F-star, a biopharmaceutical company developing novel bispecific antibodies with a focus on immuno-oncology, today announced that it has entered into an agreement with CMC Biologics for GMP manufacturing of its lead mAb2 programme, FS118, ahead of future clinical studies.
A mAb2 (pronounced ‘mAb-square’) is a full-length bispecific antibody with a normal antibody structure in which the Fc region has been replaced by an FcabTM (Fc constant region of an antibody modified by introducing a new antigen binding site). 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.
Mike Davies, Vice President, Protein Science at F-star, commented:
‘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. We are delighted to work with one of the leaders in biopharmaceutical manufacturing, whom we selected for their strong technical expertise and experience working with monoclonal antibodies.’
‘We are proud to have been chosen by F-star to manufacture their lead compound. Through their unique approach to the design of bispecific antibodies they are poised to become a pivotal player in the immuno-oncology landscape’ said Gustavo Mahler, Ph.D., President & Chief Executive Officer of CMC Biologics. ‘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 mAb’, FS118.’