IOBT IO Biotech Inc

IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win® technology platform, announced that data from a pre-defined interim analysis related to the lung cohort of the Phase 2 basket trial (IOB-022/KN-D38) with IO102-IO103 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, as first-line therapy were presented today at the IASLC 2023 World Conference on Lung Cancer (WCLC). Jonathan Riess, MD, lead investigator of the trial at the UC Davis Comprehensive Cancer Center, presented encouraging early clinical and biomarker data supporting the combination treatment for patients with metastatic non-small cell lung cancer (NSCLC).

Dr. Riess commented, “We are encouraged that the clinical activity and safety profile continue to validate the potential of IO102-IO103 in combination with pembrolizumab to treat patients with metastatic NSCLC and PD-L1 TPS ≥50%. Available biomarker results for some patients show vaccine-specific T cell expansion and complete clearance or considerable drop of ctDNA, indicating activity of the treatment after just 21 days. With this interim analysis, where more than half of the evaluable patients had a partial response (8/15 patients or 53.3%), we are optimistic about the development of this potential therapy to help serve the unmet clinical need for improved treatment options for patients with advanced NSCLC.”

Abstract #2625: Ph 2 Trial of IO102-IO103 Vaccine Plus Pembrolizumab: Preliminary Results for the First-line Treatment of Lung AdenocarcinomaThis ongoing Phase 2 trial is enrolling patients with metastatic adenocarcinoma NSCLC with a PD-L1 tumor proportion score (TPS) ≥50% and no prior treatments for metastatic disease. Previously published data of the combination of IO102-IO103 and nivolumab in anti-PD1 naïve metastatic melanoma showed robust clinical activity with an overall response rate (ORR) of 80% and a complete response rate (CRR) of 50% reached without additional systemic toxicities. The preliminary analysis in this trial suggests that the combination of IO102-IO103 with pembrolizumab as first-line therapy in patients with metastatic adenocarcinoma of the lung and PD-L1 TPS > 50% is tolerable with encouraging clinical activity.

As of the data cut-off in July 2023, 25 patients had been enrolled in the lung cohort of this basket trial. Included in today’s mini-oral presentation is data from the pre-defined interim analysis of the first 15 efficacy-evaluable patients who had received at least 2 full cycles of treatment, and either had at least 2 post-baseline tumor assessments or discontinued. The data show that 8 of these 15 patients (53.3%), had a confirmed partial response (PR). The median duration of exposure is 15 weeks. The safety profile observed in this study are similar to past studies of IO102-IO103 in combination with pembrolizumab, which have demonstrated a profile consistent with pembrolizumab monotherapy with no noted additional significant systemic toxicity.

Qasim Ahmad, MD, Chief Medical Officer of IO Biotech, added, “We believe our cancer vaccine in combination with an anti-PD-1 antibody could change the treatment paradigm for multiple tumor types and this encouraging initial data show its potential as an efficacious and well-tolerated first-line treatment option for patients with NSCLC. We continue to enroll patients in the NSCLC cohort and the squamous cell carcinoma of the head and neck (SCCHN) cohort of this basket trial, and we look forward to reporting additional clinical and biomarker data over the next several months.”

Presentation Details

The data were presented today in a mini oral presentation.Abstract Title: Ph 2 Trial of IO102-IO103 Vaccine Plus Pembrolizumab: Preliminary Results for the First-line Treatment of Lung AdenocarcinomaSession: MA15 - Bringing New Discoveries into Early Phase Clinical TrialsPresenter: Jonathan Riess, MD

The slides presented during the oral presentation are available on IO Biotech’s website at www.iobiotech.com.

About IO102-IO103

IO102-IO103 is an investigational immune-modulating cancer vaccine designed to target the immunosuppressive mechanisms mediated by the proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1. The company is currently conducting a Phase 3 trial (IOB-013/KN-D18; NCT05155254) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients, and a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced non-small lung cancer and head and neck cancer.

About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial

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 in patients with either non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN). The clinical trial is 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 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 most important immunosuppressive cells in the tumor microenvironment leading to the induction of a potent immune response within the TME to enhance the killing of tumor cells. IO Biotech is advancing in clinical trials its lead cancer vaccine candidate, IO102-IO103, targeting IDO and PD-L1, and through preclinical development its other pipeline candidates. 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 RelationsIO Biotech, Inc.617-710-7305mci@iobiotech.com