AIM ImmunoTech Announces Authorizations from Competent Authority and Ethics Board in the Netherlands to Begin a Phase 1b/2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s I

Ampligen has shown therapeutic synergies with checkpoint inhibitors, potentially increasing survival rates and efficacy

Patient enrollment expected to commence before the end of 2023

OCALA, Fla., June 27, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM” or the "Company”), an immuno-pharma company focused on the research and development of its TLR-3 agonist Ampligen (rintatolimod) as a novel and potentially powerful therapeutic in locally advanced pancreatic cancer ("LAPC”) and metastatic pancreatic cancer, today announced the required approvals from the Netherlands for Erasmus Medical Center ("Erasmus MC”) 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 Drugs 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.

"We continue to successfully advance the synergistic potential of Ampligen with checkpoint blockade therapeutics. The DURIPANC Study is an important step forward in our strategic development plan. This plan expands the reach of Ampligen with another type of checkpoint blockade therapy we believe to be ideally suited for the treatment of pancreatic cancer,” commented AIM Chief Executive Officer Thomas K. Equels.

Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC, added, "With this authorization now in hand, we are working to get the clinical study up and enrolling patients as quickly as possible. At Erasmus MC, we see the promise of combining Ampligen with durvalumab and believe this approach has the potential for synergistic anti-tumor activity.”

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.

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.

For more information, please visit aimimmuno.com and connect with the Company on Twitter, LinkedIn, and Facebook.

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