from the trial are discussed next, with Thomas Budd, MD highlighting the minimal adverse events—mostly injection site reactions—and the absence of autoimmune side effects. The conversation delves into the rationale behind the vaccine, rooted in Dr. Vince Tui’s “retired protein hypothesis,” focusing on alpha-lactalbumin’s unique overexpression in lactating breasts and its correlation with triple-negative breast cancer.

Allen probes further into the potential advantages and limitations of the Alpha-Lactalbumin vaccine, emphasizing the prospect of lifelong immunity against TNBC. Dr. Budd anticipates the challenges related to injection site reactions and cautions against expecting efficacy in advanced stages of the disease.

The dialogue concludes with a glimpse into the future of this research. Dr. Budd outlines ongoing efforts, including additional cohorts in the trial and vaccinations for individuals with specific genetic mutations. The trajectory leads toward broader applications—prophylactic adjuvant therapy and, more ambitiously, preventive measures for those genetically predisposed to TNBC.

In this exchange, Allen Wilbanks and Dr. Thomas Budd unravel the complexities of the Alpha-Lactalbumin vaccine trial, offering insight into the future of breast cancer prevention and treatment.

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