Thursday, August 10, 2023
Georgiamune Inc., a privately-held biotech firm in the clinical stage, has revealed that its Investigational New Drug (IND) application for GIM-122—a pioneering dual-function monoclonal antibody—has gained clearance from the U.S. Food and Drug Administration (FDA). The achievement coincides with the successful conclusion of a Series A financing round, yielding $75 million. These combined milestones position Georgiamune as a promising contender within the biotech sector, particularly within the domains of autoimmune diseases and oncology.
The recent FDA greenlight for Georgiamune's inaugural IND marks a significant leap for the company, signifying its entry into the realm of clinical trials, with a specific focus on oncology. GIM-122, an inventive dual-function monoclonal antibody, homes in on a distinct mechanism. This mechanism, originating from the pioneering academic contributions of Georgiamune's Founder and Chief Executive Officer, Dr. Samir Khleif, aims to tackle immunotherapy resistance—a pressing concern in the field. Through meticulous development, the company has translated this concept into the creation of GIM-122.
Furthermore, Georgiamune's future is marked by its intent to initiate a phase 1/2 clinical trial in the latter half of 2023. This trial aims to evaluate GIM-122's safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity as a standalone treatment for adults with advanced solid malignancies who have not responded to checkpoint inhibitor therapies.
Dr. Khleif stated, "Georgiamune is dedicated to reprogramming the immune system for treating cancer and autoimmune diseases. The acceptance of our first IND reflects the dedication of our team and propels us towards our mission of transforming cancer patient care."
In addition, Georgiamune has recently secured an oversubscribed $75 million Series A financing round, gathering significant support from prominent biotech investors and venture capital firms. Noteworthy participants in the funding round include General Catalyst and the Parker Institute for Cancer Immunotherapy (PICI), among others.
Deep Nishar, Managing Director at General Catalyst, remarked, "Georgiamune's approach aligns with our Health Assurance philosophy, leveraging nature's mechanisms to enhance lives. We're proud to support Georgiamune in its mission of introducing novel therapies globally."
John Connolly, PhD, Chief Scientific Officer at PICI, expressed support for Georgiamune's efforts to bring innovative technology to cancer patients. He noted the alignment between Georgiamune's strategy and PICI's mission to accelerate breakthrough therapies.
Ayman AlAbdallah, Partner at Mubadala Capital, commended Georgiamune's innovative therapeutic approach and expressed pride in partnering with the company as it advances groundbreaking programs.