Georgiamune Begins Dosing in Phase 1 Trial of GIM-407 with Healthy Volunteers

Georgiamune Inc., a clinical-stage biotechnology firm, has announced the dosing of the first participant with GIM-407 in a phase 1 clinical trial aimed at healthy volunteers. This trial is a crucial step in developing treatments for autoimmune diseases. GIM-407 is a pioneering small molecule, administered orally, and is the first selective T-regulatory cell activator of its kind under development. This marks Georgiamune’s initial foray into autoimmune disease programs.

The company has been making significant strides in both cancer and autoimmune disease therapeutics, with three first-in-class assets, GIM-122, GIM-531, and GIM-407, entering clinical trials within the past year. All these drugs are based on novel biological discoveries made by Georgiamune. The data from the ongoing study with GIM-407 will help identify the specific autoimmune diseases to target in subsequent phases of the trial.

Dr. Samir N. Khleif, the founder and CEO of Georgiamune, emphasized the company’s commitment to developing breakthrough therapeutics for patients with unmet medical needs in autoimmune diseases and cancer. He stated that GIM-407 and other innovative drugs from Georgiamune's T cell regulation discovery platforms highlight their mission to restore immune balance and tackle a variety of autoimmune conditions. These conditions include Inflammatory Bowel Disease (IBD), Systemic Lupus Erythematosus (SLE), and Type 1 Diabetes Mellitus (T1DM).

Autoimmune diseases are a significant health concern, affecting nearly 50 million Americans, making them the third most common disease category in the United States. Mark Anderson, a professor at UCSF and Director of the NIH Immune Tolerance Network, noted that GIM-407’s unique T-reg activator could offer a new treatment pathway for patients who have few other options.

The ongoing phase 1 study involves oral administration of GIM-407 to healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics. The findings from this study will guide future clinical trials targeting specific autoimmune diseases.

Deep Nishar, Managing Director at General Catalyst, praised Georgiamune's ability to rapidly translate scientific discoveries into clinical treatments. He noted that the momentum of their drug development pipeline within a year of securing series A funding demonstrates their capability to bring novel therapies to the clinic, significantly impacting the treatment landscape for disease patients.

Georgiamune Inc. focuses on reprogramming immune signaling pathways to treat diseases by restoring immune balance. The company's lead program, GIM-122, is a dual-functioning monoclonal antibody designed to overcome resistance to immune therapy in cancer patients. Alongside GIM-122, the company is advancing other first-in-class therapies for both cancer and autoimmune diseases.

Dr. Khleif, a distinguished medical oncologist and researcher in immunology and cancer, founded Georgiamune based on his lab’s discoveries about key immune cell pathways. These discoveries have led to the identification of novel targets for developing first-in-class molecules that regulate and restore immune signaling pathways, offering new treatment options for cancer and autoimmune diseases.