PDS Biotech reports 78% ORR for PDS01ADC in MSS mCRC liver metastases trial

PDS Biotechnology Corp

Stage 1 of Phase 2 NCI-led trial: 77.8% ORR (7/9) with PDS01ADC plus HAIP vs 35% in parallel study without PDS01ADC.
PDS01ADC plus HAIP showed ~85% 2-year survival rate; comparator arm had ~40% for MSS/pMMR metastatic colorectal cancer.
Extrahepatic progression-free survival median not reached at 13.1 months minimum follow-up; comparator median 8.1 months.
Data published in JCO Oncology Advances March 10, 2026; trial enrolls patients who failed at least one prior treatment.
MSS/pMMR colorectal liver metastases represent ~95% of mCRC where checkpoint inhibitors have failed.

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