Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 22

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 22
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 pCR (0% residual viable tumor) or near pathological complete response (“pCR”) (≤10% residual viable tumor) in the resected tumor tissue after neoadjuvant treatment (by central assessment). Secondary endpoints include pCR, pathologic tumor response at surgery, ORR, DFS, EFS, and safety. Following enrollment of cohorts A and B, we filed a protocol amendment with the FDA in December 2023 to initiate enrollment of new patients with resectable melanoma in a randomized cohort C study in the IOB-032/PN-E40 trial. Patients in cohort C were randomized 1:1 to receive the neoadjuvant treatment of either Cylembio in combination with pembrolizumab or pembrolizumab alone, and will continue with the same regimen in the post-surgery phase. The Company expects to begin reporting data from this trial in the second half of 2025.

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Our Product Candidates 

We are developing a pipeline of product candidates that leverage our T-win® platform to address targets within the TME. We are currently investigating Cylembio® in the IOB-013/KN-D18 trial, the IOB-022/KN-D38 trial and the IOB-032/PN-E40 trial. We are also developing earlier stage product candidates that target additional immunosuppression-related targets that are expressed in a broad range of solid tumors, which include our next product candidate, IO112, that targets Arginase 1 and the further development of a TGFβ1 vaccine, IO170. 

Our Target Indications

Melanoma 

Cylembio is currently being tested in the IOB-013/KN-D18 in treatment-naïve patients with unresectable or metastatic (advanced) melanoma. Unresectable, metastatic melanoma is a serious and life-threatening disease with a clear unmet medical need. As of January 2025, melanoma is the seventeenth most diagnosed cancer worldwide and fifth most common cancer in the United States. According to the National Cancer Institute (“NCI”), it was estimated that approximately 331,000 patients are newly diagnosed annually, with over 58,000 deaths. Further, data from Evaluate Pharma estimated that the melanoma market generated $7.2 billion in revenue globally in 2023, with the potential to grow to $13.2 billion in 2030 with a compounded annual growth rate (“CAGR”) of 9%.