Georgiamune Adds Two New Cancer Drugs in Five Months

Gaithersburg, Md., May 29, 2024 — Georgiamune Inc., a burgeoning biotechnology firm at the clinical stage, has announced that the U.S. Food and Drug Administration (FDA) has cleared its second Investigational New Drug (IND) application for GIM-531. This innovative oral treatment specifically targets T-regulatory cells while sparing other immune cells like CD4 and CD8. Additionally, the company's dual-functioning antibody, GIM-122, has progressed to human clinical trials.

Since securing Series A funding in August 2023, Georgiamune has rapidly transitioned from a preclinical startup to a company with two clinical assets. Both GIM-531 and GIM-122 are first-in-class therapies with unique mechanisms of action. GIM-122 combats cancer-mediated immune suppression and activates T cells, while GIM-531 selectively inhibits T regulatory cells, transforming the tumor microenvironment to facilitate tumor cell elimination. T regulatory cells are essential in inhibiting immune responses against cancer.

Georgiamune's development of GIM-531, an oral T regulatory cell inhibitor, marks significant progress in providing new cancer treatment options. With the FDA clearance, the company is set to initiate a first-in-human clinical trial for GIM-531, addressing cancers with high unmet medical needs, particularly those not responsive to current immunotherapies or checkpoint inhibitors.

CEO and founder Dr. Samir N. Khleif highlighted the importance of this milestone for Georgiamune. "Our second IND clearance underscores our commitment to pioneering breakthroughs in cancer and autoimmune disease treatments. At a time when many patients do not respond to existing therapies, Georgiamune is dedicated to developing novel drugs like GIM-531 and GIM-122. Our goal is to revolutionize cancer treatment and patient care through innovative science that reprograms the immune system."

Deep Nishar, Managing Director at General Catalyst, also praised the company's achievements. "Georgiamune's rapid progress in securing a second IND clearance within a year demonstrates the exceptional talent within the company. Their therapeutic approach aligns with our Health Assurance thesis, and we eagerly anticipate their progress in the clinical trial phase."

About Georgiamune Inc.

Georgiamune Inc. is a clinical-stage biotechnology company dedicated to reprogramming immune signaling pathways to combat diseases. The company has developed unique methods to restore immune balance, leading to pioneering immunotherapies that address significant unmet needs. GIM-122 and GIM-531, Georgiamune's lead programs, aim to overcome cancer-mediated immune suppression and selectively inhibit T regulatory cells. Beyond these programs, Georgiamune is advancing a pipeline of first-in-class therapies for both cancer and autoimmune diseases.

Founded by Dr. Samir N. Khleif, a renowned medical oncologist and immunologist, Georgiamune is based on groundbreaking discoveries from Dr. Khleif's lab. His research has identified novel core targets that regulate critical immune cell pathways, resulting in the development of first-in-class molecules to modulate and restore immune signaling pathways for treating cancer and autoimmune diseases.

Georgiamune's commitment to innovative science and patient care continues to drive its progress in developing novel therapies to transform the landscape of cancer treatment.

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