Currently approved oncolytic virus drugs and different clinical trials have proved promising efficacy data. Preclinical study of in vivo efficacy will provide more powerful information for later stage development, including optimization of administration route, dose, and clinical trial design. CREATIVE BIOLABS can provide a full panel of efficacy studies service in vivo in various animal species.
We have established many animal models to conduct the efficacy of oncolytic virus. The animal models include synergistic and xenograph mouse models, which can be used to validate the efficacy of oncolytic virus in mouse and human disease. All our studies can be performed in GLP-compliant and IACUC-regulated faciliteis by certified technicians. In vivo efficacy studies include but are not limited to the following categories:
Antitumor effect of oncolytic virus
The antitumor effect of oncolytic virus can be analyzed by calculating the tumor size, tumor weight or through in vivo imaging, such as bioluminescence imaging (BLI) and position emission tomography (PET).
D Kuruppu, AL Brownell, K Shah, U Mahmood, KK Tanabe. 2014. Molecular imaging with bioluminescence and PET reveals viral oncolysis kinetics and tumor viability. Cancer Res. 2014 Aug 1; 74(15): 4111–4121
Transgene expression and transgene function in vivo
In order to further demonstrate the efficacy of oncolytic virus, the transgene engineered into oncolytic viruses will be analyzed for its expression and function in vivo. Molecular biology (ELISA, western blot, qRT-PCR, etc.) and cell biology (cell culture, IHC, etc.) techniques will be applied for the analysis.
As most oncolytic viruses incorporate immune factors (antibody, cytokine, growth factor, etc.) into the tumor treatment, immunological analysis should be applied in the efficacy. Flow cytometry analysis, Elispot, T cell proliferation, activation, exhaustion and memory phenotype, chemotaxis, etc. will be used for the purpose.
Histological and pathological analysis
Histological and pathological analysis are not only used to study the toxicity of oncolytic virus, but also applied for the efficacy studies. The changes in a tumor, tumor stroma, or immune cell infiltration can be concluded from the histological and pathological analysis.
Characteristics, including feed consumption, body weight, behavior, and morphology are closely monitored. After specific end points, a complete necropsy including the assessment of organ weight and histopathology analysis is conducted. The survival data is also recorded and statistically analyzed properly.
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