Company: OSRH
Filing Date: 2025-01-29
Form Type: S-4/A
Source: 0001213900-25-007923
Chunk: 407

Company: OSR Holdings, Inc.
Filing Date: 2025-01-29
Form: S-4/A
Chunk 407
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 avelumab 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. ELISpot assay was used to measure the number of these T cells that produced interferon gamma (IFN - γ) when stimulated with different fragments of the VEGFR -2protein. VEGFR -2specific ELISpot counts were calculated as the ELISpot count per peptide pool minus the negative control. The VEGFR -2specific T cell response was defined positive when the test peptide pool had at least two -foldhigher 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 10 7CFU/mL non -resctablegroup) had a VEGFR -2specific T cell response classified as negative for all peptides at all time points tested. The VEGFR -2specific T cell response was decreased on Day 21 compared with baseline in 6 patients, was increased in 4 patients (all 10 7CFU/mL non -resectablegroup), and remained at the same level compared with baseline in 5 patients. At Week16, the VEGFR -2specific T cell response was increased compared with baseline in 7 patients (1 patient in 10 6CFU/mL group, 6 patients in 10 7CFU/mL group), decreased in 5 patients (all 10 7CFU/mL group), and remained the same in 3 patients. 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 -relatedrather than treatment -related. The observed SAEs included brain edema, epilepsy, stroke,

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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