BOSTON– Kernal Biologics, Inc., a venture-backed TechBio company developing novel therapeutics that program human cells directly inside the body, announced it has been awarded up to $48 million in funding from the Advanced Research Projects Agency for Health (ARPA-H). The award, part of ARPA-H’s EMBODY program led by Program Manager Daria Fedyukina, Ph.D., will support Kernal Bio’s in vivo CAR T-cell therapy initiative and expand the company’s mRNA 2.0 platform.
The EMBODY program focuses on engineering immune cells inside the body to create more accessible, affordable, and effective immunotherapies. Kernal Bio will use the funds to advance its lead in vivo CAR T-cell program, KR-402, which targets both autoimmune and hematologic diseases, including multiple sclerosis, acute lymphoblastic leukemia, large B-cell lymphoma, and chronic lymphocytic leukemia.
“We’re honored to join the elite cohort of ARPA-H awardees,” said Yusuf Erkul, M.D., MBA, Co-founder and Chief Executive Officer of Kernal Bio. “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.”
As part of the project, Kernal Bio will collaborate with Stanford University School of Medicine, Dana-Farber Cancer Institute, and The Jackson Laboratory to develop targeted, mRNA-encoded CARs and novel manufacturing strategies, as well as preclinical models for testing these therapies.
Developed using Kernal Bio’s mRNA 2.0 platform, KR-402 employs a two-pronged approach for precision: selective mRNA translation in specific cells based on multi-omics analysis, and targeted lipid nanoparticle (LNP) delivery decorated with antibodies that direct the therapy to T cells. This strategy enables reprogramming of T cells inside the body, minimizing risks of genomic integration and reducing costs compared to traditional ex vivo CAR-T therapies.
“Manufacturing ex vivo CAR-T therapies is a complex and expensive process. However, with our proprietary platform, there is potential to reduce the cost of manufacturing in vivo CAR T-cell therapies by as much as 100-fold,” said Burak Yilmaz, President of Kernal Bio. “Chemotherapy drugs used for lymphodepletion before CAR-T treatments carry significant toxicity, limiting access to only a small group of patients. With our technology and the support of ARPA-H and our partners, we aim to make these transformative therapies more widely available.”
The ARPA-H funding marks a major milestone for Kernal Bio as it accelerates development of next-generation, cost-effective in vivo CAR T-cell therapies designed to improve outcomes and accessibility for patients worldwide.
