Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 400

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 400
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 NDA contains sufficient data for FDA or EMA to determine the safety and effectiveness of a drug. Sometimes, though, questions arise that require additional consideration. In these cases, FDA or EMA may organize a meeting of one of its Advisory Committees to get independent, expert advice and to permit the public to make comments. These Advisory Committees include a Patient Representative that provides input from the patient perspective. The estimated timeframe for this process is as follows: •Antigen discovery and vaccine formulation: 1 -2years •Preclinical studies: 1 -2years •IND filing and review: 1month •Phase 1/2 clinical trials: 2 -3years •Phase 3 clinical trials: 2 -3years •Regulatory approval (including NDA review): 1 year Based on this timeline, Vaximm anticipates that its first oral cancer vaccine candidate beyond VXM01 could enter clinical trials within the next 3 -5years, with potential regulatory approval in the next 7 -9years. Clinical Trials Overview of VXM01 clinical trial A phase1 clinical trial of VXM01 in Glioblastoma was initiated in May 2016 (ClinicalTrials.gov ID: NCT02718443). The trial was conducted at the Neurology Clinic and National Center for Tumor Diseases in Heidelberg, Germany, and the principal investigator is Dr. Wolfgang Wick, MD, who is a professor at the Neurology Clinic and National Center for Tumor Diseases. The phase I clinical trial was evaluated for 14 patients with recurrent glioblastoma who had progressed after standard treatment and were candidates for reoperation. The primary objective of the study was to examine the safety and tolerability of the investigational VEGFR2 DNA vaccine VXM01 after four vaccinations in glioblastoma 244

patients. The secondary objective was to examine the immune and biomarker 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 -Oncologyvol.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 E