AIM ImmunoTech has entered into an agreement with Thermo Fisher Scientific’s PPD clinical research business to plan the design of a Phase 3 trial evaluating Ampligen in late-stage pancreatic cancer. The collaboration will leverage PPD’s expertise in trial protocol development to map out key components including patient selection, dosing regimens and statistical analysis.

The ongoing Phase 2 DURIPANC study, an exploratory open-label trial of Ampligen with durvalumab, has enrolled up to 25 subjects and reported encouraging progression-free survival and overall survival improvements alongside a favorable safety profile. The study is conducted jointly with AstraZeneca and Erasmus Medical Center, with final patient enrollment expected later this year.

Phase 3 planning will focus on defining primary endpoints, such as overall survival, progression-free survival and safety metrics, and establishing multicenter sites to meet regulatory standards. Company leadership expects trial design completion by mid-year to support timely initiation of patient recruitment.

Advancing to Phase 3 marks a critical step toward potential regulatory approval for Ampligen in pancreatic cancer, a market with high unmet needs and limited existing therapies. Successful Phase 3 outcomes could significantly enhance AIM’s valuation and position the company as a leader in immuno-oncology for pancreatic cancer.