On August 6, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that the strong clinical successes in oncology of its drug Ampligen will be presented in four separate aspects at the upcoming 5th Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care in Warsaw, Poland (Press release, AIM ImmunoTech, AUG 6, 2025, View Source [SID1234654852]). This will include a presentation by AIM regarding its ongoing lead clinical program in late-stage pancreatic cancer; a presentation by Pawel Kalinski, MD, PhD, a world-renowned research oncologist and senior investigator for multiple oncology clinical studies involving Ampligen, outlining his clinical research with Ampligen in multiple other solid tumor types; a presentation of Kathleen Kokolus, PhD, a senior scientist in Dr. Kalinski’ laboratory, who will discuss cellular and molecular mechanisms of action of Ampligen; and finally a presentation and abstract on positive data strongly suggesting Ampligen’s potential as a therapy in the treatment of endometriosis.
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Dr. Kalinski observed, "This important global symposium is being held September 3-5, 2025. It will be attended by many of the top oncology researchers, government health officials and major pharma companies of Europe, in an effort to showcase and bring U.S.-developed, early-phase clinical trials to patients in Central and Eastern European Countries (CEEC) and to accelerate the development and clinical testing of such treatments to benefit patients in the United States and worldwide."
Oncology
An AIM representative will present data from AIM’s pancreatic cancer Early Access Program and advances in the Phase 2 pancreatic cancer clinical trial currently underway at Erasmus Medical Center in the Netherlands. Among the expected highlights will be recent data from the DURIPANC study, an ongoing Phase 2 clinical study evaluating the combination therapy of Ampligen and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor durvalumab in the treatment of late-stage metastatic pancreatic cancer patients. Following FOLFIRINOX, maintenance or second-line immunotherapies have historically shown limited survival benefit in comparison trials. Preliminary data from DURIPANC suggests that Ampligen may prove to change that equation for the better.
Last week, the Company released a DURIPANC Mid-Year Interim Clinical Progress Update showing that the therapy is, thus far, well-tolerated with positive preliminary survival data, especially given the historical difficulty of improving outcomes in this setting. Compared to historical data, the DURIPANC study mid-year report shows continuing promising early signs of both no significant toxicity and superior PFS and OS:
No significant toxicity, an encouraging safety profile for a post-chemo setting;
~21% of patients have PFS >6 months (3/14), with an additional 21% not yet progressed; and
OS >6 months in the majority (64%) of eligible patients-better than expected in this setting.
Patient-reported outcomes indicated a consistently high level of quality of life throughout the treatment period. This is particularly notable given that patients with advanced disease typically experience substantial symptom burden and functional decline. In the context of a Phase 1/2 study, where the primary objectives often include safety, tolerability and preliminary signals of efficacy, the preservation or improvement of quality of life serves as a critical complementary endpoint.
Dr. Kalinski’s presentation will highlight Ampligen’s overall oncological advances and successes in clinical trials for multiple other solid tumors, including late-stage recurrent ovarian, Stage-four triple-negative breast and late-stage metastatic colorectal cancer.
Dr. Kokolus will discuss cellular and molecular mechanisms of the Ampligen-based chemokine-modulatory regimen’s activity in enhancing the effectiveness of PD1 blockade in "cold" tumors
All of the late-stage cancers being challenged by Ampligen therapy whose results will be discussed are lethal malignancies and constitute serious and unmet global health care issues.
Endometriosis
The endometriosis abstract and presentation will be based on an analysis of data from AIM’s Phase 2 and Phase 3 clinical trials of Ampligen for the treatment of Chronic Fatigue Syndrome ("CFS"), which showed that a large percentage of female participants had significant comorbidity with endometriosis. Approximately 80% of subjects experienced improvement in symptoms in the analyzed data.
Endometriosis is a common chronic and debilitating inflammatory disease affecting approximately 10% (190 million) of women of reproductive age globally and is associated with a risk of ovarian cancer. The hallmark of endometriosis is the presence of endometrium-like tissue on the peritoneum and ovaries. Growth of ectopic tissue in endometriosis patients leads to chronic pelvic pain; painful menstrual cramps; long-term pain in the lower back and pelvis; pain during intercourse; and infertility. Available radical treatments – such as the removal of the fallopian tubes and ovaries – can be difficult to justify in this group of young, prime-of-life patients, which highlights the need for new treatments.
Read more on the link between CFS and endometriosis: "Endometriosis as a Comorbid Condition in Chronic Fatigue Syndrome (CFS): Secondary Analysis of Data From a CFS Case-Control Study"
Read more on the link between endometriosis and ovarian cancer: "Complement Pathway Is Frequently Altered in Endometriosis and Endometriosis-Associated Ovarian Cancer"
AIM believes that the data demonstrates a compelling rationale for further optimizing a treatment protocol of IV Ampligen in patients with endometriosis.