Core Insights - Aethlon Medical has achieved a significant milestone by treating the second patient with the Hemopurifier in its clinical trial for solid tumors not responding to anti-PD-1 antibodies [1][2] - The trial aims to assess the safety and feasibility of the Hemopurifier, with the first cohort consisting of approximately 18 patients [6] - The Hemopurifier is designed to remove tumor-derived extracellular vesicles (EVs) from the bloodstream, potentially improving responses to anti-PD-1 therapies [5][7] Group 1: Clinical Trial Progress - The second patient was treated on June 11, 2025, at the Royal North Shore Hospital/University of Sydney, following the first patient treated on January 29, 2025 [1][2] - Both patients completed the 4-hour Hemopurifier treatment without device deficiencies or immediate complications, and have finished the 7-day safety follow-up period [2][4] - The Data Safety Monitoring Board (DSMB) will review the safety data after the third patient is enrolled, which is expected to occur soon [3][4] Group 2: Device and Mechanism - The Hemopurifier is an investigational device that utilizes plasma separation and affinity binding to remove enveloped viruses and EVs from circulation [7][8] - Preclinical studies indicate that the Hemopurifier can reduce the number of exosomes in cancer patient plasma, which may enhance the effectiveness of anti-PD-1 therapies [5][6] - The device holds FDA Breakthrough Device designation for treating advanced or metastatic cancer patients who are unresponsive to standard therapies [8] Group 3: Future Directions - The primary endpoint of the trial is to monitor adverse events and significant changes in safety lab tests among treated patients [6] - The study will also explore the number of Hemopurifier treatments required to decrease EV concentrations and whether this improves the immune response against tumor cells [6] - Data on the effects of the Hemopurifier on anti-tumor T cell activity is anticipated approximately three months after the enrollment of the third patient [3]

Group 1 - Halozyme Therapeutics announced that Bristol Myers Squibb received European Commission approval for a new subcutaneous formulation of Opdivo® (nivolumab) for multiple adult solid tumors [1][2] - The subcutaneous injection of Opdivo® can be administered in 3 to 5 minutes, providing a more convenient option for cancer patients [2] - The approval is valid across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway [3] Group 2 - The positive decision from the European Commission is supported by results from the Phase 3 CheckMate -67T trial [2] - Halozyme's ENHANZE® technology, which facilitates subcutaneous drug delivery, has been licensed to several leading pharmaceutical companies [4] - Halozyme has impacted over one million patients through its commercialized products and aims to improve patient experiences with rapid subcutaneous delivery [4]