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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 ContactKarbo Communications for Georgiamune georgiamune@karbocom.com

Georgiamune receives U.S. FDA clearance for GIM-531 and continues to enroll patients in clinical trial testing for GIM-122GAITHERSBURG, Md., May 29, 2024 (GLOBE NEWSWIRE) -- Today, Georgiamune Inc., a privately held, clinical-stage biotechnology company, announced the clearance of its second Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for GIM-531, a first-in-class oral treatment that selectively targets T-regulatory cells and spares other immune cells such as CD4 and CD8. The news comes just on the heels of the company’s first-in-class, dual-functioning antibody, GIM-122, progressing to clinical trial for human testing. Since Georgiamune’s Series A funding round in August of 2023, the company has evolved from a preclinical stage startup to a company with two clinical assets. Both assets are first-in-class and boast a novel mechanism of action. GIM-122 overcomes cancer-mediated immune suppression and stimulates activated T cells while GIM-531 selectively inhibits the induction and function of T regulatory cells, reprogramming the tumor microenvironment to allow the elimination of the tumor cells. T regulatory cells are immune cells that play a critical role in inhibiting the immune response against cancer. Georgiamune’s development of the first-in-class, oral T regulatory cell inhibitor, allowing the restoration of a strong immune response against cancer, represents a rapid progression in translating innovative research into promising new treatment options for patients fighting cancer. With the clearance of the second IND, Georgiamune will be initiating a first-in-human clinical trial to investigate GIM-531 in areas of high unmet need, including cancers that are currently not addressed with existing immunotherapy drugs or available checkpoint inhibitors. “Georgiamune’s second IND clearance signifies the company’s achievement in pioneering novel breakthroughs for our extensive broad pipeline in both cancer and autoimmune diseases,” said CEO and founder Dr. Samir N. Khleif. “At a time when current cancer treatment options often fail to help patients who don’t respond to checkpoint inhibitors, Georgiamune is dedicated to creating novel drugs that address this critical unmet need. As a team, we take great pride in deploying GIM-531 and GIM-122 as part of our mission to revolutionize cancer treatment and patient care using novel science to reprogram the immune system.” “Georgiamune’s second IND clearance in less than a year is a testament to the depth of talent within the company, showcasing its capacity to spearhead what we believe are novel breakthroughs for first-in-class drug discovery for cancer patients around the world,” said Deep Nishar, Managing Director at General Catalyst. “Georgiamune’s therapeutic approach to cancer treatment aligns with our Health Assurance thesis, and we look forward to the company’s progress at its clinical trial stage.” 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 programs, GIM-122 and GIM-531 are designed to overcome cancer-mediated immune suppression and selectively inhibits the induction and function of T regulatory cells. In addition to its lead programs, 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 ContactKarbo Communications PR for Georgiamune georigamune@karbocom.com

Georgiamune receives U.S. FDA clearance for GIM-531 and begins phase II of clinical trial testing for GIM-122GAITHERSBURG, Md., May 29, 2024 (GLOBE NEWSWIRE) -- Today, Georgiamune Inc., a privately held, clinical-stage biotechnology company, announced the clearance of its second Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for GIM-531, a first-in-class oral treatment that selectively targets T-regulatory cells and spares other immune cells such as CD4 and CD8. The news comes just on the heels of the company’s first-in-class, dual-functioning antibody, GIM-122, progressing to clinical trial for human testing. Since Georgiamune’s Series A funding round in August of 2023, the company has evolved from a preclinical stage startup to a company with two clinical assets. Both assets are first-in-class and boast a novel mechanism of action. GIM-122 overcomes cancer-mediated immune suppression and stimulates activated T cells while GIM-531 selectively inhibits the induction and function of T regulatory cells, reprogramming the tumor microenvironment to allow the elimination of the tumor cells. T regulatory cells are immune cells that play a critical role in inhibiting the immune response against cancer. Georgiamune’s development of the first-in-class, oral T regulatory cell inhibitor, allowing the restoration of a strong immune response against cancer, represents a rapid progression in translating innovative research into promising new treatment options for patients fighting cancer. With the clearance of the second IND, Georgiamune will be initiating a first-in-human clinical trial to investigate GIM-531 in areas of high unmet need, including cancers that are currently not addressed with existing immunotherapy drugs or available checkpoint inhibitors. “Georgiamune’s second IND clearance signifies the company’s achievement in pioneering novel breakthroughs for our extensive broad pipeline in both cancer and autoimmune diseases,” said CEO and founder Dr. Samir N. Khleif. “At a time when current cancer treatment options often fail to help patients who don’t respond to checkpoint inhibitors, Georgiamune is dedicated to creating novel drugs that address this critical unmet need. As a team, we take great pride in deploying GIM-531 and GIM-122 as part of our mission to revolutionize cancer treatment and patient care using novel science to reprogram the immune system.” “Georgiamune’s second IND clearance in less than a year is a testament to the depth of talent within the company, showcasing its capacity to spearhead what we believe are novel breakthroughs for first-in-class drug discovery for cancer patients around the world,” said Deep Nishar, Managing Director at General Catalyst. “Georgiamune’s therapeutic approach to cancer treatment aligns with our Health Assurance thesis, and we look forward to the company’s progress at its clinical trial stage.” 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 programs, GIM-122 and GIM-531 are designed to overcome cancer-mediated immune suppression and selectively inhibits the induction and function of T regulatory cells. In addition to its lead programs, 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 ContactKarbo Communications PR for Georgiamune georigamune@karbocom.com