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Orgenesis to collaborate with Fortune 500 firm Leidos on potential coronavirus treatment

Published: 10:58 22 Jun 2020 EDT

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Ranpirnase catalyzes the degradation of RNA and mediates several essential biological activities, including the regulation of cell proliferation, maturation, differentiation and cell death

Orgenesis Inc (NASDAQ:ORGS) announced that it has signed a non-binding preliminary term sheet with Leidos, a Fortune 500 IT an engineering company, to develop and potentially gain marketing approval of its drug Ranpirnase from the US Food and Drug Administration as a coronavirus treatment. 

Ranpirnase is an antiviral agent that could potentially treat SARS-CoV-2, the virus that causes the disease COVID-19. Orgenesis added the drug to its portfolio when it acquired Tamir Biotechnology Inc in April.

It catalyzes the degradation of RNA and mediates several essential biological activities, including the regulation of cell proliferation, maturation, differentiation and cell death. More than 1,000 patients have been dosed with Ranpirnase in previous cancer/mesothelioma trials, and the drug has shown a strong safety and tolerability profile.

READ: Orgenesis launches BioShield Program to fight spread of viruses such as coronavirus

“Based on the preclinical data, we are encouraged by the potential for Ranpirnase as an effective antiviral therapy for SARS-COV-2,” Orgenesis CEO Vered Caplain said. “We believe this platform could address a significant need in the market and we look forward to leveraging Leidos’ expertise in development and clinical trial oversight, as well as relationships with government agencies, to possibly accelerate the development of Ranpirnase and its use as a potential treatment of patients with SARS-CoV-2.”

Leidos, for its part, conducted SARS-CoV-2 in vitro studies of Ranpirnase at the University of Tennessee Health Sciences Center Regional Biocontainment Laboratory (UTHSC RBL) and George Mason University National Center for Biodefense and Infectious Diseases. The drug was significantly effective in killing the virus, with an eightfold average decrease in the number of plaque-forming units compared to a placebo. 

The firm subsequently submitted a pre-Investigational New Drug meeting request with the FDA to fast track the drug. 

“We are excited to team with Orgenesis for the development of Ranpirnase,” Leidos Health Group President Elizabeth Porter said. “We believe that this treatment has the potential to transform our understanding of SARS-CoV-2 and provide new ways to fight this global pandemic. We look forward to collaborating with Orgenesis through each stage of the drug’s development.”

Orgenesis, based in Germantown, Maryland, is focused on accelerating the commercialization of transforming the delivery of cell and gene therapies while also lowering costs.

Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com

Follow him on Twitter @andrew_kessel

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