On July 13, 2026 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company developing products to treat cancer and life-threatening viral infections, reported that patients in the second cohort of its Australian oncology feasibility study demonstrated biological changes consistent with those previously observed in the first cohort following treatment with the investigational Hemopurifier. Replicating these findings in a second group of patients strengthens the scientific rationale for the Company’s ongoing clinical program and supports continued enrollment in the third and final cohort before an independent statistical analysis is conducted.
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"We are encouraged to observe similar directional changes across multiple biomarkers in both the first and second patient cohorts," said James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical. " Observing these directional changes in a second patient cohort builds upon our initial observations and provides additional data as we advance toward completion of the third cohort. While these are preliminary findings from an early feasibility study, they represent an important milestone as we advance toward completion of the third cohort and an independent statistical analysis to determine whether these observations represent a dose-response to Hemopurifier treatment."
The Australian feasibility study is evaluating the safety, feasibility and dosing of the Hemopurifier in patients with advanced solid tumors whose cancers have progressed despite treatment with anti-PD-1 immunotherapies.
The second cohort continued to show directional changes in several biomarkers that researchers believe are associated with tumor growth, immune suppression and response to immunotherapy, including:
Reductions in tumor-derived extracellular vesicles (EVs), platelet-derived EVs and PD-L1-positive EVs, with these changes appearing more consistently across all participants than in the first cohort and generally persisting through the eight-week follow-up period.
Reductions in two microRNAs that have been associated with tumor growth and cancer invasion.
Improvements in multiple immune-related laboratory ratios—including neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), Systemic Immune-Inflammation Index (SII), monocyte-to-albumin ratio (MAR) and Lymphocyte Albumin Index (LAI)—that have been associated in published research with improved responses to immunotherapy.
Increases in total T cells, CD4 and CD8 T-cell populations, and tumor-specific CD137-positive T cells in all three participants, with these changes generally persisting through the eight-week follow-up period.
Taken together, the first two cohorts have now shown similar directional changes across multiple biological markers following Hemopurifier treatment. Enrollment in the third cohort is underway, with the first participant having already completed three four-hour Hemopurifier treatments during a one-week period. After all three cohorts are complete, an independent statistician will analyze the combined data to determine whether these observations support a dose-response relationship.
EVs continue to be recognized as important drivers of cancer progression and resistance to checkpoint inhibitors such as Keytruda and Opdivo. The Hemopurifier is designed to remove these tumor-derived vesicles from the bloodstream, with the goal of reducing immune suppression and potentially enhancing the body’s ability to fight cancer.
"We believe the Hemopurifier has the ability to complement existing therapies rather than replace them and could be a platform technology with potential applications across multiple disease areas such as oncology, infectious diseases, and future emerging threats. We believe there exists a ‘pipeline within a single device,’" said Mr. Frakes.
Advancing a Novel Approach to Cancer Immunotherapy
Extracellular vesicles released by tumors continue to be recognized as important drivers of cancer progression, metastasis and resistance to immunotherapy. EVs expressing PD-L1 have been associated with resistance to checkpoint inhibitors, including Keytruda and Opdivo. The Hemopurifier is designed to remove tumor-derived EVs and other pathogenic particles from circulation, potentially reducing immunosuppressive signaling and improving the body’s anti-tumor immune response.
The Hemopurifier has received FDA Breakthrough Device Designation for the treatment of patients with advanced or metastatic cancer who are unresponsive or intolerant to standard-of-care therapy, as well as for the treatment of life-threatening viral infections not addressed by approved therapies.
Important Study Limitations
The Company cautions that these findings represent descriptive observations from raw data generated in an early-stage feasibility study. Formal statistical analyses have not yet been performed and will be conducted only after completion of all three study cohorts by an independent statistician.
The study was not designed to demonstrate clinical efficacy, and no conclusions can be drawn regarding the Hemopurifier’s impact on patient outcomes. Larger, adequately powered clinical trials designed with clinical efficacy endpoints will be required to determine whether the biological changes observed translate into meaningful clinical benefit.
(Press release, Aethlon Medical, JUL 13, 2026, View Source [SID1234669176])