Georgiamune Inc. has announced the dosing of the first participant in a Phase 1 clinical trial of GIM-407, a first-in-class, orally administered, selective T-regulatory cell (T-reg) activator, for the treatment of autoimmune diseases. This trial marks a significant step in Georgiamune's development of novel therapies targeting immune homeostasis. The data generated will inform the selection of autoimmune diseases to target in future clinical phases.
The Phase 1 trial is designed to evaluate the safety, tolerability, and pharmacokinetics of GIM-407 in healthy volunteers. GIM-407's unique mechanism of action as a selective T-reg activator holds promise for restoring immune balance in patients with a range of autoimmune disorders.
Addressing Unmet Needs in Autoimmune Diseases
Autoimmune diseases affect nearly 50 million Americans, representing a substantial healthcare challenge. Current treatments often involve broad immunosuppression, which can lead to significant side effects. GIM-407's selective T-reg activation offers a potentially more targeted approach to managing autoimmune conditions, addressing a critical unmet need in this patient population.
"GIM-407's unique, selective T-reg activator may provide a novel treatment opportunity for autoimmune disease patients with profound unmet needs," said Mark Anderson, professor at UCSF and the Director of the NIH Immune Tolerance Network.
Georgiamune's Pipeline and Approach
Georgiamune is focused on reprogramming immune signaling pathways to redirect the immune system to fight diseases. GIM-407 is the company's first autoimmune disease program. Georgiamune has initiated three first-in-class assets in clinical trials (GIM-122, GIM-531 and GIM-407) in the past 12 months, all based on novel biology discovered by Georgiamune.
"GIM-407 and other first-in-class drugs we developed based on our novel discovery platforms in T cell regulation emphasizes our mission to deliver breakthrough therapeutics for autoimmune disease and cancer patients with high unmet needs," said Dr. Samir N. Khleif, Georgiamune founder and Chief Executive Officer.
