AIM ImmunoTech Announces Publication of Positive Findings from a Study Evaluating Ampligen® in the Treatment of Pancreatic Cancer in the Journal Clinical Cancer Research

Rhea-AI Summary

AIM ImmunoTech Inc. announces positive data analysis from a study on Ampligen in treating advanced pancreatic cancer. The study shows immune-stimulatory properties of TLR-3 activation, enhancing anti-tumor immunity through dendritic cell-mediated T cell responses. Ampligen treatment correlates with improved clinical outcomes and decreased expression of immune checkpoints. The company aims to expand Ampligen's application to various solid tumor types, with ongoing clinical trials to evaluate its effectiveness in pancreatic cancer treatment.

Oncology Doctor

The recent findings on Ampligen's impact on pancreatic cancer treatment suggest a potential paradigm shift in the management of advanced pancreatic ductal adenocarcinoma (PDAC). The role of dendritic cells (DCs) and T cells in anti-tumor immunity is well-documented and the ability of Ampligen to enhance peripheral immune activity is a significant discovery. The correlation between the increased presence of BTLA+XCR1+ cDC1s and CD4+SELL+ T cells with improved clinical outcomes could pave the way for more personalized immunotherapies.

Furthermore, the reduction in the expression of immune checkpoints PD-L1 and PD-L2 post-treatment is particularly promising. These proteins are often overexpressed in cancer cells and can inhibit the immune response, leading to tumor progression. By decreasing their expression, Ampligen could be enhancing the body's natural ability to fight cancer. The potential synergy with immune checkpoint inhibitors like durvalumab could be a game-changer, offering new hope for patients with PDAC, a notoriously difficult cancer to treat due to its aggressive nature and resistance to conventional therapies.

Medical Research Analyst

The analysis of Ampligen's effects on the tumor microenvironment highlights its multi-faceted mechanism of action. The modulation of gene and protein expression levels post-treatment indicates that Ampligen may be affecting the cancer not only through direct anti-tumor effects but also by altering the immune landscape. The translational significance of these findings is underscored by the observed clinical outcomes, which suggest a tangible benefit in progression-free and overall survival.

It's important to consider the broader implications of these results. If Ampligen shows consistent efficacy across different solid tumors, as suggested by the similarities in tumor microenvironment changes observed in various cancers, it could become a cornerstone treatment with far-reaching impact. The data could also influence the strategic direction of AIM ImmunoTech, potentially leading to partnerships, increased funding and a revaluation of the company's market potential.

Financial Analyst

The announcement of Ampligen's promising data in the treatment of PDAC could have substantial implications for AIM ImmunoTech's market valuation and investor sentiment. The progression of Ampligen through clinical trials and its potential broad applicability in solid tumors may attract significant attention from pharmaceutical companies interested in expanding their oncology portfolios. The ongoing DURIPANC trial, in particular, is one to watch, as it evaluates the combination of Ampligen with AstraZeneca's durvalumab, which could lead to strategic collaborations or licensing agreements.

From an investment perspective, the company's future revenue streams could be substantially altered by the success of these trials. However, investors should also be aware of the risks inherent in drug development, particularly in the highly competitive oncology market. The long-term impact will depend on further clinical validation, regulatory approvals and the ability of AIM to effectively commercialize Ampligen if it proves to be efficacious.

Data demonstrate compelling evidence of the immune-stimulatory properties linked to TLR-3 activation through Ampligen

OCALA, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced the publication of new data analysis from a long-term Early Access Program (“EAP”) studying the company’s drug Ampligen® (rintatolimod) for the treatment of advanced pancreatic ductal adenocarcinoma (“PDAC”). The manuscript titled “Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses,” appears in the journal Clinical Cancer Research, one of oncology’s most prestigious journals.

Ampligen is a dsRNA product candidate that acts via the TLR-3 receptor present on several immune cells, epithelial cells and tumors. Researchers at the Erasmus University Medical Center (“Erasmus MC”) found that Ampligen treatment in pancreatic cancer patients enhances peripheral immune activity at the transcriptomic and proteomic levels, particularly involving type 1 conventional dendritic cells (cDC1s) and T cells. Post-Ampligen, the increased peripheral abundance of BTLA+XCR1+ cDC1s and CD4+SELL+ T cells correlated with improved clinical outcomes. Patients with stable disease exhibited pronounced overexpression of genes related to DC and T cell activation. Notably, the expression of immune checkpoints PD-L1 and PD-L2 decreased post-Ampligen across all patients.

AIM Chief Executive Officer Thomas K. Equels stated: “We have already seen that Ampligen as a single-agent therapy was associated with improved progression-free survival and overall survival in these Early Access Program pancreatic cancer patients. This new data analysis provides us further insight into exactly why that’s the case, which could give us the ability to identify cancer patients who might benefit more from Ampligen treatment than they would from other known cancer treatments. Additionally, the changes in the tumor microenvironment we see in pancreatic cancer are similar to those we have seen in triple-negative breast cancer, ovarian cancer and colorectal cancer metastatic to the liver. We have hypothesized that Ampligen has the potential to be efficacious in almost every solid tumor type based on its direct effect on malignant tumor cells and its effect on the tumor micro-environment. All these data combined lend further credence to the broad applicability of Ampligen in solid tumors.”

Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC and co-author of the published paper, stated, “Based on these results, we believe Ampligen may break immunological tolerance by enhancing anti-tumor immunity through DC-mediated T-cell responses. The data suggests that Ampligen infusions modulate PD-L1 and PD-L2 expression in the tumor microenvironment, while at the same time they upregulate Ki67+CD4+ and Ki67+CD8+ T-cells. We therefore believe that combining Ampligen with an immune checkpoint inhibitor — such as durvalumab — could synergistically circumvent immune blockade and potentially mitigate the T-cell exhaustion known to occur with immune checkpoint therapies. We look forward to further evaluating Ampligen toward potentially meeting the critical need for more effective therapies to treat pancreatic cancer, including with the ongoing DURIPANC trial, which looks at the combination effect of Ampligen and AstraZeneca’s durvalumab.”

AIM is currently evaluating Ampligen as a therapy for metastatic pancreatic ductal adenocarcinoma in the Phase 1b/2 DURIPANC clinical study (NCT05927142) and as a therapy for locally advanced pancreatic adenocarcinoma in the Phase 2 AMP-270 clinical study (NCT05494697).

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. Publication of this data and clinical success seen to date does not guarantee that Ampligen will be approved for the commercial treatment of pancreatic cancer. 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.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3fb0a503-5593-4f78-bc1c-65128796be7a

What is the focus of the new data analysis announced by AIM ImmunoTech Inc.?

The focus of the new data analysis is on Ampligen's immune-stimulatory properties in treating advanced pancreatic cancer through TLR-3 activation and dendritic cell-mediated T cell responses.

Which journal published the manuscript related to the data analysis?

The manuscript titled 'Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses' was published in Clinical Cancer Research.

What are the key findings of the study regarding Ampligen treatment in pancreatic cancer patients?

The key findings include enhanced peripheral immune activity involving type 1 conventional dendritic cells (cDC1s) and T cells, improved clinical outcomes, decreased expression of immune checkpoints PD-L1 and PD-L2, and potential applicability of Ampligen in various solid tumor types.

How does AIM ImmunoTech Inc. plan to further evaluate Ampligen's effectiveness in treating pancreatic cancer?

AIM is currently evaluating Ampligen in metastatic pancreatic ductal adenocarcinoma in the Phase 1b/2 DURIPANC clinical study and in locally advanced pancreatic adenocarcinoma in the Phase 2 AMP-270 clinical study.