IO Biotech Announces Initiation of Phase 2 Trial of IO102-IO103 in Combination With KEYTRUDA® (pembrolizumab) as First-Line Treatment in a Multi-Arm Basket Trial

Apr 12 2022

NEW YORK, April 12, 2022 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win® technology platform, announced today that it has dosed the first patient, in metastatic non-small cell lung cancer (NSCLC), in its Phase 2 IOB-022 / KN-D38 trial (NCT05077709).

The IOB-022 / KN-D38 trial seeks to evaluate IO Biotech’s lead candidate, IO102-IO103, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in previously untreated patients with three different tumor types in the first line setting —NSCLC, squamous cell carcinoma of the head and neck (SCCHN), and urothelial bladder cancer (mUBC).

“Initiating this study with IO102-IO103 further progresses our late-stage development program,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “We believe IO102-IO103 has the potential to show utility for multiple cancer indications. We look forward to expanding our dataset in these additional indications.”

About IOB-022 / KN-D38

IOB-022 / KN-D38 is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in each of the following first-line indications: NSCLC, SCCHN, and mUBC. The clinical trial will be sponsored by IO Biotech and conducted in collaboration with Merck. IO Biotech maintains global commercial rights to IO102-IO103.

About IO102-IO103

IO102-IO103 is an investigational cancer immunotherapy designed to target the immunosuppressive mechanisms mediated by the key proteins indoleamine 2,3-dehydrogenase (IDO) and PD-L1. IO102-IO103, in combination with pembrolizumab, was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for treatment of unresectable/metastatic melanoma, based on the results of a Phase 1/2 clinical trial (MM1636). IO Biotech has also begun patient recruitment into a Phase 3 combination trial (IOB-013 / KN-D18) of IO102-IO103 and KEYTRUDA® (pembrolizumab) as first-line treatment in advanced melanoma patients, which is designed to be potentially registrational.

About IO Biotech

IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win® technology platform. The T-win® platform is a novel approach to cancer immunotherapy designed to activate naturally occurring T cells to target immunosuppressive mechanisms. IO Biotech is advancing in clinical studies its lead immuno-oncology candidate, IO102-IO103, targeting IDO and PD-L1, and through clinical and preclinical development its other pipeline candidates.  IO Biotech is headquartered in Copenhagen, Denmark and has additional offices within the United States (New York, New York and Rockville, Maryland) and United Kingdom (Monmouthshire).

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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, 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.


Mai-Britt Zocca, Ph.D.
President and CEO

Keith Vendola, M.D.
IO Biotech, Inc.

Corey Davis, Ph.D.
LifeSci Advisors
+1 212-915-2577

Media Contact:
Raena Mina, Ph.D.
LifeSci Communications

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

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Source: IO Biotech