AIM ImmunoTech announces first subject dosed in Netherlands for Ampligen study

AIM ImmunoTech (AIM) announced the first subject has been dosed at Erasmus Medical Center in a Phase 1b/2 clinical trial combining AIM’s Ampligen with AstraZeneca’s (AZN) anti-PD-L1 immune checkpoint inhibitor Imfinzi for the treatment of late-stage pancreatic cancer. The DURIPANC Study is an investigator-initiated, exploratory, open-label, single-center study with the full name “Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy efficacy.” The primary objective of the Phase 1b portion is to determine the safety of combination therapy with Imfinzi and Ampligen. The primary objective of the Phase 2 portion is to determine the clinical benefit rate of the combination therapy. The study is expected to enroll up to 18 subjects in its Phase 1b portion and up to 25 subjects in its Phase 2 portion. Subjects will start with Ampligen 200 mg via IV infusion twice per week for a total of 6 weeks. Ampligen dose will be escalated to 400 mg according to a 3+3 DLT design. The first dose of Ampligen will be administered preferably 4-6 weeks after the last chemotherapy FOLFIRINOX dose. After two doses of Ampligen, the first dose of durvalumab 1500 mg via IV infusion will be introduced in week 2. Patients will continue to receive 1500 mg durvalumab via IV infusion every 4 weeks for up to a maximum of 48 weeks with the last administration on week 48 or until confirmed disease progression according to Response Evaluation Criteria in solid Tumors, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.