Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 12

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 12
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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)

Brain Tumor Immunohistochemistry:

An analysis of tumor tissue from 8 re-operated patients 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-cells increased from 159 cells/mm² in the primary tumor to 296 cells/mm² in the recurrent tumor,
with a P-value of 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

In this trial, there were no notable differences observed between the
two dose groups (106 CFU and 107 CFU).

All patients experienced at least one treatment-emergent adverse
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-limiting toxicities (TLTs) were observed. Four TEAEs
(flatulence, dizziness, fatigue, and nausea) were considered related to VXM01, but all were