AIM ImmunoTech reaches last-dose milestone early in DURIPANC trial
AIM ImmunoTech has confirmed that the final patient in its DURIPANC Phase 2 trial received their last dose of Ampligen (rintatolimod) ahead of the scheduled timeline, a procedural milestone that brings the company closer to its first readout on a combination immunotherapy approach in metastatic pancreatic cancer.
The study pairs Ampligen, AIM's double-stranded RNA TLR3 agonist, with AstraZeneca's anti-PD-L1 checkpoint inhibitor Imfinzi (durvalumab). Primary endpoint analysis is expected to begin in December 2026, with topline results anticipated in the first quarter of 2027. The primary endpoint is Clinical Benefit Rate, defined as the proportion of patients achieving stable disease, partial response, or complete response at 24 weeks from the start of combination therapy.
Trial design and secondary endpoints
DURIPANC is an investigator-initiated, open-label, single-centre Phase 2 study run in collaboration with Erasmus Medical Centre in the Netherlands. Secondary endpoints include overall survival and progression-free survival, with overall survival analysis expected to begin in June 2027. The trial also incorporates an immune profiling component designed to identify biomarker subgroups that may respond most favourably, which AIM intends to use in designing a subsequent pivotal Phase 3 study.
Chief executive Thomas Equels noted that the ahead-of-schedule execution "affirms our commitment to analyse biomarker stratifications as we set about designing a pivotal Phase 3 clinical trial that will help move Ampligen toward eventual submission of a New Drug Application for the treatment of pancreatic cancer."
AIM has previously cited data from a Dutch Ministry of Health-approved Named Patient Programme covering more than 50 post-standard-of-care pancreatic cancer patients treated with Ampligen as a monotherapy. In the subgroup with a neutrophil-to-lymphocyte ratio below 4.5, the company reported a median overall survival of 34.8 months against 12.5 months for historical controls. AIM has been careful to note that the programme was not designed to assess efficacy and that the observations were exploratory; nonetheless, the biomarker stratification approach is central to DURIPANC's design rationale.
Market context and competitive landscape
Pancreatic cancer remains one of oncology's most intractable indications. Five-year survival rates for metastatic disease sit below five per cent, and the standard-of-care regimens FOLFIRINOX and gemcitabine-nab-paclitaxel have remained largely unchanged for over a decade. Immuno-oncology has yet to deliver the same advances seen in lung cancer or melanoma, in part because pancreatic tumours are characterised by an immunosuppressive microenvironment that blunts checkpoint inhibitor responses when used as monotherapy.
A number of companies are pursuing combination strategies to address this, pairing checkpoint inhibitors with TLR agonists, CD40 agonists, or tumour-targeting vaccines in an effort to prime the immune system before applying PD-1 or PD-L1 blockade. AIM's TLR3 approach is differentiated in its mechanism, but the field is competitive and the high attrition rate of immuno-oncology combinations in pancreatic cancer means that investors and clinicians will look closely at the Clinical Benefit Rate data before drawing firm conclusions. The immune profiling secondary endpoint may prove as commercially significant as the primary readout if it can reliably identify a responding subgroup, potentially supporting a biomarker-selected Phase 3 design with a higher probability of success.
AIM ImmunoTech is a small-cap company listed on NYSE American, and the DURIPANC readout in early 2027 represents a defining moment for the programme. A positive signal could support a partnership discussion with AstraZeneca, which already supplies durvalumab for the study, or attract broader interest from larger oncology-focused acquirers.