Kernal Biologics, Inc., a venture-backed TechBio company transforming the treatment landscape through mRNA-based in vivo cell programming, announced it has been awarded up to $48 million in funding from the Advanced Research Projects Agency for Health (ARPA-H). The award comes under ARPA-H’s EMBODY program, which focuses on engineering immune cells directly inside the human body — a pioneering initiative designed to accelerate breakthroughs in cell and gene therapies. The EMBODY program is led by Dr. Daria Fedyukina, ARPA-H Program Manager.
The funding will support the clinical development of Kernal Bio’s flagship in vivo mRNA-encoded CAR T-cell therapy, KR-402, a revolutionary program targeting multiple sclerosis and B-cell malignancies, including acute lymphoblastic leukemia (ALL), large B-cell lymphoma (LBCL), and chronic lymphocytic leukemia (CLL).
As part of the project, Kernal Bio will collaborate with leading research institutions, including Stanford University School of Medicine, Dana-Farber Cancer Institute, and The Jackson Laboratory. Together, the teams will focus on engineering next-generation, mRNA-encoded chimeric antigen receptors (CARs), optimizing manufacturing processes, and developing novel preclinical models to assess therapeutic performance and safety.
“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 have transformed cancer care, but they remain limited by long manufacturing times, tumor relapse, and severe side effects such as cytokine release syndrome. At Kernal Bio, we are reimagining the CAR-T paradigm by moving beyond ex vivo manipulation toward in vivo mRNA-based programming—bringing precision, safety, and scalability to the next generation of immune therapies.”
Transforming CAR T-cell Therapy with mRNA 2.0 Technology
Kernal Bio’s KR-402 program is powered by the company’s proprietary mRNA 2.0 platform, designed to deliver precise, cell-selective translation of therapeutic payloads. This innovative platform employs a two-pronged strategy that sets it apart from conventional CAR T manufacturing.
First, it utilizes custom-engineered mRNA sequences that are selectively translated only in targeted immune cells. These sequences are designed using AI and multi-omics data analysis, drawing on thousands of datapoints across various cell types to ensure unparalleled selectivity and minimal off-target activity.
Second, Kernal Bio’s technology leverages targeted lipid nanoparticles (LNPs) that are functionalized with antibodies. These LNPs act as “delivery drones,” homing in on specific T-cell populations in the body to deliver the mRNA cargo directly — bypassing the need for external cell manipulation or patient-specific manufacturing.
This approach allows T cells to be reprogrammed inside the body, creating active CAR T-cells capable of recognizing and destroying malignant or autoimmune cells — without the complex and time-consuming ex vivo manufacturing process. The result is a non-integrating, programmable therapeutic platform that promises enhanced safety, reduced costs, and greater scalability.
Redefining Affordability and Accessibility in Cell Therapy
One of the most pressing challenges in current CAR-T therapy lies in its high cost and manufacturing complexity. Traditional CAR-T therapies require extracting T cells from the patient, modifying them in specialized facilities, expanding them in culture, and reinfusing them weeks later — a process that can cost hundreds of thousands of dollars per treatment.
“In contrast, our in vivo CAR-T approach could reduce manufacturing costs by up to 100-fold, offering a scalable and cost-efficient solution,” said Burak Yilmaz, President of Kernal Bio. “Our mRNA platform not only simplifies production but also avoids the need for toxic conditioning regimens like lymphodepletion chemotherapy, which currently limits patient eligibility. By eliminating these barriers, we aim to democratize access to CAR-T therapies worldwide.”
Furthermore, traditional CAR-T therapies often pose risks of genomic integration — where viral vectors permanently alter the patient’s DNA — potentially leading to secondary malignancies. Kernal Bio’s mRNA-based system avoids this by relying on transient expression: it programs cells without integrating into their genomes, ensuring both efficacy and safety.
Collaborative Innovation Driving a New Therapeutic Frontier
Kernal Bio’s partnerships with world-renowned institutions will play a critical role in bringing this vision to life. Stanford University will lead translational studies focusing on immune response mechanisms. Dana-Farber Cancer Institute will evaluate the potential of KR-402 in hematologic malignancies, while The Jackson Laboratory will develop and validate preclinical models to study long-term efficacy and toxicity.
This consortium approach not only accelerates the technical development of in vivo CAR-T therapies but also strengthens the foundation for future clinical translation.
“With ARPA-H’s visionary support and our partners’ expertise, we’re positioned to push the boundaries of what’s possible in cell therapy,” said Dr. Erkul. “The next frontier in immunotherapy lies within — the ability to reprogram human cells directly inside the body. That’s the essence of Kernal Bio’s mission.”
A New Era for Immune Engineering
Kernal Bio’s breakthrough could have far-reaching implications beyond oncology. The same in vivo programming platform being developed for KR-402 could be applied to autoimmune disorders, infectious diseases, and aging-related immune dysfunction — unlocking new categories of precision medicines.
The company’s long-term vision is to establish a universal, programmable therapeutic toolkit capable of instructing any cell type to perform therapeutic functions in situ, paving the way for a new generation of biologically intelligent medicines.
As ARPA-H’s EMBODY program continues to fund bold, high-risk, high-reward initiatives, Kernal Bio’s project exemplifies the kind of transformative innovation the agency was created to enable — bridging biotechnology, data science, and engineering to reshape the landscape of modern medicine.
“Our partnership with ARPA-H underscores the potential of programmable mRNA therapeutics to redefine how we treat disease,” Dr. Erkul added. “We believe that in vivo CAR-T therapies will not just improve patient outcomes but also make life-saving treatments accessible and affordable to all.”
With the $48 million ARPA-H award, Kernal Bio is now poised to enter a critical phase of preclinical optimization and early clinical testing. As it advances toward the clinic, KR-402 stands as a promising step forward in making curative, scalable, and affordable cell therapies a reality for patients worldwide.
