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The alpha-lactalbumin vaccine is an investigational therapeutic and preventive cancer vaccine designed to stimulate the immune system to target cells expressing the protein alpha-lactalbumin. Alpha-lactalbumin is a milk protein normally produced only in lactating mammary glands and is not present in normal tissues of non-pregnant, non-lactating women. However, it is highly expressed in more than 70% of triple-negative breast cancers (TNBC) and some other breast cancers. The rationale for this approach is that targeting this protein should selectively attack tumor cells while sparing normal tissues except during lactation. The mechanism of action involves inducing a T-cell mediated immune response against cells expressing α-lactalbumin, leading to their destruction. Preclinical studies demonstrated efficacy in preventing and inhibiting growth of breast tumors in animal models by generating interferon gamma- or IL-17-producing T-cells specific for α-lactalbumin[2][7]. Clinical trials have shown that the majority of patients develop protocol-defined immune responses with minimal adverse effects limited mainly to injection site irritation[6][7]. The primary indication under investigation is prevention and adjuvant treatment of triple-negative breast cancer (TNBC), particularly among high-risk individuals or those who have completed standard therapy but remain at risk for recurrence[1][5][6]. The drug remains experimental and has not been approved by regulatory agencies.
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