Georgiamune Announces First Patient Dosed in A First-In-Class Phase 1 Cancer Treatment Trial of GIM-531

GAITHERSBURG, Md., July 30, 2024 (GLOBE NEWSWIRE) — Today, Georgiamune Inc., a privately held, clinical-stage biotechnology company, announced that the first patient has been dosed with GIM-531 in a first-in-human, phase 1 clinical trial for the treatment of advanced cancer patients. GIM-531 development focuses on indications that are currently not addressed with existing or available immunotherapies including anti-PD-1 antibodies. It is an oral therapy that is a first-in-class selective T regulatory cell inhibitor.

“The novel mechanism of action of GIM-531 can finally address one of the key challenges and limitations that has been facing the field in developing drugs selectively targeting suppressor immune cells like T-reg and sparing other important immune cells,” said Dr. Samir N. Khleif, Georgiamune founder and Chief Executive Officer. “This builds on Georgiamune’s ability to translate innovative research into novel therapies for patients with high unmet needs.”

GIM-531 is a key part of Georgiamune’s rich pipeline of novel drugs. This news comes on the heels of announcing treating cancer patients with GIM-122, a dual functioning antibody. Both entered the clinic in less than a year from closing series A funding.

“Our cancer patients need novel therapies beyond what’s currently available to them,” said Ryan Sullivan, M.D., medical oncologist at Massachusetts General Hospital. “We’re thrilled about the novel science that led to the development of GIM-531 and are excited to be part of this clinical trial using this promising first in class oral immunotherapy.”

“The breadth of Georgiamune’s pipeline of assets for innovative cancer treatments and beyond is unmatched,” said John Connolly, PhD, chief scientific officer at the Parker Institute for Cancer Immunotherapy. “GIM-531 represents one of many new approaches that are being developed by Georgiamune expanding the potential treatment options for cancer patients with unmet needs.”

The phase 1 trial will evaluate the safety profile, pharmacokinetics, and pharmacodynamic effects; as well as inform the dose, schedule and early anti-tumor activity of GIM-531 for patients with advanced solid tumors that have progressed on or have been intolerant of available therapies. Following the completion of the dose escalation, two additional study cohorts will be initiated for GIM-531, a single agent to be explored in a solid tumor where T-regulatory cells play an important role in the failure of the immune system to fight cancer and a combination with anti-PD-1 in anti-PD-1 failure advanced melanoma.

“Although immune checkpoint inhibitors have transformed outcomes of several cancers, they do not work for many cancer types or cancers can develop mechanisms to evade their effectiveness. Therefore, there is a need for novel immunotherapies,” said Dr. Rizwan Khawaja, Associate Clinical Investigator at HonorHealth Research & Innovation Institute. “We are excited to participate in the first-in-human clinical trial of GIM-531. Novel immunotherapies like this can help expand treatment options for cancer patients and hopefully improve their prognosis.”

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.

Media Contact
Karbo Communications for Georgiamune
georgiamune@karbocom.com