Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 21

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 21
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55% unconfirmed/48% confirmed ORR, an encouraging 8.1-month median PFS, no disease progression at 12 months in approximately half of the patients, and an 81% DCR. DOR has not yet matured at this data cut off period. 

Most common reported adverse events in the trial were Grade 1-2 Injection site reaction. Safety profile of the combination in this study was consistent with previously reported data when combined with anti-PD-1 monotherapy, with no added significant systemic toxicity.  

Decisions regarding further clinical development and larger study plans will be made based on evaluation of final data from the NSCLC and SCCHN cohorts. Final data is expected in 2025 for each cohort. 

Figure 7: Schematic Clinical Development Diagram: IOB-032/PN-E40 Trial:

 	ECOG = Eastern Cooperative Oncology Group; ClinicalTrials.gov No. NCT05280314

In addition to the IOB-022 trial, we have initiated a Phase 2 basket trial, the IOB-032/PN-E40 trial, to investigate Cylembio in combination with pembrolizumab in a perioperative setting and used before and after surgery as a neoadjuvant/adjuvant therapy in multiple solid tumor indications in anti-PD-1/PD-L1 naïve settings, focused initially on melanoma and SCCHN. The trial is a multicenter, multi-cohort clinical trial, that has enrolled 93 patients at sites in the United States, Europe, and Australia to evaluate anti-tumor activity, safety, and biomarker data of Cylembio in combination with pembrolizumab as neoadjuvant and adjuvant treatment in patients with resectable tumors. In April 2023, the FDA cleared our IND application for the IOB-032/PN-E40 trial. As of January 2025, the trial completed enrollment for all cohorts. 

The trial enrolled patients in six countries (Australia, the United States, France, Germany, Denmark, and Spain) at 20 sites. Completed patient enrollment for the following cohorts are as follows: 

•Cohort A: Melanoma (n=18)

•Cohort B: SCCHN (n=16)

•Cohort C: Melanoma (n=61)

The primary endpoint is major pathologic response (“MPR”), which refers to reduction in viable tumor cells after treatment, defined as