Clinical Data & UptakePhase 3 results showing about a 30% reduction in disease recurrence in intermediate-to-high-risk localized prostate cancer, together with strong KOL and physician feedback and supportive survival signals in other tumor types, should bolster clinician adoption and guideline consideration.
ManufacturingManufacturing for CAN-2409 has been scaled toward commercial volumes with viral and cell banks established and ongoing process performance qualification and comparability testing, addressing key CMC hurdles required for approval and launch readiness.
RegulatoryFDA alignment on comparability analysis and use of an SPA-supported disease-free survival endpoint eliminates the need for additional bridging studies and creates a clearer pathway for a biologics license application for CAN-2409, with a BLA submission planned for the fourth quarter of 2026.