Company highlights supportive survival observations, potential for biomarker-driven patient selection and upcoming Phase 2 DURIPANC milestones
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OCALA, Fla., Sept. 30, 2026 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the release of a new installment of its CEO Corner series featuring Chief Executive Officer Thomas K. Equels discussing how Ampligen® (rintatolimod) could fit into the evolving treatment landscape for pancreatic cancer.
In the CEO Corner, Equels discusses recent advances in pancreatic cancer treatment and why AIM believes Ampligen’s distinct immune-modulating approach warrants continued investigation. Rather than directly targeting a cancer-driving pathway, Ampligen has the potential to induce a broad-spectrum therapeutic effect that amplifies a patient’s innate immune response, creating the potential for a complementary role alongside or following therapies that act through different mechanisms.
The segment also highlights observations from a Dutch Named Patient Program (“NPP”) in which patients with radiologically stable pancreatic cancer after FOLFIRINOX received Ampligen as a maintenance treatment. In an exploratory analysis of 39 patients with a neutrophil-to-lymphocyte ratio (“NLR”) below 4.5, median overall survival was 34.8 months, measured from the start of FOLFIRINOX. This encouraging observation supports further investigation of Ampligen following chemotherapy.
Advances with FOLFIRINOX and daraxonrasib highlight the evolving treatment landscape in pancreatic cancer. The following chart summarizes the median overall survival results from the selected patients from NPP program as well as data from the separate clinical trials of FOLFIRINOX in metastatic pancreatic cancer and a daraxonrasib clinical trial of RAS G12 mutation patients with previously treated metastatic pancreatic cancer.
However, differences in patient selection, disease stage, treatment setting, and the timing of survival measurement prevent direct comparisons between the NPP findings and survival results from trials of these therapies. These findings provide a rationale for randomized studies to determine whether adding Ampligen after chemotherapy improves outcomes. Further research is also needed to establish whether NLR can identify patients more likely to benefit specifically from Ampligen, rather than patients with a generally more favorable prognosis.
“Pancreatic cancer continues to present an urgent need for better treatment strategies, even as important new therapies emerge,” said Equels. “Ampligen approaches the disease differently through its potential to activate the innate immune response. We believe the powerful overall survival signal seen in the Named Patient Program, together with the clinical and biomarker data being generated through DURIPANC, will provide a compelling rationale to continue evaluating Ampligen’s potential role in pancreatic cancer. Ultimately, our goal is to get drug approval, which will be based on overall survival, in all probability focused on patients with neutrophil-to-lymphocyte ratios below 4.5.”
AIM is continuing to investigate Ampligen through the ongoing Phase 2 DURIPANC study evaluating Ampligen in combination with AstraZeneca’s durvalumab in metastatic pancreatic cancer. The study’s primary endpoint is Clinical Benefit Rate at 24 weeks following initiation of combination therapy, with topline results anticipated in the first quarter of 2027. The study is also evaluating progression-free survival, overall survival and immune profiling, with overall survival analysis expected to begin in 2027.
AIM anticipates topline results from DURIPANC in the first quarter of 2027, followed by its analysis of overall survival – the gold standard for drug approval – commencing in Q3 2027. If supported by the clinical and biomarker data, the Company believes the study could help define the parameters of a potential follow-up pivotal Phase 3 program and provide positive clarity around where Ampligen fits within an evolving pancreatic cancer treatment landscape.
The latest CEO Corner segment is now available on the Company’s website here.
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, that involve a number of risks and uncertainties. Any forward-looking statements set forth in this press release speak only as of the date hereof. Such forward-looking statements may include statements relating to: Ampligen’s potential efficacy and applicability in the treatment of pancreatic cancer; the timing of commencement, enrollment, completion, and results of clinical trials; intellectual property expansion and regulatory progress; and timing for receiving government approvals, if at all. 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. All statements in this press release other than statements of historical fact, including statements regarding the potential of Ampligen’s mechanism of action, anticipated regulatory milestones, our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. Words such as “believe,” “may,” “might,” “will,” “could,” “should,” “can,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “envision,” “potential” and similar expressions are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. 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 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 pancreatic cancer. 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 these and other risk factors, 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 filed with the SEC. These filings are available at www.sec.gov and www.aimimmuno.com. You should not place undue reliance on any forward-looking statements. The information found on the Company’s website or on other websites referenced or linked to in this press release is not incorporated by reference into this press release and such information is referenced or linked for reference purposes only.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/32219329-21da-4057-bdc6-8fb8989db060
CONTACT: Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 [email protected]
