AIM ImmunoTech Reports Positive Mid-Year Interim Clinical Progress from Phase 2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca's Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer
OCALA, Fla., June 08, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) ("AIM" or the "Company") today reported positive progress in a mid-year update from the ongoing Phase 2 clinical study evaluating AIM's drug Ampligen® (rintatolimod) combined with AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the "DURIPANC" study) (see: ClinicalTrials.gov NCT05927142).
See: DURIPANC, 2026 Mid-Year Interim Clinical Progress Update
AIM recently announced enrollment of the final patient in the clinical trial, barring any disqualifying pre-treatment circumstances. The Company remains on track for a planned December 2026 evaluation of the clinical trial's primary endpoint, Clinical Benefit Rate ("CBR"), defined as stable disease, partial response or complete response (progression-free disease) at 6 months (24 weeks) after start of combination therapy.
DURIPANC is a follow-up to a 57-subject Named Patient Program ("NPP") of Ampligen as a monotherapy in late-stage pancreatic cancer, where Ampligen was associated with median survival of 19.7 months, which is an extension of median overall survival of 8.6 months when compared to the standard of care. The EAP subjects also reported improved quality of life.
AIM Chief Executive Officer Thomas Equels stated: "There is a clear need for an approved treatment that is both more effective and less toxic than what is currently available to people suffering with pancreatic cancer. Despite advances in chemotherapy, survival for these patients is too often short and agonizing. The published NPP data and the DURIPANC interim results support our belief that Ampligen has the potential to meaningfully extend survival and provide late-stage pancreatic cancer patients with a higher quality of life. For example, in the NPP stratification of subjects with immune marker Neutrophil/Lymphocyte ratios less than 4.5, we saw overall median survival of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months – and with positive measures of quality of life. We are also diligently planning the next step in Ampligen's development, with an eye toward a pivotal Phase 3 clinical trial evaluating the experimental drug in combination with a PD-1 inhibitor in an effort to demonstrate its value across multiple endpoints, most importantly overall survival and progression-free survival. If a Phase 3 clinical trial was able to pair significant survival results with AIM's impressive safety and tolerability profile, then it could position AIM as a leader in pancreatic cancer research potentially translational to the patient as a standard of care."
The DURIPANC study is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands. The primary objective of the study is the clinical benefit rate of the combination therapy. 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.
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
