GRI Bio Presents Data Supporting Innovative Pipeline of NKT Cell Modulators for the Treatment of High-Value Inflammatory, Fibrotic and Autoimmune Diseases

Data presented at the 7^th Annual Antifibrotic Drug Development (AFDD) Summit

Company’s lead program, GRI-0621, has demonstrated ability to inhibit the activity of type I invariant NKT (iNKT) cells early in the inflammatory cascade to prevent cytokine release, cellular infiltration, and interrupts disease progression at the source

Daily oral administration of GRI-0621 (a human equivalent dose) leads to reduced lung damage and a significant reduction in Bleomycin-induced lung fibrosis

LA JOLLA, CA, Oct. 31, 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 data supporting its novel approach to inflammatory diseases at the 7^th Annual Antifibrotic Drug Development (AFDD) Summit held October 24-26, 2023 in Boston, MA.

As part of the AFDD Summit, Vipin Kumar, PhD, Chief Scientific Officer of GRI Bio gave an oral presentation titled, “Exploration of NKT Cell Activation as an Immune Biomarker for Progression of Fibrosis,” and participated in a panel discussion titled, Reviewing Biomarkers Discussed in the Context of Fibrosis & Oncology, which discussed the promising new avenues for evaluating fibrosis staging in vivo, in vitro and in patient; review the advantages and pitfalls of fluid markers vs imaging for fibrosis diagnostics; and illuminate similarities and differences in biomarkers across fibrotic disease and tumor fibrosis. The slides accompanying Dr. Kumar’s oral presentation are available on the Publications page of the Company’s website.

“We continue to be encouraged by the data being generated by GRI-0621 and the translational work we are doing with our collaborators that demonstrate a significant increase in iNKT cell numbers in IPF patients and their correlation with biomarkers of fibrosis and disease,” commented Dr. Kumar. “Looking ahead, we are making progress toward launching our Phase 2a biomarker study for GRI-0621 before year end.”

Key Highlights:

• GRI-0621 has demonstrated itself as a potent inhibitor of iNKT cell activity.
• iNKT cells have an activated phenotype in NASH & IPF patients.
• Enhanced iNKT activity correlates with progression of fibrosis in NASH patients and with macrophage accumulation and key proinflammatory genes in BAL from IPF patients.
• iNKT cells are activated and accumulate in liver and lung in experimental fibrosis models.
• iNKT promotes Type 1, Type 2 and Type 3 immune pathways involved in fibrosis.
• iNKT-deficient mice have reduced inflammatory damage and fibrosis.
• Daily oral administration of GRI-0621 in experimental animals
  • Inhibits pro-inflammatory cytokines and inflammation.
  • Decreases accumulation of neutrophils and proinflammatory macrophages
  • Inhibits key fibrogenic cytokines including TGF-b and fibrosis.
• Phase 2 study with GRI-0621 in IPF patients to examine iNKT activity along with key biomarkers.

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.