ASGCT highlighted strategies to address AAV’s long-standing “one-and-done” limitation, focusing on redosing approaches and overcoming pre-existing immunity that can blunt subsequent administrations. The discussion pointed to immunologic barriers as a major factor limiting repeat dosing in rare disease gene therapy. In parallel, a BioCentury podcast episode zeroed in on the policy and regulatory friction points around redosing, including the perspective on where successor efforts may land and what evidence will satisfy regulators. Together, the materials reinforce that clinical feasibility and immune management will drive the next wave of AAV development programs. For developers, the operational takeaway is that redosing is not just a formulation challenge; it is an end-to-end immunology and clinical-development problem.
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