ACT (PS101 + focused ultrasound) plus mFOLFIRINOX shows early responses and a resection conversion signal in locally advanced/borderline PDAC

Acoustic Cluster Therapy (ACT) is an investigational ultrasound-mediated drug delivery approach in which IV PS101 (perfluorocarbon microbubbles/microdroplets) is activated by focused ultrasound to transiently increase tumor vascular permeability and potentially boost intratumoral chemotherapy exposure. In the ENACT Phase 2 multicenter, open-label, single-arm Simon two-stage study in treatment-naïve borderline resectable or locally advanced PDAC (NCT06850623; planned N=25), 9 patients were enrolled as of June 23, 2026. Across these patients, 112 treatment-emergent adverse events (TEAEs) were reported, including 16 grade ≥3 events; 11 TEAEs were considered related to both chemotherapy and PS101. Seven serious TEAEs occurred, all deemed unrelated to PS101 or the investigational device, and investigators reported no apparent alteration of the expected mFOLFIRINOX safety profile. Preliminary activity includes >90% CA19-9 reductions, RECIST partial responses in 2/3 evaluable patients, and conversion to surgical resection in 1 patient—early signals that need to be viewed against the already meaningful downstaging/resection rates reported with FOLFIRINOX-based neoadjuvant therapy in borderline/locally advanced disease (meta-analyses suggest resection rates often in the ~40%+ range depending on cohort and strategy).