Kernal Biologics has secured up to $48 million in funding from the Advanced Research Projects Agency for Health (ARPA-H) to develop its groundbreaking in vivo CAR-T cell therapy program. The award, announced on October 7, 2025, represents a significant milestone in the evolution of cell-based cancer treatments and autoimmune therapies.
The funding will support clinical development of KR-402, Kernal Bio's in vivo mRNA-encoded CAR-T cell program targeting multiple sclerosis and B-cell malignancies, including acute lymphoblastic leukemia, large B-cell lymphoma, and chronic lymphocytic leukemia. The project is funded through ARPA-H's EMBODY program, which focuses on engineering immune cells inside the body and is led by Program Manager Daria Fedyukina, Ph.D.
Revolutionary mRNA 2.0 Platform Technology
KR-402 is developed using Kernal Bio's proprietary mRNA 2.0 platform, which achieves exceptional precision through a unique two-pronged strategy. The platform uses highly selective mRNA that only translates in specific cells, intelligently designed by analyzing thousands of multi-omics datapoints across various cell types. This RNA is delivered by targeted lipid nanoparticle (LNP) delivery vehicles decorated with antibodies that home directly to target T cells.
"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," said Yusuf Erkul, M.D., MBA, cofounder and CEO of Kernal Bio. "At Kernal Bio, we believe that we have the tools to evolve the CAR-T modality towards in vivo therapies."
Transformative Cost and Safety Benefits
By reprogramming T cells inside the body, KR-402 is positioned as a differentiated in vivo CAR-T therapy that minimizes the risk of genomic integration while offering tremendous cost efficiencies over traditional ex vivo therapies. The approach also eliminates 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."
Strategic Collaborations and Development
As part of this project, Kernal Bio will collaborate with prestigious sub-awardees including Stanford University School of Medicine, Dana-Farber Cancer Institute, and The Jackson Laboratory. These partnerships will focus on engineering targeted, mRNA-encoded CARs and developing novel manufacturing strategies and preclinical models for testing these therapies.
The company's mRNA 2.0 platform exploits targeted LNP delivery and cell-selective translation of synthetic mRNA, controlling the amount and site of protein produced without genetic editing or risk of genomic integration. The proprietary decorated LNP technology enables in situ cell engineering via systemic, targeted, extra-hepatic delivery to specific tissues and cells, including T cells.
Company Background and Expertise
Kernal Bio is a venture-backed therapeutics company founded by experts from MIT, Harvard, Merck, and Bristol Myers Squibb. The leadership team brings a track record of three FDA-approved therapies and over 120 patents. The company has secured support from leading investors including Hummingbird Ventures, Amgen Ventures, Y Combinator, FoundersX, and HBM.
The platform's capabilities are enabled by Kernal Bio's proprietary machine learning-powered platform that discovers RNA sequence motifs from clinical human data with preferential translation based on cell type, eliminating off-target effects through precise cellular targeting.
