Georgiamune continues biotech innovation streak with first autoimmune disease-focused program based on novel biology

GAITHERSBURG, MD, September 24, 2024 – Today, Georgiamune Inc., a privately held, clinical-stage biotechnology company, announced that the first participant has been dosed with GIM-407 in a first-in-human, phase 1 clinical trial in healthy volunteers, which is the stepping stone of the clinical development plans to develop it for patients with autoimmune diseases. Based on novel biology, GIM-407 is the only selective T-regulatory cell activator of its kind in development. It is a small molecule that is administered orally marking the first autoimmune disease program for the company.

With this news, Georgiamune continues to advance its rich and diverse pipeline of novel drugs both in cancer and autoimmune diseases. The company 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. Data generated from this study will inform the selection of autoimmune diseases to target in the next phase.

“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. “We look forward to progressing GIM-407 in clinical trials to restore immune homeostasis to fight autoimmune diseases that apply to a wide range of common and rare autoimmune diseases, including but not limited to Inflammatory Bowel Disease (IBD), Systemic Lupus Erythematosus (SLE), and Type 1 Diabetes Mellitus (T1DM).”

“Autoimmune diseases are the third most common disease category in the country, affecting nearly 50 million Americans,” said Mark Anderson, professor at UCSF and the Director of the NIH Immune Tolerance Network. “GIM-407’s unique, selective T-reg activator may provide a novel treatment opportunity for autoimmune disease patients with profound unmet needs.”

In the ongoing phase 1 study, GIM-407 will be administered orally to healthy volunteers to further characterize the safety, tolerability, and pharmacokinetics. Data collected from this study will help guide future trials for specific autoimmune diseases.

“The Georgiamune team has proven, yet again, their ability to translate novel science and cutting-edge research into new treatments for patients with high unmet needs,” said Deep Nishar, Managing Director at General Catalyst. “The momentum of their first-in-class drug pipeline within 13 months of receiving series A funding is not a surprise. Their ability and drive to leverage novel biology to introduce new drugs into clinic continue to deliver impactful breakthroughs for disease patients.”

About Georgiamune Inc.

Georgiamune Inc. is a clinical-stage science and discovery biotechnology company focused on reprogramming immune signaling pathways to redirect the immune system to fight diseases.  Georgiamune has designed unique approaches to re-establish immune balance, and its scientific discoveries have led to pioneering immunotherapies targeting high unmet needs. The company's lead program, GIM-122, is a first-in-class, dual-functioning monoclonal antibody. GIM-122 is designed to overcome immune therapy resistance in cancer patients. In addition to its lead program, the company is advancing a pipeline of first-in-class therapies for cancer and autoimmune diseases.

Georgiamune was founded by Dr. Samir N. Khleif, a world-renowned medical oncologist and researcher in the field of immunology and cancer, based on discoveries in his lab on novel mechanisms to modulate immune response. Dr. Khleif's work has led to the discovery of novel core targets that control critical immune cell pathways leading to the development of first-in-class molecules that modulate and restore these immune signaling pathways for the treatment of cancer and autoimmune diseases.

For more information about Georgiamune, please visit the company's website at Georgiamune.com or follow the company on LinkedIn.

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Karbo Communications for Georgiamune

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