Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 9

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 9
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Patients were selected by a third-party clinical trial provider, each
of whom met the following criteria:

●Diagnosis: anaplastic astrocytoma (WHO Grade III)
or glioblastoma (WHO Grade IV) located above the tentorium cerebelli in the brain.

6

●Age: 18 years or older.

●Sex: men or women who were post-menopausal for
at least 2 years or surgically sterile.

●Disease progression: evidence of tumor growth
after at least one treatment regimen containing radiation and temozolomide chemotherapy.

●Resectable tumor: 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 (as determined by blood and urine tests); able to undergo MRI scans; no active infection at the time of vaccination;
Karnofsky performance status greater than 70; and adequate blood counts.

●No recent clinical trials: no participation in
another clinical trial within 30 days before screening.

●No specific infections: negative test results
for Hepatitis B, Hepatitis C, and HIV.

●No interfering conditions: no other medical or
social conditions that might interfere with the study or make it unsafe for the patient to participate.

The study included 14 white patients with a mean age of 56.8 years.
The majority of participants (64.3%) were male.

VXM01 phase I clinical trial — Tumor response

The tumor response was assessed by objective response rate (ORR) according
to immunotherapy Response Assessment for Neuro-Oncology (iRANO; 2015).

Overall, the tumor response to VXM01 was mixed, with some patients
showing signs of stable disease or even tumor shrinkage, while others experienced disease progression. These findings highlight the variability
in treatment response and the challenges of managing glioblastoma. The extension study results provide further insights into the potential
for long-term disease control in some patients, but also underscore the need for further research to optimize treatment strategies
and identify those most likely to benefit.

    Best Overall Response
     
    106 CFU (N=7) n (%)
     
    107 CFU (N=6) n (%)
     
    Total (N