Contract development and manufacturing organization (CDMO) AGC will develop, scale-up and manufacture Essential Pharma’s Hu14.18 (Hu1418K322A). The candidate is an anti GD2 (a surface antigen) humanized monoclonal antibody (mAb), licensed from St. Jude Children’s Research Hospital in 2023.
“This partnership is a tremendous milestone in the development of Hu14.18 and its path to commercialization. The prospect of building an inventory of Hu14.18 is very exciting,” said Simon Ball, VP of the rare disease business at Essential Pharma.
“Ahead of us is a period of intense regulatory agency interaction, which will take place alongside late-stage clinical development, and we are a step closer to providing this high-potential antibody to a patient group that is desperately in need of more optimal treatments and better outcomes.”
UK-based Essential Pharma added Hu14.18 in April 2024 after acquiring Renaissance Pharma, a clinical stage biopharmaceutical company for rare pediatric diseases. According to the firm, the candidate’s Phase II results demonstrated positive patient outcomes with a three-year event free survival (EFS) rate of 73.7% and overall survival (OS) of 86%.
“AGC Biologics is a global leader in contract antibody development and manufacturing. This partnership will help us accelerate the late-stage development of Hu14.18, which shows therapeutic promise for high-risk neuroblastoma patients, most of whom are young children. We look forward to working closely with AGC to deliver this potentially transformative therapy in an area of significant unmet need,” said Emma Johnson, CEO of Essential Pharma.
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