Oorja Bio announced its launch as a clinical-stage biotechnology company focused on developing therapies for idiopathic pulmonary fibrosis (IPF) and other fibrotic and cardiopulmonary diseases. The company also announced a $30 million Series A financing led by founding investor Westlake BioPartners.
The funding will support the advancement of ORJ-001, Oorja Bio’s lead therapeutic candidate for IPF, while also helping the company expand a broader pipeline of fibrosis-focused therapies. Oorja Bio said ORJ-001 has already received investigational new drug (IND) clearance from the U.S. Food and Drug Administration and is expected to enter a Phase 2 clinical trial in IPF patients later this year.
ORJ-001 is designed as a first-in-class peptide therapeutic administered subcutaneously to restore the function of alveolar epithelial type 2 (AEC2) cells, which play a central role in maintaining and repairing lung tissue. According to the company, dysfunction of these cells is closely linked to the progression of pulmonary fibrosis. Preclinical studies showed that ORJ-001 reversed established fibrosis and regenerated normal lung and alveolar morphology in validated animal models. Additional studies also demonstrated positive effects on biomarkers associated with fibrotic disease progression.
Oorja Bio said it acquired the global rights to ORJ-001 as part of its strategy to build a portfolio of therapeutics targeting the underlying biology of fibrotic diseases rather than simply managing symptoms. The company believes there remains a major unmet need in IPF, where currently approved therapies can slow disease progression but cannot stop ongoing lung deterioration.
The company’s founding leadership team includes executives with experience advancing therapies for pulmonary and cardiovascular diseases. Chief Executive Officer Sujay Kango and Chief Medical Officer Dr. Janethe Pena previously worked together at Acceleron Pharma on the development strategy for sotatercept, a biologic treatment for pulmonary arterial hypertension that was later approved by the FDA following Acceleron’s acquisition by Merck & Co..
Kango most recently served as CEO of Tmunity Therapeutics, which was acquired by Gilead Sciences. He also previously served as Chief Commercial Officer at Acceleron Pharma, where he led commercialization efforts for Reblozyl and sotatercept. Kango currently serves on the board of Dianthus Therapeutics.
Dr. Pena previously held leadership positions at Acceleron Pharma, Merck, and Bayer, where she worked on pulmonary hypertension clinical programs including Adempas.
Oorja Bio’s Chief Business Officer Connie Coulomb brings more than two decades of commercial and strategic transaction experience from leadership roles at Amgen, Biogen, Onyx Pharmaceuticals, and Merck.
Idiopathic pulmonary fibrosis affects more than 150,000 adults in the United States and is characterized by progressive scarring of lung tissue that ultimately leads to respiratory failure. Average life expectancy following diagnosis is typically three to five years.
The company is headquartered in Houston.
KEY QUOTES:
“Oorja Bio’s founding team is very well positioned to accelerate promising drug assets and open up a new chapter for treating IPF and other fibrotic diseases – an area of long-standing challenge for drug development that lacks disease modifying therapies. We look forward to continuing to work with the Oorja Bio team as they advance ORJ-001 in the clinic and build a pipeline to bring new therapies that can redefine the standard of care for patients with IPF and fibrotic diseases.”
Beth Seidenberg, M.D., Founding Managing Director, Westlake BioPartners
“Our team is energized to deliver on our goal of redefining the future of fibrotic diseases, beginning with ORJ-001. As we advance ORJ-001 in the clinic, we are embracing the paradigm shift in our biological understanding of IPF pathology that aligns with the central role of the alveolar epithelium. ORJ-001 was designed with this biology in mind and may provide, for the first time, a therapeutic intervention that repairs and reverses fibrosis and promotes disease modification.”
Sujay Kango, Chief Executive Officer, Oorja Bio
