Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 14

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 14
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 safety data on the vaccine’s potential impact on reproduction.

With these criteria, the trial recruited 25 patients with non-resectable tumors
and 3 with resectable tumors. Overall, the mean age of participants was 58 years, with the majority (78.6%) being male.

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-resectable patients 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 106 CFU/mL group had a DoR of 5.6 months, while the patients in the 107 CFU/mL
group had a DoR of 2.7 and 11.1 months. All patients who had stable disease (n=3) received 107 CFU/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 (8.0)
     
    3 (12.0)
  
    SD
     
    — 
     
    3 (12.0)
     
    1 (4.0)
  
    PD
     
    2 (66.7)
     
    20 (80.0)
     
    21 (84.0)
  
    ORR (%) [95% CI]
     
    33.3 [0.8 – 90.6]
     
    8.0 [1.0 – 26.0]
     
    12.0 [2.5 – 31.2]
  
    DCRR (%) [95% CI]
     
    33.