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INCITE ES clinical study results suggest the Aliya™ PEF system may stimulate an immune response

BOSTON, Nov. 10, 2022 /PRNewswire/ -- Galvanize Therapeutics, Inc., a commercial-stage biomedical platform company operating at the convergence of engineering, biology and healthcare delivery, today announced promising clinical data using its Aliya™ Pulsed Electric Field (PEF) system in patients with non-small cell lung cancer (NSCLC).

Initial results from the INCITE-ES clinical study conducted outside of the U.S., presented at this week's Society for Immunotherapy of Cancer's (SITC) 37th Annual Meeting, indicate that the Aliya PEF system has the potential to stimulate an immune response in NSCLC patients.

INCITE-ES is a prospective, two-arm, non-randomized, concurrently controlled, multi-center treat-and-resect study in patients with suspected or confirmed NSCLC stage IA2-IB. In 30 patients PEF energy was delivered to a solitary tumor either percutaneously or endoscopically at the time of biopsy, prior to surgical resection. Eight additional patients were enrolled in the non-treated control group. Data presented previously demonstrated safety and feasibility to deliver PEF with no device or procedure-related adverse events. In an initial cohort of 10 PEF treated patients, tertiary lymphoid structures (TLS) [average 43.1 ± 41.0, (range 5-113)] were observed within tumors post-PEF, whereas none were identified on pre-PEF biopsy. TLS accumulation was greater in the PEF treated group as compared to the non-treated control group. TLS formation, shown in other studies to generate anti-tumor immunity¹, is emerging as a strong prognostic and predictive biomarker2 associated with patient survival benefits in NSCLC3,4.

"The five-year survival rate for NSCLC has only modestly improved from 13% in the 1970s to 21.7% in 20195, despite advances in surgery, radiation and advanced therapeutics," explained Marcelo Jimenez, MD, PhD, Professor of Surgery, Thoracic Surgery Department, Salamanca University Hospital, Spain, investigator in the INCITE ES clinical study. "New treatment approaches are critically needed in NSCLC, and early indications of the potential for pulsed- electric field energy to activate the patient's immune system are very encouraging. I look forward to future studies assessing this novel immuno-oncology approach in more patients."

"These early clinical data build upon the recent U.S. Food and Drug Administration (FDA) 510(k) clearance for the Aliya system for soft tissue ablation and add to our confidence that PEF has the potential to mutually kill target cells and create immunogenic molecules," said Jonathan Waldstreicher, M.D., Founder and CEO of Galvanize Therapeutics. "We are eager to expand our clinical program to further understand the opportunity for PEF to stimulate the immune system to activate against NSCLC and other solid tumors."

The Aliya PEF system delivers non-thermal, high-voltage, high-frequency electrical currents through a single monopolar electrode placed in the target tissue. The PEF energy destabilizes the cells, resulting in cell death.

The non-thermal modality of the Aliya PEF system preserves surrounding healthy tissue, enabling ablation near critical 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.

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.

Galvanize Therapeutics aims to become the global leader in delivering medical technology innovations that drive biologic processes to treat a range of diseases, starting with treating chronic bronchitis symptoms, cardiac arrhythmias, and solid tumors. Formed by ATP (Apple Tree Partners) in 2022, Galvanize is based in San Carlos, Calif., and is researching and commercializing its revolutionary Aliya Pulsed Electric Field (PEF) energy platform in the United States and Europe. For more information, please visit www.galvanizetx.com.

1  Schumacher T N, Thommen D S. Tertiary lymphoid structures in cancer. Science. 2022; 375(6576):eabf9419.

2  Petitprez F, de Reynies A, Keung E. B cells are associated with survival and immunotherapy response in sarcoma. Nature. 2020;577(7791):556 - 560.

3  Sautès-Fridman C, Petitprez F, Calderaro J. Tertiary lymphoid structures in the era of cancer immunotherapy. Nat Rev Cancer. 2019; 19:307 - 325.

4  Cottrell T R, Thompson E D, Forde P M. Pathologic features of response to neoadjuvant anti-PD-1 in resected non- small-cell lung carcinoma: a proposal for quantitative immune-related pathologic response criteria (irPRC). Ann Oncol. 2018;29(8):1853-1860.

5  American Lung Association, State of Lung Cancer 2019

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SOURCE Galvanize Therapeutics, Inc.