AIM ImmunoTech Announces Planned Milestones in the Ongoing Phase 2 Trial of Ampligen and AstraZeneca’s Durvalumab in the Treatment of Metastatic Pancreatic Cancer
Rhea-AI Summary
AIM ImmunoTech (NYSE American: AIM) announced planned milestones and timelines for the Phase 2 DURIPANC study testing Ampligen (rintatolimod) with AstraZeneca’s durvalumab (Imfinzi) in metastatic pancreatic cancer.
Key items: 18 subjects enrolled to date; enrollment completion planned July 2026; full Ampligen dosing by August 2026; primary endpoint readout (6-month clinical benefit rate) in December 2026; secondary endpoint evaluations by June 2027. AIM published an updated corporate presentation prioritizing Ampligen approval in pancreatic cancer.
Positive
- 18 subjects enrolled in DURIPANC to date
- Enrollment completion targeted by July 2026
- Full Ampligen dosing scheduled for August 2026
- No significant toxicity reported; encouraging safety profile in post‑chemo setting
Negative
- Single-center investigator-initiated study limits generalizability
- Only 18 subjects enrolled so far — small sample size
- Primary endpoint readout not until December 2026, secondary endpoints by June 2027
Key Figures
Market Reality Check
Peers on Argus
Scanner shows mixed biotech momentum: HCWB and ALZN moving up, while CYCN and IBO trade down. Sector note: “2 peer stocks on Argus also moving … (median -5.3%),” indicating broader biotech volatility around AIM’s move.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 05 | Phase 2 interim update | Positive | +16.6% | Year-end DURIPANC interim data with promising PFS/OS and no significant toxicity. |
| Nov 10 | Ovarian cancer data | Positive | -6.4% | Completed Phase 2 ovarian cancer trial showing 50% ORR vs much lower historical ORR. |
| Aug 04 | Clinical update & funding | Positive | +6.4% | Positive DURIPANC mid-year data plus $8.0M equity raise and IP/designation wins. |
| Jul 28 | Mid-year DURIPANC data | Positive | -14.3% | Mid-year Phase 2 DURIPANC results with PFS/OS signals and no significant toxicity. |
| Feb 28 | Flu vaccine study plan | Positive | +5.5% | Planned Ampligen + FluMist influenza study following prior strong adjuvant data. |
Clinical-trial headlines have produced mixed reactions: several positive pancreatic cancer updates led to double-digit gains, while others with favorable data still saw double-digit declines.
Over the last year, AIM has repeatedly highlighted Ampligen’s oncology potential through Phase 2 DURIPANC updates and other clinical data. Prior pancreatic cancer readouts on Feb 5, 2026 and mid-2025 stressed promising PFS/OS signals and limited toxicity, sometimes triggering sharp moves both up and down. The current milestone-focused Phase 2 update fits this pattern of ongoing development rather than new efficacy data, extending the DURIPANC narrative rather than changing it.
Historical Comparison
Clinical-trial headlines for AIM have averaged a 1.57% move. Today’s roughly -6.25% reaction to DURIPANC timeline milestones is weaker than past trial-related responses.
Clinical news has tracked Ampligen’s evolution from early oncology combinations into ongoing Phase 2 DURIPANC updates with interim efficacy and safety signals, while also expanding into vaccine-adjuvant studies.
Regulatory & Risk Context
An effective S-3/A shelf from Jun 27, 2025 authorizes up to $100 million in various securities, providing flexible capital-raising capacity that has already been tapped via multiple prospectus supplements.
Market Pulse Summary
This announcement sets clear milestones for the ongoing Phase 2 DURIPANC trial, including enrollment completion by July 2026 and primary endpoint evaluation at 6 months. Prior updates have emphasized promising PFS/OS signals and limited toxicity, but financing needs and dilution from offerings remain key risks in parallel SEC filings. Investors may watch subsequent interim data, safety updates, and funding steps as Ampligen advances toward potential late-stage studies.
