Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 4

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 4
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 which provides a significant
competitive advantage. See “Government Regulation — Orphan 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)-enabling studies.

●VXM04: A preclinical-stage oral T-cell vaccine
targeting mesothelin

●VXM06: A preclinical-stage oral T-cell vaccine
targeting Wilms Tumor Protein (WT1)

●VXM08: A preclinical-stage oral T-cell vaccine
targeting CEA(Carcinoembryonic antigen)

●VXM10 : A preclinical-stage oral T-cell vaccine
targeting PD-L1

These products are currently undergoing preclinical studies to evaluate
their safety, immunogenicity, and anti-tumor efficacy. 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-stage clinical 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-target effects, 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-made therapies
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