GRI Bio Presents Translational Data Demonstrating Connection Between NKT Cells and the Pathogenesis of Idiopathic Pulmonary Fibrosis (IPF) at the 2023 Pittsburgh-Ireland International Lung Conference

Findings demonstrate that the number of NKT cells positively correlates with the number of airway macrophages in IPF patients

GRI Bio on track to launch Phase 2a biomarker study for lead program, GRI-0621 a type 1 invariant NKT (iNKT) antagonist for the treatment of IPF before year end

LA JOLLA, CA, Oct. 19, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the presentation of translational data at the 2023 Pittsburgh-Ireland International Lung Conference: Precision Medicine in Lung Diseases: From Cellular Mechanisms to Clinical Phenotypes held October 16-17, 2023 at the RCSI University of Medicine and Health Sciences in Dublin, Ireland. The abstract titled “Altered NKT cell populations in the airways of patients with IPF,” was presented in a poster presentation by collaborator Emily Calamita of Dr. Adam Byrne’s laboratory.

IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. Natural killer T (NKT) cells are a subset of innate-like T lymphocytes that recognize lipid antigens, by expressing the T-cell receptor (TCR) Vα24-Jα18 chain. Upon activation, NKT cells produce numerous cytokines, including those that have been shown to drive IPF pathogenesis. In animal models of lung fibrosis, NKT cells have been shown to drive IPF pathology. However, their role in human IPF remains unknown.

“There remains an urgent need to understand the mechanism underlying IPF. These data add to our growing belief in the key role of NKT cells in the pathogenesis of IPF and bolsters our confidence in GRI-0621’s ability to provide a much-needed therapeutic option for patients,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “Supported by a growing body of data, we are on track to launch our Phase 2a biomarker study before year end to evaluate GRI-0621 as a potential treatment option for this devastating disease.”

For the translational study, surface and intracellular flow cytometry of cells isolated from bronchoalveolar lavage (BAL) and blood of healthy donors and IPF patients was conducted to characterize their NKT cell compartment.

Key Findings: 

• In the BAL of IPF patients, a significant increase in the number of NKT cells was observed in comparison to healthy controls.
• Numbers of NKT cells correlated positively with the number of airway macrophages (AMs) in IPF BAL.
• Increased expression of NKT-IFN_γ was also observed in the BAL of IPF patients relative to controls.
• The number of NKT cells positively correlated with the number of airway macrophages in IPF patients. However, the correlation with lung function parameters did not reach significance in this small study.

GRI Bio’s lead program, GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human type 1, iNKT cells. In preliminary trials to date¹ and previous trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients.