Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 36

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 36
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 such as IDO and arginase, either as a monotherapy or in combination with other therapies. 

In the United States, the head and neck cancer market was expected to generate $1.7 billion in revenue in 2023 and is expected to grow to $4.6 billion by 2028, reflecting a CAGR of 6%.

•As part of the IOB-032/PN-E40 trial, we commenced another development track in curative settings with neoadjuvant (before surgery or radiotherapy)/adjuvant treatment (after surgery or radiotherapy). SCCHN is one of these indications. As of January 2025, the study has completed enrollment for all cohorts and the Company expects to begin reporting data from this trial in 2025.

•We are also investigating the dual antigens strategy in first-line setting of previously untreated solid tumors. R/M SCCHN is one of these indications. 

As presented at ESMO in September 2024, preliminary results from the IOB-022/KN-D38 Phase 1/2 study of Cylembio® in combination with pembrolizumab in metastatic SCCHN met its primary endpoint. Of the 21 patients enrolled in cohort B, 18 were efficacy evaluable and met the primary endpoint for this cohort with a confirmed ORR of 44.4%. Among the secondary endpoints, the data showed an encouraging 6.6-month median PFS, and a 66.7% DCR.

Figure 17: IOB-022/KN-D38 SCCHN (Cohort B) - Treatment duration, time to response and best overall response per RECIST 1.1

Clinical Development in Neoadjuvant / Adjuvant Setting, other than the IOB-032 trial

There are multiple potential indication expansion opportunities in various cancer settings with limited anti-PD-1 mAb efficacy or tolerability and toxicity concerns. Both IDO and PD-L1 are highly expressed in numerous other solid tumor indications where anti PD-1-mAb is also approved. Therefore, we believe the potential for the dual antigen Cylembio product candidate in combination with anti PD-1-mAB is significant beyond first-line treatment of advanced melanoma—both as a first-line treatment, but also as a neoadjuvant (before surgery)/adjuvant (after surgery) therapy. A series of investigator-initiated trials has been completed and others are ongoing that will inform our own development.