- 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.
BASEL, Switzerland, February 19, 2025 / Biotech Newswire / -- 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."
From left to right: Samanta Cimitan, CEO Celonic Group, Horst Lindhofer, CEO LINDIS Biotech.
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About LINDIS Biotech
LINDIS Biotech is a bio-pharmaceutical company that is committed to the development of Triomab® antibodies - a new class of T-cell engaging bispecific trifunctional antibodies, empowering the immune system to turn malignant cancers into manageable and possibly curable diseases.
About catumaxomab
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(ii),(iii).
About Celonic
Celonic is a “Pure Play” Biologics Contract Development Manufacturing Organization (CDMO) with significant expertise in cell culture technologies, process development and manufacturing of recombinant proteins. Celonic’s roots trace back to 1982 as a spin-off of the Max Planck Institute in Germany. Today Celonic has a state-of-the-art Biologics Development and Innovation Center in Basel, Switzerland (Headquarters), and clinical and commercial GMP manufacturing facilities in Heidelberg, Germany. This facility is equipped to handle complex biologics and bioprocessing technologies including fed-batch, N-1 perfusion and full perfusion production processes. At present, more than 500 highly qualified employees work at Celonic across the two locations.
Contact
Celonic Group
Elisa Witt
Marketing and Communications Manager
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+41 76 588 67 59
(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) Atanackovic et al., Human Vaccines & Immunotherapeutics 9:12, 1–10; 2013; https://pubmed.ncbi.nlm.nih.gov/23955093/
Keywords: Manufacturing and Industrial Facilities; Neoplasms; catumaxomab; Ascites; Antibodies, Monoclonal; Biotechnology; Germany; Celonic Group; LINDIS Biotech; EMA Marketing Authorization; Malignant ascites; Trifunctional bispecific monoclonal antibody; EpCAM-positive carcinomas; Intraperitoneal treatment; GMP manufacturing; Heidelberg, Germany; Biologics CDMO; T-cell engaging antibodies; Triomab® antibodies; CD3 antigen; Fc-gamma receptor; Immune system activation; Samanta Cimitan; Horst Lindhofer; Basel, Switzerland; Bioprocessing technologies; Fed-batch production; N-1 perfusion; Full perfusion production
Source: Biotech Newswire