F-star and CMC Biologics are collaborating for Good Manufacturing Practice (GMP) of the FS118 cancer programme, ahead of future clinical studies
F-star, a biopharmaceutical company developing novel bispecific antibodies with a focus on immuno-oncology, has entered into an agreement with CMC Biologics for GMP manufacturing of its lead mAb2 programme, FS118.
A mAb2 is a full-length bispecific antibody with a normal antibody structure in which the Fc region has been replaced by an Fcab.
The mAb2 format has the advantage of maintaining the ease of manufacturing and structural properties of an ordinary antibody while at the same time enabling novel biology to outperform monoclonal antibodies.
FS118 is a first-in-class bispecific antibody targeting two checkpoint inhibitor pathways with the potential to deliver greater efficacy and tolerability than combinations or monotherapies across a wide range of tumours, according to F-star.
Mike Davies, vice president, protein science at F-star, said: “Our collaboration with CMC Biologics for the GMP manufacturing of our lead candidate ahead of preclinical toxicology studies and a subsequent IND filing is a crucial step towards bringing FS118 to patients.”
Gustavo Mahler, president and chief executive officer of CMC Biologics, said: “We are proud to have been chosen by F-star to manufacture their lead compound.
“Our teams are building a strong and fruitful relationship and we are delighted to scale-up and produce GMP material for clinical trials of their first immuno-oncology mAb², FS118.”