On November 10, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported a recent abstract containing data from the completed Phase 2 advanced recurrent ovarian cancer clinical study utilizing Ampligen (rintatolimod), which was presented at the 40th Annual SITC (Free SITC Whitepaper) Meeting on November 7, 2025, at National Harbor, MD.
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Platinum-sensitive patients with measurable peritoneal disease were eligible for combination therapy with up to six treatment cycles at 3-week intervals of intraperitoneal cisplatin, intravenous pembrolizumab (also known as Merck’s Keytruda) and intraperitoneal Ampligen. Of the 27 patients included in the trial, 24 were evaluable for response and of those 24 there were 5 patients with complete response and 7 patients with partial response, for an Objective Response Rate ("ORR") of 50%. In contrast, a previous study titled Keynote-100 found ORRs of 7.4% and 9.9% in two arms of a pembrolizumab-only study in advanced recurrent ovarian cancer.
Read the full abstract titled "A Phase II Trial of Combination Locoregional Chemoimmunotherapy in Recurrent Platinum-Sensitive Ovarian Cancer Triggers a T Lymphotactic Response Correlating with Clinical Outcomes."
Read more about the study at ClinicalTrials.gov: NCT03734692
These new ovarian cancer study results are consistent with AIM’s belief that Ampligen can act as a synergistic agent when combined with checkpoint inhibitors. This could be especially encouraging for refractory patients whose cancers do not respond to checkpoint inhibitors alone, such as in the Keynote-189 study in non-small cell lung cancer, which found that approximately 52% of study subjects did not respond in the pembrolizumab-combination group.
"Ampligen’s demonstrated ability to enhance the effectiveness of traditional cancer treatments could make it a difference maker that dramatically improves tumor immune responses and significantly prolongs the lives of people who have otherwise few effective options for prolonged remission and even possible cure," said Robert Edwards, MD, Milton Lawrence McCall Professor and Chair, Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Pittsburgh School of Medicine.
AIM’s "synergistic" patents include a U.S. patent (expires August 9, 2039) for methods involving use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody; a patent in Japan (expires December 20, 2039) for the use of Ampligen in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer; and a patent in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab).
For more information about the SITC (Free SITC Whitepaper) Annual Meeting, please visit sitcancer.org.
(Press release, AIM ImmunoTech, NOV 10, 2025, View Source [SID1234659701])