Galvanize Therapeutics, Inc.

REDWOOD CITY, Calif., Aug. 6, 2024 /PRNewswire/ -- Galvanize Therapeutics, Inc., a leader in developing pulsed electric field therapies for chronic bronchitis and solid tumors, has completed enrollment in the AFFINITY study evaluating Aliya PEF ablation in patients with stage IV non-small cell lung cancer (NSCLC) or metastasis to the lung who are not surgical candidates. The 30-patient study is examining the safety of adding Aliya PEF, delivered either bronchoscopically or percutaneously, to standard of care therapies for these advanced disease patients and further assessing immune stimulation and treatment effect. "Completing enrollment in AFFINITY is a significant milestone towards our goal of providing patients with solid tumors a biology-based therapy that extends beyond focal ablation," said Jonathan Waldstreicher, M.D., Founder and CEO of Galvanize Therapeutics. "We look forward to reporting the results next year." Aliya delivers high voltage, short duration electrical energy locally to alter the transmembrane potential of cells, which results in loss of homeostasis, inducing non-thermal programmed cell death without denaturing cellular proteins and the extracellular matrix. In addition to focal ablation, preclinical and prior clinical feasibility 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. Aliya can be delivered percutaneously or endoscopically with the new INUMI™ Flex needle. To date over 1,000 patients have been treated commercially and in clinical trials in the US using Aliya PEF. "I'm excited to see the study results for this new technology", said David DiBardino, MD, Associate Director of Clinical Research, Section of Interventional Pulmonology and Associate Professor of Clinical Medicine, Pulmonology, Allergy, and Critical Care at University of Pennsylvania, and investigator in the AFFINITY trial. "It's great to be able to diagnose and ablate in the same procedure, however the added potential to stimulate the patient's immune system to create a systemic response represents a breakthrough for patients with metastatic disease." The Aliya PEF System and the INUMI Flex needle are 510(k) cleared in the United States for the surgical ablation of soft tissue. They are not currently commercially available in any other geography. About Galvanize™ Galvanize aims to become the global leader in delivering medical technology innovations that drive biologic processes to treat a range of diseases, including solid tumors, and chronic bronchitis symptoms. Formed by ATP (Apple Tree Partners), Galvanize is based in Redwood City, Calif., and is developing and commercializing its revolutionary Aliya® PEF energy platform in the United States. For more information, please visit . SOURCE Galvanize Therapeutics, Inc.

Doug Godshall Becomes Executive Chairman Zhen Su, MD, MBA, Appointed to the Board of Directors to Bring Oncology Expertise REDWOOD CITY, Calif., July 2, 2024 /PRNewswire/ -- Galvanize, a leader in Pulsed Electric Field (PEF) technologies, today announced the appointments of Doug Godshall to Executive Chairman and Zhen Su, MD, PhD to its board of directors. Godshall was CEO of Shockwave Medical from 2017 until the sale of the company to Johnson & Johnson for $13.1 billion in May, 2024. Before, he was CEO of HeartWare International which was acquired by Medtronic in 2016 for $1.1 billion. Doug started his career at Boston Scientific where he rose from a sales representative to President of the Vascular Surgery division and a member the Operating Committee. He also serves as Chairman of Saluda Medical. Godshall commented: "Over the last several years I have been impressed by the clinical impact Galvanize products are having on patients and look forward to this expanded role as Executive Chairman where I can work more closely with the team on the INUMI Flex launch and scaling the commercial business. I believe the interventional oncology space is primed for growth, as new advancements, by Galvanize and others, will make devices a more integral component of the treatment continuum." Zhen Su is CEO of Marengo Therapeutics, a clinical-stage biotech company which is developing novel T-cell Receptor-targeting antibodies to provide lifelong protection against cancer and other diseases. Prior to Marengo, Zhen served as Senior Vice President and Global Head of Oncology for Merck KGaA, where he led the franchise's turnaround to achieve double-digit organic growth and an annual revenue above €1B. He also held leadership roles with EMD Serono, Sanofi Oncology and GSK. Dr. Su stated: "Having spent almost three decades of my career studying tumor immunology and developing immune-oncology treatments, I am impressed that Galvanize is developing innovative medical devices with exciting clinical impacts for patients, especially for late-stage cancer patients. Preclinically, there appears to be a synergy between Galvanize's Aliya energy with standard of care IO therapeutics, particularly neoantigen release, which we hope to prove out in trials. I look forward to joining the board of directors to support the company in its ambition to build strong clinical evidence and pursue indications to establish Aliya in the care pathway for patients with solid tumors." "We are thrilled to have Doug expand his role with Galvanize and for Zhen to join the board. With the recent FDA 510(k) clearance of the INUMI Flex Endoscopic Needle and growing clinical trial experience, we are excited to bring these technologies to patients and their physicians with the appropriate oversight and leadership." Aliya, with the INUMI Flex needle, is the first commercially available system to deliver PEF energy through an endoscope, enabling physicians to reach and non-thermally ablate soft tissue lesions. Aliya delivers high voltage, short duration electrical energy locally to alter the transmembrane potential of cells, which results in loss of homeostasis, inducing non-thermal programmed cell death without denaturing cellular proteins and the 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. Aliya can be delivered using either an endoscopic or percutaneous approach. The Aliya PEF System and the INUMI Flex needle are 510(k) cleared in the United States for the surgical ablation of soft tissue. They are not currently commercially available in any other geography. About Galvanize™ Galvanize Therapeutics aims to become the global leader in delivering medical technology innovations that drive biologic processes to treat a range of diseases, including solid tumors and chronic bronchitis symptoms. Formed by ATP (Apple Tree Partners), Galvanize is based in Redwood City, Calif., and is developing and commercializing its revolutionary Aliya® PEF energy platform in the United States. For more information, please visit . SOURCE Galvanize Therapeutics, Inc.

