- LINDIS Biotech has received EMA Marketing Authorisation for catumaxomab, making it the only medicine licensed for the targeted and cancer-directed therapy of malignant ascites.
- Celonic Group will produce catumaxomab for commercial use.
- Catumaxomab will be manufactured at Celonic’s advanced GMP facility in Heidelberg, Germany.
LINDIS Biotech has received EMA Marketing Authorisation for catumaxomab, making it the only medicine licensed for the targeted and cancer-directed therapy of malignant ascites.
Celonic Group will produce catumaxomab for commercial use.
Catumaxomab will be manufactured at Celonic’s advanced GMP facility in Heidelberg, Germany.
Celonic Group, a “pure play” biologics contract development and manufacturing organisation (CDMO), said today that it has signed a multi-year commercial manufacturing arrangement with LINDIS Biotech to produce 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. Malignant ascites is an abnormal accumulation of fluid in the peritoneal cavity that commonly arises from advanced-stage cancers.
Catumaxomab effectively destroys cancer cells by attaching to two antigens: EpCAM and CD3 to form a bridge between the cancer cells and the T-cells. This brings the cells close together so that the T-cells can kill the cancer cells. Catumaxomab also attaches to and activates Fc-gamma receptor positive immune cells like e.g. monocytes and macrophages, which also helps the body’s immune system to not only attack and destroy cancer cells, but also potentially induce a vaccination effect.
Under the terms of the multi-year commercial production agreement, Celonic Group will use its expertise in GMP manufacturing to create catumaxomab at its cutting-edge 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.”
Ref:
[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/
