Galvanize Therapeutics’ Aliya PEF System Studied in Solid Tumors

March 7, 2023—Galvanize Therapeutics announced that new interventional oncology data demonstrated positive preclinical and early clinical study results using the company’s Aliya pulsed electric field (PEF) system. The data include PEF safety and feasibility results in patients with non–small cell lung cancer (NSCLC) as well as preclinical results comparing PEF and radiofrequency ablation (RFA).

The findings were presented at SIR 2023, the Society for Interventional Radiology’s annual scientific meeting held March 4-9, 2023, in Phoenix, Arizona.

According to Galvanize Therapeutics, the Aliya PEF device, which is designed to stimulate the patient’s own immune system to activate against the tumor, is being studied in Europe and Asia to treat solid tumors by inducing PEF-mediated cell death and neoantigen creation.

The Aliya system is 510(k) cleared in the United States for the surgical ablation of soft tissue and is available for this indication. It is not currently commercially available in any other geography, advised the company.

Results from two Aliya PEF studies were presented during oral sessions at SIR 2023.

The first presentation was data from the INCITE-ES clinical study, a treat-and-resect study conducted outside of the United States. The study is designed to assess safety, including impact on sensitive structures such as vessels, airways, and pleura, and examine immune activation in patients with NSCLC.

Results from INCITE-ES of PEF treatment demonstrated the following:

• High technical success with a favorable safety profile in delivering PEF energy with a single needle, with no PEF-related adverse events and no impact on planned surgical resections
• Significant reduction of malignant tissue
• 95% of the assessed sensitive structures within the PEF treatment zone remained viable and unaffected by the PEF energy
• Increased tertiary lymphoid structure accumulation, indicating potential immunoactivation with PEF

The second presentation at SIR 2023 was findings from a preclinical study comparing tumor response with incomplete ablation using PEF versus RFA in mice with breast cancer tumors. Results showed that PEF induced a greater infiltration of immune cells in the ablated zone and increased tumor recruitment of antigen cells as compared to RFA. PEF also showed greater suppression of tumor growth and had a synergistic effect in combination with immunotherapy, unlike RFA.

As noted in the Galvanize Therapeutics press release, the Aliya PEF system delivers high-voltage, high-frequency electrical pulses through a single monopolar electrode placed in the target tissue. PEF energy destabilizes the cells, resulting in cell death. Aliya does not rely on thermal mechanisms to induce cell death.

The company stated that the nonthermal modality of cell death with the Aliya PEF system preserves surrounding healthy tissue, enabling ablation near sensitive structures, such as nerves and blood vessels. The Aliya waveform and electrode are designed to maximize the potential for releasing tumor antigens and may stimulate an immune response, potentially disrupting the immunosuppressive tumor microenvironment.

Jonathan Waldstreicher, MD, Founder and CEO of Galvanize Therapeutics, commented in the company’s press release, “Galvanize’s unique approach to improving cancer outcomes through electrosurgical immunotherapy continues to show compelling promise, and we are excited to share our newest study results with leading interventional radiologists and other medical experts around the world. We are making additional investments to expand our Aliya clinical research program, including a United States clinical study of patients with NSCLC.”