AIM ImmunoTech Reports Positive Preliminary Data in Phase 1b/2 Study of Ampligen and Imfinzi as a Combination Therapy for Late-Stage Pancreatic Cancer

Preliminary finding of stable disease in two out of three patients at 6 months in the first subject cohort

Combination of Ampligen and Imfinzi continues to be generally well-tolerated with no severe adverse events or dose-limiting toxicities

OCALA, Fla., Sept. 19, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM”) today announced positive preliminary data from the Phase 1b/2 study ("DURIPANC”) evaluating the combination of AIM’s Ampligen^® (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi^® (durvalumab) in the treatment of late-stage pancreatic cancer.

DURIPANC is an investigator-initiated, exploratory, open-label, single-center study. AIM previously announced that investigators at Erasmus Medical Center ("Erasmus MC”) in the Netherlands had completed the safety evaluation of subjects enrolled in the first dose level of the dose escalation design, finding the combination therapy to be generally well-tolerated with no severe adverse events or dose-limiting toxicities. That first cohort has now reached the pre-determined 6-month stability assessment timepoint and AIM is pleased to announce that two of the three subjects remain stable. The subjects will continue to be treated and receive formal assessment of progression every three months. The standard for calculating median progression-free survival ("PFS”) requires that 50% or more of the subjects have seen disease progression. Because 67% of the patients in the cohort evaluated at 6 months have remained stable, AIM cannot yet report on PFS.

Two of the three subjects in the higher-dose second cohort of subjects also have stable disease, although they have not yet reached the 6-month stability assessment timepoint. Investigators continue to treat and monitor these subjects.

Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC and Coordinating Investigator for the DURIPANC study, commented: "First of all, we have observed improvements in quality of life and we saw no toxicity at all — with ‘quality of life’ recognized as an indicator of stable disease. As a comparison, approximately 80% of patients at Erasmus with similar disease, but who did not receive the treatment, showed disease progression after only three months. While this new data is extremely preliminary, it is also highly encouraging. To have multiple patients with metastatic pancreatic cancer who still have stable disease after six or seven months of maintenance therapy is remarkable — as is having stable disease for 15 or more months after starting FOLFIRINOX. Based on the changes we have seen in immune infiltration into metastatic lesions, I am optimistic that there is a chance that these patients could still have partial or complete responses to this therapy.”

"Ampligen continues to demonstrate its synergistic potential as a combination therapy with checkpoint inhibitors and these data — following the positive data from the Dutch-government approved Early Access Program — underscore Ampligen’s potential for the treatment of late-stage pancreatic cancer, where there remains a significant and lethal unmet need,” commented AIM Chief Executive Officer Thomas K. Equels.

Read more at ClinicalTrials.gov NCT05927142 — "Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect”

Learn more about the clinical collaboration between AIM, AstraZeneca and Erasmus MC.

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 X, LinkedIn, and Facebook.

Cautionary Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA”). Words such as "may,” "will,” "expect,” "plan,” "anticipate,” "continue,” "believe,” "potential,” "upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Data, pre-clinical success and clinical success seen to date does not guarantee that Ampligen will be approved as a combination therapy for late-stage pancreatic cancer. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.