Context Therapeutics granted Fast Track Designation to CTIM-76 by FDA

Context Therapeutics (CNTX) announced that the FDA has granted Fast Track Designation to CTIM-76, a CLDN6 x CD3 T cell engaging bispecific antibody, for the treatment of platinum-resistant ovarian cancer in patients that have received all standard of care therapies. Context is currently evaluating CTIM-76 in a Phase 1 clinical trial designed to evaluate the safety and efficacy of CTIM-76 in subjects with CLDN6-positive advanced or metastatic ovarian, endometrial and testicular cancers. The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability and pharmacokinetics, as well as anti-tumor activity by overall response rate, duration of response and disease control rate.