Essential Pharma Reaches Agreement With AGC Biologics For Late Phase Clinical Manufacturing Of Its Immunotherapy Candidate For The Treatment Of High-Risk Neuroblastoma

( MENAFN - GlobeNewsWire - Nasdaq) Essential Pharma reaches agreement with AGC Biologics for late phase clinical manufacturing of its immunotherapy candidate for the treatment of high-risk neuroblastoma Egham, UK and Copenhagen, Denmark – 11 June, 2024 – Essential Pharma, an international specialty pharma group focused on ensuring that patients have sustainable access to low volume, clinically differentiated, niche Pharmaceutical products across key therapeutic areas, today announced its rare disease business has signed a strategic agreement with AGC Biologics . As a leading global biopharmaceutical contract development and manufacturing organisation (CDMO), AGC Biologics will produce Hu1418K322A (Hu14.18), a humanised monoclonal antibody being developed for Essential Pharma for the treatment of high-risk neuroblastoma (HRNB).

Under the agreement, AGC Biologics will support the process development, scale-up and manufacturing as Essential Pharma plans to commence clinical activities and ongoing regulatory agency interactions over the coming months. Simon Ball, Vice President of the rare disease business at Essential Pharma, commented : "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. 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 providin.