Liberate Bio’s CAR-M

CAR-M cell therapy shows promise in preclinical studies

Liberate Bio’s CAR-M cell therapy almost completely depleted B-cells in nonhuman primates, suggesting the approach may be used to treat B-cell diseases such as multiple sclerosis (MS) and some cancers.

B-cells almost completely deleted in primates, company says

The therapy is designed to genetically engineer monocytes and macrophages, two types of immune cells, to target and eliminate B-cells. That modification is done in vivo, or inside the patient’s body, eliminating the need to wait several weeks as seen with traditional cell therapies. It also doesn’t require patients to undergo chemotherapy to prepare for treatment.

The company said it plans additional studies that will support an investigational new drug application seeking clearance to begin clinical studies. The goal is to launch an investigator-initiated trial in the second half of 2026.

“CAR-M opens the door to treating millions of patients who have been beyond the reach of traditional cell therapy,” Shawn P. Davis, PhD, CEO of Liberate Bio, said in a company press release. “We envision a future where immune programming can be performed safely, repeatably, and at scale—extending the benefits of engineered cell therapies.”

The preclinical data were presented at the American Society of Gene and Cell Therapies’ Advancing Cell and Gene Therapies for Cancer conference, held Oct. 15-16 in Philadelphia.