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Biodistribution and toxicity evaluation of oncolytic adenovirus Adf35(OGN) in Syrian hamster and mouse
Erik Yngve1, Malin Eriksson2,3, Anders Hedin1
1Department of immunology, genetics and pathology, Uppsala University, Uppsala, Sweden.
Abstract:
Oncolytic adenovirus has been widely evaluated as a cancer treatment agent with tolerable toxicity profile. We have recently developed a new oncolytic adenovirus Adf35(OGN) with two immunostimulatory transgenes alpha-1,3-galactosyltransferase (GGTA1) from Sus scrofa and neutrophil-activating protein (NAP) from Helicobacter pylori. Adf35(OGN) can kill tumor cells and trigger a strong immune response against tumor antigens. Here, we report the toxicity and biodistribution of Adf35(OGN) in Syrian hamster and GGTA1-knockout mouse. The virus was delivered subcutaneously in naïve hamsters and intratumorally in GGTA1-knockout mouse in multiple doses at dosages of 1-5 × 1011 viral particles (VP)/kg. The virus did not replicate in any tissues, evidenced as low or no viral copies detected by qPCR. The virus was also found at low levels in biofluids (saliva, urine, and feces), indicating that spread to the environment is low with a low risk of secondary infections via shedding. The virus did not cause any biochemical, hematological, or histopathological alterations. In summary, Adf35(OGN) has a good safety profile in these animal models and these results support future clinical evaluation for Adf35(OGN).
Insights
The novel oncolytic adenovirus Adf35(OGN) demonstrated a favorable safety profile in preclinical models. This engineered virus, carrying immunostimulatory genes, showed no significant toxicity or replication, supporting its potential for cancer therapy.
Area of Science:
- Oncolytic virotherapy
- Cancer immunotherapy
- Gene therapy
Background:
- Oncolytic adenoviruses are promising cancer therapeutics with good safety.
- Adf35(OGN) is a novel oncolytic adenovirus engineered with immunostimulatory transgenes GGTA1 and NAP.
- This agent is designed to eliminate tumor cells and stimulate anti-tumor immune responses.
Purpose of the Study:
- To evaluate the toxicity and biodistribution of the novel oncolytic adenovirus Adf35(OGN).
- To assess the safety of Adf35(OGN) in preclinical animal models.
- To provide data supporting the future clinical evaluation of Adf35(OGN).
Main Methods:
- Adf35(OGN) was administered subcutaneously to Syrian hamsters and intratumorally to GGTA1-knockout mice.
- Multiple doses ranging from 1-5 × 10^11 viral particles (VP)/kg were used.
- Viral replication was assessed using qPCR, and biodistribution was evaluated in tissues and biofluids.
Main Results:
- Adf35(OGN) did not replicate in any tested tissues, with low or undetectable viral copies.
- Low levels of the virus were detected in biofluids (saliva, urine, feces), indicating minimal shedding.
- No significant biochemical, hematological, or histopathological abnormalities were observed.
Conclusions:
- Adf35(OGN) exhibits a robust safety profile in Syrian hamsters and GGTA1-knockout mice.
- The virus demonstrated limited replication and low levels of shedding.
- These findings support the further clinical investigation of Adf35(OGN) as a cancer therapeutic.
