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IO Biotech Provides Update Following Pre-BLA Meeting with FDA
Globenewswire· 2025-09-29 11:05
Core Viewpoint - IO Biotech's Cylembio (imsapepimut and etimupepimut) will not proceed with a Biologics License Application (BLA) based on the current clinical trial data, as recommended by the FDA, despite showing improved progression-free survival (PFS) in the IOB-013 trial [1][6] Regulatory Update - The FDA advised against submitting a BLA for Cylembio based on IOB-013 trial data, which narrowly missed statistical significance for PFS [1][6] - IO Biotech plans to engage in further discussions with the FDA to design a new registrational study for Cylembio [2][6] Clinical Trials - Cylembio is currently being evaluated in multiple clinical trials, including a pivotal Phase 3 trial (IOB-013/KN-D18) in combination with Merck's KEYTRUDA (pembrolizumab) for advanced melanoma [3][5] - The IOB-013 trial enrolled 407 patients across over 100 centers globally, with topline results reported in Q3 2025 [5][7] Financial and Operational Strategy - The company is implementing a restructuring plan to conserve capital, which includes a workforce reduction of approximately 50% and expects a non-recurring charge of $1.0 - $1.5 million in Q3 2025 [2][6] - IO Biotech has sufficient capital to sustain operations into Q1 2026 while pursuing regulatory approval for Cylembio [2] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines using its T-win platform [8]
IO Biotech Named Among Fast Company's World's Most Innovative Companies of 2025
Newsfilter· 2025-03-18 12:00
Core Insights - IO Biotech has been recognized as the 9th most innovative company in the biotechnology category by Fast Company for its development of immune-modulatory therapeutic cancer vaccines [1][2][4] - The company is focused on creating off-the-shelf cancer vaccines that can be available at the time of patient diagnosis, aiming to change the oncology treatment paradigm [2][4] - IO Biotech's T-win® platform is designed to target both tumor cells and immune-suppressive cells in the tumor microenvironment, potentially leading to improved patient outcomes [2][4][6] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company headquartered in Copenhagen, Denmark, with a US office in New York [6] - The company is advancing its lead investigational cancer vaccine candidate, Cylembio® (imsapepimut and etimupepimut, adjuvanted), which is currently in a global Phase 3 clinical trial for advanced melanoma [4][6] - Cylembio® has received Breakthrough Therapy Designation from the US FDA for the treatment of advanced melanoma in combination with Merck's KEYTRUDA® (pembrolizumab) [6] Industry Recognition - Fast Company's list of the Most Innovative Companies is a highly anticipated feature that evaluates thousands of submissions to recognize organizations driving progress across various industries [3] - The recognition highlights companies that are leveraging innovative technologies and strategies to enhance customer experiences and introduce vital competition in their sectors [4][3]