Galvanize Therapeutics billed its forthcoming system as the first commercial product to combine pulsed field ablation with an endoscope, allowing for minimally invasive treatment alongside biopsy procedures. Pulsed field ablation has been making waves in cardiac procedures in the past few months following a series of green lights among major devicemakers looking to offer treatments for atrial fibrillation and irregular heart rhythms with fewer side effects. Now, Galvanize Therapeutics is jumping in with its system that broadens the use of the tech to patients with cancer. The company collected an FDA 510(k) clearance for its INUMI Flex endoscopic needle ablation system, a part of its Aliya pulsed field energy portfolio, for use against soft-tissue lesions including lung nodules that can harbor tumor cells. Compared to traditional surgical ablation approaches that deliver heat or cold energy to a broader area, pulsed field ablation aims to be more selective by using tuned electricity to break down the membranes of troublesome cells. According to Galvanize—which billed its forthcoming system as the first commercial product to combine pulsed field ablation with an endoscope—clinical trials have shown reductions in malignant tissue among patients with early-stage non-small cell lung cancer, with the energy being delivered immediately after a biopsy. In addition, the company said that opening up those tumor cells and releasing certain proteins could pave the way for stronger responses from the body’s wider immune system—as seen in preliminary data from a clinical trial of the Aliya system, which was previously cleared for needle-based procedures conducted through the skin. “The ability to diagnose and treat in a single non-invasive endoscopic procedure represents a major advancement,” said Michael Pritchett, director of the FirstHealth Chest Center of the Carolinas and an investigator in the company’s ongoing clinical trial of Aliya’s first-line use among metastatic lung cancer patients. “The potential to stimulate the patient's immune system to create a systemic response beyond the focal ablation could be a game changer and may provide new hope for patients with metastatic disease,” Pritchett said in a statement. Today’s Galvanize Therapeutics was born in late 2022 from a three-way merger of portfolio companies incubated under Apple Tree Partners, including separate developers of pulsed field ablation tech for solid tumors, chronic bronchitis and arrhythmias.  A coinciding series B funding round netted the outfit $100 million, led by Fidelity Management and joined by Intuitive Surgical, which has a robotic bronchoscopy system that is being used with the Aliya system in its clinical trial. “In a patient with two suspected oligometastatic lesions in the lung, we used the Intuitive Ion robotic platform to navigate to a 10 mm lesion on the left and biopsy,” explained Pritchett late last year as the company’s study got underway. “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 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,” he said. “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,” Pritchett added. “Best of all, the patient went home the same day with a recovery equivalent to a biopsy alone.” Last year also saw Galvanize conduct layoffs; the company did not disclose how many people or departments were affected at the time. Its cardiac electrophysiology division was later acquired by CardioFocus. Galvanize’s other product, the CE marked RheOx system, targets patients with chronic obstructive pulmonary disease, or COPD, to disrupt the mucus-producing cells in the airway that are linked with long-term bronchitis. Aliya, meanwhile, is also being explored for liver, kidney and breast cancers. “As physicians increasingly shift from percutaneous to endoscopic access of target lesions, our team developed INUMI Flex to meet their needs,” Galvanize CEO Jonathan Waldstreicher, M.D., said in a statement. “Having demonstrated the effects of Aliya beyond focal ablation in early studies, we continue to invest in understanding the full potential of biologic activation and its unique immune response in clinical trials.”