Georgiamune Announces First Patient Dosed in Phase 1 Trial of GIM-531 for Cancer Treatment

GAITHERSBURG, Md., July 30, 2024 – Georgiamune Inc., a biotechnology firm at the clinical stage, has announced the inaugural dosing of a patient with GIM-531 in a phase 1 clinical trial aimed at treating advanced cancer patients. GIM-531 is pioneering in its approach as an oral therapy that selectively inhibits T regulatory cells, marking it as a first-in-class treatment for cancer patients who have not benefitted from existing immunotherapies, including anti-PD-1 antibodies.

Dr. Samir N. Khleif, the founder and CEO of Georgiamune, highlighted the significance of GIM-531's mechanism of action. He noted that it addresses a major challenge in drug development by selectively targeting suppressor immune cells like T-reg while sparing other essential immune cells. This innovation is in line with Georgiamune's mission to translate cutting-edge research into groundbreaking therapies for patients with unmet medical needs.

GIM-531 is a key component of Georgiamune’s extensive pipeline of innovative drugs. This announcement follows the recent initiation of treatment for cancer patients with GIM-122, a dual-functioning antibody. Both therapies have entered clinical trials within a year since the company closed its series A funding.

Ryan Sullivan, M.D., a medical oncologist at Massachusetts General Hospital, expressed enthusiasm for the novel science behind GIM-531. He emphasized the urgent need for new therapies that go beyond current options for cancer patients and conveyed excitement about participating in the clinical trial of this promising oral immunotherapy.

John Connolly, PhD, the chief scientific officer at the Parker Institute for Cancer Immunotherapy, praised Georgiamune's unmatched pipeline of innovative cancer treatments. He highlighted GIM-531 as one of many new approaches being developed by the company to expand treatment options for cancer patients with unmet needs.

The phase 1 trial aims to evaluate the safety profile, pharmacokinetics, and pharmacodynamic effects of GIM-531. It will also provide insights into the appropriate dosage, schedule, and early anti-tumor activity for patients with advanced solid tumors who have either progressed on or been intolerant to available therapies. Post dose-escalation, two additional cohorts will be initiated. One will explore GIM-531 as a single agent in solid tumors where T-regulatory cells hinder the immune system's ability to combat cancer. The other will examine its combination with anti-PD-1 in advanced melanoma cases that have failed anti-PD-1 treatment.

According to Dr. Rizwan Khawaja, Associate Clinical Investigator at HonorHealth Research & Innovation Institute, while immune checkpoint inhibitors have significantly transformed the outcomes of several cancers, they remain ineffective for many cancer types. He stressed the necessity for novel immunotherapies and expressed eagerness to participate in the first-in-human clinical trial of GIM-531, which could potentially expand treatment options and improve prognoses for cancer patients.

Georgiamune Inc. is dedicated to reprogramming immune signaling pathways to combat diseases. The company has developed innovative strategies to restore immune balance, leading to pioneering immunotherapies targeting high unmet needs. Its lead program, GIM-122, is a first-in-class, dual-functioning monoclonal antibody designed to overcome immune therapy resistance in cancer patients. Georgiamune is also advancing a pipeline of first-in-class therapies for both cancer and autoimmune diseases.

Founded by Dr. Samir N. Khleif, a distinguished medical oncologist and researcher in immunology and cancer, Georgiamune builds on his discoveries of novel mechanisms to modulate immune responses. His work has identified crucial core targets that regulate immune cell pathways, leading to the creation of first-in-class molecules to modulate and restore these pathways for treating cancer and autoimmune diseases.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!