AIM ImmunoTech Signs Agreement for Planning of a Proposed Phase 3 Clinical Trial of Ampligen in the Treatment of Late-Stage Pancreatic Cancer
Rhea-AI Summary
AIM ImmunoTech (NYSE American: AIM) signed an agreement with the PPD clinical research business of Thermo Fisher Scientific to design an anticipated Phase 3 trial of Ampligen for late-stage pancreatic cancer on March 2, 2026. AIM said its ongoing Phase 2 DURIPANC study with durvalumab is showing positive progress in PFS, OS and safety.
The Phase 2 study is investigator-initiated, open-label and expected to enroll up to 25 subjects in its Phase 2 portion; AIM plans to work with Thermo Fisher on Phase 3 design as enrollment completes later this year.
Positive
- Signed agreement with Thermo Fisher’s PPD to design a Phase 3 trial
- Reported positive progress in PFS, OS and safety in DURIPANC Phase 2
Negative
- DURIPANC Phase 2 is small (up to 25 subjects), limiting statistical power
- Phase 3 remains planning-stage; no Phase 3 protocol or enrollment timeline provided
Key Figures
Market Reality Check
Peers on Argus
AIM fell 8.32% while peers showed mixed moves: TNFA -9.72%, PMCB -1.41%, NCNA -0.46%, BCLI -0.07%, HCWB +0.37%. No clear sector-wide direction.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 23 | Phase 2 milestones | Positive | +2.9% | Outlined DURIPANC enrollment timelines and key efficacy readout milestones. |
| Feb 05 | Interim Phase 2 data | Positive | +16.6% | Reported promising interim PFS/OS and no significant toxicity in DURIPANC. |
| Nov 10 | Ovarian cancer data | Positive | -6.4% | Detailed 50% ORR from completed ovarian cancer trial with Ampligen combo. |
| Aug 04 | Pipeline and funding update | Positive | +6.4% | Highlighted positive DURIPANC data and $8M equity raise for development. |
| Jul 28 | Mid-year DURIPANC data | Positive | -14.3% | Shared mid‑year DURIPANC efficacy and safety metrics in pancreatic cancer. |
Clinical trial updates have produced mixed reactions, with both strong rallies and selloffs on ostensibly positive data.
Over the past year, AIM has repeatedly highlighted Ampligen’s oncology potential through Phase 2 DURIPANC updates and other clinical data. Prior releases reported promising PFS and OS signals, no significant toxicity, and supportive ovarian cancer ORR data, with several updates generating double‑digit moves (both up and down). Today’s Phase 3 planning agreement follows these earlier pancreatic cancer milestones, extending the program’s trajectory toward a potential registrational path while the share price remains far below the 52‑week high of $20.33.
Historical Comparison
In the past year AIM released 5 clinical‑trial updates averaging a 1.03% move. Today’s -8.32% reaction to Phase 3 planning is meaningfully more negative than prior same‑tag events.
Clinical updates have moved from early DURIPANC mid‑year data to multiple interim readouts and milestone timelines; this agreement to design a Phase 3 trial represents the next step toward a potential registrational program in pancreatic cancer.
Regulatory & Risk Context
AIM has an effective S-3/A shelf filed on 2025-06-27, authorizing up to $100 million of securities across multiple instruments. Recent prospectus supplements (424B5 debt, and rights offering supplements 424B4/424B3) indicate the shelf has been actively used, underscoring ongoing dilution capacity alongside this clinical progress.
Market Pulse Summary
This announcement extends AIM’s Ampligen program by engaging Thermo Fisher’s PPD unit to design a proposed Phase 3 trial in late‑stage pancreatic cancer, building on DURIPANC data showing encouraging PFS and OS with up to 25 planned Phase 2 subjects. Historically, clinical updates have produced volatile but mixed price reactions. Against an active $100 million shelf and recent rights offering, investors may watch future trial design details, enrollment progress, and any additional capital raises closely.
Key Terms
phase 3 clinical trial medical
progression-free survival medical
overall survival medical
investigator-initiated medical
open-label medical
metastatic pancreatic cancer medical
AI-generated analysis. Not financial advice.
OCALA, Fla., March 02, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced an agreement with the PPD™ clinical research business of Thermo Fisher Scientific to design AIM’s anticipated Phase 3 clinical trial in the use of the Company’s drug Ampligen in the treatment of late-stage pancreatic cancer.
AIM CEO Thomas K. Equels states: “The ongoing Phase 2 DURIPANC clinical trial of Ampligen and AstraZeneca’s durvalumab in the treatment of late-stage pancreatic cancer is producing promising results. Based on the success so far, as well as anticipated final patient enrollment later this year, we believe it is now time to start mapping out the next steps for AIM’s development of Ampligen as a therapy for pancreatic cancer. AIM’s scientific team will work closely with Thermo Fisher’s experts in the design of a Phase 3 study and we look forward to their expertise and guidance in this critical endeavor. Pancreatic cancer is a deadly unmet medical need – and AIM believes that Ampligen could be a gamechanger in the treatment of pancreatic cancer.”
AIM recently published 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.
AIM has thus far reported positive progress in Progression-Free Survival (“PFS”), Overall Survival (“OS”) and safety in the DURIPANC study, which 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.
See: DURIPANC, Year-End Interim Clinical Progress Update
About AIM ImmunoTech
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
What did AIM (AIM) announce on March 2, 2026 about Ampligen and Phase 3 planning?
What Phase 2 results did AIM report for Ampligen in pancreatic cancer in 2026?
How will the Thermo Fisher agreement affect AIM’s timeline for a Phase 3 Ampligen trial?
Does the DURIPANC trial involve partners for Ampligen development (AIM ticker AIM)?
How large is the Phase 2 DURIPANC study for Ampligen mentioned by AIM (AIM)?
