Georgiamune Inc. Achieves US FDA Clearance for Investigational New Drug (IND) Application and Secures $75 Million in Series A Financing

GAITHERSBURG, Md., Aug. 9, 2023 /PRNewswire/ -- Today, Georgiamune Inc., a privately held, clinical stage biotechnology company, announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for GIM-122, a dual-functioning monoclonal antibody. Furthermore, the company successfully completed a $75M Series A financing, positioning Georgiamune as a promising new biotechnology company in the fields of oncology and autoimmune diseases.

The clearance of Georgiamune's first IND represents a significant milestone for the company as it embarks on its first clinical trial in oncology. GIM-122, a first-in-class dual-functioning monoclonal antibody, targets a highly novel mechanism discovered through the distinguished academic work of Georgiamune's Founder and Chief Executive Officer Dr. Samir Khleif and developed by the company to overcome immunotherapy resistance.

Georgiamune will initiate a first-in-human, open-label, phase 1/2 dose-escalation with enrichment and dose expansion study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and antitumor activity of GIM-122 as a single agent in adults with advanced solid malignancies who have failed treatment with a checkpoint inhibitor. Georgiamune plans to initiate its phase 1/2 clinical trial in the second half of 2023 and continue development of its extensive first-in-class pipeline for cancer and autoimmune diseases with high unmet needs.

Dr. Khleif stated, "Georgiamune is a discovery and early clinical development biotech company focused on transforming immunotherapy by reprogramming the immune system for the treatment of cancer and autoimmune diseases. The acceptance of our first IND is a testament to the hard work and dedication of our talented team, and brings us closer to fulfilling our mission of transforming cancer patient care."

In addition to the IND acceptance, Georgiamune has successfully closed an oversubscribed $75M Series A financing round, securing substantial financial support from leading biotech investors and venture capital firms. General Catalyst and Parker Institute for Cancer Immunotherapy (PICI) co-led the round. Mubadala Capital, Alexandria Venture Investments, Catalio Capital Management, CJNV BioVenture, and Verition Fund Management also participated.

"Georgiamune's therapeutic approach to unlock and reprogram the immune system seeks to enable patients to recover from cancer or autoimmune diseases, and is a remarkable example of leveraging nature's mechanisms for improved healthcare solutions, a core part of our Health Assurance thesis," said Deep Nishar, Managing Director at General Catalyst. "We are proud to support Georgiamune in getting its novel therapies to patients worldwide, in what we believe will help people live higher quality and longer lives."

"PICI is proud to support Georgiamune in bringing this novel technology to cancer patients worldwide," said John Connolly, PhD, Chief Scientific Officer at PICI. "Georgiamune's approach of leveraging fundamental discoveries in next generation checkpoint blockade to develop novel immuno-oncology treatments is directly in line with PICI's mission to accelerate breakthrough therapies to patients."

"Georgiamune's innovative therapeutic approach targets critical challenges in immunotherapy, adeptly tuning the immune system to reestablish equilibrium in cancer and autoimmune conditions and presenting a promising way forward for patients with high unmet needs," said Ayman AlAbdallah, Partner at Mubadala Capital. "We are proud to partner with the Georgiamune team as they emerge from a period of intense research and development and advance several groundbreaking preclinical and clinical programs."

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.

SOURCE Georgiamune Inc.