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Material Event

AIM's DURIPANC trial nears full Ampligen dosing as pancreatic cancer readout builds

The Erasmus MC-run study of Ampligen plus AstraZeneca's Imfinzi finishes dosing in August, setting up a December clinical-benefit-rate readout in post-FOLFIRINOX pancreatic cancer.

Trial NCT05927142

Executive Summary

  • A combination trial pairing a checkpoint inhibitor with a TLR3 agonist in pancreatic cancer patients who stabilized on chemotherapy is set to finish dosing all enrolled subjects, clearing the way for its primary endpoint analysis.
  • The trial tests whether adding an innate-immune agonist to checkpoint blockade can extend disease control in a setting where checkpoint inhibitors alone have not shown benefit, a mechanism combination with no direct precedent in this population.
  • The study's completion date and enrollment target have stayed fixed since one early amendment, and the sponsor has kept to its own disclosed milestone sequence, an operational signal that timing risk is lower than in typical early-phase combination trials.
  • The dosing completion is a step toward, not a substitute for, the clinical benefit rate readout the sponsor has scheduled for December 2026, which will be the first test of whether the combination clears any meaningful bar in this population.

The milestone

AIM ImmunoTech Inc., in collaboration with AstraZeneca and Erasmus Medical Center, disclosed a milestone timeline for DURIPANC (NCT05927142), a Phase 1/2 trial combining Ampligen (rintatolimod), a TLR-3 agonist, with AstraZeneca's Imfinzi (durvalumab), a PD-L1 inhibitor, in metastatic pancreatic cancer patients who reached stable disease after at least eight cycles of FOLFIRINOX chemotherapy. The company said it plans to complete enrollment in July 2026 and finish dosing all subjects with Ampligen the following month, August 2026. As of the February 2026 disclosure, 18 subjects had enrolled in the single-center, investigator-initiated, open-label study, against a target of 43. AIM+1AIM ImmunoTech Announces Planned Milestones in the Ongoing Phase 2 Trial of Ampligen and ...Feb 23, 2026Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy EfficacyNCT05927142

Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.

Endpoint Met40%
Completes52%
Clinical Significance4%
Regulatory68%

The endpoint bar

The trial's primary endpoint is clinical benefit rate, defined as stable disease, partial response, or complete response at six months (24 weeks) after starting combination therapy, with a separate Phase Ib safety objective for the durvalumab-rintatolimod combination. The sponsor has scheduled evaluation of that primary endpoint for December 2026, once enough subjects reach the six-month mark, followed by secondary endpoints, including progression-free survival, overall survival, and an immunogenic-efficacy measure defined as a greater than 50% rise in circulating Ki67+ CD8+ T cells, in June 2027. Lead investigator Marjolein Y.V. Homs of Erasmus MC Cancer Institute said the Phase 1 portion showed progression-free survival and overall survival results that supported advancing to the current Phase 2 stage, and that no significant toxicity has emerged so far, with subjects reporting high quality of life during treatment. NCT05927142+1Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy EfficacyNCT05927142AIM ImmunoTech Announces Planned Milestones in the Ongoing Phase 2 Trial of Ampligen and ...Feb 23, 2026

Trial stability

The registry shows one protocol amendment since the trial's 2023 registration: the primary completion date moved from October 2025 to April 2026 in January 2024, alongside the trial's status change to Recruiting. There has been no subsequent change to that completion date, no enrollment target change, and the enrollment figure of 43 subjects has held since the trial's anticipated count was first set, a pattern the trial's own protocol-stability tracking labels Stable. That single early slip, and the absence of further churn since, is a different signal than a trial whose completion date keeps moving as it nears readout. NCT05927142Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy EfficacyNCT05927142

The competitive frame

No industry-sponsored trial combines a PD-L1 inhibitor with a TLR3 agonist in this exact post-FOLFIRINOX pancreatic cancer population, making DURIPANC the only trial in that specific niche. The nearest comparators sharing a PD-L1 lead target and pancreatic ductal adenocarcinoma indication use different modalities, including a personalized neoantigen vaccine paired with a checkpoint inhibitor now in Phase 2 testing in the same tumor type. Checkpoint inhibition alone has not established a validated disease-modifying benefit in pancreatic ductal adenocarcinoma, the broader field DURIPANC sits in; against that backdrop, a clinical benefit rate that exceeds what stable-disease patients would be expected to sustain on observation alone, sustained through the trial's six-month assessment window, is the result that would distinguish this combination.

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.