Key Terms
phase 2 medical
immune checkpoint inhibitor medical
progression-free survival medical
overall survival medical
eortc qlq-c30 medical
open-label medical
AI-generated analysis. Not financial advice.
OCALA, Fla., Feb. 23, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced milestones in the expected timeline for 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).
DURIPANC is an investigator-initiated, exploratory, open-label, single-center study, and 18 subjects have enrolled in the study so far. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center (“Erasmus MC”) in the Netherlands.
Planned DURIPANC milestones:
- July 2026 – Complete subject enrollment.
- August 2026 – Complete full Ampligen dosing for all subjects.
- December 2026 – Evaluation of the Primary Endpoint of Clinical Benefit Rate, defined as stable disease, partial response or complete response (progression-free disease) at 6 months (24 weeks) after start of combination therapy.
- June 2027 – Evaluation of the Secondary Endpoints once last subject reaches week 49
- Progression-Free Survival, defined as the time between the start of combination therapy with Ampligen and durvalumab to date of progression or death, whichever occurs first.
- Overall Survival, defined as the time between the start of combination therapy with Ampligen and durvalumab to date of death,
- Immunogenic efficacy, defined as >
50% increase in circulating Ki67+ CD 8+ T cell in peripheral blood evaluated 12 weeks after start of combination therapy. - Infiltrating immune profile, defined as the change in infiltrating immune profile after start of combination therapy.
- Reporting of Quality of life (EORTC QLQ-C30) based upon evaluations at baseline, 6 weeks, 3 months, 9 months and 1 year after the start of immunotherapy.
AIM is committed to releasing mid-year and year-end interim progress reports on DURIPANC, with the most recent update released at the beginning of February. Lead investigator Marjolein Y. V. Homs, MD, PhD, Department of Medical Oncology, Erasmus MC Cancer Institute, emphasized that the promising Progression-Free Survival and Overall Survival seen in Phase 1 of the study – which supported advancement to the ongoing Phase 2 portion of the study – continue to be seen and that enrollment is ongoing. Erasmus MC expects that detailed data will be published later this year.
According to Erasmus MC, there has also been no significant toxicity – an encouraging safety profile for a post-chemo setting – and Ampligen subjects are consistently reporting “high quality of life” during treatment.
See: DURIPANC, Year-End Interim Clinical Progress Update
Additionally, AIM has published on its website an updated corporate presentation that emphasizes the Company’s priority goal of a new drug approval for Ampligen in the treatment of pancreatic cancer. The presentation details AIM’s research and development work in pancreatic cancer; how Ampligen is believed to work in the treatment of pancreatic cancer; and why AIM believes that pancreatic cancer research and development holds the most potential for AIM’s stockholders. The largest mergers and acquisitions deals in the biotech space often involve oncology drugs in Phase 3 clinical trials or later in development, and so AIM believes that moving Ampligen toward – and ultimately into – a Phase 3 clinical trial has great financial potential for the Company and its stockholders.
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.
Forward-Looking Statements
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in the press release speak only as of the date of the press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. 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 these conditions. Results obtained in animal models 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, 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 or require additional funding. Among the studies are clinical trials that provide only preliminary data with a small number of subjects, and no assurance can be given that the findings in these studies will prove true or that the study or studies will yield favorable results. No assurance can be given 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.
Please review the “Risk Factors” section in the Company’s latest annual report on Form 10-K and subsequent quarterly reports on Form 10-Q and the Registration Statement. Its filings are available at www.aimimmuno.com. The information found on the Company’s website is not incorporated by reference herein and is included for reference purposes only.
Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com
FAQ
How many patients are enrolled in the AIM (AIM) DURIPANC Phase 2 trial as of Feb 23, 2026?
When will AIM (AIM) report the primary endpoint results for the Ampligen plus durvalumab study?
What safety findings has AIM (AIM) reported for Ampligen with durvalumab in pancreatic cancer?
What secondary endpoints will AIM (AIM) evaluate in the DURIPANC Phase 2 trial and when?
What are AIM’s strategic goals for Ampligen following DURIPANC updates on Feb 23, 2026?
