IOBT IO Biotech Inc

IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines, announced encouraging preliminary data from the company’s Phase 2 basket trial of IO102-IO103 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) (IOB-022/KN-D38) at the ESMO Congress being held in Madrid from October 20-24, 2023. Jonathan Riess, MD, lead investigator of the trial at the UC Davis Comprehensive Cancer Center, shared encouraging clinical and biomarker data from patients with metastatic non-small cell lung cancer (NSCLC) with PD-L1 TPS ≥ 50% and recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) with PD-L1 CPS ≥ 20. As of the data cut off for this poster presentation, 10 out of 18 evaluable NSCLC patients (56%) had achieved a partial response as their best overall response and 3 out of 6 evaluable SCCHN patients had achieved partial response as their best overall response.

Dr. Riess commented, “These preliminary data further support the potential of combining IO102-IO103 and pembrolizumab in patients with metastatic NSCLC and recurrent/metastatic SCCHN. Although it is early in the study, we are encouraged by these data as they indicate that the activity with this combination is favorable compared to historical controls.”

“The data presented today strengthen the evidence that IO102-IO103 plus a PD-1 inhibitor may improve upon the activity expected from treatment with a PD-1 inhibitor alone,” said Qasim Ahmad, Chief Medical Officer of IO Biotech. “Emerging data from this basket study and the prior melanoma Phase 1/2 study (MM1636) are building evidence on the effect of this combination as a first line treatment in patients with three types of metastatic solid tumors – melanoma, NSCLC and SCCHN. Although the data from this Phase 2 study are still evolving, 5/10 NSCLC and 3/3 SCCHN patients with partial responses had more than 180 days progression-free survival (PFS) and are ongoing. We look forward to receiving additional longer-term data that could demonstrate durability of response in numerous types of cancers.”

The Phase 2 basket study (IOB-022/KN-D38; NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab as a first-line treatment in up to 60 patients with metastatic NSCLC with PD-L1 TPS ≥ 50% or recurrent and/or metastatic SCCHN with PD-L1 CPS ≥ 20. The primary endpoint of the study is overall response rate. Patients enrolled in the study who had at least 2 post-baseline tumor assessments or who discontinued after 2 cycles of study treatment as of the data cut off of August 21, 2023 were considered efficacy evaluable and were included in the ESMO poster presentation. To date, the safety profile observed in this study is consistent with prior studies of IO102-IO103 in combination with checkpoint inhibitors, with no noted additional significant systemic toxicity, with low grade injection site reactions being the most common treatment related adverse event reported​. The trial is ongoing and continuing to enroll patients in both cohorts.              Poster title: A Phase 2 trial of the IO102-IO103 vaccine plus pembrolizumab: preliminary analysis for first line (1L) treatment of Non-Small Cell Lung Cancer (NSCLC) and Squamous Cell Carcinoma of the Head and Neck (SCCHN) Poster presentation number: 1038PPoster first author: Jonathan W. Riess, MDOnsite poster display date: Monday, October 23, 2023, 9:00 AM – 5:00 PM CET

The poster will be available on the “Posters & Publications” page of the IO Biotech website.

About IO102-IO103

IO102-IO103 is an investigational immune-modulating therapeutic cancer vaccine designed to target the immunosuppressive mechanisms mediated by the proteins indoleamine 2,3-dioxygenase (IDO) and programmed cell death protein 1 (PD-1). 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 in first-line advanced non-small cell lung cancer and head and neck cancer, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) evaluating IO102-IO103 plus pembrolizumab as a perioperative treatment in solid tumors including melanoma and SCCHN. The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck. 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® vaccine platform. The T-win platform is 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 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.

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 future clinical trials and results, 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