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The collaboration will provide GMP manufacturing ahead of future clinical studies.
F-star, a clinical-stage biopharmaceutical company developing bispecific antibodies with a focus on immuno-oncology, has entered into an agreement with contract manufacturing organization (CMO) CMC Biologics for GMP manufacturing of its lead mAbÂ² program, FS118, ahead of future clinical studies, the company announced in a June 6, 2016 press release.
An mAbÂ² is a full-length bispecific antibody with a normal antibody structure in which the Fc region has been replaced by an Fcab (i.e., Fc constant region of an antibody modified by introducing a new antigen binding site). The mAbÂ² 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 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 tumors.
“Our collaboration with CMC Biologics for the GMP manufacturing of our lead candidate ahead of preclinical toxicology studies and a subsequent IND [investigational new drug] filing is a crucial step toward bringing FS118 to patients," said Mike Davies, vice-president, Protein Science at F-star, in the press release.
Through the application of its efficient Modular Antibody Technology platform, F-star is the only biotechnology company able to create bispecific antibodies where the second binding site is in the constant Fc region of an antibody. F-star has currently one program in the clinic with a second immuno-oncology program heading toward IND.