- Funds will advance Kernal Bio’s in vivo CAR T-cell therapy program and expand the capabilities of its mRNA 2.0 platform
- Program aims to improve cancer care by increasing the accessibility of advanced CAR T-cell therapies at a lower cost to patients
BOSTON–(BUSINESS WIRE)–Kernal Biologics, Inc., a venture-backed TechBio company pioneering novel therapeutics to program human cells directly inside the body, today announced that it has been awarded up to $48 million in funding by the Advanced Research Projects Agency for Health (ARPA-H). This project is to be funded by ARPA-H’s EMBODY program, which focuses on the engineering of immune cells inside the body. EMBODY is led by ARPA-H Program Manager Daria Fedyukina, Ph.D.
The funds will be used to support the clinical development of Kernal Bio’s in vivo mRNA-encoded CAR T-cell program, KR-402, which targets multiple sclerosis and B-cell malignancies, including acute lymphoblastic leukemia, large B-cell lymphoma and chronic lymphocytic leukemia. 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.
“We’re honored to join the elite cohort of ARPA-H awardees,” said Yusuf Erkul, M.D., MBA., cofounder 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.”
KR-402 is a next-generation CAR-T therapy program 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 analyzing 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 minimizes 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 of 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.”
About Kernal Biologics, Inc.
Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. By developing in vivo CAR-T therapies, Kernal Bio is advancing precision treatments for autoimmune diseases and blood cancers. The company was founded by experts from MIT, Harvard, Merck, and BMS, and its leadership team brings a track record of three FDA-approved therapies and over 120 patents. With support from leading investors — including Hummingbird Ventures, Amgen Ventures, Y Combinator, FoundersX, and HBM — Kernal Bio is transforming the future of cell therapy design and delivery. For more information, please visit our website at www.kernalbio.com. You can also connect with us on LinkedIn and X.
About the mRNA2.0 Platform
Kernal Bio is at the forefront of mRNA therapeutics and synergistically exploits targeted LNP (lipid nanoparticle) delivery and cell-selective translation of its synthetic mRNA, controlling the amount and site of protein produced, without the need for any genetic editing or the risk of genomic integration. Our proprietary best-in-class decorated LNP technology allows us to achieve in situ cell engineering via systemic, targeted, extra-hepatic delivery to specific tissues and cells, such as T cells. This delivery capability, combined with the translation of cell-selective mRNA, eliminates off-target effects. This expertise is enabled by Kernal Bio’s proprietary machine learning (ML) powered platform that discovers RNA sequence motifs from clinical human data with preferential translation based on cell type.
This research was funded, in part, by the Advanced Research Projects Agency for Health (ARPA-H). The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the U.S. Government.
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