The U.S. government has awarded Kernal Bio and three other sub-awardees up to $48 million to help advance the biotech’s in vivo mRNA-encoded CAR T-cell program.
In an interesting—if not somewhat confusing—twist, the Advanced Research Projects Agency for Health (ARPA-H) is supporting Kernal’s KR-402, a next-generation cell therapy designed using the biotech’s “mRNA 2.0” platform, according to an Oct. 7 release.
Recently, Trump administration officials have distanced themselves from mRNA vaccine work, with the Biomedical Advanced Research and Development Authority calling off $500 million in funding for such projects. Leaders in the administration cited different reasons for the pullback, including concerns over efficacy and “public distrust.”
While the previous cuts impacted mRNA vaccines—and some projects that didn’t even include work in mRNA or vaccines—the main differentiator at issue may be the vaccine delivery approach versus the mRNA science itself.
As of publication, the Department of Health and Human Services and ARPA-H had not responded to Fierce’s requests for comment.
With the newly announced project, ARPA-H is hoping the Boston biotech’s science can be used to create less expensive in vivo CAR T-cell therapies for hematological cancers and autoimmune diseases, according to the release. The funding is delivered via ARPA-H’s Engineering of Immune Cells Inside the Body (EMBODY) program, which is led by Daria Fedyukina, Ph.D.
The financing will help Kernal advance the early-stage program through clinical development in multiple sclerosis and B-cell malignancies.
The biotech’s science is built to improve therapeutic precision by using a two-pronged strategy: first, by utilizing selective mRNA that only translates in specific cells, and, second, by delivering RNA with a targeted lipid nanoparticle vehicle covered with antibodies so it can narrow in directly on target T cells.
The money will also be used to help expand Kernal’s mRNA 2.0 platform, according to the release.
Some government funding is also going to Kernal collaborators the Stanford University School of Medicine, the Dana-Farber Cancer Institute and the Jackson Laboratory, which are all working to engineer targeted, mRNA-encoded CARs and to create new manufacturing strategies for the potential therapies.
“Current CAR-T therapies heralded a true revolution in cancer treatment,” Kernal CEO and co-founder Yusuf Erkul, M.D., said in the release. “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,” Erkul concluded.
The Hummingbird- and Amgen-backed biotech was formed by industry vets across Harvard, Merck & Co., Bristol Myers Squibb and MIT.