Kyverna Therapeutics and CDMO ElevateBio have signed a manufacturing agreement for both U.S. commercial and global clinical supply of miv-cel, Kyverna’s autologous CD19-directed CAR-T cell therapy currently awaiting FDA approval.
If approved, miv-cel has the potential to become the first FDA-approved CAR T-cell therapy for an autoimmune disease and the first approved treatment for people living with stiff person syndrome (SPS).
“Kyverna’s highest priority is to bring the transformative potential of miv-cel to patients, and this agreement with ElevateBio further strengthens our commercialization readiness and long-term manufacturing supply as we prepare for launch in stiff person syndrome and future indications,” said Mayo Pujols, CTO of Kyverna.
Kyverna has initiated its rolling BLA submission in stiff person syndrome, seeking priority review under the program's RMAT designation, and anticipates completing the submission in Q4 2026.
The company is also testing the therapy in myasthenia gravis and progressive multiple sclerosis.
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