The phase 1 trial is a dose-escalating clinicalstudy 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 AntibodyTechnology™. 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."