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

Rhea-AI Summary

AIM ImmunoTech (NYSE American: AIM) announced the print publication of data analysis from a long-term Early Access Program studying Ampligen® (rintatolimod) for treating advanced pancreatic ductal adenocarcinoma (PDAC) in Clinical Cancer Research. The study, conducted at Erasmus University Medical Center, found that Ampligen enhances peripheral immune activity in pancreatic cancer patients, particularly involving type 1 conventional dendritic cells and T cells.

Key findings include:

• Increased peripheral abundance of BTLA+XCR1+ cDC1s and CD4+SELL+ T cells correlated with improved clinical outcomes
• Decreased expression of immune checkpoints PD-L1 and PD-L2 post-Ampligen
• Potential for Ampligen to improve progression-free survival and overall survival

AIM is currently evaluating Ampligen in two clinical studies for pancreatic cancer: the Phase 1b/2 DURIPANC study and the Phase 2 AMP-270 study.

Positive

• Publication of Ampligen study results in prestigious Clinical Cancer Research journal
• Ampligen enhances peripheral immune activity in pancreatic cancer patients
• Increased abundance of specific immune cells correlated with improved clinical outcomes
• Decreased expression of immune checkpoints PD-L1 and PD-L2 post-Ampligen treatment
• Ongoing clinical trials (DURIPANC and AMP-270) to further evaluate Ampligen's potential in pancreatic cancer treatment

Negative

• None.

Insights

Medical Research Analyst

The publication of Ampligen's study results in Clinical Cancer Research is a significant milestone for AIM ImmunoTech. The data reveals promising immune-stimulatory properties of Ampligen in pancreatic cancer treatment, particularly its ability to enhance dendritic cell-mediated T cell responses. This could potentially address the unmet need in pancreatic cancer therapeutics.

Key findings include:

• Enhanced peripheral immune activity post-Ampligen treatment
• Correlation between increased BTLA+XCR1+ cDC1s and CD4+SELL+ T cells and improved clinical outcomes
• Decreased expression of immune checkpoints PD-L1 and PD-L2

These results suggest Ampligen's potential to improve progression-free survival and overall survival in pancreatic cancer patients. The ongoing DURIPANC and AMP-270 clinical trials will be important in further validating these findings and determining Ampligen's efficacy in combination therapies.

Oncology Doctor

The study's findings on Ampligen are intriguing from a clinical perspective. The modulation of PD-L1 and PD-L2 expression in the tumor microenvironment, coupled with the upregulation of Ki67+CD4+ and Ki67+CD8+ T-cells, suggests a potential synergy with existing immunotherapies. This could be particularly valuable in pancreatic cancer, which has historically been resistant to immunotherapy approaches.

The correlation between B-cell enrichment and long-term survival is also noteworthy. If confirmed in larger studies, this could serve as a valuable prognostic marker. However, it's important to temper enthusiasm with caution. While these results are promising, the true clinical impact of Ampligen will only be determined through the Phase 1b/2 DURIPANC and Phase 2 AMP-270 clinical studies. These trials will provide critical data on efficacy, safety and potential combination strategies.

Financial Analyst

The publication of Ampligen's study results in a prestigious journal like Clinical Cancer Research is a positive development for AIM ImmunoTech (NYSE American: AIM). This validation could potentially increase investor confidence and attract partnerships or funding opportunities. However, it's important to note that the company is still in the clinical trial phase for Ampligen in pancreatic cancer treatment.

The ongoing DURIPANC and AMP-270 clinical trials are critical milestones to watch. Positive results from these studies could significantly impact AIM's market position and stock performance. Investors should also consider:

• The potential market size for pancreatic cancer treatments
• AIM's financial position and burn rate
• Possible competition in the immunotherapy space

While the news is encouraging, it's important to remember that drug development is a long and risky process. Investors should carefully weigh the potential rewards against the inherent risks in biotech investments.

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

Additional commentary published discussing the potential of Ampligen and two other drugs

OCALA, Fla., Aug. 20, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced the official print publication of the 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.

“We are grateful to the Erasmus team for their continued contributions to the advancement of Ampligen,” said AIM Chief Executive Officer Thomas K. Equels “There remains a large and growing unmet need for safe and effective treatments for pancreatic cancer. This data continues to provide us with further insight into Ampligen’s ability to improve progression-free survival and overall survival and enables us to identify cancer patients who might benefit more from Ampligen treatment than they would from other known cancer treatments.”

Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC and co-author of the published paper, added, “We continue to be encouraged by this data which suggests 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 continue to make progress in the ongoing DURIPANC trial, which looks at the combination effect of Ampligen and AstraZeneca’s durvalumab and look forward to continuing evaluation of its potential for the treatment of pancreatic cancer.”

In addition to the published manuscript, further commentary discussing the potential of Ampligen and two other drugs, referencing findings from the journal article, were published. Key highlights from the additional commentary include:

• Ampligen has been found to be also safely used through a systemic route.
• Interesting increases in cDC1 numbers and cytokines governing T-cell activation and migration are found to be upregulated.
• Researchers detected an important enrichment of B-cell numbers in peripheral blood from patients treated with Ampligen.
  • B-cells correlated with long-term (>1 year) survival in a previous study.

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 pre-clinical and clinical success seen to date, does not guarantee that Ampligen will be approved for the commercial treatment of cancers. 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.

FAQ

What is the main finding of the AIM ImmunoTech Ampligen study for pancreatic cancer?

The main finding is that Ampligen enhances peripheral immune activity in pancreatic cancer patients, particularly involving type 1 conventional dendritic cells and T cells, which correlated with improved clinical outcomes.

How does Ampligen affect immune checkpoints in pancreatic cancer patients?

The study found that Ampligen treatment decreased the expression of immune checkpoints PD-L1 and PD-L2 across all patients, potentially improving the immune response against cancer cells.

What clinical trials is AIM ImmunoTech (AIM) currently conducting for Ampligen in pancreatic cancer?

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

What is the significance of the Ampligen study results being published in Clinical Cancer Research?

The publication in Clinical Cancer Research, one of oncology's most prestigious journals, lends credibility to the study results and increases visibility of Ampligen's potential in treating pancreatic cancer within the scientific community.