OCALA, Fla., Nov. 10, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today detailed 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 Meeting on November 7, 2025, at National Harbor, MD.
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 Annual Meeting, please visit sitcancer.org.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.
For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.
Cautionary Statement:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a therapy for any indication. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com
