On September 22, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported to have issued a letter to stockholders from Chief Executive Officer Thomas Equels addressing the recent U.S. Food and Drug Administration (the "FDA") approval of daraxonrasib and outlining the Company’s view of Ampligen’s differentiated mechanism, clinical profile and potential role in the future treatment of pancreatic cancer.
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The full letter follows:
Dear Fellow Stockholders,
The FDA’s recent approval of daraxonrasib is meaningful progress for people with metastatic pancreatic cancer. In fact, it is significant enough that you may be asking – and I should answer – two questions:
Question 1: How is AIM’s drug Ampligen different from daraxonrasib?
Daraxonrasib is a selective, targeted therapy that inhibits RAS, a major driver of pancreatic cancer. A pivotal, randomized, well-controlled study demonstrated median overall survival of 13.2 months with daraxonrasib compared to 6.7 months with standard chemotherapy, for an improvement of 6.5 months (See Figure 1 below, NEJM). These results are an important part of the basis for the FDA’s approval of daraxonrasib, but they also indicate that many patients on both daraxonrasib and on standard therapy experience disease progression and mortality. Further, in laboratory studies, pancreatic tumors have been seen to develop resistance to RAS inhibition.
Ampligen has a different mechanism of action from daraxonrasib. We believe that Ampligen is the only clinically advanced investigational TLR3 agonist with a well-developed safety profile that is designed to activate innate immunity and help therapeutically reshape the tumor microenvironment to provide a natural mechanism to eliminate cancer cells. While daraxonrasib directly inhibits one driver mutation related to pancreatic cancer, Ampligen has the potential to induce a broad-spectrum therapeutic effect that amplifies a patient’s innate immune system, with data suggesting the potential for consequent stabilization of the pancreatic cancer tumor immune responses with improvement in a patient’s Quality of Life. We have seen evidence of this therapeutic potential not only in pancreatic cancer, but in a range of other solid tumors.
Question 2: What role will Ampligen serve in the future of pancreatic cancer care?
Daraxonrasib is an important therapeutic advance, but pancreatic cancer is not a simple disease where one successful targeted drug makes additional therapeutic development unnecessary. We believe Ampligen has the potential to complement and extend therapies such as daraxonrasib by helping to overcome the immune biological barriers that have historically limited treatment success in pancreatic cancer.
Further, we believe that Ampligen has significant potential in pancreatic cancer as a monotherapy. In an analysis of patients with a blood neutrophil-to-lymphocyte ratio below 4.5 who participated in a Dutch government-approved Named Patient Program, Ampligen as a monotherapy was linked to a median overall survival of 34.8 months compared with only 12.5 months in well-matched historical controls, representing an observed increase in median overall survival of 22.3 months over the historical controls.
The accompanying chart visually summarizes the respective overall-survival results cited in this letter, including the separate control and treatment comparisons for daraxonrasib and Ampligen based on the separate cited datasets.
In conclusion, daraxonrasib’s approval does not preclude a potentially important role for Ampligen. Daraxonrasib targets a single driver of pancreatic cancer, while Ampligen is designed to work by activating and enhancing the body’s innate immune system to target multiple types of solid tumors, including cancers of the pancreas. Based on all that we know to date, we believe that Ampligen continues to have an important potential role to serve in pancreatic cancer treatment.
AIM is also invested in Ampligen’s potential as a part of a combination therapy with checkpoint inhibitors in a broad range of other solid tumors, including pancreatic cancer. The ongoing Phase 2 DURIPANC clinical trial is evaluating Ampligen with AstraZeneca’s durvalumab (Imfinzi) in patients whose pancreatic cancer was stable post-FOLFIRINOX. This is an exploratory, open-label, single-center study with a small number of patients. Its primary endpoint is the proportion of patients who have stable disease or a tumor response 24 weeks after combination treatment begins. We anticipate topline results from the DURIPANC study in Q1 2027, followed by a detailed analysis of overall survival in Q3 2027. AIM believes that Ampligen’s observed immune activity will translate into a meaningful clinical signal and allow us to establish the parameters of a follow-up, pivotal Phase 3 clinical trial.
While there is still work to be done, including rigorous pivotal trials, our goal remains clear: to determine whether Ampligen can contribute to longer and better lives for patients with pancreatic cancer. We believe it can.
(Press release, AIM ImmunoTech, SEP 22, 2026, View Source [SID1234670992])