Enrollment Open for Phase 1b/2 Pancreatic Cancer Study Combining AIM's Ampligen with Imfinzi

AIM ImmunoTech Inc., a company listed on the NYSE American stock exchange under the ticker AIM, has recently announced the initiation of a Phase 1b/2 clinical trial at Erasmus Medical Center in the Netherlands. The trial, known as the DURIPANC Study, aims to evaluate the combination of AIM's drug Ampligen (rintatolimod) with AstraZeneca's Imfinzi (durvalumab), an anti-PD-L1 immune checkpoint inhibitor, for pancreatic cancer treatment. Ampligen has demonstrated potential synergistic effects with checkpoint inhibitors, which could lead to improved survival rates and treatment efficacy.
The collaboration between AIM, Erasmus MC, and AstraZeneca was established in January 2023 through a clinical research agreement. The DURIPANC Study is an open-label, single-center trial designed to assess the safety and clinical benefit of the combined therapy. The Phase 1b segment focuses on the safety profile of the treatment, while the Phase 2 segment is aimed at determining the clinical benefit rate.
Coordinating Investigator Prof. Casper H.J. van Eijck, a pancreato-biliary surgeon at Erasmus MC, expressed optimism about the potential of Ampligen to enhance the immune response in advanced pancreatic ductal adenocarcinoma (PDAC) and its possible synergy with ICI therapy. He anticipates that the combination therapy could significantly impact the current treatment landscape for metastatic pancreatic cancer patients.
AIM has been granted a U.S. patent for the use of Ampligen in combination with an anti-PD-L1 antibody, which supports the company's belief in the drug's potential as both a standalone and combined therapy. CEO Thomas K. Equels highlighted the strategic value of Ampligen in enhancing an already approved drug within a successful pharmaceutical market, suggesting that this could be an attractive proposition for partnerships or acquisitions.
The DURIPANC Study plans to enroll up to 18 participants in the Phase 1b segment and up to 25 patients in the Phase 2 segment. The treatment protocol involves administering Ampligen through IV infusion twice weekly for six weeks, followed by an escalation to a higher dose. After two doses of Ampligen, Imfinzi will be introduced, with patients receiving 1500 mg via IV infusion every four weeks for up to 48 weeks or until disease progression is confirmed.
AIM ImmunoTech Inc. is an immuno-pharma company dedicated to developing therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19. Their flagship product, Ampligen, is a dsRNA and a highly selective TLR3 agonist with a broad spectrum of activity in clinical trials.