AIM ImmunoTech Opens Enrollment for Pancreatic Cancer Combo Therapy Trial

AIM ImmunoTech Inc., a biopharmaceutical firm, has announced the initiation of a Phase 1b/2 clinical trial at Erasmus Medical Center, Rotterdam, Netherlands. The study will explore the combination of AIM's Ampligen® (rintatolimod) with AstraZeneca's Imfinzi® (durvalumab) in treating pancreatic cancer. Ampligen is known to enhance the immune response when paired with checkpoint inhibitors, which could potentially increase the survival rate and effectiveness of the treatment.

The clinical trial is a collaborative effort between AIM ImmunoTech, Erasmus MC, and AstraZeneca. It is an open-label, single-center study aimed at determining the safety and clinical benefit rate of the combined therapy. The Phase 1b will primarily assess the safety of the therapy, while Phase 2 will focus on its clinical efficacy.

Prof. Casper H.J. van Eijck, the study's coordinating investigator, highlighted the limited efficacy of immune checkpoint inhibitors in pancreatic ductal cancer and expressed optimism about the potential synergistic effect of Ampligen with durvalumab. He believes that the combination could significantly impact the current treatment landscape and improve patient outcomes.

AIM has recently been granted a U.S. patent for the use of Ampligen in combination with an anti-PD-L1 antibody. Thomas K. Equels, AIM's CEO, emphasized the potential of Ampligen both as a monotherapy and in combination with other treatments. He suggested that a combination therapy could be an attractive target for partnerships or acquisitions, as it would enhance an already approved drug in a well-established pharmaceutical market.

The trial is designed to enroll up to 18 subjects in Phase 1b and up to 25 patients in Phase 2. Participants will receive Ampligen via IV infusion, with the dosage escalating according to a 3+3 dose-limiting toxicity design. Durvalumab will be introduced after two doses of Ampligen, with patients receiving the drug every four weeks for up to 48 weeks.

AIM ImmunoTech specializes in the research and development of therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19. Their lead product, Ampligen, is a dsRNA and a highly selective TLR3 agonist with broad-spectrum activity in clinical trials.