On September 20, 2023 Galvanize Therapeutics, Inc. reported the treatment of the first patient in the AFFINITY clinical study (Press release, Galvanize Therapeutics, SEP 20, 2023, View Source [SID1234635294]). This prospective trial is intended to demonstrate the safety and technical success of the Aliya Pulsed Electric Field (PEF) System in patients with stage IV non-small cell lung cancer (NSCLC) or metastasis to the lung who are not surgical candidates. Dr. Michael Pritchett, pulmonology specialist with Pinehurst Medical Clinic and Director of Chest Center of the Carolinas at FirstHealth in Pinehurst, North Carolina, used the Aliya Endobronchial Needle for the first time in the United States via robotic-assisted bronchoscopy to complete the procedure.

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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 and prior 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.

Dr. Pritchett commented: "Today’s procedure was a glimpse into the future. In a patient with two suspected oligometastatic lesions in the lung, we used the Intuitive Ion robotic platform to navigate to a 10mm lesion on the left and biopsy. Onsite pathologic evaluation confirmed malignancy, mostly likely secondary to metastatic renal cell carcinoma. We then maintained our position at the lesion and treated it with Aliya. After this we moved to a 5mm lesion on the right and completed treatment of this lesion as well, using Cone Beam CT to confirm accurate positioning within the small lesion. 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."

The AFFINITY study is a prospective, single-arm, non-randomized, multi-center, open-label, early feasibility study conducted at 3 centers in the U.S. The study will enroll up to 10 non-surgical patients with stage IV NSCLC or lung metastasis who are indicated for first line standard of care therapy. Aliya PEF may be delivered using either a bronchoscopic or percutaneous approach. The study 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.

"Our team spent years developing Aliya PEF to synergize with immunotherapy and other standard-of-care therapies in order to provide patients with solid tumors a biology-based therapy that extends beyond what is possible with focal thermal ablation," said Jonathan Waldstreicher, M.D., Founder and CEO of Galvanize Therapeutics. "The AFFINITY study represents a significant step towards treating a broad range of tumor types and in early and late-stage disease."

Galvanize’s INCITE-ES clinical study in NSCLC patients outside the U.S. demonstrated the safety and feasibility of Aliya to deliver PEF prior to 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 geography. The Aliya Endobronchial Needle, which enables delivery through a bronchoscope, is an investigational device in the U.S. Limited by Federal (or United States) law to investigational use only.