US FDA accepts Morphotek’s IND application for MORAb-202
It is noteworthy that U.S FDA has accepted an investigational New Drug Application for MORAb-202, an antibody-drug conjugate (ADC), to treat solid tumors that express folate receptor alpha (FRA). MORAb-202 is a novel investigational ADC that uses a cathepsin-cleavable linker to combine investigational farletuzumab with the microtubule inhibitor payload, eribulin. Farletuzumab is a humanized antibody targeting FRA and has been studied in clinical trials in patients with FRA-expressing tumors. FRA expression is observed in a large number of cancers, including endometrial, gastric, non-small cell lung, ovarian and triple-negative breast, but is not present in normal tissue.
Nicholas Nicolaides, President and CEO of Morphotek. “This investigational agent has shown robust antitumor effects in a number of preclinical FRA-expressing tumor models, making it a potential promising candidate for the treatment of cancers that express this biomarker.”