Researchers at SINTEF in Norway are using fresh human blood to test mRNA-lipid nanoparticle (LNP) formulations, a method designed to reduce the failure rate of drug candidates transitioning from animal models to human trials. According to lead researcher Sjoerd Hak, this ex vivo approach identifies which LNP variants are most effectively captured by immune cells and predicts allergic reactions before patients are exposed to the drugs.
Reducing Drug Failure Rates with Ex Vivo Blood Testing
Nine out of ten drug candidates fail during the transition from animal testing to human clinical trials.
The process observes how the LNP’s outer fat layer binds to plasma proteins and interacts with circulating immune cells. Hak states that because LNPs can be manufactured in “a thousand different ways,” their specific composition determines how they enter cells and perform therapeutically. This method allows scientists to eliminate poor candidates early and select those with the strongest immune cell uptake.
Did you know? The method doesn’t replace animal testing but acts as a complement. It provides relevant data, potentially saving resources and avoiding risks.
Advancing In Vivo CAR-T Cell Therapy for Cancer
The SINTEF research has implications for CAR-T therapy, an immunotherapy used to treat specific cancers. Current CAR-T procedures require removing a patient’s T-cells, modifying them genetically in a lab, and re-infusing them into the body. Hak suggests that mRNA could enable “CAR-T in vivo,” where the reprogramming happens directly inside the patient.
By injecting mRNA into the bloodstream, it can find and modify immune cells. Hak notes that testing this strategy in whole blood is useful because the target immune cells circulate right there, allowing for a rapid evaluation. If successful, this shift could lower costs and expand patient access to treatment.
Predicting Allergic Reactions in Nanomedicines
Safety remains a hurdle for LNP-based medicines. Hak warns that some drugs cause allergic reactions in up to half of the recipients; while most cases have no serious complications, some can be fatal. He admits that current models are not sufficiently accurate in predicting these episodes.
According to the researcher, human blood has proven to be a good predictor of these allergic responses. By testing formulations on blood samples before administration in people, researchers can help prevent participants in clinical trials from becoming seriously ill.
Industry Insight: The move toward human blood testing represents an effort to make the development of mRNA medicines more rational and secure.
mRNA Applications Beyond Vaccines
While mRNA was associated almost exclusively with COVID-19 vaccines, the technology is expanding into therapeutic areas. According to the research published based on an article from ScienceDirect, mRNA-based drugs are being developed for:
- Cardiovascular diseases: Revolutionizing treatment.
- Rare hereditary conditions: Expanding into broader horizons.
- Autoimmune pathologies: Expanding into broader horizons.
- Oncology: Particularly promising for cancer.
Comparison: Traditional Preclinical vs. SINTEF Ex Vivo Approach
| Feature | Traditional Animal Models | SINTEF Ex Vivo Blood Test |
|---|---|---|
| Biological Relevance | Observations in animals of laboratory | Directly uses human blood and cells |
| Allergy Prediction | Not sufficiently good | Good predictor of such allergic reactions |
| Primary Goal | Conventional procedures | Complementary test ex vivo |
Frequently Asked Questions
Does this method replace animal testing?
No. Sjoerd Hak emphasizes that this method is not a substitute for animal models and is just a piece of the puzzle.
What are lipid nanoparticles (LNPs)?
LNPs are the invólucro that protects unstable mRNA until it reaches its destination.
How does this help cancer patients?
It offers a particularly promising approach for cancer and supports therapies like CAR-T in vivo.
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