PDS01ADC Shows Strong Early Results in Metastatic Colorectal Cancer Trial
Event summary
- PDS01ADC achieved a 78% objective response rate (ORR) in Stage 1 of a Phase 2 trial for metastatic colorectal cancer (mCRC), compared to 35% in a parallel trial without PDS01ADC.
- 2-year survival rate with PDS01ADC was >80%, versus ~35% in the parallel trial.
- Trial data published in the March 10, 2026 issue of Journal of Clinical Oncology (JCO) Oncology Advances.
- PDS01ADC is designed to deliver Interleukin-12 (IL-12) directly to tumors, enhancing immune response while minimizing systemic exposure.
- Trial led by Dr. Jonathan Hernandez at the National Cancer Institute (NCI).
The big picture
PDS Biotech's PDS01ADC shows promising early results in a tough-to-treat cancer indication, where immune checkpoint inhibitors have largely failed. The data suggest a potential breakthrough in targeting metastatic colorectal cancer with liver metastases, a high-unmet-need area. If confirmed in later-stage trials, this could reshape treatment paradigms for mCRC patients who have limited options.
What we're watching
- Clinical Validation
- Whether PDS01ADC can sustain these response rates in larger, randomized trials.
- Regulatory Pathway
- The pace at which PDS Biotech advances PDS01ADC toward potential approval.
- Competitive Positioning
- How these results position PDS01ADC against existing and emerging therapies for mCRC.
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