Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 16

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 16
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 T cells that
produced interferon gamma (IFN-γ) when stimulated with different fragments of the VEGFR-2 protein.

VEGFR-2 specific ELISpot counts were calculated as the ELISpot
count per peptide pool minus the negative control. The VEGFR-2 specific T cell response was defined positive when the test peptide
pool had at least two-fold higher spot counts compared to the negative control and the difference of the triplicates was significant
in an unpaired two-tailed student’s t-test.

Overall, 12 of 28 patients (42.9%, all in the 107 CFU/mL
non-resctable group) had a VEGFR-2 specific T cell response classified as negative for all peptides at all time points tested.
The VEGFR-2 specific T cell response was decreased on Day 21 compared with baseline in 6 patients, was increased in 4 patients (all
107 CFU/mL non-resectable group), and remained at the same level compared with baseline in 5 patients. At Week 16,
the VEGFR-2 specific T cell response was increased compared with baseline in 7 patients (1 patient in 106 CFU/mL
group, 6 patients in 107 CFU/mL group), decreased in 5 patients (all 107 CFU/mL group), and remained the
same in 3 patients.

9

VXM01 phase I/II clinical trial — Safety result

The majority of reported events in this trial being mild to moderate
severity in nature but would need to be assessed in a larger patient population. Notably, while SAEs were observed during the study period,
all of them were target disease-related rather than treatment-related. The observed SAEs included brain edema, epilepsy, stroke,
hyponatremia, gait disturbance, and pulmonary embolism, which are commonly reported symptoms in patients with brain tumors or severe illnesses
as their disease progresses and were not attributable to VXM01 administration. A safety evaluation will be determined following review
of all safety data by relevant regulatory agencies.

All patients (n=28; 100%) experienced multiple AEs, but no treatment-limiting toxicities
(TLT) related to VXM01 or avelumab, or infusion-related adverse events (AEs) were recorded for any group