BioNTech mRNA Cancer Treatment Begins Human Trials

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After success in mice, BioNTech has begun human trials of its mRNA cancer treatment against advanced solid tumors.

The pandemic has led to great advances in vaccine technology; one of them being, mRNA vaccines. Pfizer and BioNTech’s mRNA vaccine have shown great success in preventing infections and deaths among people. Building on that success, BioNTech has now begun using mRNA technology to develop a new treatment for cancer.

The treatment, called SAR441000 (BNT131), is similar to the COVID-19 vaccine. It involves the injection of cytokine-encoding messenger RNAs directly into tumors. Once the body receives these instructions, it begins creating proteins called cytokines. Although cytokines are naturally produced in the body, doctors often supplement them in treating cancer due to their ability to activate immune system cells and shrinking tumors. However, current systemic treatments result in toxic levels of cytokines. Thus, resulting in side effects and a halt in the cancer treatment.

Through the new mRNA treatment, researchers want to supply the cytokines directly to the tumor, preventing its circulation in the body.

First Mice, Now Humans

BioNTech, in collaboration with Sanofi, tested the mRNA cancer treatment on 20 mice with melanomas. Results revealed that 17 of the mice produced enough cytokines to cause shrinkage of their tumors. Moreover, when the treatment was tested on mice with melanomas and lung cancer, the on-site cytokines caused a shrinkage of the melanoma then travelled to the lungs and inhibited the growth of the tumor. Thus, suggesting that the new treatment is not only effective against targeted tumors, but also secondary tumors. Furthermore, the researchers did not note any adverse effects in the mice.

Following the success in mice, researchers have now begun a phase 1/2 trial for the mRNA cancer treatment. The trial aims to recruit a total of 231 participants with advanced melanomas or solid tumors. Currently, the trial is assessing the treatment’s efficacy in conjunction with Cemiplimab, a monoclonal antibody, and on its own.

In the past, the company has also used mRNA technology for developing vaccines against melanomas.


Hotz, Christian, et al. “Local Delivery of Mrna-Encoding Cytokines Promotes Antitumor Immunity and Tumor Eradication across Multiple Preclinical Tumor Models.” Science Translational Medicine, vol. 13, no. 610, 2021, doi:10.1126/scitranslmed.abc7804.



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