Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 404

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 404
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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 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 With the majority of reported events in this trial being mild to moderate severity in nature, we believe VXM01 could have a favorable safety profile but would need to be further assessed in a larger patient population. Notably, while SAEs were observed during the study period, all of them were target disease -relatedrather than

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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 full safety evaluation will be determined following further review of all safety data by relevant regulatory agencies. All patients (n=28; 100%) experienced multiple AEs, but no treatment -limitingtoxicities (TLT) related to VXM01 or avelumab, or infusion -relatedadverse events (AEs) were recorded for any group. No treatment -relatedSAEs were recorded for the 10 6CFU/mL and 10 7CFU/mL resectable groups. No VXM01- or avelumab -relatedSAEs or treatment -emergentSAEs were recorded for any group. One patient discontinued study treatment due to rheumatoid arthritis which occurred after the first 5