AIM reports preliminary data in Phase 1b/2 study of Ampligen, Imfinzi

AIM ImmunoTech (AIM) announced positive preliminary data from the Phase 1b/2 study evaluating the combination of AIM’s Ampligen and AstraZeneca’s (AZN) anti-PD-L1 immune checkpoint inhibitor Imfinzi in the treatment of late-stage pancreatic cancer. DURIPANC is an investigator-initiated, exploratory, open-label, single-center study. AIM previously announced that investigators at Erasmus Medical Center in the Netherlands had completed the safety evaluation of subjects enrolled in the first dose level of the dose escalation design, finding the combination therapy to be generally well-tolerated with no severe adverse events or dose-limiting toxicities. That first cohort has now reached the pre-determined 6-month stability assessment timepoint and AIM announces that two of the three subjects remain stable. The subjects will continue to be treated and receive formal assessment of progression every three months. The standard for calculating median progression-free survival requires that 50% or more of the subjects have seen disease progression. Because 67% of the patients in the cohort evaluated at 6 months have remained stable, AIM cannot yet report on PFS. Two of the three subjects in the higher-dose second cohort of subjects also have stable disease, although they have not yet reached the 6-month stability assessment timepoint. Investigators continue to treat and monitor these subjects.