IO Biotech, Inc. (IOBTQ)

IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win technology platform. The vaccines are designed to activate pre-existing T cells to target immunosuppressive mechanisms in the tumor microenvironment. They use a dual mechanism of action: direct killing of immunosuppressive cells, including tumor cells and stable cells in the microenvironment that express targets such as IDO and PD-L1, and modulation of the microenvironment into a more pro-inflammatory, anti-tumor state. The company was established in December 2014 as a spin-off of the National Center for Cancer Immune Therapy at Herlev University Hospital in Denmark.

Its lead product candidate, IO102-IO103, combines two fully owned vaccines, IO102 (targeting IDO) and IO103 (targeting PD-L1). In a 30-patient Phase 1/2 trial in metastatic melanoma with nivolumab, it showed a confirmed overall response rate of 73% and a 50% complete response rate. The FDA granted it Breakthrough Therapy Designation in combination with pembrolizumab for unresectable or metastatic melanoma. A potentially registrational Phase 3 trial (IOB-013/KN-D18) in first-line advanced melanoma with pembrolizumab began enrolling in May 2022, with a target of 300 patients. It is aimed at potential accelerated approval based on an interim response-rate analysis, and a possible EMA marketing authorization application based on progression-free survival. The company is also running a Phase 2 basket trial (IOB-022) in NSCLC, head and neck, and bladder cancers, and plans a neo-adjuvant/adjuvant basket trial (IOB-032). Other pipeline assets include IO112, an Arginase 1-targeting vaccine in a Phase 1 investigator-initiated trial at the University of Copenhagen, and preclinical TGFB1-targeting vaccines.

The company's focus is solid tumors, beginning with first-line advanced melanoma and extending to lung, head and neck, bladder and other cancers, including those with high levels of myeloid-derived suppressor cells. It holds worldwide development and commercial rights to its pipeline and intends to commercialize product candidates, if approved, in key geographies. It has no approved products.

Merck supplies the pembrolizumab for the Phase 3 trial under a Clinical Trial Collaboration and Supply Agreement from September 2021, and a non-exclusive clinical supply agreement with MSD International/Merck covers other combinations. The platform is supported by 17 patent families filed in major markets. Management is led by founder, President and CEO Mai-Britt Zocca. The text describes competing approaches that block single immunosuppressive pathways or target specific tumor antigens, but names no specific competitors or manufacturing arrangements.