On November 6, 2023 Galvanize Therapeutics, Inc., a leader in developing pulsed electric field therapies, reported compelling data from the INCITE-ES clinical study at the recent Society for Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) conference (Press release, Galvanize Therapeutics, NOV 6, 2023, View Source [SID1234637074]). The study evaluated the ability of the Aliya Pulsed Electric Field (PEF) system to induce adaptive anti-tumor immunity in patients with Non-Small Cell Lung Cancer (NSCLC).

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The Aliya PEF System delivers high voltage, short duration electrical energy locally to alter the transmembrane potential of a cell, which results in loss of homeostasis, inducing non-thermal programmed cell death without denaturing cellular proteins and extracellular matrix. In addition to focal ablation, preclinical studies suggest this process may release damage associated molecular patterns (DAMPs) and antigens from the dying tumor cells that may stimulate an immune response for a potential systemic effect beyond focal ablation.

The INCITE-ES clinical study is a treat and resect study conducted outside of the U.S., designed to assess safety and examine immune activation in patients with early stage IA2‐IB NSCLC (NCT04732520). The two-arm study enrolled 34 patients in the PEF treatment group and 8 in the control group. Blood, bronchoalveolar lavage, and tumor tissue samples were collected from treated and untreated patients. Single‐cell RNA sequencing (scRNA‐Seq) from pre‐PEF and post‐PEF tumor samples was performed to examine PEF‐induced changes in the cell frequency and gene expression of tumor immune cells. Flow cytometry and serum cytokine profiling were used to evaluate systemic changes in the immune cell populations and cytokines after PEF treatment. Data presented previously demonstrated safety and feasibility to deliver PEF with no device or procedure-related adverse events, a significant reduction in malignant tissue, and an increase in formation of tertiary lymphoid structures (TLS) in PEF-treated patients.

Initial results from the INCITE-ES study highlight the potential for the Aliya PEF system to enhance the body’s natural defenses against tumors. The data suggest that Aliya PEF may facilitate and stimulate the migration of immune cells into the tumor, as well as the activity of the immune cells against tumor cells. This could lead to a stronger immune response, allowing the body to better target and fight the tumors.

Single-cell RNA sequencing in PEF-treated samples revealed a shift in gene expression in cell types that are instrumental in supporting a local inflammatory response.
Single-cell RNA sequencing showed that PEF‐treated tumors had a significant increase in plasma B cells and cytotoxic CD8 T cells (p < 0.05), which are key cells that target cancer cells.
Ingenuity Pathway Analysis (IPA) of serum cytokines in PEF-treated samples demonstrated that PEF induces immunogenic cell death, a type of cell death that triggers the stimulation of the immune system.
Flow cytometry showed higher levels of circulating B cells and effector memory T cells, and lower Tregs in PEF-treated samples, further suggesting activation of multiple aspects of the patients’ immune system.
Jonathan Waldstreicher, M.D., Founder and CEO of Galvanize Therapeutics, commented on the significance of the findings, stating, "The data from the INCITE-ES study underscores the potential of Aliya PEF as a transformative approach in the fight against cancer. By harnessing the body’s own immune system, we are moving closer to offering patients a personalized and potentially more effective treatment option. Our team has been dedicated to investigating the biologic mechanism of action and the data presented at SITC (Free SITC Whitepaper) reflects our ongoing efforts to establish Aliya in the treatment of solid tumors."

The Aliya System is 510(k) cleared in the United States for the surgical ablation of soft tissue. It is not currently commercially available in any other geography.