Kyverna, ElevateBio Ink Manufacturing Agreement for Miv-Cel Supply

Editor’s Take: This is the latest step in a growing clinical-stage partnership between Kyverna and ElevateBio.

Kyverna Therapeutics and ElevateBio have a manufacturing agreement for United States commercial and global clinical supply of miv-cel (mivocabtagene autoleucel). Miv-cel is Kyverna’s autologous, CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy.

Miv-Cel’s Potential Indications

As a late-stage clinical biopharmaceutical company specializing in autoimmune diseases, Kyverna is potentially launching miv-cel in two specific indications. These are stiff person syndrome (SPS) and generalized myasthenia gravis (gMG), although other clinical studies are ongoing.

ElevateBio, meanwhile, is a technology-focused CDMO with which Kyverna has partnered for the last three years. In that time, the companies say they have built a strong clinical-stage relationship. This includes successes in process development, quality systems, and cell product manufacturing optimization.

In practice, these elements support a Biologics License Application (BLA) for miv-cel in SPS. Kyverna says it is on track to complete this rolling BLA submission in the fourth quarter of 2026.

Kyverna and ElevateBio Tout Partnership

“Kyverna’s highest priority is to bring the transformative potential of miv-cel to patients,” Mayo Pujols, Kyverna Chief Technology Officer, said. “This agreement strengthens our commercialization readiness and long-term manufacturing supply as we prepare for launch in SPS and future indications.”

Pujols said ElevateBio’s clinical manufacturing success rate clocks in at more than 98% for miv-cel.

“This agreement affirms ElevateBio’s commitment to the commercial supply of miv-cel,” ElevateBio CEO Chris Murphy said. “By combining technology and manufacturing expertise with Kyverna’s leadership in autoimmune cell therapies, we are well-positioned to deliver reliable supply.”

If approved, miv-cel stands to become the first FDA-approved CAR-T therapy for an autoimmune disease. Additionally, it would be the first approved treatment for people living with SPS.