AIM ImmunoTech’s Oncology Drug Ampligen to Be Featured in Key Presentations and Abstract at the International 5th Annual Marie Skłodowska-Curie Symposium on Cancer Research and Care (MSCI MSCS-2025)

There will be presentations on the latest positive progress from AIM’s clinical program in pancreatic cancer, the positive therapeutic effects of AIM’s drug Ampligen on multiple cancer types, and Ampligen’s mechanism of action in oncology

Discussion will also feature an abstract and oral presentation on Ampligen’s positive impact on endometriosis, a known precursor to ovarian cancer

OCALA, Fla., Aug. 06, 2025 (GLOBE NEWSWIRE) -- (NYSE American: AIM) (“AIM” or the “Company”) today announced that the strong clinical successes in oncology of its drug Ampligen will be presented in four separate aspects at the upcoming  in Warsaw, Poland. 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.

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 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 , 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:

Read more on the link between endometriosis and ovarian cancer:

AIM believes that the data demonstrates a compelling rationale for further optimizing a treatment protocol of IV Ampligen in patients with endometriosis.

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.



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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 in pancreatic cancer or endometriosis. 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.