Essential Pharma Ink Pact with AGC Biologics To Treat high-risk Neuroblastoma

Essential Pharma, an international specialty pharmaceutical group dedicated to guaranteeing patients' long-term availability of low volume, clinically differentiated, niche pharmaceutical products across key therapeutic fields, declared that its rare disease business has signed a strategic agreement with AGC Biologics. 

AGC Biologics, a major worldwide biopharmaceutical contract development and manufacturing organization (CDMO), will manufacture Hu1418K322A (Hu14.18), a humanized monoclonal antibody being developed for Essential Pharma to treat high-risk neuroblastoma (HRNB). According to the agreement, AGC Biologics will help with process development, scale-up, and manufacturing as Essential Pharma prepares to begin clinical activities and continued regulatory agency engagements in 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 providing this high-potential antibody to a patient group that is desperately in need of more optimal treatments and better outcomes.”

"AGC Biologics is a global leader in contract antibody development and manufacturing,” stated Emma Johnson, CEO of Essential Pharma. “This partnership will help us to accelerate the late-stage development of Hu14.18, which shows therapeutic promise for high-risk neuroblastoma patients, the majority 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.”