- Kyverna Therapeutics has signed a manufacturing agreement with ElevateBio to provide U.S. commercial and global clinical supply of miv-cel, its autologous CD19-directed CAR T-cell therapy for autoimmune diseases.
- The agreement supports Kyverna’s planned commercial launches in stiff person syndrome (SPS) and generalized myasthenia gravis (gMG), while the company remains on track to complete its rolling Biologics License Application (BLA) submission for SPS in the fourth quarter of 2026.
Kyverna Therapeutics has entered into a manufacturing agreement with ElevateBio to support U.S. commercial and global clinical supply of miv-cel (mivocabtagene autoleucel), the company’s autologous CD19-directed CAR T-cell therapy for autoimmune diseases. The agreement expands the companies’ collaboration and provides manufacturing capacity to support potential commercial launches and ongoing clinical development through ElevateBio’s CDMO and contract manufacturing capabilities.
The agreement is intended to provide flexible and scalable manufacturing for miv-cel, supporting Kyverna’s planned launches in stiff person syndrome (SPS) and generalized myasthenia gravis (gMG), as well as other clinical studies. According to the companies, the partnership over the past three years has included process development, quality systems, and cell therapy manufacturing optimization, supporting Kyverna’s SPS Biologics License Application (BLA).
“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. ElevateBio has achieved a clinical manufacturing success rate of more than 98% for miv-cel while demonstrating the ability to scale production.”
Mayo Pujols, Chief Technology Officer of Kyverna
Kyverna said it remains on track to complete the rolling BLA submission for miv-cel in SPS during the fourth quarter of 2026. If approved, the therapy 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 SPS.
ElevateBio said the agreement reinforces its role in supporting the commercial supply of miv-cel through its advanced therapy CDMO operations. The company stated that its manufacturing technology and expertise will support reliable product supply as Kyverna advances commercialization and future clinical programs.
