Kalobios Pharmaceuticals inked a research and commercial agreement for the use of BioWa and Lonza’s Potelligent® CHOK1SV cell line for the development and production of its Humaneered® antibody products. Launched in 2009, the Potelligent CHOK1SV cell line for manufacturing recombinant antibodies combines BioWa’s Potelligent engineered glycosylation technology for generating fucose-free antibodies with Lonza’s GS Gene Expression System™.
Lonza and BioWa claim the resulting cell line enables the production of recombinant antibodies that exhibit enhanced antibody-dependent cellular cytotoxicity, and potent cytotoxic effects even when their target antigen is at low density. Resulting antibodies are also effective in whole blood, the firms add. Daiichi Sankyo was the first company to announce the Potelligent CHOK1SV cell line back in June 2010.
Kalobios is exploiting its Humaneering technology to develop antibody therapeutics for a range of diseases. It says the platform has been designed to address current issues associated with antibody engineering such as specificity, affinity, and immunogenicity, and also to tackle downstream processing issues associated with antibody R&D such as solubility, expression, and aggregation. Kalobios claims the overall process is fast and produces antibodies close to human germ-line in sequence while retaining the specificity and improving the affinity of the reference antibody.
The firm’s lead KB001 antibody for the treatment of Pseudomonas aeurginosa infection, partnered with Sanofi Pasteur, is a PEGylated antibody Fab' fragment designed to bind to the PcrV component of the organism’s type three secretion system (TTSS) and inhibit its activity. Phase I/II studies have been completed in both in cystic fibrosis patients and intensive care patients on ventilators.
Clinical-stage candidate KB002/003 is an anti-GM-CSF program for the potential treatment of inflammatory diseases. KB002 and KB003 are both engineered human IgG1κ antibodies targeting GM-CSF. KB002, the precursor to KB003, is a first-in-class chimeric anti-GM-CSF antibody that Kalobios used for initial human proof-of-concept studies. Phase I/II studies in patients with rheumatoid arthritis and persistent asthma have been completed. KB003 is what Kalobios believes is a best-in-class Humaneered anti-GM-CSF antibody designed to minimize immunogenicity for chronic use in broad populations. KB003 will be used for all future development. KaloBios recently initiated a multidose Phase IIb trial with KB003, and is in addition in potential partnership discussions for the program.
A third oncology candidate, KB004, is a Phase I-stage Humaneered IgG1κ antibody targeting the EphA3 receptor tyrosine kinase. Kalobios believes the antibody has the potential to kill tumors through a number of distinct mechanisms including direct apoptosis of tumor cells through EphA3 cross-linking, direct killing of leukemic stem cells, tumor cell killing via potent ADCC activity, and blood vessel disruption due to tumor endothelial cell shape change.