AIM ImmunoTech Inc. announced the required approvals from the Netherlands for Erasmus Medical Center to begin a Phase 1b/2 study under the previously announced external sponsored collaborative clinical research agreement with AstraZeneca and Erasmus MC. The authorizations are from the Central Committee on Research Involving Human Subjects, which is the Competent Authority for the review of clinical trials in the Netherlands, and the Medical Ethics Review Committee Erasmus MC, which is the governing ethics board. The investigator-initiated clinical study, entitled "Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect" (the "DURIPANC Study"), is an exploratory, open-label, single center, Phase 1b/2 study which will use Study Drug provided by AstraZeneca and AIM ImmunoTech.

The primary objective of the Phase 1b portion of the study is to determine the safety of combination therapy with durvalumab and Ampligen. The primary objective of the phase 2 portion of the trial is to determine the clinical benefit rate of combination therapy with durvalUMab and Ampligen. The DURIPANC Study is expected to enroll between 9 and 18 subjects in the Phase 1b portion and between 13 and 25 patients in the Phase 2 portion of the study.

All included patients will receive combination therapy with Ampligen and durvalumab. Patients will start with Ampligen 200mg via IV infusion twice per week for a total of 6 weeks (12 doses). Ampligen dose will be escalated to 400mg 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 1500mg 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 (up to 12 doses/cycles) with the last administration on week 48 or until confirmed disease progression according to Response Evaluation Criteria in solid Tumors (RECIST 1.1), unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.