The $48 million award, granted through the Advanced Research Projects Agency for Health, will help Kernal take its in vivo mRNA-encoded CAR T therapy forward.
Two months after axing 22 mRNA vaccine projects, the Department of Health and Human Services has put federal funding behind Kernal Bio’s mRNA-based CAR T-cell program for multiple sclerosis and B-cell malignancies.
The funding, awarded by the Advanced Research Projects Agency for Health (ARPA-H), will give the Boston biotech up to $48 million to support its lead immunology asset KR-402, an in vivo and mRNA-encoded CAR T therapy developed using Kernal’s “mRNA 2.0” platform, according to a Tuesday announcement. Kernal’s approach uses a targeted lipid nanoparticle vehicle to deliver mRNA payloads that can only be translated inside specific cells, achieving what the biotech claimed is “exceptional precision.”
Kernal believes that KR-402’s in vivo functionality— the ability to reprogram T cells while inside the body—will set it apart. This mecanism minimizes the risk of genomic integration and removes the need for lymphodepletion, resulting in a more tolerable regimen overall, Kernal claimed.
Aside from multiple sclerosis, Kernal is developing KR-402 for B cell cancers, such as chronic lymphocytic leukemia, large B cell lymphoma and acute lymphoblastic leukemia.
As part of the ARPA-H grant, Kernal will also work with other sub-awardees—including the Stanford University School of Medicine, The Jackson Laboratory and the Dana-Farber Cancer Institute—to develop other mRNA-encoded CAR therapies and come up with models and manufacturing strategies to test these treatments.
“Current CAR T therapies heralded a true revolution in cancer treatment,” Kernal CEO Yusuf Erkul said in a statement. However, he noted that the modality continues to suffer from several “limitations,” such as the need for frequent dosing, tumor resistance and severe toxicities, such as cytokine release syndrome or secondary malignancies. Kernal has the capacity “to evolve the CAR T modality towards in vivo therapies,” he said.
The Trump administration’s health leaders, particularly HHS Secretary Robert F. Kennedy Jr., have had a conflicting relationship with mRNA technology. In August, Kennedy terminated some $500 million in funding for mRNA vaccine research under the Biomedical Advanced Research and Development Authority, claiming at the time that “the data show these vaccines fail to protect effectively against upper respiratory infections.”
A few days later, however, Kennedy said that mRNA vaccines “may be very effective” for cancer, claiming that HHS will continue supporting mRNA projects in oncology. In an interview with Scripps News, Kennedy clarified that the mRNA pullout is only for upper respiratory diseases.
Nevertheless, Kennedy’s antagonism towards mRNA could have far-reaching implications, according to Jonathan Kagan, Professor of Pediatrics at Harvard Medical School. In an opinion piece that same month for BioSpace, Kagan argued that Kennedy’s “short-sighted moves” against mRNA vaccines “will derail some of the most promising medical advancements of our time.”
