BioNTech is now disclosing a major achievement: the first clinically relevant and systemic mRNA cancer vaccine in the world. Results show that the therapy has a body-wide effect and elicits a strong immune response.
The work was published in renowned scientific journal Nature, and also has the contributions of several academic and clinical partners – TRON, Research Center for Immunotherapy (FZI), the University Medical Center at the Johannes Gutenberg University Mainz and the Heidelberg University Hospital.
With this research, the group has pioneered a novel approach to target a nanoparticle mRNA vaccine (RNA-LPX) to dendritic cells (that collect antigens to present to cells of the immune system) in different parts of the body – spleen, lymph nodes and bone marrow.
Once the mRNA interacts with the dendritic cells, it rapidly sparks off a potent response that mimics a natural antiviral immune response.
It works with a dual mechanism, involving both the adaptive (T-cell-mediated) and innate (type-I interferon (IFN)-mediated) immune system. This innate response is particularly important for the full anti-tumor effects of the vaccines.
Besides a promising mode of action and efficacy data from preclinical tumor models, the work also presents early data from a Phase I trial in patients with melanoma.
In this clinical study, the vaccine has again shown to elicit very strong immune responses (even at a lower dose). It was also very well tolerated by patients, with no severe toxicities observed to date.
This is a great step forward in mRNA therapeutics, which could bring about a truly personalised immunotherapy for all kinds of cancer.
UPDATE (3/6/2016): Following the publication of this article, a reader reached out to us to mention CureVac‘s results. The company also has proof for RNActive in various clinical studies showing systemic immune responses and overall survival benefit in its prostate trial – as published in the Journal of ImmunoTherapy of Cancer.