Kyverna Therapeutics and ElevateBio Enter into Commercial Manufacturing and Supply Agreement for Miv-cel

About this update from Kyverna Therapeutics, Inc.

New agreement secures flexible and scalable manufacturing to support the U.S. commercial and global clinical supply of miv-cel EMERYVILLE, Calif., and WALTHAM, Mass., July 27, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company developing cell therapies for patients with autoimmune diseases, and ElevateBio, a technology-driven advanced therapy contract development and manufacturing organization (CDMO), today announced a manufacturing agreement for both U.S. commercial and global clinical supply of miv-cel (mivocabtagene autoleucel), Kyverna's autologous CD19-directed CAR T-cell therapy. The new agreement provides Kyverna with flexible and scalable supply of miv-cel, supporting the Company's potential launches in stiff person syndrome (SPS) and generalized myasthenia gravis (gMG), as well as other ongoing clinical studies. Over the past three years, Kyverna and ElevateBio have built a strong clinical-stage partnership, delivering a track record of success in process development, quality systems, and cell product manufacturing optimization, supporting the SPS Biologics License Application (BLA) and laying the foundation for future growth. "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, Chief Technology Officer of Kyverna. "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." Kyverna remains on track to complete the rolling BLA submission for miv-cel in SPS in the fourth quarter of 2026. 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 SPS. "This agreement affirms ElevateBio's commitment to the commercial supply of miv-cel and highlights the quality of our partnership with Kyverna," said Chris Murphy, Chief Executive Officer of ElevateBio. "By combining our technology and manufacturing expertise with Kyverna's lead...

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