By M. Marin
NASDAQ:AEMD
READ THE FULL AEMD RESEARCH REPORT
ENROLLMENT FOR ONCOLOGY TRIAL COHORT 2 HAS COMMENCED
Data Safety Monitoring Board Recommended AEMD Progress Trial Without Modification
Aethlon Medical (NASDAQ:AEMD) announced FY 1Q (quarter ended June 30, 2025) results and provided a business update last week. The company has recorded several recent milestones as it advances its primary focus on researching the Hemopurifier® therapeutic blood filtration system as a potential treatment in oncology.
AEMD is conducting a basket oncology trial1 to study the impact of the Hemopurifier 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 adjuvant therapy can increase the percent of patients who can benefit from combined treatment. The trial is intended to assess the Hemopurifier's safety, feasibility, and optimal dosing.
The first three patients in Cohort 1 have been treated, completing a single 4-hour Hemopurifier treatment without device deficiencies or immediate complications. The primary endpoint of this trial is the incidence of adverse events and clinically significant changes in safety laboratory tests of Hemopurifier-treated patients. The DSMB reviewed data from Cohort 1 in which no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier have been reported to date.
The independent Data Safety Monitoring Board (DSMB) overseeing its clinical trial reported finding no safety concerns related to the Hemopurifier and that the device continues to show a favorable safety and tolerability profile.
Cohort 2 participants will receive two Hemopurifier treatments over one week
AEMD has commenced enrollment for Cohort 2, in which participants will receive two Hemopurifier treatments over one week. The trial is planned to enroll about 9 to 18-participants and evaluate the safety and feasibility of administering the Hemopurifier at varying dosing intervals.
The company recently expanded the study protocol to reflect evolving immunotherapy standard of care such as adjuvant or combination therapy. While initially the Hemopurifier was being evaluated as an added therapy in conjunction with Keytruda or Opdivo, the device is also now also being evaluated as a treatment in conjunction with Keytruda or Opdivo in combination with other therapy. This is because Keytruda and other therapy are not only used as standalone treatment, but often used in combination with other therapies. Thus, the AEMD trial will analyze whether the Hemopurifier can help decrease the concentration of EVs in cancer patients being treated with standard of care approaches and thereby improve overall patient outcomes.
Initial observations from Cohort 1 data analysis expected next month
Central lab samples from the first patient cohort to assess the effects of the Hemopurifier on extracellular vesicle counts and anti-tumor T cell activity are being analyzed. Initial observations from the analysis are expected next month. Preliminary data to be reported includes the effects of Hemopurifier treatment combined with standard of care on EV removal and anti-tumor T-cell activity. The primary endpoint is safety. The study will also explore how many Hemopurifier treatments are needed to decrease the concentration of EVs, and whether potential changes in EV concentrations improve the body's natural ability to fight tumors. Findings will inform the design of future safety and efficacy trials, potentially including a Premarket Approval (PMA) study the FDA and other international regulatory agencies require.
The company expects the Hemopurifier, in conjunction with checkpoint inhibitor and combined therapy treatment can increase the percent of patients who can benefit from combined treatment and improve overall patient outcomes. In turn, this would show proof of concept about the Hemopurifier’s benefits in treating solid tumors. AEMD anticipates that data from the first treatment cohort will support the Hemopurifier’s potential ability to reduce tumor-derived EVs and enhance T-cell activity against tumors.
Continuing pre-clinical research outside of oncology when expenses are de minimis
With the timeline to launch a study in India similar to the one being conducted in Australia significantly longer than AEMD had initially anticipated, the company has decided not to move forward in India at this time. AEMD will continue to focus on the ongoing oncology study in Australia, where it benefits from attractive economic that are expected to help reduce costs, lower risk and accelerate time to market. When appropriate, the company continues pre-clinical research and analysis of the Hemopurifier in areas outside of oncology when expenses associated with these efforts are de minimis.
Hemopurifier removed 98.5% of platelet-derived extracellular vesicles in ex vivo study
For example, the results from Aethlon's preclinical ex vivo study were published in bioRxiv on May 12, 2025, and the manuscript has been submitted for publication in a peer-reviewed journal. The results demonstrate that the Hemopurifier removed 98.5% of platelet-derived extracellular vesicles (PD-EVs) from human plasma. Other examples include recent research conducted in collaboration with UCSF that led to AEMD’s CMO presenting last week on the potential benefits of the Hemopurifier in treating Long COVID & papers on preclinical data showing the Hemopurifier’s ability to remove platelet-derived EVs from plasma published in the Transplant Immunology Journal.
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1. Titled Safety, Feasibility, and Dose-Finding Study of Aethlon Hemopurifier in Patients with Solid Tumors Who Have Stable or Progressive Disease While on a Treatment That Includes Pembrolizumab or Nivolumab