AIM ImmunoTech Approaches Major Clinical Inflection Point with Phase 2 Pancreatic Cancer Data Expected Q1 2027; Reports Third Quarter 2026 Financial Results

C.H.J. van Eijck, Professor Dr. at Erasmus Medical Center and AIM’s Consulting Oncologist

“KRAS and RAS inhibition may leave important immune barriers intact. T-cells entering the tumor can become exhausted or be suppressed by other immune cells. Combining daraxonrasib or MRTX1133 with CTLA-4 checkpoint blockade improved tumor control in pancreatic cancer models. This demonstrates that an immune treatment can improve targeted therapy in experimental settings and provides a rationale for investigating other complementary immune approaches. The proposed combination has a specific rationale: KRAS or RAS inhibition could reduce tumor burden and make surviving cancer cells more vulnerable, while Ampligen could help activate the immune response needed to control those cells. This may be particularly relevant when RAS targeted treatment recruits immune cells but does not sufficiently activate them against the cancer. Ampligen, a Toll-like receptor 3 agonist, is an ideal candidate for such investigation because it can stimulate dendritic-cell and T-cell responses. In a study of patients with advanced pancreatic cancer, Ampligen treatment was associated with changes consistent with activation of these immune cells. Higher post-treatment levels of selected dendritic-cell and CD4⁺ T-cell populations correlated with better clinical outcomes. These observations support biological activity in patients, although only a focused future clinical trial can establish that Ampligen, in combination or as a maintenance therapy, will cause better outcomes.”

Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech

“I believe that Revolution Medicines’ daraxonrasib will be the first-line therapy for metastatic pancreatic cancer in the near future, and I believe Ampligen's immune-modulating mechanism offers a compelling scientific rationale for further investigation in this setting. Importantly, as the pancreatic cancer treatment landscape evolves with the emergence of RAS-targeted therapies, we also see opportunities to explore how Ampligen could potentially complement these advances. We believe the upcoming Phase 2 DURIPANC clinical trial results will be an important step in determining how best to advance this strategy toward pivotal development. We intend to design our Phase 3 to be relevant as a maintenance therapy based upon the first-line therapies we expect in the near future – not just FOLFIRINOX.”

Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech

“We are entering one of the most consequential periods in AIM's pancreatic cancer development program. DURIPANC’s Ampligen dosing is complete and analysis of the clinical benefit endpoint is imminent, in Q1 2027. In mid-year 2027 we will be able to calculate median overall survival, which is viewed as the ‘gold standard’ for approval by the FDA. Our focus has been on disciplined execution and advancing Ampligen toward the clinical evidence needed to support its next stage of development. The upcoming readout represents an important milestone in AIM's pancreatic cancer development strategy, providing an opportunity to evaluate whether Ampligen-based immunotherapy can help sustain disease control in a patient population facing limited treatment options.”