IOBT IO Biotech Inc

IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today announced the acceptance of an abstract related to IO102-IO103, the company’s lead investigational therapeutic cancer vaccine candidate, for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago May 31-June 4, 2024. A trial-in-progress poster from the actively recruiting IOB-032/PN-E40 Phase 2 trial (NCT05280314) studying treatment with IO102-IO103 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) given in the perioperative setting in patients with resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN) will be presented.

“We are committed to investigating the use of IO102-IO103 combined with PD-1 inhibitors to treat various types of cancer, including melanoma, lung cancer and head and neck cancer,” said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. “The IOB-032 Phase 2 study is designed to provide us with insights into treatment outcomes in earlier disease settings with neoadjuvant and adjuvant treatment of patients with melanoma and SCCHN and we look forward to the results of this trial.”

Presentation Details

Title: A randomized phase 2 trial of the IO102-IO103 (IDO and PD-L1) cancer vaccine plus pembrolizumab as neoadjuvant/adjuvant treatment of patients with solid tumorsAbstract Number: TPS2701Presenter: Georgina V. LongDate: June 1, 2024Location and time: 9:00 AM - 12:00 PM CDT

About IOB-032/PN-E40

IOB-032/PN-E40 (NCT05280314) is a Phase 2 basket trial investigating the IO102-IO103 therapeutic cancer vaccine in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. The study will enroll approximately 45 patients with melanoma, and 15 patients with SCCHN. Patients entering the study will be scheduled for surgery and begin neoadjuvant treatment 4-9 weeks prior. During the neoadjuvant period, patients will receive IO102-IO103 in combination with pembrolizumab every 3 weeks (Q3W) for 3 cycles (melanoma) or 2-3 cycles (SCCHN). After patients recover from surgery, they will receive adjuvant treatment with IO102-IO103 in combination with pembrolizumab Q3W for up to 15 cycles. The primary endpoint will be the percentage of patients with major pathologic response (MPR) in the resected tumor tissue after neoadjuvant treatment.

About IO102-IO103

IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors.

The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About IO Biotech

IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target the immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a breakthrough therapy designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York.

For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech).

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding the timing of the interim and primary analyses of the company’s Phase 3 trial, current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.

Contact:Maryann Cimino, Director of Investor Relations IO Biotech, Inc.617-710-7305mci@iobiotech.com