Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 8

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 8
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arker response to the vaccine. During the course of this clinical trial, 7 patients
were alive and survived for more than 12 months after initiation of treatment. No adverse effects related to VXM01 were observed.

source : Wick, W et al. “P01.031 VXM01 phase I study in
patients with progressive glioblastoma — final results.” Neuro-Oncology vol. 20, Suppl 3 (2018): iii235.
doi:10.1093/neuonc/noy139.073

As the Phase 1 trial progressed, VXM01 was granted orphan drug
status by the FDA and EMA in 2017 for the treatment of glioma.

    Authority
     
    Orphan
Designation
     
    Designation date
     
    Source
  
    FDA
     
    Treatment of Malignant glioma
     
    08/31/2017
     
    https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=596117
  
    EMA
     
    Treatment of glioma
     
    23/08/2017
     
    https://ec.europa.eu/health/documents/community-register/html/o1909.htm

As a next step, on November 21, 2018, a combination study of
VXM01 and anti-PD-L1 checkpoint inhibitor avelumab in 28 patients with relapsed glioblastoma began (ClinicalTrials.gov ID NCT03750071).
The trial included 25 patients with non-resectable tumors and 3 with resectable tumors. The main objective of the study is to evaluate
the safety and tolerability of VXM01 vaccine treatment in combination with avelumab.

Dr. Wolfgang Wick, the principal investigator for the Phase I
clinical trial, also conducted this combination study.

This Phase I/II clinical trial was not sized or designed to yield
advanced comparative statistical results. Larger patient cohorts and additional design features typical of Phase 2/PoC studies (including
randomization, Blinding, control groups) are required to obtain data yielding advanced statistics and guide the design of registrational
(Ph3) studies. Initiation of such trials is planned for 2026.

VXM01 Phase I clinical trial — Patient selection
criteria