SAN DIEGO - Marylandian -- OrPro Therapeutics, Inc., a San Diego Johnson & Johnson JLABS alumni and 2022 SD CONNECT Cool Company, is pleased to announce that it has been awarded a Fiscal Year 2021 (FY21) Peer Reviewed Medical Research Program (PRMRP) Technology/Therapeutic Development grant under the Congressionally Directed Medical Research Program (CDMRP) of the US Department of Defense. This $2.147M award entitled "Development of Monothiol Human Thioredoxin-1 (ORP100S) as an Inhaled Treatment for Acute Viral Lung Injury" involves OrPro researchers and collaborators at the Institute for Airway Sciences in the Icahn School of Medicine at Mount Sinai (New York, NY), Lovelace Biomedical (Albuquerque, NM), and KCAS Bioanalytical Services (Olathe, KS). Project advisors include innate immunity opinion leader Dr. Richard Ulevitch, Professor and former Chair of the Department of Immunology at Scripps Research; 3-D stem cell derived human lung organoid pioneer Dr. Ya-Wen Chen at Mount Sinai; and internationally recognized inhalation toxicology expert Dr. Jeffrey Tepper.

The objective of the grant-funded research is to understand the pharmacodynamic effect of ORP100S in vitro and in vivo for treatment of relevant viral diseases (COVID-19 and influenza), as well as to establish a validated bioanalytical method for the detection and quantification of ORP100S in plasma/serum and lung matrices from humans and non-clinical toxicology species. These objectives represent key ORP100S development milestones toward a US FDA Investigational New Drug (IND) filing and human clinical trials.

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"CDMRP funding is highly competitive. Our team is tremendously excited to be recognized by the Department of Defense for the potential of our drug platform to impact respiratory health by filling a critical gap in the prevention of lung injury associated with viral infection and inflammation," said Dr. Peter Heifetz, Founder, President and CEO of OrPro Therapeutics. "This award will enable us to rapidly advance ORP100S for multiple indications with high unmet medical need."

"Our 3-D human lung organoid system has been proven to accurately recapitulate respiratory viral infection and host responses, making it ideal for evaluation of the efficacy and mechanism of novel therapeutics. I am looking forward to working with Principal Investigator Dr. Heifetz and the project team to combine our in vitro human system with parallel in vivo studies in relevant animal infection models, said Dr. Ya-Wen Chen, Assistant Professor, Icahn School of Medicine at Mount Sinai. "This dual approach has great promise for enabling successful translation to clinical studies."

Thioredoxin

Secreted human thioredoxin (TRX) is a target-selective thiol-disulfide exchange enzyme that acts homeostatically to modulate inflammatory cytokine release, oxidative stress, and abnormal airway mucus viscoelasticity via regulatory interaction with extracellular cell-surface protein disulfides. TRX lowers inflammation in acute lung injury, and published studies show it can prevent viral pneumonia and increase survival in influenza-infected animal models. OrPro has developed the proprietary Theradux® platform of TRX derivatives optimized for extracellular delivery and function with increased half-life and decreased potential for intracellular uptake and off-target activity. Lead development candidate ORP100S is highly active extracellularly as a cell protectant without promoting cellular proliferation and is being advanced as an inhaled nebulized solution for treatment of acute and chronic obstructive/inflammatory airway diseases.

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About OrPro Therapeutics

OrPro Therapeutics, Inc is a privately held preclinical-stage company pioneering a novel biologic drug platform for treating severe respiratory, ophthalmic, and mucosal diseases. The company's differentiated approach targets both lung clearance and inflammation as well as obstructive/inflammatory disorders associated with non-respiratory mucosal surfaces in the body. Launched in 2013 with technology in-licensed from National Jewish Health, the leading US respiratory research center, the company has secured Series A financing and significant non-dilutive grant funding from the National Institutes of Health and the Cystic Fibrosis Foundation with over $7M raised to date. For more information visit www.orprotherapeutics.com.

Contact

Peter Heifetz, Ph.D. OrPro Therapeutics, Inc. pheifetz@orprotherapeutics.com;

Media:  Joleen Schultz, joleen@joleenschultzassociates.com; 760-271-8150