AIM ImmunoTech Achieves Clinical Milestone as Final Subject Receives First Dose in Phase 2 DURIPANC Study in Metastatic Pancreatic Cancer
OCALA, Fla., June 18, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) ("AIM" or the "Company") today announced that the final subject has received their first dose in the Phase 2 DURIPANC clinical trial evaluating Ampligen® (rintatolimod) in combination with AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of metastatic pancreatic cancer.
With this final subject, Primary Endpoint analysis is anticipated to begin in December 2026 and topline results are anticipated in Q1 2027. DURIPANC's primary endpoint is Clinical Benefit Rate ("CBR"), defined as the proportion of patients achieving stable disease, partial response or complete response at 24 weeks following initiation of combination therapy.
Analysis of Secondary Endpoints is expected to begin in June 2027, or 49 weeks after this final subject received their first dose. DURIPANC's Secondary Endpoints include Overall Survival ("OS") – the gold standard in oncology trials – as well as progression-free survival and immune profiling analysis that could potentially help identify subsets of future pancreatic cancer patients likely to experience the best survival results, which could be critical to the design of a pivotal Phase 3 clinical trial.
AIM Chief Executive Officer Thomas K. Equels stated: "AIM hopes to utilize the exploratory biomarker data generated through DURIPANC to design a Phase 3 study involving Ampligen in the treatment of pancreatic cancer. We are particularly interested in evaluating whether specific biomarkers may help to identify ‘super-responder' patient subsets most likely to benefit from Ampligen-based therapy, thus supporting a more targeted and personalized treatment approach."
DURIPANC is a follow-up to the AIM/Erasmus Medical Center Named Patient Program utilizing Ampligen as a monotherapy in late-stage pancreatic cancer, where data suggested impressive improvements in survival, particularly when broken down by biomarker stratifications:
- Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, Progression-Free Survival ("PFS") of 17.7 months compared to 8.6 months for historical controls, for an improvement of 9.1 months in PFS
- Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, OS of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months in OS
- Based upon stratification for immune marker CA 19-9 less than 1000, PFS of 13.1 months compared to 8.6 months for historical controls, for an improvement of 4.5 months in PFS
- Based upon stratification for immune marker CA 19-9 less than 1000, OS of 24.1 months compared to 12.5 months for historical controls, for an improvement of 11.6 months in OS
These results were accompanied by consistent reports of improved quality of life.
About DURIPANC
DURIPANC is an investigator-initiated, exploratory, open-label, single-center Phase 2 study. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands. In addition to the Primary Endpoint of clinical benefit rate, the secondary/exploratory objectives include assessing overall survival (OS) and progression-free survival (PFS); exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life.
Read more about the DURIPANC study at ClinicalTrials.gov NCT05927142.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of its lead product, Ampligen® (rintatolimod), for the treatment of late-stage pancreatic cancer, a lethal and unmet global health problem. Ampligen is a dsRNA and highly selective TLR3 agonist immuno-modulator that has shown broad-spectrum activity in clinical trials.
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 Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor created by those sections. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. For all forward-looking statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "believes," "expects," "intends," "may," "will," "plans," "potential," "anticipates," "projects," or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, but the absence of these words does not mean that a statement is not forward-looking. Any forward-looking statements set forth in this press release speak only as of the date hereof. These forward-looking statements are based upon the Company's current expectations, estimates, assumptions, and beliefs concerning future events and conditions, which are subject to change. Such forward-looking statements may include statements relating to: the timing of evaluation of the DURIPANC study's primary endpoint; the Clinical Benefit Rate; the anticipated survival outcomes, quality-of-life measures, and the safety profile of subjects and the expected timing thereof; the Company's Phase 3 clinical trial planning efforts; the potential advancement of Ampligen toward pivotal-stage development; the timing of commencement, enrollment, completion, and results of clinical trials; IP expansion and regulatory progress; and timing for receiving government approvals, if at all. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof, except as required by applicable law. The Company is in various stages of seeking to determine whether Ampligen will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders, and disclosures in the Company's reports filed with the U.S. Securities and Exchange Commission (the "SEC"), on its website, and in its press releases set forth its current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of these conditions. Results obtained in preclinical studies do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data, and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, lack of adequate funding, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data. No assurance can be given that the findings in preliminary studies will prove true or that such studies will yield favorable results, or that future studies will not result in findings that are different from those reported in the studies referenced in the Company's reports filed with the SEC, on the Company's website, and in its press releases. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its potential foreign operations will not be adversely affected by these risks.
For a detailed discussion of risk factors that could cause actual results to differ materially from those described in the forward-looking statements, please review the "Risk Factors" section in the Company's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the SEC. The forward-looking statements in this press release should be read in conjunction with such filings. These filings are available at www.sec.gov and www.aimimmuno.com. The information found on the Company's website is not incorporated by reference into this press release and is included for reference purposes only.
Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com
