Galvanize Therapeutics announced the publication of six-month results from the AFFINITY clinical trial in Cancers, demonstrating the safety and efficacy of its Aliya pulsed electric field (PEF) ablation in patients with stage IV non-small cell lung cancer or lung metastases. The study showed 96 percent local tumor control and evidence of systemic immune activation.
In the single-arm study, 28 evaluable patients underwent PEF ablation during diagnostic biopsy, followed by standard-of-care therapy when appropriate. Local control reached 100 percent in patients receiving ablation alone and 94 percent in those on concurrent therapy. The procedure was well-tolerated, with only one serious adverse event (pneumothorax) that resolved without complications.
Data from 12 patients treated with ablation alone indicated robust activation of adaptive and innate immunity, suggesting an immunogenic effect. Unlike thermal ablation, Aliya PEF uses high-voltage pulses to induce cell death while preserving surrounding structures. The system is delivered percutaneously or endoscopically via the INUMI Flex needle.
Galvanize Therapeutics, based in Redwood City, develops PEF therapies for oncology and chronic lung disease. The Aliya system is FDA 510(k)-cleared for soft tissue ablation in the United States.
