Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 5

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 5
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 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 glioblastoma patients in the United States.

If VXM01 demonstrates efficacy in the treatment of recurrent glioblastoma,
Vaximm intends to expand by developing oral cancer vaccines targeting other solid tumor indications. The company’s strategy generally
involves the following key steps:

1.Identify novel tumor-specific antigens: Vaximm will leverage
its expertise in antigen discovery to identify new tumor-specific antigens that can be targeted by Vaximm’s platform.

2.Conduct preclinical studies with the FDA’s good laboratory
practice (“GLP” regulations): Before testing any drug or biological product candidate in humans, the product candidate must
undergo rigorous pre-clinical testing. The pre-clinical developmental stage generally involves laboratory evaluations of drug
chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, to assess the potential for adverse events
and, in some cases, to establish a rationale for therapeutic use. The conduct of pre-clinical studies is subject to federal regulations
and requirements, including GLP regulations for safety/toxicology studies. Vaximm will perform preclinical studies to evaluate the safety,
immunogenicity, and anti-tumor efficacy of its oral cancer vaccine candidates in line with the GLP regulations that the FDA requires.

4

3.File an Investigational New Drug (IND) application: Upon the
successful completion of preclinical studies, Vaximm will submit an IND application to regulatory authorities such as the FDA. IND
is a request for authorization from the FDA to ship an investigation product and then administer it to humans and must be allowed to
proceed by the FDA before human clinical trials may begin. This submission includes all relevant data from preclinical studies and outlines
the proposed clinical trial protocols. The IND review period typically takes 30 days, during which the regulatory agency evaluates
the submission to ensure the safety of proceeding to human trials.

4.Initiate clinical trials: Based on the preclinical data and
IND approval, the company will design and conduct additional Phase 1/2 clinical trials to assess the safety, tolerability, and preliminary
efficacy of its oral cancer vaccines in other cancer indications.

5.Conduct Phase 3 clinical trials: Phase 3 trials