Manufacturing CapacityAn established manufacturing partnership lowers the risk of production delays and supports broad treatment center availability and rapid product turnaround, improving commercial launch prospects for anito-cel.
Regulatory OutlookFDA draft guidance endorsing minimal residual disease negativity and complete response as primary endpoints supports an accelerated approval pathway and increases the likelihood of priority review for the biologics license application for anito-cel.
Safety ProfileAnito-cel's D-Domain binder avoids antigen-independent tonic signaling and off-target CLDN9 activity, reducing the risk of delayed neurotoxicity and inflammatory side effects compared with traditional CAR-T binders.