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)

Rhea-AI Summary

AIM ImmunoTech (NYSE American: AIM) announced that its drug Ampligen will be featured in four presentations at the 5th Annual Marie Skłodowska-Curie Symposium in Warsaw, Poland from September 3-5, 2025. The presentations will highlight positive clinical data across multiple areas:

The DURIPANC Phase 2 study shows promising results for pancreatic cancer treatment, with 21% of patients achieving PFS >6 months and 64% reaching OS >6 months. Additional presentations will cover Ampligen's effectiveness in other solid tumors, including ovarian, triple-negative breast, and colorectal cancers.

Notably, analysis of previous clinical trials revealed Ampligen's potential in treating endometriosis, showing approximately 80% symptom improvement in female participants, opening new therapeutic possibilities for this condition affecting 190 million women globally.

Positive

• DURIPANC study shows 21% of patients achieving PFS >6 months with additional 21% not yet progressed
• 64% of eligible patients achieved OS >6 months in pancreatic cancer trials
• No significant toxicity reported in pancreatic cancer treatment
• 80% of subjects showed symptom improvement in endometriosis analysis
• High quality of life maintained throughout treatment period

Negative

• None.

Insights

Oncology Clinical Trials Expert

AIM's Ampligen shows promising early survival data in pancreatic cancer trial with tolerable safety profile; detailed results to be presented at international symposium.

The upcoming presentations at the Marie Skłodowska-Curie Symposium represent a significant platform for AIM ImmunoTech to showcase their Ampligen drug's clinical progress across multiple oncology indications. The most substantive data comes from the DURIPANC study, a Phase 2 trial evaluating Ampligen combined with durvalumab in late-stage metastatic pancreatic cancer patients after FOLFIRINOX chemotherapy.

The preliminary data reveals three critical metrics worth analyzing: 21% of patients achieved progression-free survival exceeding 6 months, with another 21% not yet progressed. More impressively, 64% of eligible patients demonstrated overall survival beyond 6 months – notably better than historical expectations for this difficult-to-treat population. These signals are particularly meaningful given pancreatic cancer's notoriously poor response to immunotherapies and limited second-line treatment options.

The absence of significant toxicity is equally important in the post-chemotherapy setting, where patients are often debilitated. The reported maintenance of quality-of-life metrics throughout treatment further distinguishes this approach from typical late-stage interventions that frequently diminish patient wellbeing.

Beyond pancreatic cancer, the symposium will highlight Ampligen's application in other difficult-to-treat malignancies including ovarian, triple-negative breast, and colorectal cancers. The mechanistic presentation on enhancing PD-1 checkpoint inhibition in "cold" tumors (those with limited immune infiltration) suggests broader applications beyond current studies.

The unexpected finding regarding endometriosis – with 80% symptom improvement in chronic fatigue syndrome patients with comorbid endometriosis – opens potential new therapeutic avenues, particularly given endometriosis' link to ovarian cancer risk.

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) -- AIM ImmunoTech Inc. (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 5^th Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care 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 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.

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 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.

Investor Contact:

JTC Team, LLC
Jenene Thomas
908.824.0775
AIM@jtcir.com

FAQ

What are the key findings from AIM ImmunoTech's DURIPANC study for pancreatic cancer?

The DURIPANC study showed that 21% of patients achieved PFS >6 months, with an additional 21% not yet progressed. Additionally, 64% of eligible patients reached OS >6 months with no significant toxicity reported.

How effective is Ampligen in treating endometriosis according to AIM's clinical trials?

Analysis of AIM's Phase 2 and 3 trials showed that approximately 80% of female subjects experienced improvement in endometriosis symptoms, suggesting potential therapeutic benefits.

When and where will AIM ImmunoTech present its Ampligen research in 2025?

AIM will present at the 5th Annual Marie Skłodowska-Curie Symposium in Warsaw, Poland from September 3-5, 2025, featuring four separate presentations on Ampligen's oncology applications.

What types of cancer is AIM ImmunoTech's Ampligen being studied for?

Ampligen is being studied for multiple solid tumors, including late-stage pancreatic cancer, late-stage recurrent ovarian cancer, Stage-four triple-negative breast cancer, and late-stage metastatic colorectal cancer.

What is the safety profile of Ampligen in pancreatic cancer treatment?

According to the DURIPANC study, Ampligen showed no significant toxicity and an encouraging safety profile in the post-chemotherapy setting, while maintaining high quality of life for patients.