LINDIS Biotech GmbH, a German biotechnology company, has announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued positive opinions regarding Korjuny (catumaxomab). The trifunctional anti-CD3 x anti-EpCAM antibody (trAb) is recommended for the intraperitoneal treatment of malignant ascites (MA) in adults with EpCAM-positive carcinomas who are not eligible for further systemic anticancer therapy.
The recommendation is supported by the results of IP-REM-AC-01, a large randomized, global multi-center Phase II/III study that demonstrated a statistically significant improvement in the primary endpoint of puncture-free survival. Patients treated with catumaxomab experienced a four-fold increase in puncture-free survival compared to those treated with puncture alone, which remains the most common intervention and standard therapy for chemotherapy-refractory MA patients.
Catumaxomab was originally discovered by German firm Trion Pharma and co-developed with Fresenius. It became the first T-cell engaging bispecific antibody to be approved by the European Medicines Agency in 2009 for the treatment of malignant ascites before being withdrawn from the market for commercial reasons. Catumaxomab’s inventor and primary patent holder, Dr. Horst Lindhofer, the founder of Trion Pharma, is one of the co-founders of LINDIS Pharm, and also founded Lindis Pharma in Germany, which is continuing the development of catumaxomab.
This positive opinion from the COMP highlights the potential for Korjuny to provide a new treatment option for patients with EpCAM-positive carcinomas and malignant ascites, offering hope for improved outcomes in this challenging disease area.- Flcube.com
