
US clinical-stage US autoimmune drug developerKyverna Therapeutics (Nasdaq: KYTX) and ElevateBio, a contract development and manufacturing organization (CDMO), today announced a manufacturing agreement for both US commercial and global clinical supply of miv-cel (mivocabtagene autoleucel), Kyverna’s autologous CD19-directed CAR T-cell therapy.
The new agreement provides Kyverna – whose shares rose 3.2% to $7.65 in pre-market activity - 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.
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