Georgiamune – a privately held clinical-stage biotechnology company – recently 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. And the company completed a $75 million 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 is a significant milestone for the company as it embarks on its first clinical trial in oncology. And 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 CEO Dr. Samir Khleif and developed by the company to overcome immunotherapy resistance.
Georgiamune is going to 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. And 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.
Along with 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. And 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.
KEY QUOTES:
“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.”
— Dr. Khleif
“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. 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.”
— Deep Nishar, Managing Director at General Catalyst
“PICI is proud to support Georgiamune in bringing this novel technology to cancer patients worldwide. 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.”
— John Connolly, PhD, Chief Scientific Officer at PICI
“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. 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.”
— Ayman AlAbdallah, Partner at Mubadala Capital
