Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 403

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 403
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 [95% CI]     |     | 100.0 [59.0 – 100.0] |     | 83.3 [35.9 – 99.6]  |     | 92.3 [64.0 – 99.8] |

Note: A hyphen (-) indicates no events were reported. n = number of patients with an event; N = number of patients; NR = non -resectable . Percentages are based on the number of patients. CR = complete response; PR = partial remission; SD = stable disease; PD = progressive disease; ORR = objective response rate (CR and PR); DCR = disease control rate (CR, PR, and SD). In this study, we assessed clinical response using several measures, including progression -freesurvival (PFS) and overall survival (OS). PFS ranged from 9 to 366 days, with a median PFS of 0.8 months in the 10 7CFU dose group and 2.6 months in the 10 6CFU dose group. OS ranged from 67 to 416 days, with a median OS of greater than 14 months in the 10 6CFU group and 7.6 months in the 10 7CFU group. For the 3 patients who entered the prolongation phase, PFS ranged between 30 and 960 days, and overall survival ranged between 776 and 1147 days. These findings suggest a potential advantage in terms of PFS and OS for the lower dose group, although they may be influenced by the slightly better baseline status of the patients in the 10 6CFU dose group. VXM01 phase I clinical trial — Immune response The effect of VXM01 was explored by evaluating the VEGFR -2specific T cell response and frequency of immune cells in peripheral blood, and by staining of immune- and biomarkers in tumor tissue obtained during resection. Peripheral T-cell response: All 9 tested patients showed a VEGFR2 -specificT -celland IFN - γimmune response, with a clear increase observed after the initial vaccination and further increases after the first booster dose. This indicates that VXM01 effectively stimulated an immune response against VEGFR2, a protein involved in tumor growth. ELISpot assay was used to measure the number of these T cells that produced interferon gamma (IFN - γ) when stimulated with different fragments