Essential Pharma partners with AGC Biologics for late-stage production of neuroblastoma immunotherapy

Essential Pharma, a global specialty pharmaceutical group, has announced a strategic collaboration with AGC Biologics to manufacture its immunotherapy candidate, Hu14.18K322A (Hu14.18), aimed at treating high-risk neuroblastoma (HRNB). The alliance will facilitate Essential Pharma's clinical and regulatory pursuits in the coming months.

Hu14.18 is a humanized monoclonal antibody, and its development is a significant milestone towards addressing the critical needs of HRNB patients. This partnership will see AGC Biologics, a renowned biopharmaceutical contract development and manufacturing organization (CDMO), handling the process development, scaling up, and production of Hu14.18. Essential Pharma's Vice President for Rare Diseases, Simon Ball, underscored the importance of this collaboration, noting the exciting prospect of building an inventory of Hu14.18. This inventory will play a crucial role during the anticipated intense regulatory interactions and late-stage clinical development.

Emma Johnson, CEO of Essential Pharma, emphasized the partnership's potential to expedite Hu14.18's development, which shows promising therapeutic benefits for high-risk neuroblastoma, a condition predominantly affecting young children. Johnson expressed optimism about working with AGC Biologics to deliver this transformative therapy to an underserved patient group.

Christoph Winterhalter, Chief Business Officer at AGC Biologics, expressed his satisfaction with the partnership, highlighting the expertise and experience at their Copenhagen facility in accelerating the development and manufacturing of therapeutic antibodies like Hu14.18. He reiterated AGC Biologics' commitment to meeting the high standards required for future clinical trials and regulatory submissions, ensuring that patients worldwide could benefit from this innovative treatment.

The development of Hu14.18 was furthered by Essential Pharma's acquisition of Renaissance Pharma in April 2024. Previous Phase II trials incorporating Hu14.18 into first-line and post-consolidation therapies for HRNB have shown positive outcomes, with a 3-year event-free survival (EFS) rate of 73.7% and an overall survival (OS) rate of 86.0%. These encouraging results, published in the Journal of Clinical Oncology, are nearing their five-year overall survival readouts.

Essential Pharma is committed to maintaining access to clinically differentiated, niche medicines for small patient populations. With over two decades of collaboration with healthcare providers, the group continues to address clinical unmet needs and offer essential medications that might otherwise be unavailable. Operating in more than 70 countries, Essential Pharma focuses on the central nervous system, gastroenterology, ophthalmology, and rare diseases. Their growth strategy involves optimizing their product portfolio and pursuing targeted mergers and acquisitions to acquire commercial and late-stage clinical assets in these key therapeutic areas. Essential Pharma has a proven track record of integrating new assets and managing complex technology transfers without disrupting the continuous supply of medicines to patients.

AGC Biologics, a part of AGC Inc.’s Life Science Company, is a leading global CDMO dedicated to developing and manufacturing mammalian and microbial-based therapeutic proteins, plasmid DNA, messenger RNA, viral vectors, and genetically engineered cells. With a global network spanning the U.S., Europe, and Asia, AGC Biologics leverages its cGMP-compliant facilities and employs over 2,500 team members worldwide. The company is committed to innovation and technical creativity, specializing in fast-track projects and rare diseases, ensuring high-quality solutions for their clients' most complex challenges.