process and function
New safe and cost-effective approach for blood management in cancer surgery for EpCAM positive cancers that can be easily integrated into hospital routines
The bispecific trifunctional antibody binds tumor cells including cancer stem cells via the general tumor marker EpCAM
The antibody induces the bond between cancer
cells and immune cells
Resulting cell complexes are removed in two steps:
-during a standard IBS procedure and
-filtration of cell complexes with a leukocyte depletion filter (LDF)
The MoA is purely physical and does not involve any pharmacological, immunological or metabolic action
IN VITRO DATA
LBC has started the development of Catuvab® by generating in vitro data regarding the ability of Catuvab® to remove EpCAM positive Tumor Cells from blood, including Cancer Stem Cells
Proof of Principle demonstrated in an in vitro study
Study completed in 2019
Blood drawn from volunteers was spiked with tumor cells, samples then treated with CATUVAB® and a standard IBS device
Samples then screened for tumor cells and residual antibody in the final erythrocyte concentrate (EC) after leukocyte depletion
Also at a very low antibody concentration no residual tumor cells were detected in the final Erythrocyte Concentrate
LBC performed successfully an Exploratory Study, („Pilot Study“) at a German University. In this study Catuvab® procedure was used to treat intraoperative blood from 15 Patients during an oncological surgery. Remaining tumor cells were measured in the erythrocyte concentrates (EC), as well as remaining antibodies and other safety parameters.
Based on convincing data from the PILOT STUDY, LBC`s Confirmatory Study REMOVE was started.
Ex vivo Pilot Study: CATUVAB® shown to be safe and effective
Study completed in 2020
15 volunteers from surgeries of different EpCAM positive carcinomas,
Parameters measured in the intraoperative blood and ECs:
-EpCAM positive tumor cells
-Study was successfully completed
-No residual EpCAM positive Tumor Cells were found after use of Catuvab®.
Results demonstrate the efficacy and safety of CATUVAB®
Publication in preparation
LBC has started the multi center, international clinical validation study REMOVE.
REMOVE is designed for cancer patients with human epithelial cell adhesion molecule (EpCAM)-positive tumor indications (such as lung-, gastric-, pancreas-, colon-, endometriosis- and ovarian cancer including Cancer Stem Cells) and expected high blood loss during surgery.
The device will be used to remove cancer cells from extracorporal blood during tumor surgery by mechanically processed autologous transfusion (MAT) and additional filtration after antibody addition (Salvaged Blood Filter included in the Catuvab® kit). This procedure enables the retransfusion of autologous erythrocyte concentrate to the patient.
Confirmation study REMOVE to achieve CE certification
Study started in December 2020, multi center, international
Up to 110 patients shall be included
-Study design is identical to Pilot Study Retransfusion of EC
-Demonstrate depletion of EpCAM-positive tumor cells
REMOVE is designed to enable CE Certification of CATUVAB®