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[271] The applicant stated that it has no ownership stake in the development of these cancer treatment vaccines and does not possess control or influence over the design and execution of the clinical trials

This limits efficacy and increases the risk of off-target effects, including neuropsychiatric side effects and motor complications 77

Their therapeutic potential lies in leveraging diet-microbiota-metabolite crosstalk to overcome ICI resistance, though clinical translation is constrained by interindividual microbial heterogeneity, inconsistent metabolite production, and the need for context-specific targeting (263)