BRZ-101 (BreezeBio)

BRZ-101 is a novel mRNA-based immune modulation therapy developed by BreezeBio (formerly GenEdit) for the treatment of type 1 diabetes. The therapy utilizes the proprietary NanoGalaxy® platform to engineer hybrid nanoparticles (HNPs) that deliver mRNA encoding islet-specific autoantigens along with tolerogenic co-factors to antigen-presenting cells (APCs). Upon delivery, the APCs present these antigens to T cells in a tolerogenic context, inducing the formation of antigen-specific regulatory T cells (Tregs). These Tregs are designed to selectively suppress the autoimmune response against pancreatic beta cells without compromising the overall function of the immune system. BRZ-101 is currently in the lead optimization and IND-enabling stage of development.