By M. Marin
NASDAQ: AEMD
READ THE FULL AEMD RESEARCH REPORT
Early observations from 1st two cohorts showed consistent improvements in immune function
Aethlon Medical (NASDAQ: AEMD), a clinical-stage medical therapeutic company advancing its lead asset, the Hemopurifier, to treat cancer and life-threatening viral infections, reported 1Q FY 2027 financial results (quarter ended June 30, 2026) last week and provided a business update.
Importantly, the company’s Australian oncology study has advanced to the final Cohort 3 dosing. AEMD recently treated the first participant in Cohort 3 at Australia’s Royal North Shore Hospital, where the participant completed three Hemopurifier treatments over a one-week period with no device deficiencies. Moving the final dosing cohort ahead brings AEMD closer to generating and reporting data to inform future development and dosing strategy to move toward potential regulatory approval. Early biomarker signals support continuing clinical evaluation of the Hemopurifier medical device.
The Hemopurifier is an investigational extracorporeal device designed to bind and remove harmful extracellular vesicles (EVs) from the blood. It has FDA Breakthrough Device designation for the treatment of people with advanced or metastatic cancer who are either unresponsive to or cannot tolerate standard of care therapy, and with cancer types in which exosomes are indicated in the development or severity of the disease, and also for life-threatening viruses that are not addressed with approved therapies. The company believes the Hemopurifier is the only device currently being evaluated to remove EVs.
In Cohort 1, participants received one Hemopurifier treatment during a one-week period. Cohort 2 participants received two treatments. Once enrollment and treatment of participants in Cohort 2 were completed, the independent Data Safety Monitoring Board (DSMB) overseeing the clinical trial completed its safety review of the data from the participants in Cohort 2. The DSMB recommended that the trial progress to the final third cohort, indicating that "no safety concerns were noted with the Hemopurifier device/procedure." Specifically, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier treatment have been reported to date.
1st Cohort 3 participant dosed
In Cohort 3, the first participant was dosed in this final cohort in Australia. Early observations from the first two cohorts showed consistent decreases in particles linked to cancer progression, specifically in tumor-derived extracellular vesicles (EVs) and microRNAs linked to cancer progression. Early observations from the first two cohorts also showed consistent improvements in immune function associated with potential response to immunotherapy.
Recent and upcoming expected milestones
- Announce Cohort 2 safety ✓
- Board decision regarding progressing to Cohort 3 ✓
- Initiate Cohort 3 ✓
- Complete Cohort 3
- Announce overall trial data
- Potentially advance to efficacy trial
Studying whether Hemopurifier + standard of care therapies increases % of patients who benefit
The trial is a safety and dose-finding study. The trial will monitor any adverse events and clinically significant changes in treated patients who have solid tumors with stable or progressive disease following treatment with Keytruda® or Opdivo® or combined therapy. Despite the strong success of these standard of care therapies, only about 30% of cancer patients who receive pembrolizumab (Keytruda®) or nivolumab (Opdivo®) treatment for solid tumors have lasting clinical responses. The company’s hypothesis is that using the Hemopurifier in conjunction with these and with combination therapy can increase the percentage of patients who benefit.
In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body's own natural ability to attack tumor cells.
Device has shown reduction in EVs, which is seen as potentially beneficial in oncology & a range of diseases
The device has shown reduction in EVs and other harmful particles. Moreover, to date, over time, 173 Hemopurifier treatments have been administered in 44 patients with no SAEs. Once Cohort 3 treatment is completed, AEMD plans to report data from the overall study and, depending on Cohort 3 data, potentially form a partnership to assist with funding a subsequent efficacy trial.
EVs are seen to contribute to metastasis and to suppressing the immune system. Down the road, if the company’s current evaluation of the Hemopurifier in oncology proves beneficial, AEMD believes the device could support broader potential clinical application in a range of diseases. Excessive levels of PD-EVs (platelet-derived EVs) have been implicated in many diseases, including cancer, lupus, systemic sclerosis, multiple sclerosis, Alzheimer's disease, sepsis, acute and Long COVID, rheumatoid arthritis and chronic kidney disease.
Long COVID publication to strengthen scientific case for studying EVs in post-viral conditions
In addition, as the company continues to build a database supporting the application of the Hemopurifier, AEMD had a Long COVID manuscript accepted for publication in the International Journal of Molecular Sciences. The company believes this strengthens the scientific case for studying EVs in post-viral conditions. The manuscript shows that the EVs isolated from the plasma of individuals with Long COVID bind to the proprietary GNA affinity resin in the Aethlon Hemopurifier.
Moreover, AEMD has advanced preclinical research evaluating Hemopurifier applications in additional indications, including rheumatoid arthritis and chronic kidney disease. These activities are expected to support the expansion of the device's potential addressable market beyond oncology and infectious disease and could potentially create future opportunities to expand the platform into large markets characterized by significant unmet medical need. The company’s activities are being conducted in a cost-efficient manner consistent with AEMD’s continued focus on managing operating expenses.
In addition, an interview was published in IEEE Spectrum subsequent to FY-end featuring Aethlon's Chief Medical Officer and a physician involved in the treatment of an Ebola virus patient with the Hemopurifier during the 2014 outbreak, highlighting AEMD's experience with Ebola treatments. In addition, the company also confirmed the continued availability of its FDA-authorized expanded access (compassionate use) protocol and shared the protocol as well as past in vitro and in vivo data with organizations involved in global and U.S. emerging pathogen preparedness efforts, including the World Health Organization's R&D Blueprint expert panel and the National Emerging Special Pathogen Training and Education Center. Presumably, this could potentially lead to the treatment of an Ebola patient if appropriate.
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