IO Biotech says FDA reccomends not submitting BLA based on IOB-013 trial data

IO Biotech (IOBT) provided an update on the regulatory pathway for Cylembiofollowing a pre-BLA meeting with the U.S. Food and Drug Administration . The FDA has recommended that IO Biotech not submit a BLA based on the data from the IOB-013 clinical trial. As previously announced, in the IOB-013 trial, treatment with Cylembio plus pembrolizumab improved progression free survival, however the results narrowly missed statistical significance. The company plans to continue the dialogue with FDA to align on the design of a potential new registrational study for Cylembio. “We had a productive meeting with FDA; while this is not the outcome we had hoped for, we respect FDA’s feedback and remain confident in the therapeutic potential of Cylembio,” said Mai-Britt Zocca, cEO. “We look forward to continuing the dialogue with FDA to align on the design for a potential new registrational study. Additionally, we plan to discuss the data from our IOB-013 study with European regulators and determine a path to submission in the EU.”