Orgenesis Inc., a biotech company working to accelerate commercialization and transform the delivery of cell and gene therapies (CGTs), has announced that it has entered into a preliminary, non-binding term sheet with Leidos, to develop, and potentially obtain FDA marketing approval of Orgenesis’ Ranpirnase for the systemic treatment of patients suffering with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19.
Orgenesis recently acquired the assets of Tamir Biotechnology, Inc., including Ranpirnase, a broad spectrum antiviral agent. Ranpirnase catalyzes the degradation of RNA, and mediates several essential biological activities, including the regulation of cell proliferation, maturation, differentiation, and cell death. Therefore, it is a potential candidate for the development of therapeutics for life-threatening diseases, including viral and autoimmune diseases, that require anti-proliferative and pro-apoptotic properties.
Over 1,000 patients have been dosed with Ranpirnase in previous cancer/mesothelioma clinical trials. Ranpirnase has already demonstrated a strong safety and tolerability profile. Ranpirnase has also demonstrated preclinical antiviral activity in serious viral diseases, such as cytomegalovirus (CMV), influenza, HIV, Ebola, and SARS. This is based on its unique mechanism of action, which was shown to eradicate the virus and modulate the immune system in a series of in vitro studies.
Leidos conducted 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 (GMU NCBID) against the SARS CoV-2 virus. The in vitro studies demonstrated that Ranpirnase was significantly effective in killing the SARS CoV-2 virus – with an eight-fold average decrease in the number of plaque forming units when cultures with Ranpirnase were compared to the controls treated with a placebo. Based on these initial pre-clinical results, a pre-IND meeting request to fast track Ranpirnase for the treatment of SARS-COV-2 has been submitted by Leidos to the FDA.
Vered Caplan, CEO of Orgenesis, stated, “Based on the pre-clinical data, we are encouraged by the potential for Ranpirnase as an effective antiviral therapy for SARS-COV-2. 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.”
Elizabeth Porter, Leidos Health Group president, said, “We are excited to team with Orgenesis for the development of Ranpirnase. 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.”
