AIM doses final patient in Phase 2 DURIPANC pancreatic cancer trial; CBR readout expected Dec 2026
AI Summary
AIM ImmunoTech reported the final subject has received the first dose in the Phase 2 DURIPANC study testing Ampligen (rintatolimod) with AstraZeneca's Imfinzi in metastatic pancreatic cancer, triggering a primary endpoint Clinical Benefit Rate (CBR) analysis expected to begin December 2026 and topline results anticipated in Q1 2027. The open-label, single-center investigator-initiated trial also lists overall survival and immune profiling as key secondary/exploratory endpoints (secondary analyses begin ~June 2027), which AIM says could help identify biomarker-defined “super-responder” subsets to inform a potential Phase 3. AIM cites prior named-patient data showing large PFS/OS differences in patients with favorable Neutrophil/Lymphocyte and CA19-9 biomarkers, but those were non-randomized historical comparisons and thus exploratory.
Positives
- Final subject dosed in Phase 2 DURIPANC — trial now complete for enrollment/dosing milestone
- Primary endpoint (Clinical Benefit Rate at 24 weeks) analysis expected to start Dec 2026 with topline in Q1 2027
- Secondary endpoints include overall survival and immune profiling that could enable biomarker-driven Phase 3 design
Negatives
- DURIPANC is an open-label, single-center, investigator-initiated Phase 2 — limits generalizability and increases exploratory nature
- Supportive prior data cited are from a named-patient program versus historical controls, not randomized trials
- Timelines and advancement are forward-looking and subject to typical clinical and regulatory risks