AIM ImmunoTech Enters Pivotal Value Inflection Phase with Planned Phase 3 Study of Ampligen® in Pancreatic Cancer, Backed by Positive Clinical Signals, Orphan Drug Status, and Global IP
Company to participate in Live Virtual Investor Closing Bell segment today, April 16th at 4:00 PM ET; Register for the event here
OCALA, Fla., April 16, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) ("AIM" or the "Company") today highlighted accelerating momentum in its pancreatic cancer program, underscored by Phase 3 trial planning underway, encouraging Phase 2 clinical signals, and a rapidly strengthening global regulatory and intellectual property ("IP") position.
"The initiation of Phase 3 planning marks a critical step forward in our mission to bring Ampligen to patients with pancreatic cancer," said Thomas K. Equels, Chief Executive Officer of AIM. "With a growing body of positive late-stage pancreatic ductal adenocarcinoma clinical data, more than 100 subjects treated, Orphan Drug Designations in the U.S. and EU, and a strong global IP portfolio, we believe Ampligen has the potential to be a game-changing therapy in one of the most lethal cancers and a significant driver of long-term stockholder value."
The Company recently announced a strategic agreement with the PPD™ clinical research business of Thermo Fisher Scientific to design its planned Phase 3 clinical trial of Ampligen® in late-stage pancreatic cancer. This collaboration brings world-class clinical development expertise to support trial design and positions AIM to efficiently advance Ampligen into late-stage development.
The planned Phase 3 program is supported by very positive published data from a Dutch government-approved Named Patient Program ("NPP") with Ampligen as a monotherapy in late-stage pancreatic ductal adenocarcinoma and reported encouraging data from the ongoing Phase 2 DURIPANC study, which is evaluating Ampligen in combination with AstraZeneca's durvalumab. That ongoing study is showing promising improvement in progression-free survival and overall survival, as well as a favorable safety profile. Conducted in collaboration with AstraZeneca and Erasmus Medical Center, the study is expected to complete enrollment later this year and represents a key clinical validation step for our upcoming pivotal trial. As mentioned above, similar positive data was observed in the NPP, where Ampligen as a monotherapy was administered to 82 total patients and which had a significant positive findings on both progression-free and overall survival compared to historical controls. We believe these extremely positive data help to de-risk the path forward.
Pancreatic cancer represents a large and rapidly growing global market opportunity, with incidence rising and limited innovation over several decades. It is projected to become the second leading cause of cancer-related deaths in the United States, underscoring both the urgency and the commercial potential for new therapeutic options.
Ampligen, a selective TLR3 agonist, is designed to activate innate immunity and improve tumor responsiveness, making it a strong candidate for use as both a monotherapy and in combination with checkpoint inhibitors in multiple solid tumor types, and specifically with positive Phase 1/2 safety and efficacy data in combination with AstraZeneca's durvalumab and Merck's pembrolizumab in pancreatic cancer.
The Company continues to expand its global IP portfolio. AIM recently obtained final approval of a Japanese patent covering Ampligen in combination with checkpoint inhibitors, which is set to expire in 2039. Existing patents in the United States and Europe also extend to 2039, with broad claims supporting combination use across multiple oncology indications. This IP estate positions Ampligen for long-term commercial protection across major markets.
AIM's IP portfolio includes orphan drug designations for pancreatic cancer in both the United States and Europe, and the Company announced in March 2026 that it would seek similar status in Japan. The United States, Europe and Japan are the three largest accessible pharma markets in the world – and pancreatic cancer is potentially one of the most lucrative global health markets, as it is a serious and unmet need that is expected to become an even greater health burden. These designations provide potential market exclusivity upon approval, regulatory incentives, reduced development costs, and opportunities for accelerated development pathways, reinforcing the Company's strategy and enhancing long-term value creation.
Looking ahead, AIM anticipates several near-term milestones that may serve as significant value drivers. These include the completion of Phase 2 DURIPANC enrollment and additional data updates; continued clinical data readouts; further IP expansion and regulatory progress; the potential for new developments from existing strategic collaborations; and the design, IND approval and commencement of a Phase 3 pivotal study in pancreatic cancer.
As previously announced, Thomas K. Equels, MS JD, Chief Executive Officer of AIM, will participate in a Virtual Investor Closing Bell Event today, April 16, 2026 at 4:00 PM ET. A live video webcast of the presentation will be available on the Events page of the Company's website (aimimmuno.com). A webcast replay will become available two hours following the live presentation and will be accessible for 90 days.
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.
Forward Looking Statements
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. For those 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," or similar expressions. 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 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 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, 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. 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 [email protected]
