Kyverna Therapeutics and ElevateBio Sign Commercial Manufacturing Agreement for Miv-Cel

Kyverna Therapeutics and ElevateBio, a technology-driven advanced therapy contract development and manufacturing organization, have entered into a commercial manufacturing and supply agreement for miv-cel (mivocabtagene autoleucel), Kyverna's autologous CD19-directed CAR T-cell therapy.¹ The agreement secures flexible, scalable manufacturing to support both the drug's potential US commercial launch and its ongoing global clinical supply.¹

Why does this agreement matter now?

The new supply arrangement supports Kyverna's planned launches in stiff person syndrome (SPS) and generalized myasthenia gravis (gMG), along with the company's other ongoing clinical studies.¹ Kyverna and ElevateBio have worked together for three years, building what the companies describe as a track record in process development, quality systems, and cell product manufacturing optimization.¹ That existing relationship has already supported Kyverna's rolling Biologics License Application (BLA) for miv-cel in SPS, which the company expects to complete in the fourth quarter of 2026.¹ If approved, miv-cel would become the first FDA-approved CAR T-cell therapy for an autoimmune disease and the first approved treatment specifically for SPS, a rare autoimmune neurological disorder with an estimated prevalence of only one to two cases per million people worldwide.²

How does miv-cel work?

Miv-cel is a fully human, autologous CD19-targeting CAR T-cell therapy that incorporates CD28 co-stimulation, a design intended to balance potency with tolerability.¹ The therapy is administered as a single infusion and is designed to achieve deep B-cell depletion, with the goal of resetting the immune system to produce durable, drug-free, disease-free remission in B-cell-driven autoimmune diseases.¹ Kyverna is investigating miv-cel across multiple such conditions beyond SPS and gMG, including multiple sclerosis and rheumatoid arthritis, through its ongoing KYSA clinical trial program.¹

What did company leadership say?

Mayo Pujols, chief technology officer of Kyverna, said, "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 SPS and future indications. With ElevateBio's proven expertise in manufacturing innovation and quality, demonstrated by a clinical manufacturing success rate of more than 98% for miv-cel, as well as their ability to scale production, we're pleased to continue to advance our partnership."¹ Chris Murphy, chief executive officer of ElevateBio, said, "This agreement affirms ElevateBio's commitment to the commercial supply of miv-cel and highlights the quality of our partnership with Kyverna. By combining our technology and manufacturing expertise with Kyverna's leadership in autoimmune cell therapies, we are well-positioned to deliver reliable supply that supports patients today and growing demand in the years ahead."¹

What happens next?

Kyverna remains on track to complete its rolling BLA submission for miv-cel in SPS during the fourth quarter of 2026.¹ ElevateBio's manufacturing capabilities have separately been validated through third-party certification: the company's BaseCamp facility in Waltham, Massachusetts, the same site supporting the Kyverna agreement, became the first genetic medicine manufacturing facility to receive Initiative for Certification of Manufacturing Capabilities certification across viral gene delivery, non-viral gene delivery, and cell therapy modalities, evaluated against nine systems benchmarked to FDA and EU regulatory standards.³

References

1. Kyverna Therapeutics and ElevateBio enter into commercial manufacturing and supply agreement for miv-cel. News release. Kyverna Therapeutics, Inc; July 27, 2026. Accessed August 4, 2026.
2. Boubga T, Naji Y, Adali N. Stiff-person syndrome: diagnostic and therapeutic insights into a rare autoimmune neurological disorder. Cureus. 2025;17(11):e96786. doi: 10.7759/cureus.96786.
3. ElevateBio BaseCamp achieves ICMC certification for commercial cell and gene therapy manufacturing capabilities. News release. ElevateBio; August 13, 2025. Accessed August 4, 2026.