Why Are IO Biotech Shares Trading Lower Today

IO Biotech IOBT randomized 225 patients in its global Phase 3 clinical trial for IO102-IO103, in combination with Merck & Co Inc MRK Keytruda (pembrolizumab) in patients with advanced melanoma.

IO102-IO103 is an investigational immune-modulating cancer vaccine designed to target immunosuppressive mechanisms.

This clinical milestone is significant as the Phase 3 trial protocol calls for an interim analysis of the overall response rate one year after 225 patients have been enrolled. 

If positive, data obtained from this interim analysis could allow for the submission of an FDA Biologics License Application for accelerated approval in the U.S.

Additionally, the company announced increasing the number of patients enrolled by 80 in the Phase 3 trial to 380, potentially accelerating the time to reach the primary endpoint of progression-free survival. 

If the data are supportive, the PFS endpoint will serve as the basis for submitting marketing applications on a global basis.

"Even with this increase in target enrollment to 380 patients, we continue to expect to reach full enrollment in this trial by the end of this year and expect our cash to support our activities through the third quarter of 2024," said Mai-Britt Zocca, President and CEO of IO Biotech.

Dr. Zocca continued, "Should the interim analysis for this Phase 3 trial be positive, and we have the potential to have our first vaccine candidate approved and available for patients in 2025."

Price Action: IOBT shares are down 27.40% at $1.59 on the last check Wednesday.