– Submission of Investigational New Drug Application (IND) to US FDA expected in 2025 –

NEW YORK, Feb.  04, 2025  (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today announced the publication of results from a preclinical study of its second immune-modulatory therapeutic cancer vaccine candidate, IO112, targeting arginase 1 (Arg1), in the Journal for ImmunoTherapy of Cancer.

These preclinical data further expand upon previously reported data that IO112 treatment inhibits tumor growth through dynamic changes in the tumor microenvironment (TME). The present study showed how Arg1-specific T cells expanded by the vaccine enhance anti-tumor immunity by reprogramming tumor-associated macrophages (TAMs) and promote a proinflammatory TME. Arg1 plays a central role in immune suppression, and its overexpression has been reported in several cancers.

“Arg1-expressing TAMs remain a major hurdle in cancer immunotherapy due to their role in creating an immunosuppressive TME,” said Ayako Wakatsuki Pedersen, PhD, Senior Vice President of Translational Research at IO Biotech. “TAMs represent one of the most abundant immune cell subsets found within the TME and it’s really exciting to learn that IO112 treatment directly impacts TAMs, changing the phenotype of TAMs completely. These findings further support the continued clinical development of Arg1-based immune-modulatory vaccines.”

“These data published in the Journal of ImmunoTherapy of Cancer add to the strong body of evidence that the unique approach of our T-win® platform, designed to kill both tumor cells and immune-suppressive cells in the TME, could potentially change the treatment paradigm in the management of a number of cancers,” said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. “We look forward to submitting an IND for IO112 in 2025 and advancing into clinical development as part of our commitment to transform the treatment of cancer patients.”

About IO112

IO112 is the company’s fully-owned, novel investigational product candidate containing a single Arginase 1-derived peptide designed to engage and activate Arginase 1-specific human T cells. IO112 is designed to target T cells that recognize epitopes derived from Arginase 1, which is an immunoregulatory enzyme highly expressed in difficult-to-treat tumors associated with high levels of myeloid-derived suppressor cells (MDSCs) including renal cell carcinoma, head and neck, breast, pancreatic, ovarian, colorectal and prostate cancers. Arginase overexpression is a well-documented tumor escape mechanism. IO112 has been studied in a single arm first-in-human Phase 1 trial in patients with arginase-positive solid tumors, conducted in an investigator-initiated trial at the University of Copenhagen. The company anticipates filing an IND for IO112 in 2025.

About IO Biotech

IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf 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 both tumor cells and the immune-suppressive cells in the tumor microenvironment. IO Biotech is advancing its lead investigational cancer vaccine candidate, Cylembio™ (imsapepimut and etimupepimut, adjuvanted) 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 Merck’s anti-PD-1 therapy, KEYTRUDA® (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).

Cylembio is a trademark of IO Biotech ApS.

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 submission of an IND for IO112, other current or future regulatory submissions or 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:

Investors
Maryann Cimino, Director of Investor Relations 
IO Biotech, Inc.
617-710-7305
[email protected]

Media
Julie Funesti
Edelman
917-498-1967
[email protected]