US Government Invests $48M in Kernal Bio's mRNA CAR-T Program

The U.S. government, through the Advanced Research Projects Agency for Health (ARPA-H), has awarded up to $48 million to Kernal Bio and three sub-awardees to advance the development of an innovative in vivo mRNA-encoded CAR T-cell program. This significant investment aims to push forward next-generation cell therapies for both cancer and autoimmune diseases.

ARPA-H Backs mRNA Technology Despite Recent Pullbacks

In a surprising move, ARPA-H has thrown its support behind Kernal Bio's mRNA-based technology, even as other government agencies have recently distanced themselves from mRNA vaccine work. The Biomedical Advanced Research and Development Authority (BARDA) had previously cancelled $500 million in funding for mRNA vaccine projects, citing concerns over efficacy and public distrust.

This latest funding decision suggests a nuanced approach to mRNA technology within the government, distinguishing between vaccine applications and other therapeutic uses. The ARPA-H investment focuses on Kernal's "mRNA 2.0" platform, which aims to create less expensive in vivo CAR T-cell therapies.

Kernal's Innovative Approach to CAR-T Therapy

Kernal Bio's KR-402 program, the focus of this funding, represents a novel approach to CAR-T cell therapy. The company's technology employs a two-pronged strategy:

1. Utilizing selective mRNA that only translates in specific cells
2. Delivering RNA with targeted lipid nanoparticles covered with antibodies to focus directly on target T cells

This approach aims to overcome limitations of current CAR-T therapies, including long production times, tumor resistance, and side effects such as cytokine release syndrome.

"Current CAR-T therapies heralded a true revolution in cancer treatment," said Kernal CEO and co-founder Yusuf Erkul, M.D. "Yet, they have their limitations, including a three-week vein-to-vein turnaround time, tumor resistance leading to relapse, and side effects such as cytokine release syndrome or secondary T-cell malignancies."

Collaboration and Future Directions

The ARPA-H funding will support Kernal Bio's advancement of KR-402 through clinical development for multiple sclerosis and B-cell malignancies. Additionally, the investment will help expand Kernal's mRNA 2.0 platform.

Part of the funding will also go to Kernal's collaborators: Stanford University School of Medicine, Dana-Farber Cancer Institute, and the Jackson Laboratory. These institutions will work on engineering targeted, mRNA-encoded CARs and developing new manufacturing strategies for potential therapies.

As the pharmaceutical industry continues to explore innovative approaches to cell therapy, this government investment signals strong interest in pushing the boundaries of mRNA technology beyond vaccines and into novel therapeutic applications.