March 25, 2025 Company Name: AnGes Inc.
Presentative: Ei Yamada, President & CEO
Following our disclosure on September 4, 2025, entitled "Notice of Initiation of a New Clinical Study of the Jointly Developed Tie2 Receptor Agonist (AV-001)", we hereby announce that the first patient has been dosed in a new clinical trial of AV-001 (Pegevongitide), a Tie2 receptor agonist jointly developed by our company and Vasomune Therapeutics, Inc. (Headquarters: Canada; CEO: Dr. Brian E. Jahns), a Canadian biopharmaceutical company.
This new clinical study is being conducted to evaluate AV-001 for the prevention of acute ischemic brain injury in patients receiving regular hemodialysis.
This investigator-initiated clinical trial has been approved by Health Canada and is being conducted with grant support from the prestigious Heart and Stroke Foundation. The study has the potential to redefine approaches to protecting brain health in patients receiving hemodialysis.
Please note that this approval will have no impact on our consolidated financial results for the fiscal year ending December 2026. Should any matters requiring disclosure arise in the future, we will provide prompt notification.
For further details, please refer to the attached press release.
(Note)This document has been translated from the Japanese original for reference purposes only.
In the event of any discrepancy between this translation and the Japanese original, the original shall prevail.
Toronto, ON -March 24- The first patient has been treated in a unique clinical trial to evaluate the safety and efficacy of a novel pharmacologic intervention aimed at preventing acute ischemic brain injury in patients undergoing routine hemodialysis. Pegevongitide (AV-001), a made-in-Canada drug candidate codeveloped by Vasomune Therapeutics Inc., and AnGes., Inc., will work to stabilize the cerebral vasculature, which undergoes significant
circulatory stress during the hemodialysis procedure. Cerebrovascular destabilization is linked to vascular cognitive impairment in up to 70% of patients initiating routine hemodialysis.
The study is led by Dr. Christopher McIntyre, Professor of Medicine, Medical Biophysics, and Paediatrics at Western University and holder of the Robert Lindsay Chair of Dialysis
Research and Innovation. Dr. McIntyre also serves as Director of the Lilibeth Caberto Kidney Clinical Research Unit at London Health Sciences Centre, where he practices as a Clinical Nephrologist. A recognized leader in kidney research, Dr. McIntyre leads a multidisciplinary team investigating the pathophysiological impact of chronic kidney disease on cardiovascular, neurological, hepatic, and gastrointestinal systems. His recent work increasingly focuses on mitigating the adverse consequences of dialysis therapy itself. Hemodialysis patients are uniquely vulnerable to recurrent ischemic brain injury caused by circulatory stress during treatment. Pegevongitide (AV-001) offers a promising new approach by targeting the
Tie2/Angiopoietin-1 signaling pathway to stabilize blood vessels and prevent vascular leakage. With the initiation of this study, Vasomune now moves into a new and exciting arena of working to improve cerebrovascular health in patients. Positive findings from this study will inform a
larger confirmatory trial and could lead to improved quality-of-life and functionality for this high-risk population.
About Vasomune Therapeutics, Inc.Vasomune Therapeutics, Inc. is a private clinical-stage biopharmaceutical company developing the next generation of medicines to boost the body's ability to defend against vascular leak. Founded in 2014, Vasomune has focused on vascular normalization strategies, and has progressed the lead candidate Pegevongitide (AV-001) from bench to bedside. Vascular dysfunction and vascular leak are associated with the pathology of several disease states, including bacterial and viral pneumonia and acute respiratory distress syndrome, sepsis, hemorrhagic shock, acute kidney injury, stroke, and vascular dementia. Vasomune's corporate headquarters and laboratories are in Toronto, Canada with US offices in Raleigh, NC. For more information about the company please visit http://www.vasomune.com.
About AnGes, Inc.AnGes, Inc., a biopharmaceutical company founded in December 1999, focuses on the development of gene-based medicines. The company's flagship development product and genetic drug, HGF gene therapy products, received Breakthrough Therapy designation from the FDA in 2024. AnGes is currently working on the development of a Tie2 tyrosine kinase receptor agonist (AV-001) for viral and bacterial-associated pneumonia and an NF-κB decoy oligonucleotide for chronic discogenic lumbar back pain.
Furthermore, AnGes acquired EmendoBio in December 2020 to expand its capabilities in genome-editing technologies. For more information, visit https://www.anges.co.jp/en/.