AIM ImmunoTech Reports Positive Year-End Interim Clinical Progress from Phase 2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer
Rhea-AI Summary
AIM (NYSE American: AIM) reported a year-end Phase 2 interim update (Feb 5, 2026) for Ampligen (rintatolimod) combined with AstraZeneca’s Imfinzi (durvalumab) in metastatic pancreatic cancer.
Key points: 18 patients enrolled of up to 25, continuation of promising PFS and OS signals from Phase 1, no significant toxicity reported, patent protection to 2039, and orphan drug designations in US and EU.
Positive
- EAP median survival reported at 19.7 months
- No significant toxicity reported in post‑chemo setting
- Patent protection for Ampligen combination extends to August 9, 2039
- Orphan drug designations awarded in US and EU
- Promising PFS and OS signals supporting Phase 2 continuation
Negative
- Phase 2 is single‑center and open‑label, limiting generalizability
- Only 18 enrolled of up to 25 subjects, small sample size
- Interim data are not yet fully published or peer‑reviewed
- Advancing to Phase 3 remains speculative and not guaranteed
Market Reaction
Following this news, AIM has declined 5.69%, reflecting a notable negative market reaction. Our momentum scanner has triggered 28 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $1.16. This price movement has removed approximately $238K from the company's valuation. Trading volume is exceptionally heavy at 19.7x the average, suggesting significant selling pressure.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.
Key Figures
Market Reality Check
Peers on Argus
AIM fell 8.26% while several biotech peers (e.g., TNFA -9.72%, PMCB -5.96%, BCLI -4.92%) also declined. However, momentum data flags only one peer mover and no broad, same-direction sector push, suggesting today’s move is more company-specific than a wholesale biotech rotation.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 10 | Ovarian cancer data | Positive | -6.4% | Completed Phase 2 ovarian cancer trial showed 50% ORR versus lower historical benchmarks. |
| Aug 04 | Pancreatic update & financing | Positive | +6.4% | Mid-year DURIPANC update plus $8.0M equity raise supporting about 12 months of funding. |
| Jul 28 | Mid-year DURIPANC data | Positive | -14.3% | Phase 2 DURIPANC positive safety and efficacy signals with no significant toxicity reported. |
| Feb 28 | Influenza vaccine study | Positive | +5.5% | Announcement of planned Ampligen + FluMist clinical study for influenza, including avian strains. |
| Feb 25 | DURIPANC Phase 2 start | Positive | -7.5% | First new subject dosed in DURIPANC Phase 2 pancreatic cancer combination trial at Erasmus MC. |
Clinical trial updates for Ampligen have generally been framed positively, but share reactions skew negative to mixed, with more divergences than alignments and an average move of -3.24% on similar news.
Over the past year, AIM has repeatedly highlighted Ampligen’s clinical potential. Key milestones include dosing the first new subject in Phase 2 DURIPANC on Feb 25, 2025, followed by positive pancreatic cancer Phase 2 updates in July–August 2025 and an ovarian cancer Phase 2 dataset with a 50% ORR on Nov 10, 2025. Despite generally upbeat messaging, stock reactions to these clinical-trial announcements have often been negative or volatile, providing important context for how the market processed today’s positive interim DURIPANC data.
Historical Comparison
In the last five clinical-trial announcements, AIM’s average move was -3.24%. Today’s -8.26% decline is more negative than that typical reaction to similar Ampligen data.
Historically, AIM has advanced Ampligen from early pancreatic cancer combination dosing in DURIPANC through mid-year Phase 2 updates and into additional oncology and vaccine settings, including ovarian cancer and intranasal influenza, building a multi-indication clinical narrative around the same core agent.
Regulatory & Risk Context
AIM has an effective Form S-3/A shelf filed on 2025-06-27 authorizing up to $100 million in various securities, with at least one 424B5 usage on 2025-07-30. This provides significant flexibility for future capital raises, which could be dilutive depending on security mix and pricing.
Market Pulse Summary
The stock is down -5.7% following this news. The decline reflects a familiar pattern where positive clinical trial news coincided with weak share performance; prior Ampligen trial updates averaged a -3.24% move, and today’s -8.26% drop is more severe. Despite favorable safety and quality-of-life comments and a 19.7-month median survival signal from earlier work, the market may focus on execution and funding risks. An effective $100 million shelf and recent capital-raising activity add potential dilution overhang to otherwise constructive clinical messaging.
Key Terms
mechanism of action medical
immune checkpoint inhibitor medical
progression-free survival medical
overall survival medical
clinical benefit rate medical
orphan drug designations regulatory
open-label medical
AI-generated analysis. Not financial advice.
Year-end report discusses combination therapy’s Mechanism of Action activating both innate and adaptive immune responses
OCALA, Fla., Feb. 05, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today reported positive data in a year-end 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). This is a follow-up Phase 2 to a 57-subject early access program (“EAP“) 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 CEO Thomas K. Equels states: “We know all too well that metastatic pancreatic cancer is a killer. Ampligen has the potential to be a gamechanger in the treatment of this highly lethal and unmet oncological need. Quality of life for pancreatic cancer patients is extremely painful and subject to co-morbidities due to the tumor-induced immune suppressive state. Additionally, other metastatic pancreatic cancer chemotherapies and immunotherapies typically have harsh side effects. However, Erasmus has informed us that the pancreatic cancer patients who received Ampligen have reported meaningful improvements in their quality of life. This data sharply focuses our aim on late-stage pancreatic cancers, which killed more than 100,000 people in the American and European Union markets and more than 450,000 people worldwide as recently as 2022. I do not believe there is any other therapeutic in this stage of the pipeline that is producing these types of survival results combined with improvement in quality of life.”
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 (“Erasmus MC”) 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.
Eighteen patients have been enrolled in the study. 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
Prof. Casper van Eijck, MD, PhD, of Erasmus MC, states: “Erasmus MC clinicians and researchers are seeing immune system changes that suggest a coordinated activation of innate and adaptive responses – or, to put it more simply, the combination of Ampligen and Durvalumab seems to be enhancing the body’s natural immune system. This perceived mechanism of action together with the clinical results supports continued investigation of this combination in post-FOLFIRINOX patients with pancreatic ductal adenocarcinoma.”
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.
AIM’s intellectual property portfolio includes a U.S. patent for Ampligen as an oncology treatment in combination with anti-PD-L1 therapies, similar to that seen in the DURIPANC clinical trial combining Ampligen and AstraZeneca’s durvalumab; this patent extends protection to August 9, 2039. AIM has also been awarded orphan drug designations in pancreatic cancer by both the United States and the European Union, granting years of market exclusivity to AIM for Ampligen post-commercial approval.
Equels adds: “This patent protection and the orphan drug designations’ market exclusivity have the potential to create great value for our stockholders in this large-market unmet medical need.”
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 do not guarantee that any Ampligen-involved clinical trial will be successful or that Ampligen will be approved as a therapy in 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.
Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com
FAQ
What did AIM announce on February 5, 2026 about Ampligen (AIM) in pancreatic cancer?
How many patients are enrolled in AIM’s DURIPANC Phase 2 study (AIM) as of Feb 5, 2026?
What survival results has AIM reported previously for Ampligen in pancreatic cancer (AIM)?
What safety findings did AIM report for Ampligen plus durvalumab (AIM) in the interim update?
What intellectual property and exclusivity protections does AIM have for Ampligen in pancreatic cancer (AIM)?
What are the next steps and timeline for AIM’s Ampligen pancreatic cancer program (AIM)?
