Georgiamune Expands Cancer Treatment Pipeline with FDA Clearance and Phase II Trials

GAITHERSBURG, Md., May 29, 2024 – Georgiamune Inc., a biotechnology company in the clinical-stage, has announced the U.S. Food and Drug Administration (FDA) approval for its second Investigational New Drug (IND) application. This approval pertains to GIM-531, a pioneering oral treatment that specifically targets T-regulatory cells while sparing CD4 and CD8 immune cells. This announcement follows closely on the heels of another milestone for the company, where its innovative dual-functioning antibody, GIM-122, began human clinical trials.

Georgiamune has rapidly advanced since its Series A funding round in August 2023, evolving from a preclinical startup to a company with two clinical-stage assets. Both GIM-122 and GIM-531 are first-in-class treatments with unique mechanisms of action. GIM-122 works to combat cancer by overcoming immune suppression and activating T cells. Conversely, GIM-531 inhibits T regulatory cells, which play a pivotal role in suppressing immune responses against cancer. This inhibition reprograms the tumor microenvironment, facilitating the destruction of tumor cells.

The development of GIM-531, an oral inhibitor of T regulatory cells, signifies a substantial advancement in cancer treatment. This treatment aims to reinvigorate the immune system’s ability to fight cancer. With the FDA's clearance of this second IND application, Georgiamune is set to commence a first-in-human clinical trial for GIM-531, targeting cancers that lack effective immunotherapy options.

Dr. Samir N. Khleif, CEO and founder of Georgiamune, expressed his pride in the company's achievements. “The clearance of our second IND is a significant milestone, showcasing our commitment to developing novel treatments for cancer and autoimmune diseases. In light of current limitations in cancer treatments, especially for patients unresponsive to checkpoint inhibitors, our focus remains on delivering groundbreaking therapies that address these urgent needs. GIM-531 and GIM-122 are integral to our mission to revolutionize cancer treatment and improve patient outcomes by leveraging novel science to reprogram the immune system.”

Deep Nishar, Managing Director at General Catalyst, also highlighted the company’s progress. “Georgiamune’s swift advancement in securing its second IND clearance within a year underscores the exceptional talent within the company. This achievement demonstrates Georgiamune’s potential in pioneering first-in-class drug discoveries for global cancer patients. Their therapeutic approach is aligned with our Health Assurance thesis, and we eagerly anticipate the progress of their clinical trials.”

Georgiamune Inc. is dedicated to reprogramming immune signaling pathways to combat diseases. The company focuses on restoring immune balance through its innovative scientific discoveries, which have led to novel immunotherapies targeting significant unmet medical needs. The company’s leading programs, GIM-122 and GIM-531, are designed to overcome cancer-induced immune suppression and selectively inhibit T regulatory cells' function. Besides these lead programs, Georgiamune is also developing a pipeline of first-in-class therapies for cancer and autoimmune diseases.

Founded by Dr. Samir N. Khleif, a distinguished medical oncologist and immunology researcher, Georgiamune is built on groundbreaking discoveries from his lab. These findings have identified core targets that regulate critical immune cell pathways, leading to the development of unique molecules aimed at modulating and restoring these pathways for treating cancer and autoimmune diseases.