Kernal Biologics has been awarded up to USD 48 million in funding by the Advanced Research Projects Agency for Health (ARPA-H).

This project is funded by Advanced Research Projects Agency for Health’s EMBODY programme, which focuses on the engineering of immune cells inside the body. EMBODY is led by Advanced Research Projects Agency for Health Programme Manager Daria Fedyukina, PhD.

The funds will be used to support the clinical development of Kernal Bio’s in-vivo mRNA-encoded CAR T-cell programme, KR-402, which targets multiple sclerosis and B-cell malignancies, including acute lymphoblastic leukemia, large B-cell lymphoma and chronic lymphocytic leukaemia.

As part of this project, Kernal Bio will collaborate with sub-awardees–Stanford University School of Medicine, Dana-Farber Cancer Institute and The Jackson Laboratory–to engineer targeted, mRNA-encoded CARs, as well as develop novel manufacturing strategies and preclinical models for testing these therapies.

Speaking in this regard, Yusuf Erkul, Co-Founder and Chief Executive Officer (CEO), Kernal Bio, said, “We’re honoured to join the elite cohort of ARPA-H awardees. Current CAR-T therapies heralded a true revolution in cancer treatment. 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. At Kernal Bio, we believe that we have the tools to evolve the CAR-T modality towards in-vivo therapies.”

KR-402 is a next-generation CAR-T therapy programme developed using Kernal Bio’s mRNA 2.0 platform. This platform achieves exceptional precision using a unique two-pronged strategy. First, it uses a highly selective mRNA that only translates in specific cells—intelligently designed by analysing thousands of multi-omics datapoints across various cell types. Second, this RNA is delivered by a targeted Lipid NanoParticle (LNP) delivery vehicle decorated with antibodies that allow it to home in directly on target T cells.

By reprogramming T cells inside the body with this approach, KR-402 is positioned to be a differentiated in vivo CAR-T therapy that minimises the risk of genomic integration, while offering tremendous cost efficiencies over traditional ex vivo therapies. Furthermore, the in vivo CAR-T approach may also improve patients’ treatment journey by eliminating the need for additional toxic procedures, such as lymphodepletion agents.

“Manufacturing ex vivo CAR-T therapies is a complex and expensive process. However, with our proprietary platform, there is a potential of reducing the cost of manufacturing in vivo CAR T-cell therapies by as much as 100-fold,” commented Burak Yilmaz, President, Kernal Bio. In addition, chemotherapy drugs used for lymphodepletion prior to CAR-T therapies carry significant toxicity, making these therapies viable for just a small group of patients. We believe that with our technology and the support of our partners and ARPA-H, we can greatly transform access to this category of therapies.”