Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 397

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 397
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 Drug Designation and Exclusivity.” While VXM01 moves into planned phase 2 clinical trials, we are continuing to advance Vaximm’s other preclinical candidates in investigational new drug (IND) -enablingstudies. •VXM04: A preclinical -stageoral T -cellvaccine targeting mesothelin •VXM06: A preclinical -stageoral T -cellvaccine targeting Wilms Tumor Protein (WT1) •VXM08: A preclinical -stageoral T -cellvaccine targeting CEA(Carcinoembryonic antigen) •VXM10 : A preclinical -stageoral T -cellvaccine targeting PD -L 1 These products are currently undergoing preclinical studies to evaluate their safety, immunogenicity, and anti -tumorefficacy. Vaximm will need to complete these preclinical studies and submit Investigational New Drug (IND) applications to the relevant regulatory authorities before initiating clinical trials for each of these product candidates. While Vaximm has direct experience advancing a therapeutic candidate from preclinical to late -stageclinical trials and developed a pipeline of other preclinical therapeutic candidates, other than receiving Orphan Drug Designation for VSMO1, Vaximm has limited experience in applying for regulatory or marketing approval for any of its product candidates. As Vaximm continues to advance its line of oral immunotherapies, it will remain flexible and opportunistic to explore partnering options. Opportunity Current approaches to targeted immunotherapies have various limitations, such as drug biodistribution, off -targeteffects, immunotolerance, and evasion. The complex and diverse makeup of tumor microenvironments creates further difficulties. Production of targeted immunotherapies is expensive and time -intensive, making tailor -madetherapies challenging to produce and manufacture at scale and, thus, not readily accessible. Optimally, the development of innovative new strategies can overcome drug resistance, enhance druggability, and improve drug biodistribution to maximize treatment efficacy. Vaximm seeks to overcome these limitations by leveraging our foundational science and innovative platform of attenuated bacterial strains to produce effective, customizable, oral vaccines efficiently and cost -effectively. Vaximm’s lead product candidate, VXM01, targets the tumor vasculature and specific tumor antigens. VXM01 is currently being evaluated in a Phase 2 clinical trial in Europe for the treatment of recurrent glioblastoma. Vaximm also plans to initiate a new clinical trial of VXM01 in recurrent