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).
