Galvanize Therapeutics’ Aliya Pulsed Electric Field Studied for Lung Cancer

September 20, 2023—Galvanize Therapeutics, Inc. announced the commencement of the AFFINITY clinical study with the treatment of the first patient. The prospective trial is intended to demonstrate the safety and technical success of the company’s Aliya pulsed electric field (PEF) system in patients with stage IV nonsmall-cell lung cancer (NSCLC) or metastasis to the lung who are not surgical candidates.

According to company, AFFINITY is a prospective, single-arm, non-randomized, multicenter, open-label, early feasibility study conducted at three centers in the United States. The study will enroll up to 10 nonsurgical patients with stage IV NSCLC or lung metastasis who are indicated for first-line standard of care therapy.

In the study, the Aliya PEF device may be delivered using either a bronchoscopic or percutaneous approach. Investigators will examine the safety of adding Aliya PEF treatment to the care pathway for these advanced disease patients and further assess the potential immune modulation and treatment effect, noted the company.

Galvanize Therapeutics’ 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 nonthermal programmed cell death without denaturing cellular proteins and extracellular matrix. In addition to focal ablation, preclinical and previous clinical studies suggest this process may release antigens from the dying tumor cells that may stimulate an immune response for a potential systemic effect beyond focal ablation, stated the company.

The Aliya endobronchial needle, which enables delivery of the Aliya PEF through a bronchoscope, was used for the first time in the United States via robotic-assisted bronchoscopy. The procedure was conducted by Michael Pritchett, DO, a pulmonology specialist with Pinehurst Medical Clinic and Director of Chest Center of the Carolinas at FirstHealth in Pinehurst, North Carolina.

“Today’s procedure was a glimpse into the future,” commented Dr. Pritchett in the company’s press release. “In a patient with two suspected oligometastatic lesions in the lung, we used the Intuitive Ion robotic platform (Intuitive Surgical, Inc.) to navigate to a 10-mm lesion on the left and biopsy. Onsite pathologic evaluation confirmed malignancy, mostly likely secondary to metastatic renal cell carcinoma.”

Dr. Pritchett continued, “We then maintained our position at the lesion and treated it with Aliya. After this we moved to a 5-mm lesion on the right and completed treatment of this lesion as well, using cone beam CT to confirm accurate positioning within the small lesion.”

Dr. Pritchett concluded, “It’s exciting to be able to diagnose and treat in a single procedure, but we have the added prospect of creating a systemic response in a patient with metastatic disease which is a game changer. Best of all, the patient went home the same day with a recovery equivalent to a biopsy alone.”

In March 2023, Galvanize Therapeutics announced the presentation of the positive preclinical and early clinical study results using the Aliya PEF system, including safety and feasibility in patients with NSCLC, and preclinical results comparing PEF and radiofrequency ablation. The findings were presented at SIR 2023, the Society for Interventional Radiology’s annual scientific meeting in Phoenix, Arizona.

The company noted that the INCITE-ES clinical study in NSCLC patients outside the United States demonstrated the safety and feasibility of Aliya to deliver PEF before surgery, as well as Aliya’s potential to stimulate an immune response.

The Aliya PEF 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 markets. The Aliya endobronchial needle is an investigational device in the United States, advised the company.