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
Rhea-AI Summary
AIM (NYSE American:AIM) reported positive mid-year interim progress from the Phase 2 DURIPANC study evaluating Ampligen (rintatolimod) plus AstraZeneca’s Imfinzi (durvalumab) in metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX.
The final patient has been enrolled, and AIM remains on track for a planned December 2026 evaluation of the primary endpoint, Clinical Benefit Rate (CBR) at 6 months. DURIPANC follows a 57-subject Named Patient Program where Ampligen monotherapy was associated with median survival of 19.7 months versus 8.6 months for standard of care, with reported quality-of-life improvements.
In NPP subjects with Neutrophil/Lymphocyte ratios <4.5, overall median survival was 34.8 months versus 12.5 months for historical controls. AIM is planning a potential pivotal Phase 3 trial of Ampligen with a PD-1 inhibitor focused on overall and progression-free survival.
AI-generated analysis. Not financial advice.
Positive
- Final patient enrolled in DURIPANC Phase 2 study; primary endpoint readout targeted December 2026
- Named Patient Program: Ampligen median survival 19.7 months vs 8.6 months standard of care
- NPP subgroup (N/L <4.5): median survival 34.8 months vs 12.5 months historical controls
- Reported improvements in quality of life in prior Ampligen Named Patient Program
- Planned pivotal Phase 3 trial of Ampligen with a PD-1 inhibitor under consideration
- Collaboration with AstraZeneca and Erasmus Medical Center on DURIPANC study
Negative
- None.
Market Reaction – AIM
Following this news, AIM has declined 10.68%, reflecting a significant negative market reaction. Argus tracked a trough of -1.3% from its starting point during tracking. Our momentum scanner has triggered 41 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $0.46. This price movement has removed approximately $1M from the company's valuation.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.
Key Figures
Market Reality Check
Peers on Argus
AIM fell 12.77% with 2 momentum-screen peers also down (median about -5.5%), indicating sector-wide biotech pressure alongside company news.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jun 01 | Clinical trial milestone | Positive | +120.3% | Phase 2 DURIPANC enrollment completed ahead of schedule with clear milestone timelines. |
| May 07 | Clinical data update | Positive | +16.4% | UPMC Phase 2 ovarian cancer trial reported 50% ORR and 79% clinical benefit rate. |
| Mar 02 | Phase 3 planning | Positive | -14.9% | Agreement to design proposed Phase 3 pancreatic cancer trial with positive Phase 2 signals noted. |
| Feb 23 | Clinical milestones plan | Positive | +2.9% | Outlined DURIPANC enrollment, dosing, and December 2026 primary endpoint timelines. |
| Feb 05 | Interim trial update | Positive | +16.6% | Year-end interim DURIPANC update citing promising signals and no significant toxicity. |
Clinical trial announcements have usually been followed by positive price reactions, with one notable negative divergence.
Over recent months, AIM has repeatedly highlighted Ampligen’s pancreatic and ovarian cancer programs. Clinical trial updates on Feb 5, Feb 23, and May 7, 2026 each cited positive efficacy and safety signals and were followed by share gains. The June 1, 2026 DURIPANC enrollment completion drove a 120.35% move, underscoring market sensitivity to pancreatic cancer milestones. Today’s mid-year DURIPANC progress update fits this clinical narrative but occurs after multiple financings and prior trial communications already in the market.
Historical Comparison
In the past 6 months, AIM’s 5 clinical-trial updates averaged a 28.27% move, often positive. Today’s -12.77% drop marks an atypical downside divergence versus that pattern.
Clinical news has progressed from early DURIPANC milestones and interim signals toward Phase 3 planning in pancreatic cancer and strong Phase 2 data in ovarian cancer, framing Ampligen as a multi-indication oncology asset.
Regulatory & Risk Context
AIM has an effective S-3/A shelf from Jun 27, 2025 authorizing up to $100 million of securities, already tapped via at least 3 prospectus supplements. This structure provides flexible access to capital but also ongoing dilution capacity for existing shareholders.
Market Pulse Summary
This announcement reinforces AIM’s focus on Ampligen in metastatic pancreatic cancer, reporting interim Phase 2 DURIPANC progress and survival advantages seen in prior Named Patient Program data, including median survival of 19.7 and 34.8 months in key subgroups. Historically, clinical-trial updates have moved the stock meaningfully, both up and down. Investors may watch the planned December 2026 primary endpoint readout, future Phase 3 planning steps, and any use of the $100 million shelf for additional funding.
Key Terms
folfirinox medical
immune checkpoint inhibitor medical
clinical benefit rate medical
neutrophil/lymphocyte ratios medical
overall survival (os) medical
progression-free survival (pfs) medical
open-label technical
single-center technical
AI-generated analysis. Not financial advice.
Company remains on track for a planned December 2026 evaluation of the clinical trial’s primary endpoint
OCALA, Fla., June 08, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: 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