On April 16, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported 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.
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"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.
(Press release, AIM ImmunoTech, APR 16, 2026, View Source [SID1234664429])