New interventional oncology data from Galvanize demonstrate positive preclinical and early clinical study results using the Aliya pulsed electric field (PEF) system.
The Aliya PEF system, which has US Food and Drug Administration (FDA) clearance for soft tissue ablation, is being studied in Europe and Asia to treat solid tumours by inducing PEF-mediated cell death and neoantigen creation, designed to stimulate the patient’s own immune system to activate against the tumour. Results from two Aliya PEF studies were presented during oral sessions at the Society of Interventional Radiology (SIR) annual scientific meeting (4–9 March, Phoenix, USA).
The INCITE-ES clinical study is a treat and resect study conducted outside of the USA, designed to assess safety, including impact on sensitive structures such as vessels, airways and pleura; and examine immune activation in patients with non-small cell lung cancer (NSCLC) (NCT04732520). Results demonstrated high technical success with a favourable safety profile in delivering PEF energy with a single needle with no PEF-related adverse events and no impact on planned surgical resections. PEF treatment significantly reduced malignant tissue, and 95% of the assessed sensitive structures within the PEF treatment zone remained viable and unaffected by the PEF energy. Additionally, PEF increased tertiary lymphoid structure accumulation, indicating potential immunoactivation with PEF.
A preclinical study, which was featured by SIR as an SIR 2023 exceptional abstract, compared tumour response with incomplete ablation using PEF vs radiofrequency ablation (RFA) in mice with breast cancer tumours. Results showed that PEF induced a greater infiltration of immune cells in the ablated zone and increased tumour recruitment of antigen cells as compared to RFA. PEF also showed greater suppression of tumour growth and had a synergistic effect in combination with immunotherapy, unlike RFA.
“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,” said Jonathan Waldstreicher, founder and CEO of Galvanize Therapeutics. “We are making additional investments to expand our Aliya clinical research programme, including a US clinical study of patients with NSCLC.”