HHS Awards $48M for Kernal's mRNA CAR T Program Despite Recent Vaccine Pullback

The Department of Health and Human Services (HHS) has granted a substantial $48 million award to Kernal Bio for its innovative mRNA-based CAR T-cell program, focusing on multiple sclerosis and B-cell malignancies. This funding, administered through the Advanced Research Projects Agency for Health (ARPA-H), comes just two months after the department's controversial decision to terminate approximately $500 million in funding for mRNA vaccine research.

Kernal's Groundbreaking mRNA 2.0 Platform

Kernal Bio's lead immunology asset, KR-402, utilizes the company's proprietary "mRNA 2.0" platform to deliver an in vivo and mRNA-encoded CAR T therapy. The biotech claims its approach achieves "exceptional precision" by employing a targeted lipid nanoparticle vehicle that ensures mRNA payloads are only translated within specific cells.

CEO Yusuf Erkul highlighted the potential of KR-402, stating, "Current CAR T therapies heralded a true revolution in cancer treatment." However, he noted that existing modalities face limitations such as the need for frequent dosing, tumor resistance, and severe toxicities. Erkul believes Kernal's technology has the capacity "to evolve the CAR T modality towards in vivo therapies," potentially addressing these challenges.

Collaborative Efforts and Expanded Applications

As part of the ARPA-H grant, Kernal Bio will collaborate with several prestigious institutions, including:

• Stanford University School of Medicine
• The Jackson Laboratory
• Dana-Farber Cancer Institute

These partnerships aim to develop additional mRNA-encoded CAR therapies and establish models and manufacturing strategies for testing these treatments. Beyond multiple sclerosis, Kernal is exploring applications of KR-402 in B cell cancers, such as chronic lymphocytic leukemia, large B cell lymphoma, and acute lymphoblastic leukemia.

HHS's Conflicting Stance on mRNA Technology

The substantial funding for Kernal's mRNA-based program comes in stark contrast to recent actions taken by HHS Secretary Robert F. Kennedy Jr. In August, Kennedy terminated approximately $500 million in funding for mRNA vaccine research under the Biomedical Advanced Research and Development Authority. At the time, he claimed that "the data show these vaccines fail to protect effectively against upper respiratory infections."

However, Kennedy later clarified that the mRNA pullout was specific to upper respiratory diseases, stating that mRNA vaccines "may be very effective" for cancer and that HHS would continue supporting mRNA projects in oncology. This apparent shift in stance has raised concerns among some in the scientific community.

Jonathan Kagan, Professor of Pediatrics at Harvard Medical School, criticized Kennedy's approach in a recent opinion piece. Kagan argued that the Secretary's "short-sighted moves" against mRNA vaccines "will derail some of the most promising medical advancements of our time."

As the pharmaceutical industry continues to navigate these conflicting signals from HHS, the substantial funding for Kernal Bio's mRNA CAR T program suggests a potential refocusing of federal support towards non-vaccine applications of mRNA technology.