Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 406

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 406
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 of whom met the following criteria: • Diagnosis:confirmed glioblastoma (WHO Grade IV) located above the tentorium cerebelli in the brain. • Disease progression:evidence of tumor growth after receiving standard treatment with radiation and temozolomide chemotherapy. • Prior treatment:completion of radiotherapy at least 3 months before entering the trial. • Resectable tumors (subset of patients):eligible for a repeat surgery to remove the tumor, with the surgery able to be delayed for 30 days. • General health:good bone marrow, liver, and kidney function; able to undergo MRI scans; no active serious infections; and a Karnofsky performance status of 70 or higher (meaning they could mostly care for themselves). • Tumor samples:availability of tumor tissue for analysis. • Sex:men were eligible. Women had to be post -menopausalor surgically sterile due to a lack of safety data on the vaccine’s potential impact on reproduction. With these criteria, the trial recruited 25 patients with non -resectabletumors and 3 with resectable tumors. Overall, the mean age of participants was 58 years, with the majority (78.6%) being male.

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VXM01 phase I/II clinical trial — Tumor response The tumor response was assessed by Objective Response Rate (ORR) and Duration of Response (DoR) according to immunotherapy Response Assessment for Neuro -Oncology(iRANO; 2015) Overall, in the non -resectablepatients the ORR was 12.0% (95% CI: 2.5 – 31.2), with 3 responders out of 25 patients (12.0%) who had a partial remission. Of the patients with a partial remission, 1 patient in the 10 6CFU/mL group had a DoR of 5.6 months, while the patients in the 10 7CFU/mL group had a DoR of 2.7 and 11.1 months. All patients who had stable disease (n=3) received 10 7CFU/mL VXM01.

| Best Overall Response |     | 106 CFU/mL (N=3) n (%) |     | 107 CFU/mL (N=25) n (%) |     | Total NR (N=25) n (%) |
| PR                    |     | 1 (33.3)               |     | 2