Kyverna Therapeutics And ElevateBio Sign Manufacturing Deal To Support Miv-Cel Commercial Launch

Kyverna Therapeutics, Inc., a late-stage clinical biopharmaceutical company developing cell therapies for autoimmune diseases, has entered into a manufacturing agreement with ElevateBio, an advanced therapy contract development and manufacturing organisation (CDMO), to support the U.S. commercial and global clinical supply of miv-cel (mivocabtagene autoleucel). The agreement covers the production of Kyverna's autologous CD19-directed CAR T-cell therapy as the company prepares for potential commercial launches and continued clinical development.

The new partnership is designed to provide Kyverna with a flexible and scalable manufacturing network for miv-cel, supporting potential launches for stiff person syndrome (SPS) and generalized myasthenia gravis (gMG), while also meeting the needs of ongoing clinical studies. Over the past three years, the two companies have worked closely together on process development, quality systems and manufacturing optimisation, helping support Kyverna's Biologics License Application (BLA) for SPS and establishing a strong foundation for future commercial expansion.

Commenting on the agreement, Mayo Pujols, Chief Technology Officer of Kyverna Therapeutics, said the company's top priority is to make the potential benefits of miv-cel available to patients with autoimmune diseases. He noted that the expanded collaboration with ElevateBio strengthens Kyverna's commercial readiness and long-term manufacturing capabilities as it prepares for a potential launch in stiff person syndrome and other future indications. He also highlighted ElevateBio's manufacturing expertise, pointing to a clinical manufacturing success rate of more than 98% for miv-cel and its ability to scale production efficiently.

Kyverna also confirmed that it remains on schedule to complete the rolling submission of its Biologics License Application for miv-cel in stiff person syndrome during the fourth quarter of 2026. If approved by the U.S. Food and Drug Administration (FDA), miv-cel could become the first CAR T-cell therapy approved for the treatment of an autoimmune disease, as well as the first approved therapy specifically for patients living with stiff person syndrome.

Chris Murphy, Chief Executive Officer of ElevateBio, said the agreement reflects the company's commitment to supporting the commercial production of miv-cel and further strengthens its partnership with Kyverna. He added that by combining ElevateBio's manufacturing technology and expertise with Kyverna's leadership in autoimmune cell therapies, the companies are well positioned to ensure a reliable supply of the therapy while meeting future patient demand as clinical programmes continue to expand.

Miv-cel (mivocabtagene autoleucel, KYV-101) is an investigational, fully human, autologous CD19-targeting CAR T-cell therapy developed for B-cell-driven autoimmune diseases. Designed with CD28 co-stimulation to enhance both potency and tolerability, the therapy is intended to achieve deep B-cell depletion and reset the immune system through a single administration. Researchers believe this approach has the potential to provide long-lasting, drug-free and disease-free remission for patients with autoimmune conditions, although the therapy is still under clinical investigation and has not yet received regulatory approval.