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By M. Marin

NASDAQ:AEMD

READ THE FULL AEMD RESEARCH REPORT

Cohort 2 recruitment has begun following positive data from Cohort 1

Aethlon Medical (NASDAQ:AEMD) announced FY 2Q (quarter ended September 30, 2025) results and provided a business update this week. The company’s primary focus is on researching lead asset, the Hemopurifier® therapeutic blood filtration system, as a potential treatment in oncology. The device has received 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.

AEMD is conducting a basket oncology trial to study the impact of the Hemopurifier as a potential treatment in patients with various solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment. Unfortunately, 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 treatment of checkpoint inhibitors and / or combination therapy can increase the percent of patients who can benefit and early data looks promising. The trial is intended to assess the Hemopurifier’s safety, feasibility, and optimal dosing.

Cohort 2 recruitment facilitated by engagement of Trialfacts

The first three patients (Cohort 1) have been treated, completing a single 4-hour Hemopurifier treatment without device deficiencies or immediate complications. All participants also completed a 7-day safety follow-up. No serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier have been reported to date. AEMD recently reported early preliminary data from Cohort 1 and is recruiting participants for Cohort 2.

Cohort 2 recruitment is being conducted under an amended protocol that allows patients receiving combination therapies with pembrolizumab or nivolumab to participate in the AEMD trial. The study design is for Cohort 2 participants to receive two Hemopurifier treatments over one week to help determine whether there is a dose response with additional Hemopurifier treatments.

To accelerate enrollment, AEMD is working with clinical trial facilitator Trialfacts to perform clinical trial advertising, online prescreenings and refer potential participants to the three sites in Australia participating in the trial. Potential trial participants who have been prescreened for Cohort 2 are reviewing consent documentation.

Data from Cohort 2, as well as Cohort 3 subsequently as the study progresses, will help determine whether the positive observations from Cohort 1 (see below) can be reproduced and also whether additional Hemopurifier treatments produce a dose response in terms of the magnitude and duration of changes. In other words, the study is designed to examine whether an increased number of Hemopurifier treatments can help extend positive patient responses. The company’s goal is to build its database supporting development of the Hemopurifier as an oncology treatment and this data appears to support that goal.

Data from Cohort 1

Preliminary data from Cohort 1 is encouraging. It appears that the study is on track to support AEMD’s hypothesis that the Hemopurifier, in conjunction with standard of care treatment, can increase the percent of patients who benefit. Following a single 4-hour Hemopurifier treatment in Cohort 1, decreases were observed in several harmful particles:

• Thus far, the data suggests the Hemopurifier decreases the levels of particles in the body that are associated with the spread – or metastasis – of cancer and suppressing the immune system.
• Levels of certain of these harmful particles typically returned to pre-treatment levels 1-3 weeks after treatment ended, suggesting a potential benefit to patients while being treated.
• In seven out of ten microRNAs – which are one component of EVs thought to promote cancer growth and metastasis – decreases were observed in two of the three participants.
• Improvements in laboratory ratios associated with responses to immunotherapy[1] were observed in at least two participants.
• Increases were seen in total T cell numbers.

Evaluating potential of using the Hemopurifier with a simplified blood treatment system

Currently, Hemopurifier treatment requires a dialysis catheter and dialysis machine and nephrologists and dialysis nurses to supervise and administer the treatment. AEMD has started to evaluate the potential of using the Hemopurifier with a simplified blood treatment system that could replace the use of dialysis infrastructure. The company recently signed a material transfer agreement to study the compatibility of the Hemopurifier with a system that uses a single small-lumen vascular catheter and a simplified blood pump.

This research potentially could lead to a simplified system for performing Hemopurifier treatments in oncology units in the future using a PICC (peripherally inserted central catheter) line. If the company can move to this delivery system of Hemopurifier treatment, it could prove to be transformational for the ease of using the device as an oncology treatment, we believe.

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