TORONTO--(BUSINESS WIRE)-- Vasomune, a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of diseases associated with vascular dysfunction, announced today it has received a Peer-Reviewed Medical Research Program (PRMRP) Clinical Trial Award (CTA) grant for US $6.4 million from the U.S. Department of Defense (DOD). In addition, the company is receiving advisory services and research and development funding of up to $2.8 Million from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP).

“We are extremely grateful for the financial support from the DOD’s Congressionally Directed Medical Research Programs’ (CDMRP) PRMRP and NRC IRAP programs which will enable Vasomune to accelerate clinical development of AV-001” said Douglas A. Hamilton, President and CEO of Vasomune.“ Preclinical data suggest AV-001’s mechanism of action has the potential to reduce mortality and morbidity of SARS-CoV-2 including the emergence of new variants.”

“Our strategic approach to SARS-CoV-2 involves the development of AV-001 for treating patients with severe COVID-19 disease and vaccines to prevent infection”, said Ei Yamada, President and CEO of AnGes, Inc., Vasomune’s co-development partner, “We very much appreciate the government grants that will help to accelerate the clinical development of AV-001.”

Vasomune’s grant was received from PRMRP and awarded effective September 1, 2021. Vasomune’s clinical development program for AV-001 received an application score of “Excellent” or 1.6 on a scale of 1 to 5 through a rigorous two-tiered peer-review system in which 13.8% of overall invited applicants receive recommendations for funding. The funding from the PRMRP award will be utilized to support the Phase 2a study of AV-001 in patients hospitalized with severe COVID-19 disease. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

The NRC IRAP funding, which was initially set up for $1.2 million, was amended on August 25, 2021, increasing the total level of funding up to $2.8 million. Funding from NRC IRAP program will support Phase 1 clinical development and other studies required for submission of the Clinical Trial Application (CTA) to Health Canada.

About AV-001

Originally discovered and designed at Sunnybrook Hospital in Toronto, AV-001 is being developed by Vasomune Therapeutics, Inc. under a co-development agreement with AnGes, Inc. [TYO: 4563]. AV-001 is a novel investigational medicine that targets the Tie2 receptor, a transmembrane protein target most highly expressed on the surface of endothelial cells in the vasculature.

AV-001 activates the nonredundant Tie2-Angiopoietin signaling axis, and through stimulation of multiple downstream pathways restores normal vascular function and endothelial stability. Vascular dysfunction contributes to the underlying disease pathophysiology in patients with COVID-19, including respiratory distress, hypercoagulopathy, viral sepsis, myocardial inflammation and acute kidney injury, especially in those patients with pre-existing vascular comorbidities, such as hypertension, diabetes and obesity. Emerging evidence suggests SARS-CoV-2 infects pulmonary endothelial cells and causes microvascular leaks, contributing to the initiation and propagation of respiratory distress in COVID-19 patients by altering blood vessel barrier integrity, promoting a coagulated state and inducing vascular inflammation (endotheliitis). In preclinical studies involving a lethal RNA virus infection animal model of influenza,

AV-001 has been shown to stabilize the vasculature by enhancing endothelial cell stability, restoring normal barrier defense and blocking vascular leak. Importantly, AV-001 monotherapy significantly improved survival and lung function compared to untreated controls and showed the benefit of enhanced recovery in combination with antiviral therapy.

About Vasomune Therapeutics, Inc.

Vasomune Therapeutics, Inc. is a private clinical-stage biopharmaceutical company developing the next generation of medicines to harness the body’s ability to defend against illness. Originally founded in 2014, Vasomune discovers and develops drugs using a novel therapeutic approach focused on vascular normalization strategies. Vascular dysfunction is associated with the pathology of several disease states, including COVID-19, viral and bacterial-associated pneumonia, acute kidney injury, glaucoma, hemorrhagic shock, sepsis, stroke and complications associated with diabetes. Vasomune’s corporate headquarters and laboratories are located in Toronto, Canada with US offices in San Mateo, CA. For more information about the company and its product candidates, please visit www.vasomune.com.

About AnGes, Inc.

AnGes, Inc., a biopharmaceutical company founded in December 1999, focuses on the development of gene-based medicines. In March 2019, AnGes obtained conditional and time-limited approval for its lead product, Collategene® (Hepatocyte Growth Factor; HGF—plasmid gene therapy), for the treatment of lower limb ischemic ulcers. In September 2019, AnGes commenced commercialization in Japan of Collategene®, the world’s first marketed drug using plasmid DNA. AnGes is currently working on the development of DNA vaccines for COVID-19 and hypertension, a Tie2 tyrosine kinase receptor agonist (AV-001) for COVID-19 treatment 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/.

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