Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 400

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 400
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 days                    |     | -17.5 (2)              |     | 30.6 ± 20.96 (5)       |     | 16.9 ± 30.39 (7)     |
| Week 24 + 10 days                    |     | -2.0 (1)               |     | -4.5 ± 9.57 (4)        |     | -4.0 ± 8.36 (5)      |
| Week 36 + 10 days                    |     | 20.4 (1)               |     | 27.0 (2)               |     | 24.8 ± 4.45 (3)      |
| Week 48 + 10 days                    |     | 29.6 (1)               |     | 28.7 (1)               |     | 29.2 (2)             |

246

Brain Tumor Immunohistochemistry: An analysis of tumor tissue from 8 re -operatedpatients showed a statistically significant increase in CD8 T -cells(immune cells that kill cancer cells) after vaccination with VXM01. Specifically, the mean number of CD8 T -cellsincreased from 159 cells/mm² in the primary tumor to 296 cells/mm² in the recurrent tumor, with a P -valueof 0.0239 (paired t -test). Additionally, there was a decrease in regulatory T -cells(Treg), which are immune cells that suppress immune responses. The median number of Treg cells dropped from 32 cells/mm² in the primary tumor to 12 cells/mm² in the recurrent tumor. This resulted in a higher CD8:Treg ratio, which has been associated with better clinical outcomes in other studies. VXM01 phase I clinical trial — Safety result VXM01 demonstrated a favorable safety profile in this trial, with no notable differences observed between the two dose groups (10 6CFU and 10 7CFU). All patients experienced at least one treatment -emergentadverse event (TEAE), but most were mild or moderate in severity and considered unrelated to VXM01. The most common TEAEs were consistent with the underlying disease or progression of disease, and included aphasia, hemiparesis, fatigue, headache, and lymphopenia. No treatment -limitingtoxicities (TLTs) were observed. Four TEAEs (flatulence, dizziness, fatigue, and nausea