Company: OSRH
Filing Date: 2025-01-29
Form Type: S-4/A
Source: 0001213900-25-007923
Chunk: 401

Company: OSR Holdings, Inc.
Filing Date: 2025-01-29
Form: S-4/A
Chunk 401
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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-L1checkpoint inhibitor avelumab in 28 patients with relapsed glioblastoma began (ClinicalTrials.gov ID NCT03750071). The trial included 25 patients with non -resectabletumors 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 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. • Age:18 years or older. • Sex:men or women who were post -menopausalfor 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