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

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 25
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 However, American Society of Clinical Oncology guidelines do not recommend a specific order of therapies for patients with BRAF wild-type (“WT”) unresectable and metastatic cutaneous melanoma. 

As combination therapy with ipilimumab/nivolumab is associated with more severe toxicity, physicians must make a treatment decision between combination therapy and single agent anti-PD-1 antibody therapy after thorough evaluation regarding clinical activity and potential severe toxicity. Accordingly, we believe novel anti-PD-1 combinations with improved overall outcomes are needed for patients with advanced melanoma. 

We are developing Cylembio® for potential treatment of patients with anti PD-1 naïve advanced melanoma who are candidates for anti PD-1 monotherapy, regardless of PD-L1 expression and BRAF mutation status, except for patients with rapidly progressing disease. We are also testing Cylembio as a neoadjuvant used before surgery, followed by adjuvant therapy after surgery, in patients with melanoma, in a basket trial, the IOB-032/PN-E40 trial, with multiple solid tumor indications. We completed enrollment in the IOB-032/PN-E40 trial ahead of schedule in January 2025. 

Development of Cylembio in the First-line Setting 

Summary 

The MM1636 trial evaluated Cylembio in combination with an anti-PD-1 monoclonal antibody, nivolumab, in 30 anti-PD-1 naïve, first-line metastatic melanoma patients. A brief summary of the MM1636 trial is below: 

•30 patients from Herlev University Hospital in Denmark included in cohort A; 

•Baseline characteristics were largely comparable with benchmark trials with the majority of patients having one or more poor prognostic factors, such as negative tumor expression, M1c stage/visceral metastases and high lactate dehydrogenase (“LDH”); 

•Investigators initially observed an ORR of 80% (24 out of 30 patients); however, two of 24 patients in which a response was observed progressed before subsequent radiological confirmation, which resulted in a confirmed ORR of 73%. CRR was 50% with DOR not yet reached at a median follow up time of 45.3 months as of January 5, 2023; 

•Median PFS was 25.5 months and median OS had not yet been reached as of January 5, 2023;

•Correlative biomarker data from the