InJennie A Therapeutics (Reg.S) (hereinafter InJennie A) has entered the U.S. clinical trial procedures for its kidney disease treatment candidate, ‘IGT-303.’ Following the technology transfer of pipeline asset ‘IGT-427’ (MK-8748) to Seong Gong-han (CEO), the company’s follow-on commercialization strategy is expected to accelerate.
InJennie A announced on the 29th that it has submitted an Investigational New Drug (IND) application for a Phase 2a clinical trial of IGT-303 to the U.S. Food and Drug Administration (FDA). The study will evaluate the safety, tolerability, and pharmacokinetics of IGT-303 in 94 participants across five institutional investors in the United States. The duration is approximately six months from the approval of the clinical trial.
InJennie A’s IGT-303 is a novel drug candidate that activates ‘TIE2,’ a signaling receptor on the surface of microvascular endothelial cells within the glomerulus, to restore normal glomerular filtration in the kidney. It can increase the survival of vascular endothelial cells within the glomerulus, strengthen and maintain the health of the vascular layer, and reduce inflammation. It is being developed as a treatment for chronic kidney disease, administered via subcutaneous (SC) injection every four to eight weeks.
InJennie A observed an efficacy of more than 50% reduction in proteinuria in preclinical non-human primate (monkey) trials of IGT-303. This figure surpasses the proteinuria reduction efficacy (25–40%) demonstrated by current standard treatments for chronic kidney disease in Phase 3 clinical trials.
InJennie A initiated the Australian Phase 1/2a trial of IGT-303 on November 19, 2025. Subsequently, expanding the clinical regions, the company is currently conducting trials in New Zealand and South Korea. It has completed Phase 1 and is now in the Phase 2a stage.
InJennie A transferred its lead pipeline asset, the retinal disease treatment IGT-427, to EyeBio, a U.K.-based ophthalmic disease specialist biotech company, for a deal worth over 1 trillion won in October 2022. Following this, global big pharma (major pharmaceutical company) Merck (MSD) of the United States acquired EyeBio in July 2024. Currently, MSD is conducting four Phase 3 clinical trials of IGT-427 under the name MK-8748.
After demonstrating its novel drug platform capabilities with IGT-427, InJennie A is actively pursuing the commercialization of its follow-on pipeline. IGT-303 is the most advanced follow-on pipeline asset in terms of research progress. If IGT-303 enters U.S. clinical trials, discussions regarding commercialization, such as global technology transfers, are highly likely to accelerate. InJennie A aims to sign a technology transfer agreement for IGT-303 next year.
InJennie A is also researching ‘IGT-532,’ a triple antibody anticancer novel drug that simultaneously targets immunity and tumor vasculature. IGT-532 is in the preclinical stage, with plans to enter Phase 1 clinical trials in the second half of next year.
An official from InJennie A stated, “IGT-303 has completed Phase 1 and is currently undergoing technology transfer discussions with multiple global big pharma companies.” The official added, “InJennie A entered U.S. clinical trials proactively to enhance the potential for technology transfer of IGT-303 and to smoothly advance late-stage clinical development for future U.S. approval and commercialization.”
The official further stated, “With entry into U.S. clinical trials, we plan to significantly elevate the value of IGT-303 and accelerate technology transfer discussions.” The official added, “In this process, we will collaborate with EyeBio, which possesses specialized expertise in FDA approval and U.S. clinical development, and actively leverage its know-how (experience).”
in THEBIO
