AIM ImmunoTech has announced encouraging data from the ongoing Phase II trial of its Ampligen (rintatolimod) drug plus AstraZeneca’s Imfinzi (durvalumab) for metastatic pancreatic cancer subjects with stable disease after Folfirinox treatment.
The exploratory, open-label, investigator-initiated, single-centre DURIPANC trial is a partnership of the companies with Erasmus Medical Center (Erasmus MC) in the Netherlands.
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It is anticipated to enrol up to 25 participants in the Phase II segment.
As of the mid-year report, 14 participants have been enrolled in the DURIPANC trial. The primary goal is to evaluate the clinical benefit rate of the combo while secondary objectives are evaluating progression-free survival (PFS), overall survival (OS), and commencing immune-monitoring utilising tissue biopsies and peripheral immune profiling.
The mid-year data have shown promising early signs, without significant toxicity reported, suggesting a favourable safety profile.
Approximately 21% of subjects are said to have experienced PFS greater than six months, with another 21% not yet progressed.
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By GlobalDataAdditionally, the majority (64%) of eligible subjects have seen OS for more than six months.
AIM noted that it has been focusing on Ampligen’s development for pancreatic cancer treatment since 2017.
More than 50 subjects have been treated with Ampligen as a monotherapy under a Compassionate Use/early access programme approved by the Dutch government, at Erasmus MC, with Professor van Eijck as the lead investigator.
AIM entered clinical agreements with AstraZeneca and Erasmus MC in January 2023 to further study the combination therapy.
AIM ImmunoTech CEO Thomas Equels said: “I am hopeful that pending immune-monitoring data analysis by professor van Eijck and the team at Erasmus Medical Center will identify additional mechanistic insights or predictive biomarkers in this potentially groundbreaking clinical trial, bringing hope for a future therapy for this highly lethal and clearly unmet medical need that kills more than 100,000 people in the American and European Union markets each year, and more than 500,000 worldwide.”
In 2023, AIM completed subject dosing in the Phase II trial of Ampligen for post-Covid fatigue treatment.
