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, announced today that the first patient has been dosed in its Phase 2 trial (NCT05280314) studying treatment with IO102-IO103 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in neoadjuvant and adjuvant patients with resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN) before and after surgery with curative intent.

“We continue to see promising data and a favorable safety profile supporting use of our lead investigational therapeutic cancer vaccine candidate, 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, PhD, President and CEO of IO Biotech. “In patients with advanced melanoma, the activity and tolerability profile of IO102-IO103 and a PD-1 inhibitor has been demonstrated in the Phase 1/2 trial and we are now conducting a pivotal Phase 3 trial in patients with advanced melanoma, with enrollment completed in that study and an interim analysis planned in 2024. We are embarking on this neoadjuvant/adjuvant trial with the goal of also helping patients in earlier disease settings.”

Qasim Ahmad, MD, Chief Medical Officer of IO Biotech, added, “The importance of systemic immunotherapy before surgery is becoming a critical area of research, with the potential to change early treatment paradigms. In this perioperative disease setting, the IOB-032 study will provide clinical and translational data on the activity of IO102-IO103 in combination with pembrolizumab in patients with resectable melanoma and squamous cell carcinoma of the head and neck. Dosing the first patient in this trial demonstrates our commitment to further explore the potential our therapeutic cancer vaccine may offer to a broader group of patients with cancer. Leading global experts from centers of excellence in this field in the US, Australia and Europe are involved in this clinical trial. We look forward to following the progress of this study.”

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 up to 15 patients with melanoma, and 15 patients with SCCHN. Patients entering the study will be scheduled for surgery and begin neoadjuvant treatment 6 weeks prior. During the neoadjuvant period, patients will receive IO102-IO103 weekly (6 doses) in combination with pembrolizumab every 3 weeks (Q3W) (2 doses). After patients recover from surgery (for up to 13 weeks) they will receive adjuvant treatment with IO102-IO103 in combination with pembrolizumab for 12 months. 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 off-the-shelf, investigational therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME), by stimulating the activation and expansion of T cells against IDO+ and/or PD-L1+ cells. This results in the modulation of the TME, creates a more pro-inflammatory environment, and potentiates anti-tumor activity via unleashing the tumor killing by effector T cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) evaluating IO102-IO103 in combination with pembrolizumab as first-line treatment in patients with advanced non-small cell lung cancer or squamous cell cancer of the head and neck (SCCHN), and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) evaluating IO102-IO103 plus pembrolizumab as a perioperative treatment in patients with solid tumors, including melanoma and SCCHN.

The clinical trials are sponsored by IO Biotech, 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 therapeutic cancer vaccines based on its T-win® cancer vaccine platform. The T-win platform is a novel approach to cancer vaccines designed to activate T cells to target tumor cells and immune-suppressive 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 advanced melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a breakthrough therapy designation for the treatment of unresectable / metastatic 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 analysis of our Phase 3 trial, the timing of our Phase 2 basket trials and other current and 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.

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