Clevegen binds a receptor called Clever-1 on the surface of Tumour Associated Macrophages (TAM), which are immune cells that have been linked to tumor profileration and survival.
The idea is that binding Clever-1 prevents TAM cells from entering tumors and exerting any immunosuppressive effects.
Under the manufacturing deal Abzena will produce the Master Cell Bank and make Phase I and II clinical volumes of the antibody at its single-use equipped facility in San Diego, California, acquired last September through the purchase of CDMO PacificGMP.
“Faron selected Abzena to optimise and manufacture Clevegen based on Abzena’s high level of expertise and know-how in antibody and protein engineering as well as cell line development and documentation, which can be used both in Europe and USA,” Faron’s CEO Markku Jalkanen said.
The terms of the agreement between the two companies are currently not disclosed.
However, Jalkanen told Biopharma-Reporter.com the firm is also working with Selexis which has produced high-expressing and stable clonal cell lines for Clevegen.
“The best selected clone will be now be used by Abzena to produce the Master Cell Bank for Faron. There will be co-operation between all parties.”
We asked Abzena if this deal marks the first contract win for Abzena since it added the biopharma cGMP capacity through the PacificGMP acquisition.
“This is not the first manufacturing contract we have been won since Abzena acquired PacificGMP, but it is the first for an ‘Abzena inside’ product since the acquisition,” said Dr Sally Waterman, SVP corporate development at Abzena.
Abzena has been helping to develop Clevegen, humanising the antibody using its proprietary Composite Human Antibody technology.
“Abzena’s technology tries to make non-human therapeutic antibodies - e.g. those derived from mice, llamas etc - as human-like as possible, to reduce any unwanted immune responses,” Waterman told us.
“Its Composite Human Antibodies are built using multiple sequence segments from unrelated human antibodies as building blocks.”
She added the technology is different to standard humanising techniques because it removes T-cell epitopes which are known to produce immune responses.