On June 11, 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, reported its rare disease business has signed a strategic agreement with AGC Biologics (Press release, Essential Pharma, JUN 11, 2024, View Source [SID1234644255]). 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).
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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 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."
Christoph Winterhalter, CBO at AGC Biologics, said: "We are very pleased that Essential Pharma has chosen us to manufacture this innovative therapy. Our Copenhagen site has the expertise and experience in therapeutic antibodies to accelerate the late-stage development and manufacturing of Hu14.18. We look forward to partnering with Essential Pharma and working together to ensure the product meets the high level of quality, yield and all data packages needed to successfully master future clinical trials and regulatory agency submissions to supply patients across the globe with this life-saving product."
Essential Pharma acquired Renaissance Pharma in April 2024 and is now responsible for the development of Hu14.18. A Phase II trial incorporating Hu14.18 into first-line therapy, and additionally within post-consolidation therapy for HRNB patients, demonstrated positive patient outcomes with 3-year event-free survival (EFS) of 73.7% and overall survival (OS) of 86.0%. Data from this study were published in the Journal of Clinical Oncology in December 2021 and are approaching five-year OS readouts.