F-star announces an agreement with CMC Biologics for manufacture of mAb² ™ bispecific antibodies
Supporting F-star’s strong pipeline development in immuno-oncology
CAMBRIDGE, UK – 7 June 2016 – 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“mAb-square”) is a full-length bispecific antibody with a normal antibody structure in which the Fc region has been replaced by an FcabTM (Fc constant region of an antibody modified by introducing a new antigen binding site).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 mAb², FS118.”
For further information, please contact:
Chief Executive Officer
+ 44 7881 244 040
Chief Business Officer
+ 44 7739 174 297
Hume Brophy for F-starMary Clark, Eva Haas, Alexia Faure
+44 207 862 6381
Robert J. Broeze, PhD
Senior Vice President, Global Business Development
+1 (609) 273-3414
F-star is a clinical-stage biopharmaceutical company developing bispecific antibody immuno-oncology products selected for their potential to transform the treatment of cancer. Through the application of its highly 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. The strength of the technology and programmes has been leveraged through partnerships with leading biopharmaceutical companies including AbbVie, Bristol-Myers Squibb, Merck Serono and Boehringer Ingelheim. F-star has currently one program in the clinic with a second immuno-oncology program heading toward IND. The Company has built a comprehensive IP estate around its technology and product pipeline, with over 50 patent applications filed and over 25 granted patents.
F-star’s management team has a well-established track record in building successful biotech companies, and developing biologics. The team is advised by a world-leading scientific advisory board and a highly experienced board of directors. F-star has raised close to $100M in non-dilutive capital and revenues. The company currently employs over 60 people at its research site in Cambridge, UK.
For more information visit www.f-star.com
About CMC Biologics
CMC Biologics is leading the industry among CMOs in reliability, technical excellence, and quality — Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical, and commercial production. The Company’s wide range of integrated services includes cell line development, bioprocess development, formulation development, and comprehensive analytical testing. Clients can also benefit from CMC Biologics’ proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes. More detailed information can be found at www.cmcbio.com.