- LINDIS Biotech has received an EMA Marketing Authorization for catumaxomab, making it the only drug approved for the specific and cancer-directed treatment of malignant ascites.
- Celonic Group will manufacture catumaxomab for commercial supply.
- Catumaxomab will be manufactured at Celonic’s state-of-the-art GMP facility in Heidelberg, Germany.
Celonic Group, a “Pure Play” biologics contract development and manufacturing organization (CDMO), announced today the signing of a multi-year commercial manufacturing agreement with LINDIS Biotech for the production of catumaxomab for Commercial Supply.
Catumaxomab is a first-in-class, trifunctional bispecific monoclonal antibody designed for the intraperitoneal treatment of malignant ascites in adults with epithelial cell adhesion molecule (EpCAM)-positive carcinomas who are not eligible for other systemic anticancer therapy[i]. Malignant ascites is an abnormal accumulation of fluid in the peritoneal cavity that commonly arises from advanced-stage cancers.
Under the terms of the multi-year commercial manufacturing agreement, Celonic Group will leverage its expertise in GMP manufacturing to produce catumaxomab at its state-of-the-art manufacturing facility in Heidelberg, Germany.
Dr. Horst Lindhofer, CEO of LINDIS Biotech, commented: “Partnering with Celonic Group is a vital part of our mission to bring catumaxomab to patients suffering from malignant ascites and fill this unmet clinical need. With Celonic’s proven manufacturing capabilities and commitment to quality, we are confident in their ability to ensure a reliable and high-quality supply of our innovative therapy.”
Samanta Cimitan PhD, CEO of Celonic Group, added: “We are honored to collaborate with LINDIS Biotech on the production of catumaxomab. This partnership underscores our dedication to supporting the development and commercialization of groundbreaking biologics that address unmet medical needs.”
[i] https://www.ema.europa.eu/en/medicines/human/EPAR/korjuny
[ii]https://www.ema.europa.eu/en/documents/overview/removab-epar-summary-public_en.pdf
[iii] https://pubmed.ncbi.nlm.nih.gov/23955093/
