IO Biotech Plans To Design New Registrational Study For Cylembio For Treatment Of First-Line Patients With Advanced Melanoma; Implements Restructuring, Reducing Workforce By ~50%

Author: Benzinga Newsdesk | September 29, 2025 07:16am

• FDA recommends that IO Biotech not submit a Biologics License Application (BLA) based on the data from the IOB-013 clinical trial
• Company plans to design new registrational study for Cylembio for the treatment of first-line patients with advanced melanoma
• Company implementing a restructuring, reducing its workforce by approximately 50 percent

NEW YORK, Sept. 29, 2025 (GLOBE NEWSWIRE) -- IO Biotech (NASDAQ: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today provided an update on the regulatory pathway for Cylembio® (imsapepimut and etimupepimut, adjuvanted) following a pre-BLA meeting with the U.S. Food and Drug Administration (FDA). 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 (PFS), 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.

Posted In: IOBT