CAMBRIDGE, UK I January 9, 2015 I F-star, a biopharmaceutical company focused on oncology and immuno-oncology, today announced the initiation of a phase 1 clinical study of FS102, its lead compound for treatment of HER2 -positive breast and gastric cancer. The phase 1 trial is a dose-escalating clinical study being conducted in the United States by Bristol-Myers Squibb, which acquired exclusive rights to the programme in October 2014. FS102 is a HER2-targeting antibody fragment derived from F-star’s Modular Antibody Technology™. In pre-clinical studies, FS102 demonstrated significant biological activity, including complete elimination of certain types of HER2 positive tumours resistant to standard-of-care due to tumour apoptosis (cell death). In addition, the company was able to identify a well-defined biomarker that has the potential to select patients that will best respond to therapy.

“There is a tremendous medical need for novel HER2-targeted therapies for breast cancer, and other HER2-positive cancers. The first generation treatments, while ground-breaking, have their limitations due to inherent or acquired resistance,” said John Haurum, M.D., D.Phil., chief executive officer at F-star. “FS102, if approved, has the potential to become an important addition to the treatment of several types of HER2-positive solid tumours including breast, gastric and colorectal cancer. As the company’s first programme to enter human clinical trials, this novel, targeted therapy not only represents a significant milestone for F-star, but more importantly has the potential to be of great value to patients. ”

About FS102

FS102 is a HER2-targeted Fcab™ that can eliminate cancer cells through a novel mechanism of action in a biomarker-defined patient population. FS102 works differently to current HER2-targeted therapies, with the potential to overcome resistance to these drugs. It binds to a unique site on HER2 and then induces programmed cell death in HER2-positive tumour cells. In preclinical studies FS102 shows remarkable efficacy against certain HER2- positive cancers. It completely eliminates tumours, including those that are refractory to treatment with trastuzumab plus pertuzumab. Moreover, F-star has identified a tumour biomarker that highly correlates with efficacy.

About F-star

F-star is a biopharmaceutical company dedicated to developing novel bispecific antibody products that provide a significant improvement over the current standard of care. Given its strong patent position, it is the only biopharmaceutical company with the ability to create and develop Fcab™ antibody fragments and bispecific antibodies, by modifying the constant region of an antibody. In particular, F -star’s Modular Antibody Technology™ enables rapid discovery and development of bispecific antibodies by introducing additional binding sites to the constant region of an antibody and offers unprecedented ease in the development and manufacturing of bispecific antibody products. Using the Modular Antibody Technology™, F-star generates bispecific antibodies (mAb2™) that possess the favourable characteristics of traditional monoclonal antibodies, without the production challenges often associated with other antibody formats. F-star is now applying its proprietary technology to the development of a pipeline of product candidates.

Since its founding in 2006 the company has secured funding and support from leading VC investors: Aescap Venture, Atlas Venture, Novo Ventures and TVM Capital; as well as from strategic corporate investors: Merck Serono Ventures, MP Healthcare Venture Management and SR One.

In 2013, F-star established an asset-centric vehicle structure through the formation of F-star Alpha Ltd., and licensed FS102 to F-star Alpha Ltd. F-star Beta Ltd. was formed in October 2014 and 22 targets licensed to F-star Beta.

Bristol-Myers Squibb obtained world-wide rights through a license to FS102, as well as an exclusive option to buy F-star Alpha in October 2014. F-star also has alliances with Boehringer Ingelheim and Merck Serono, each covering multiple targets. In 2011, F-star was selected by FierceBiotech as one of the Fierce 15 winners. F-star currently employs 40 people at its research site in Cambridge, UK.

SOURCE: F-star